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sharelooker
Posted on: Dec 14 2018, 11:12 PM


Group: Member
Posts: 327

The advisory committee meeting was already mentioned in the March newsletter and it's quite common for a NME like SC. So i don't think it's gonna have much impact on the length of the review process.
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sharelooker
Posted on: Dec 13 2018, 06:08 AM


Group: Member
Posts: 327

https://www.fda.gov/downloads/AboutFDA/Cent...R/UCM628150.pdf
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sharelooker
Posted on: Dec 13 2018, 05:24 AM


Group: Member
Posts: 327

I'm pretty certain that the recent NDA delay is due to the new implementations of the FDA regarding RWE and GMP.

https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm628244.htm
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sharelooker
Posted on: Dec 12 2018, 07:57 AM


Group: Member
Posts: 327

Newsletter is out:

https://www.asx.com.au/asxpdf/20181212/pdf/...4szm77yczfm.pdf

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sharelooker
Posted on: Dec 9 2018, 08:04 PM


Group: Member
Posts: 327

Belgium

https://www.afmps.be/sites/default/files/co...nt/bt_afmps.pdf
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sharelooker
Posted on: Dec 9 2018, 05:48 AM


Group: Member
Posts: 327

I dont't know if this has been posted before:

QUOTE
Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or BLA, helping companies to correct such issues rather than wait for FDA to issue a complete response letter.

Incomplete applications, including applications for which minor components have not been received within 30 calendar days after receipt of the original application, as may have been agreed upon at a pre-submission meeting, may also be refused for filing, the agency explains.


https://www.raps.org/regulatory-focus%E2%84...idance-explains

Maybe the GMP inspection was under way during the 2-month NDA validation period and they knew that the need to hand in the results of the manufacturing process later. This would be consistent with Stan's statement that they've expected the FDA's requests.
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sharelooker
Posted on: Dec 9 2018, 05:05 AM


Group: Member
Posts: 327

https://trademarks.justia.com/search?q=clinuvel
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sharelooker
Posted on: Dec 7 2018, 04:33 AM


Group: Member
Posts: 327

Mandarine Gestion SA

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Dec 7 2018, 04:21 AM


Group: Member
Posts: 327

More about the new program:

https://www.fda.gov/downloads/ScienceResear...e/UCM627769.pdf
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sharelooker
Posted on: Dec 7 2018, 04:02 AM


Group: Member
Posts: 327

The official statement:

https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm627760.htm
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sharelooker
Posted on: Dec 7 2018, 03:10 AM


Group: Member
Posts: 327

QUOTE
The US Food and Drug Administration (FDA) on Thursday unveiled a new framework discussing how the agency will use real world evidence (RWE) and real-world data (RWD) to help companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements.

As far as what the framework will guide FDA on specifically, the agency said its RWE program will evaluate the potential use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, such as a change in dose, dose regimen or route of administration; new populations; or the addition of comparative effectiveness or safety information.


https://www.raps.org/news-and-articles/news...s-to-support-ef
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sharelooker
Posted on: Dec 1 2018, 05:26 AM


Group: Member
Posts: 327

FCS Asset Management Ltd. (Spain)

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Nov 28 2018, 06:45 AM


Group: Member
Posts: 327

Just updated!

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009

Committee meeting 3: 14 March 2019
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sharelooker
Posted on: Nov 28 2018, 05:54 AM


Group: Member
Posts: 327

QUOTE
Afamelanotide has a promising future as a treatment for a variety of skin diseases including EPP, solar urticaria, PMLE, acne vulgaris, vitiligo and Hailey-Hailey disease. In consideration of the limited data available on afamelanotide use in children, elderly patients, pregnant or lactating women, and those with hepatic or renal impairment, more studies are needed to evaluate safety and efficacy in these populations.5 The anti-inflammatory, pigmenting and free radical scavenging effects produced by the stimulation of melanin production, coupled with a mild side effect profile, make afamelanotide an attractive and versatile compound that shows therapeutic potential in a variety of dermatologic conditions.


http://www.skintherapyletter.com/dermatology/afamelanotide/
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sharelooker
Posted on: Nov 25 2018, 08:37 PM


Group: Member
Posts: 327

Interesting publications regarding the reimbursement processes in europe:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5491965/

https://reader.elsevier.com/reader/sd/pii/S...55DED00FA79E29A

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sharelooker
Posted on: Nov 25 2018, 01:26 AM


Group: Member
Posts: 327

QUOTE
- Erythropoietic protoporphyria: The Scenesse, a symptomatic treatment for Erythropoietic Protoporphyria, is still not available or reimbursed in France, but the Clinuvel company that markets it has finally started the reimbursement request to the health authorities. Our center gives all its support to advance in their efforts.


https://www.porphyrie.net/action-et-soutien/
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sharelooker
Posted on: Nov 24 2018, 07:46 AM


Group: Member
Posts: 327

QUOTE
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs


https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm625601.htm

Maybe this could be the cause for the recent delay?!
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sharelooker
Posted on: Nov 24 2018, 03:09 AM


Group: Member
Posts: 327

23 November 2018

QUOTE
To date, what are the therapeutic options?

"An innovative drug is currently available, called afamelanotide [which is the subject of a recent parliamentary question , Ed], which is implanted under the skin at the iliac crest, after local anesthesia. It is a powerful antioxidant, which does not cure the underlying disease but significantly mitigates phototoxic reactions. The circulating levels of protoporphyrin remain therefore high, but the patient increases his tolerance to sun exposure, thus managing to perform outdoor activities that were previously impossible. Studies are currently being carried out on the safety and efficacy of pediatric afamelanotideIn fact, to date, the drug is authorized only in adults. Alternatively, it is possible to prescribe UV-ray filtering creams , however of low efficacy, and antioxidant supplements . Other isolated experiences on the use of zinc sulphate, cimetidine in pediatric age and UVB phototherapy are published in the literature ".


https://www.osservatoriomalattierare.it/por...l-sole-fa-paura
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sharelooker
Posted on: Nov 15 2018, 04:57 PM


Group: Member
Posts: 327

https://www.osservatoriomalattierare.it/por...o-la-burocrazia
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sharelooker
Posted on: Nov 13 2018, 07:54 PM


Group: Member
Posts: 327

Is there a possibility to watch this interview online?
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sharelooker
Posted on: Nov 8 2018, 02:09 AM


Group: Member
Posts: 327

Interesting! A medical doctor in Canada.

QUOTE
Certifications
Certification for the administration of Scenesse (afamelanotide)- Clinuvel


https://my.clevelandclinic.org/canada/staff/champagne-trevor
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sharelooker
Posted on: Nov 5 2018, 09:19 PM


Group: Member
Posts: 327

Mr. Max Otte's fund is now holding 36k shares.

QUOTE
Privatinvestor Verwaltungs AG


https://www.barrons.com/quote/stock/au/xasx/cuv?mod=DNH_S
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sharelooker
Posted on: Nov 1 2018, 07:07 PM


Group: Member
Posts: 327

6.) November 10, Häm O'Globin and Family: Therapy of a rare light disease in Zürich
https://www.kispi-150.ch/forschungstage-im-...ahnhof-zuerich/
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sharelooker
Posted on: Oct 31 2018, 09:17 PM


Group: Member
Posts: 327

31 October 2018

QUOTE
Rome - The procedures for obtaining the drug afamelanotide, essential for patients affected by erythropoietic protoporphyria , are too complex: now a question presented to the Senate asks the Minister of Health Giulia Grillo which initiatives she intends to take to streamline them. The text, presented last October 24 by the senators Paola Binetti (president of the Rare Disease Parliamentary Intergroup) and Maria Rizzotti , suggests a possible intervention at the European Medicines Agency (EMA) in order to facilitate access to therapy throughout Europe .


QUOTE
The difficulties for access to therapy come from the reserves of the EMA , which in 2014 published the report EMA / CHMP / 601433/2014 , raising a series of concerns, especially on the time of effectiveness of the drug , reducing it to a handful of minutes .


QUOTE
Senators Binetti and Rizzotti , in the written answer to question no. 4-00736, then asked the Minister what initiatives he intends to take to streamline procedures and facilitate access to the drug for patients who need it: "rare patients", but who are in extreme need of the medicine. It also asks if the Minister does not consider intervening at the EMA to request a review of his report, so as to facilitate access to the drug throughout Europe, also on the basis of data collected in Italy, which confirm its effectiveness and security.


https://www.osservatoriomalattierare.it/por...l-afamelanotide
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sharelooker
Posted on: Oct 30 2018, 03:33 AM


Group: Member
Posts: 327

5.) November 24, First Meeting Doctors Porfiria Patients in Rome
https://www.osservatoriomalattierare.it/app...zienti-porfiria



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sharelooker
Posted on: Oct 29 2018, 08:32 PM


Group: Member
Posts: 327

https://www.finnewsnetwork.com.au/archives/...work201065.html
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sharelooker
Posted on: Oct 28 2018, 07:18 PM


Group: Member
Posts: 327

A lot of conferences and meetings in November:

1.) November 6, World Orphan Drug Congress 2018 in Barcelona
https://www.terrapinn.com/conference/world-...genda-day-1.stm

2.) November 13, Bio Connections Australia Conference in Melbourne
https://www.informa.com.au/event/conference...ions-australia/

3.) November 17, German EPP Patient Meeting in Hamburg
http://www.epp-deutschland.de/

4.) November 21, CUV AGM Meeting in Melbourne
https://www.clinuvel.com/investors/news/ite...nfirms-agm-date

I've never seen such a packed schedule.

+ possible regulatory outcomes from NICE and FDA
+ possible announcements of the new indication and skincare products. Hopefully, they'll be ready soon. So they can catch the Christmas trade.
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sharelooker
Posted on: Oct 24 2018, 01:23 AM


Group: Member
Posts: 327

Johnson & Johnson Announces Offer to Acquire Ci:z Holdings Co., Ltd.
Acquisition is Expected to Expand J&J's Consumer Portfolio of Science-based Dermocosmetic Beauty Products

http://www.investor.jnj.com/releasedetail....leaseID=1079631

QUOTE
"Health and beauty consumers are actively seeking science-based innovation to improve their skin," said Jorge Mesquita, Worldwide Chairman, Johnson & Johnson Consumer. "This transaction will maximise value creation for Johnson & Johnson's Consumer business by bringing in an agile innovation model and rapidly accelerating sales through our global commercialization expertise."
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sharelooker
Posted on: Oct 21 2018, 10:32 PM


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Posts: 327

only in german:

http://www.epp-deutschland.de/mediapool/21...ata/FR7_EPP.PDF
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sharelooker
Posted on: Oct 20 2018, 08:00 AM


Group: Member
Posts: 327

Farma, I agree with you! Moreover, if they prove that SC can enhance the repair mechanism of UV-damaged DNA in XP, CUV will have the ultimate proof that SC can be used to prevent skin cancer in (healthy) fair-skinned people.
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sharelooker
Posted on: Oct 20 2018, 02:21 AM


Group: Member
Posts: 327

PAD, why don't you think it's XP? They often stated that the new indication would involve "DNA-repair" which perfectly fits for XP. And they said:
QUOTE
...starting to evaluate SCENESSE® in patients with a genetic affliction.
. HHD wouldn't be a start since there has already been studies with SC.
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sharelooker
Posted on: Oct 19 2018, 07:29 PM


Group: Member
Posts: 327

Wow, this is brilliant! Have they ever talked about an investor relations team before?! Let's see, if they reply to emails now!
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sharelooker
Posted on: Oct 19 2018, 06:02 PM


Group: Member
Posts: 327

OTC products seem to be ready!

QUOTE
We all share the excitement about the potential clinical – and therefore commercial – value we could create from these follow-on prescriptive and complementary OTC products coming out of Singapore. We carefully position these chronologically so as to make sure that each pharmaceutical product addresses an unmet clinical need or a genuine demand for non-prescriptive products. Although regulatory requirements are less stringent for over the counter (OTC) products, we are working towards market launch once our teams have fulfilled all legal, regulatory and commercial requirements. These OTC product lines will need to provide more prominence to the CLINUVEL brand, and position us further as specialists in photomedicine while we enter defined channels to distribute our non-prescriptive products.
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sharelooker
Posted on: Oct 19 2018, 05:23 PM


Group: Member
Posts: 327

I dont't think the indication will be HHD!

They stated:
QUOTE
..starting to evaluate SCENESSE® in patients with a genetic affliction.

SC has already been studied in a phase 2 HHD trial. Five years of preparation work indicates that the new inidication must be very complex.
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sharelooker
Posted on: Oct 19 2018, 03:47 PM


Group: Member
Posts: 327

What could be the 3rd indication? I would bet on XP and you?
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sharelooker
Posted on: Oct 19 2018, 02:59 AM


Group: Member
Posts: 327

http://www.brickcourt.co.uk/news/detail/ni...ccessful-appeal
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sharelooker
Posted on: Oct 18 2018, 10:57 PM


Group: Member
Posts: 327

https://www.ncbi.nlm.nih.gov/pubmed/16396514

QUOTE
Should these trends be validated in humans, alpha-MSH-based therapeutics specifically active in the CNS or peripheral circulation may be promising for the treatment of type 2 diabetes.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034615/

QUOTE
These data describe a novel endocrine circuit that modulates glucose homeostasis by pituitary α-MSH, which increases muscle glucose uptake and thermogenesis through the activation of a MC5R-PKA-pathway, which is disrupted in obesity.


https://pdfs.semanticscholar.org/f3f2/5a771...e70cf80b791.pdf

QUOTE
We conclude that MSH improves global heart functions in ZDF rats, but these effects are not related to the vascular status
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sharelooker
Posted on: Oct 18 2018, 10:06 PM


Group: Member
Posts: 327

Ok, let's sum it up! PW is now preparing the company for the long run and long term stability. With WB, he has an expert for distribution and logistics, with Mr. Luger from Münster he has an expert for MS and other inflammatory diseases and with Ms. Agersborg he has an expert in the field of diabetes (there is plenty of research that alpha-MSH could be effective in type 2 diabetes).

All this reminds me of the movie Independance Day when the mothership from space coordinated its smaller ships around the globe. And then, when the final countdown was over:.....BAAANG! This is probably the end game!
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sharelooker
Posted on: Oct 18 2018, 05:46 PM


Group: Member
Posts: 327

QUOTE
Hence, this compound
(Scenesse®) might represent a perfect possibility for drug repurposing.
Scenesse®, based on our in vitro data and the observations
made in mice models (Mykicki et al., 2016), could be an interesting and
promising target for further clinical development in MS therapy. Thus,
the characterization of the external factor UVB light as potent immunomodulator
in MS (Breuer et al., 2014) and the identification of a
possible mechanism by which external signals might be transmitted
into susceptible organisms (Mykicki et al., 2016) followed by the
identification of approved drugs that could be repurposed (Scenesse®)
might represent an innovative concept of using environment mimetics
for the development of novel MS therapeutics.


Breuer, J., Loser, K., Mykicki, N., Wiendl, H., & Schwab, N. (2018). Does the environment influence multiple sclerosis pathogenesis via UVB light and/or induction of vitamin D?. Journal of Neuroimmunology.

https://www.sciencedirect.com/science/artic...165572817304782
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sharelooker
Posted on: Oct 17 2018, 10:14 PM


Group: Member
Posts: 327

I think we'll hear something about the the FDA process next week which is exactly two month after the initial feedback on 22th August.
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sharelooker
Posted on: Oct 17 2018, 05:38 AM


Group: Member
Posts: 327

Very impressive lecture from Mr. Luger from the University of Münster about the anti-inflammatory and neuroprotective effects of afamelanotide. They've found many surprising effects that haven't been published yet. I really hope, that CUV is going after these indications! Unfortunately, it's only in german language.

http://www.medroom.at/p.php?action=vortrag...2061&PREV=0
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sharelooker
Posted on: Oct 16 2018, 10:32 PM


Group: Member
Posts: 327

Max Otte, a well-known german fund manager, has accumulated CUV shares for his "Multiple Opportunities Fund". He is a fan of the Buffett-strategy ("buy and hold").

https://www.privatinvestor.li/wp-content/up...10/momo18Q3.pdf (only in german language)

QUOTE
Positioning, acquisitions and sales
In the last quarter, we have, among other things
with the Australian Clinuvel Pharmaceuticals,
the American shoe manufacturer Skechers and
United Internet (WEB-Mail, 1&1) strengthened. Clinuvel
is the only pharmaceutical company that can offer a
drug against the rare, genetically caused
light intolerance disorder EPP has. The sufferers
have to be constantly shielded in the dark
in Europe will gradually become treatment centres. In Europe, treatment centres are gradually becoming
In the USA, the In the USA, the
Admission applied for a few weeks ago. The patients
have reported great progress in
a rate of re-treatment of well over 90%.
Since our purchase, the price has been calculated in EUR.
96.6% up at the end of the quarter.

Translated with www.DeepL.com/Translator


https://en.wikipedia.org/wiki/Max_Otte
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sharelooker
Posted on: Oct 13 2018, 08:03 PM


Group: Member
Posts: 327

Thanks for posting!
I really like this interview! I've a gut feeling that PW is very optimistic about a positive outcome of the process. Was there ever been a similar case where a pharma company sued the NICE?
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sharelooker
Posted on: Oct 13 2018, 06:34 PM


Group: Member
Posts: 327

Does anybody have access to the article? Is it useful?
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sharelooker
Posted on: Oct 13 2018, 08:17 AM


Group: Member
Posts: 327

UK Appeal Panel Tells NICE To Revisit Scenesse Rejection

https://pink.pharmaintelligence.informa.com...nesse-Rejection
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sharelooker
Posted on: Oct 12 2018, 03:48 AM


Group: Member
Posts: 327

Interesting discussion here!

My thoughts: There is a lot of restructuring work going on at the FDA at the moment. Trump/Gottlieb want to modernize the FDA regarding drug reviews/approvals. So it can be that the SC review falls into a new process route where we still don't know the details. Remember that CUV is very open for new routes (patient input at the EMA, Real World Data for FDA etc.).

https://endpts.com/reorganization-of-ond-to...-woodcock-says/
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sharelooker
Posted on: Oct 6 2018, 03:36 AM


Group: Member
Posts: 327

QUOTE
The CLINUVEL team are looking forward to presenting at the annual #BPA conference held at #Reading tomorrow.

Find out more by following the link below!

http://www.porphyria.org.uk/?event=2018-au...-conference-agm

In the past, they've never posted such events on their fb page. Maybe, they'll announce something important about the NICE process?!
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sharelooker
Posted on: Sep 23 2018, 06:05 AM


Group: Member
Posts: 327

The two sites https://www.clinuvel.com/Categories/pharmac...rch-development and https://www.clinuvel.com/Categories/pharmaceuticals/pipeline are currently not accessible (error 404).

I think they are updating the pipeline bar chart with the new indication! Very exciting!
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sharelooker
Posted on: Sep 16 2018, 03:12 AM


Group: Member
Posts: 327

CUV is already in their portfolio with 0.00018% of net assets! Check out 'Holding details'!

https://www.vanguardinvestments.com.au/reta...8205/?portfolio
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sharelooker
Posted on: Sep 2 2018, 10:21 PM


Group: Member
Posts: 327

A nicely updated profile of CUV on barrons smile.gif

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Sep 2 2018, 06:33 PM


Group: Member
Posts: 327

QUOTE
NewsMakers is the best opportunity — in a single day — for the investment and pharma business development communities to evaluate investment and licensing opportunities.


QUOTE
NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each Fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.


QUOTE
The 25th Annual
NEWSMAKERS IN THE BIOTECH INDUSTRY
Friday, September 7, 2018 • Millennium Broadway Hotel • 145 West 44th Street • New York City
Presented by BIOCENTURY

Clinuvel Pharmaceuticals Ltd.
(ASX:CUV; Pink:CLVLY)
Breakout Room - 301 (9:30 - 10:00)


https://www.biocentury.com/conferences

https://www.biocentury.com/conferences/newsmakers-2018

https://www.biocentury.com/sites/default/fi...M18schedule.pdf
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sharelooker
Posted on: Sep 2 2018, 03:46 AM


Group: Member
Posts: 327

Interesting! B&S acquired a majority stake in an online discount US retailer. Maybe relevant for the roll-out of the skincare products in the future?

QUOTE
FragranceNet.com’s proprietary technology enables B&S Group to strengthen the Group’s
sourcing network, buying power and assortment in its Health & Beauty category. The acquisition
allows B&S Group to generate a substantial footprint in North America for its Health & Beauty
category
and to roll out FragranceNet.com’s business model to other geographical areas.


https://www.bs-group-sa.com/wp-content/uplo...ragranceNet.pdf
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sharelooker
Posted on: Aug 31 2018, 05:16 AM


Group: Member
Posts: 327

Now, all trademarks are registered!

https://www.trademarkia.com/ctm/ctm-company...810201-page-1-2
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sharelooker
Posted on: Aug 31 2018, 05:07 AM


Group: Member
Posts: 327

https://www.clinuvel.com/pharmaceuticals/pipeline
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sharelooker
Posted on: Aug 25 2018, 10:10 PM


Group: Member
Posts: 327

I agree with mrdax. Please do not read on the german board. It's full of crap, nonsense, stupidity and misleading information.
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sharelooker
Posted on: Aug 12 2018, 12:33 AM


Group: Member
Posts: 327

Did they change the design of the barchart of their pipeline products?

https://www.clinuvel.com/pharmaceuticals/pi...rch-development
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sharelooker
Posted on: Aug 11 2018, 08:28 PM


Group: Member
Posts: 327

From the patent:

QUOTE
Despite the high level of DNA damage occurring in XP patients, we realized that XP patients have remaining -low or very low- DNA repair capability. We further realized that such residual activity however means that the complexes and pathways in XP patients are at least partially intact. Based on these insights and despite the XP protein in XP patients having a different structure with associated dysfunctionality, we realized not only that these different XP proteins are still being recruited for complexes used in the DNA repair pathways, but also -importantly- that administration of MCIR agonists according to the invention to XP patients further enhances such recruitment of factors -including the different XP protein- for these complexes. Further, we realized that alpha-MSH analogues of the invention, as MCIR agonists, often better associate with various allele variants of the MCIR receptor associated with DNA repair in comparison with natural alpha-MSH levels, rendering the subsequent factor recruitment and DNA repair in XP patients more effective. We also realized that exposure of XP patient to alpha-MSH analogue compounds over longer periods enhances factor recruitment and subsequent DNA repair even further. We conclude that use of alpha-MSH analogue compounds of the invention in XP patients leads to an improved DNA repair capability reducing the cancer risk for XP patients particularly when compared to alpha-MSH at natural levels.


https://patentscope.wipo.int/search/de/deta...Id=WO2018142318

And it's not only the DNA-repair mechanism, that can reduce the incident of melanoma in XP patients but also the melanin enhancing effect of alpha-MSH. In my opinion, both mechanisms can result in a synergistic effect.
  Forum: By Share Code

sharelooker
Posted on: Aug 11 2018, 02:20 AM


Group: Member
Posts: 327

Now, it's official. They aim at XP! It's a brand new patent!

https://patentscope.wipo.int/search/en/search.jsf

https://worldwide.espacenet.com/publication...KC=A1&ND=5#

https://register.epo.org/ipfwretrieve?apn=I...29.W&lng=en

QUOTE
WO/2018/142318 ALPHA-MSH ANALOGUES USED IN THE TREATMENT OF XERODERMA PIGMENTOSUM

The present invention relates to alpha-MSH analogue compounds for treatment of Xeroderma Pigmentosum (XP), specifically for repairing DNA in a subject suffering from XP.

Attached thumbnail(s)
Attached Image


 
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sharelooker
Posted on: Jul 28 2018, 08:03 PM


Group: Member
Posts: 327

I think, we won't see an APPENDIX 4C ever again! I've tracked this for the australian company "Nanosonics" (ASX: NAN). After the fourth consecutive CF positive statement on 16/01/2017, they've never issued it again.
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sharelooker
Posted on: Jul 5 2018, 01:30 AM


Group: Member
Posts: 327

http://www.clinuvel.com/social-media/subq/asx-listed

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sharelooker
Posted on: Jul 3 2018, 08:03 AM


Group: Member
Posts: 327

https://www.fidelity.com.hk/static/pdf/inve...ance_report.pdf

Page: 103. CUV on a TOP 10 list together with tencent, alibaba and softbank smile.gif
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sharelooker
Posted on: Jun 28 2018, 03:58 AM


Group: Member
Posts: 327

https://pink.pharmaintelligence.informa.com...nce-From-Europe

You can register for a free trial and read the article
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sharelooker
Posted on: Jun 28 2018, 01:01 AM


Group: Member
Posts: 327

9 - 11 mln!
  Forum: By Share Code

sharelooker
Posted on: Jun 26 2018, 11:11 PM


Group: Member
Posts: 327

From APF on facebook:

QUOTE
URGENT We are friends and care about each other. Our EPP friends desperately need SCENESSE, an EPP treatment that is revolutionary. It is at the FDA now for their review for approval. PLEASE , please take a few minutes of your life and write a letter. Remember , our EPP friends can only have a few minutes in the light before they are in searing pain. Scenesse prevents this. We need the FDA to give the drug PRIORITY REVIEW . Finally, we have a chance for approval. Even if you don't have EPP, you can help by writing a letter to ask for PRIORITY REVIEW OF SCENESSE AND APPROVAL . We want to have a huge stack of letters when we arrive at the FDA to deliver them by hand. Everyone write...Get your friends to write.

Ask them to grant the Priority Review and approve Scenesse as soon as possible. Our dear EPP friends are suffering. Lets all help get them a treatment that works. We are all friends here and all care about each other. Please address as shown below and send to the APF for hand delivery to the FDA in one huge stack.
Begin your letter:
Scott Gottlieb, M.D.
FDA Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear FDA Commissioner:

Mail your letter to:
American Porphyria Foundation
4915 St. Elmo Avenue, Suite 105
Bethesda, Maryland 20814
:

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sharelooker
Posted on: Jun 25 2018, 03:20 AM


Group: Member
Posts: 327

QUOTE
22/06/2018

Reinforced EU/US collaboration on medicines
Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018


Senior officials from the European CommissionExternal link icon (EC), the European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal link icon (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals.

The collaboration between EMA and FDA formally started in 2003 and has gone from strength to strength. The two agencies have daily interactions, most of them structured around working groups or ‘clusters’, with the aim to advance scientific and regulatory excellence worldwide.

Topics discussed at the 18-19 June meeting included:

The EU-US mutual recognition agreement (MRA) on pharmaceutical inspections on good manufacturing practices ('GMP') which came into operation in November 2017. The agreement allows the recognition of each other’s inspection outcomes of manufacturing sites for human medicines and hence better use of inspection expertise and resources. EC/EMA and the FDA discussed the progress made and experience gathered in the implementation of this agreement, which presently covers 14 EU Member States. Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track. The two parties committed to continue to work closely together at a technical level to further streamline the process, measure progress made, and monitor closely the implementation of the MRA. The partners also confirmed their intention to consider including veterinary medicines in the scope of the MRA no later than July 2019 and vaccines and plasma derived pharmaceuticals no later than July 2022.

Advanced therapies (ATMPs): ATMPs, comprising gene therapies, tissue engineered products and somatic cell therapies, have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate. Regulators on both sides of the Atlantic are actively supporting the development of these novel medicines and are facing similar regulatory challenges. The parties therefore agreed to encourage early parallel scientific advice and to further strengthen the existing ‘cluster’ on ATMPs with a view to develop common scientific approaches on the regulation of these medicines, that could best facilitate their preclinical and clinical development, and the way data collection on these medicines can be optimised after authorisation.

Generic medicines: The opportunity was taken to better understand the fundamentals of legal, regulatory and scientific requirements for approving generic and hybrid applications on both sides and to identify possible ways of streamlining the scientific requirements for such approvals with a particular focus on complex generics (FDA) and hybrids (EU). Options for next steps included the continued access for companies to EMA-FDA parallel scientific advice and further collaboration between regulators on the product-specific guidelines they develop.

Real-World Evidence (RWE): RWE has been used for the post-authorisation monitoring of medicines for many years, and EC/EMA and FDA agreed that RWE holds major promise to strengthen decision-making on medicines throughout their lifespan. There are benefits from transatlantic collaboration to leverage expertise, experience and available data. Collaboration will help to address methodological and practical challenges and in analysing RWE. The parties collaborate on RWE, whereby EMA and FDA will regularly exchange information and work together on methodologies to optimise the use of RWE to support regulatory decision making throughout the product lifecycle.
The EC/EMA and FDA will continue their strong cooperation in numerous activities under their responsibilities, including innovation. The activities planned in the next couple of years will need to take into account EMA’s business continuity needs during and after its relocation to Amsterdam.


http://www.ema.europa.eu/ema/index.jsp?cur...b01ac058004d5c1
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sharelooker
Posted on: Jun 24 2018, 06:27 PM


Group: Member
Posts: 327

The case of Alkermes was odd. Although they got a RTF letter on 02/04/18, two weeks later the NDA was accepted.

http://phx.corporate-ir.net/phoenix.zhtml?...&ID=2342624
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sharelooker
Posted on: Jun 22 2018, 04:56 AM


Group: Member
Posts: 327

https://clinicaltrials.gov/ct2/show/NCT0352...yria&rank=4
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sharelooker
Posted on: Jun 21 2018, 11:42 PM


Group: Member
Posts: 327

Great find, FZ! So on the list, there are 95 appeals and only six rejections?Does it mean, that there is a good chance of a successful appeal for CUV?

Here's an example of a so called "Managed access agreement" which i think was proposed by British Association of Dermatologists.

https://www.nice.org.uk/guidance/ta397/reso...-pdf-2665741069
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sharelooker
Posted on: Jun 21 2018, 09:25 PM


Group: Member
Posts: 327

QUOTE
Afamelanotide for treating erythropoietic protoporphyria [ID927]: Notice of Appeal

NICE has received four appeals against the Final Evaluation Determination on the above HST evaluation from the following organisations:

Clinuvel UK Ltd
International Porphyria Patient Network
British Porphyria Association
British Association of Dermatologists
The appeal panel will convene on Monday 30 July 2018 at NICE, 10 Spring Gardens, London, SW1A 2BU to hear oral representations from the appellants.

Members of the public, including consultees and commentators for this appraisal, and the press, may request to attend the hearing. The number of places for observers is constrained by the venue, and priority will be given to members of the public who are not employed by the appellant. There are twenty five places available for this appeal hearing.

Where possible, requests to attend should be made using the form that will be available on the Institute’s website https://www.nice.org.uk/event/porphyria-afamelanotide-appeal This form will be available from 20 June 2018 only. The website registration will allow requests to attend to be granted on a first-come, first-served basis. The registration period for this appeal will end at 5pm on 4 July 2018. Further details relating to public attendance at this appeal are available on the same webpage as above.

A limited number of places at the appeal hearing will be reserved for members of the public who do not have access to the internet. These places should be applied for in writing, addressed to the Appeals Coordinator at NICE, to arrive before 5pm on 4 July 2018. Written requests to attend will also be granted on a first-come, first-served basis.


https://www.nice.org.uk/guidance/gid-hst100.../html-content-3
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sharelooker
Posted on: Jun 14 2018, 04:26 AM


Group: Member
Posts: 327

CUVs instagram channel is exploding. Almost 30 new subscribers overnight!
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sharelooker
Posted on: Jun 14 2018, 04:11 AM


Group: Member
Posts: 327

A major event could be imminent! I noticed a similar trading pattern in December 2013 followed by the takeover bid from Shkreli and in September 2014 follwed by EMA approval.
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sharelooker
Posted on: Jun 11 2018, 03:25 AM


Group: Member
Posts: 327

Priority review of SC is very likely. In 2017, all drugs with fast track designation got priority review. So my guess: PDUFA date on March 1, 2019.

Slide no. 16.

https://www.fda.gov/downloads/AboutFDA/Cent...s/UCM591976.pdf

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sharelooker
Posted on: Jun 5 2018, 02:23 AM


Group: Member
Posts: 327

FDA Proposes Process Modernization to Support New Drug Development

QUOTE
Emphasizing the importance of safety across a drug’s lifecycle –
Safety remains a key component of our new plans. We will work to establish a unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their lifecycles, both before and after approval.
Incorporating the patient voice –
Patients are the FDA’s most important stakeholder and our vision includes incorporating the patient voice in modern patient-focused drug development. In fact, all the elements in our proposal have a common thread: they ultimately serve to improve health for patients.
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sharelooker
Posted on: Jun 4 2018, 12:26 AM


Group: Member
Posts: 327

The impact of the recent vitiligo post on CUVs instagram channel is quite remarkable. Since then, almost 20 new subscribers and 150 likes. I hope they will ramp up the whole vitiligo thing from now on and publish the results of the CUV103 trial soon after NDA submission. This will cause a lot of publicity, especially in facebook vitiligo groups, which have around 20k members.
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sharelooker
Posted on: Jun 2 2018, 06:23 AM


Group: Member
Posts: 327

Google trends:
Attached image(s)
Attached Image

 
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sharelooker
Posted on: May 31 2018, 08:30 PM


Group: Member
Posts: 327

SCIENTIFIC COMMUNIQUÉ II
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sharelooker
Posted on: May 27 2018, 08:46 PM


Group: Member
Posts: 327

http://www.sachsforum.com/18bef-presenters.html

QUOTE
The CLINUVEL story starts in 1987 when university researchers launched an idea of synthesising human hormones to protect the skin. During this period, little was known about the properties of alpha-MSH (melanocyte stimulating hormone), although the scientists had discovered the biomimicry which these hormones could evoke (providing a golden glow without sun exposure). A basis was laid, but the majority of the research & development work was ahead to actually build a relevant product and successful company around this beginning scientific idea.

The CLINUVEL team in Australia obtained the rights to the technologies and established a company around alpha-MSH, its derivatives and knowledge. With an unabating focus and unusual willpower the CLINUVEL teams charged ahead and developed innovative technology which would release the hormonal analogue in picograms (10¯¹² grams) per day in a controlled fashion. With the world’s first dissolvable implant releasing a novel hormone to mimic the effects of the sun on human skin but without incurring the photo damage, our teams worked for two decades to test the technology - SCENESSE® - in more than 1,400 patients worldwide through 4,500 doses. Innovation came with rigid testing.

In 2014, the European Medicines Agency and the European Commission approved SCENESSE® as the world’s first photo protective drug for market authorisation to be distributed to European patients treated by specialist hospitals, dermatologists and other specialists. What had once been thought of as science fiction had become reality in October 2014, when SCENESSE® became the first systemic drug providing protection to the entire skin surface without exposure to light and UV. Currently, the Food and Drug Administration is reviewing the innovative pharmaceutical product for release in the United States. At CLINUVEL we focussed and specialised for two decades on extreme disorders which were provoked by environmental conditions, such as erythropoietic proto- and congenital porphyria [EPP, CEP], Solar Urticaria and other light-induced diseases. Worldwide the erythropoietic protoporphyria patients are forced to live an indoors existence deprived of any light source.
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sharelooker
Posted on: May 18 2018, 04:14 AM


Group: Member
Posts: 327

The NICE publication date was postponed to 27 June 2018 (previous date was 23 May). Maybe they are considering the annual reports and PSURs from the EMA!??Or further patient meetings?

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009
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sharelooker
Posted on: May 12 2018, 08:49 AM


Group: Member
Posts: 327

New insto!

Wil Asset Management (Liechtenstein) AG


Attached thumbnail(s)
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sharelooker
Posted on: May 4 2018, 06:44 AM


Group: Member
Posts: 327

New insto:

Acadian Asset Management LLC (https://www.acadian-asset.com/)

http://www.barrons.com/quote/stock/au/xasx/cuv


Attached thumbnail(s)
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sharelooker
Posted on: Apr 25 2018, 04:18 AM


Group: Member
Posts: 327

Maybe the recent rise in sp is due to our new insto "McKinley Capital Management LLC"

https://www.mckinleycapital.com/

http://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Apr 19 2018, 10:53 PM


Group: Member
Posts: 327

Congrats to "MinusSinus"!!

His website and fb page contain valuable infos about CUV.

https://www.minussinus.de/2017/11/14/for-en...-of-minussinus/

https://www.facebook.com/minus0sinus/
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sharelooker
Posted on: Apr 19 2018, 12:15 AM


Group: Member
Posts: 327

QUOTE
The new guidance documents will aim to make drug development more efficient and focus more on developing drugs targeted to less-common conditions where there’s a lack of available therapy and development pathways can be challenging.


QUOTE
In addition to the guidance, he said FDA is looking to set up a policy office‎ inside the Office of New Drugs in CDER that will “distill and align regulatory, clinical and scientific reasoning of review divisions to promote policy transparency and consistency.”


https://endpts.com/fda-chief-scott-gottlieb...-for-biopharma/
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sharelooker
Posted on: Apr 17 2018, 03:36 AM


Group: Member
Posts: 327

double post!
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sharelooker
Posted on: Apr 17 2018, 03:36 AM


Group: Member
Posts: 327

No,first they got a "Refuse-to-File" letter but after two weeks the NDA was accepted suddenly. The PDUFA date was set for January 31, 2019.

Here is the press release:

http://phx.corporate-ir.net/phoenix.zhtml?...&ID=2342624

QUOTE
DUBLIN, April 16, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019.
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sharelooker
Posted on: Apr 17 2018, 01:29 AM


Group: Member
Posts: 327

https://endpts.com/in-a-stunning-about-face...ed-2-weeks-ago/

QUOTE
The change up marks another sign of the dramatic shift in the FDA’s stance on drug applications and its standards for reviews, raising some major questions for the industry as well as consumers. Since Scott Gottlieb became commissioner in 2017 after he was nominated for President Donald Trump with a mandate to speed new drug approvals, the agency reversed itself on three key drug rejections for Eli Lilly, TherapeuticsMD and Amicus, waving off its earlier demands for more work.
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sharelooker
Posted on: Apr 16 2018, 09:33 PM


Group: Member
Posts: 327

New trademark: "TSUMOYLE"

DPMA register:
https://register.dpma.de/DPMAregister/marke...52&CURSOR=4

QUOTE
Klasse(n) Nizza 03: Skin care preparations; cosmetic preparations for skin care; cosmetic preparations for skin care, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; cosmetic oils; skin creams (cosmetic); skin care creams (cosmetic), lotions (cosmetic) and oils (cosmetic); wrinkle removing skin care preparations; sunscreens; waterproof sunscreen; sunscreen preparations; sunscreen creams and lotions; cosmetics for protecting the skin from sunburn; sunblock; sun barriers (cosmetics); sun creams; cosmetic preparations for protecting the skin from the sun's rays; sun care lotions; compounds for skin care after exposure to the sun's rays; after-sun milks, creams, lotions and moisturizers; sun bronzers; sun-tanning preparations; cosmetics for tanning the skin including preparations for tanning without sunlight, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; self-tanning preparations (cosmetic); self -tanning creams (cosmetic) and lotions (cosmetic); suntan creams, lotions, oils and gels; skin rejuvenation preparations; skin rejuvenation products with and without analogues of alpha-melanocyte stimulating hormone (alpha-MSH); antiaging skincare preparations; antiaging creams, lotions, moisturizers, gels, balms and serums; cleansing creams, lotions, milks, foam, gels and masks.
Klasse(n) Nizza 05: Pharmaceuticals; pharmaceutical drugs; pharmaceutical preparations; pharmaceutical preparations, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; sun tanning preparations for pharmaceutical purposes, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; pharmaceutical preparations for skin care; pharmaceutical preparations for treating skin disorders; dermatological preparations; dermatological pharmaceutical substances; dermatological pharmaceutical products; medicinal creams for the protection of the skin; skin care creams for medical use; skin care preparations for medical use; medicated skin creams and lotions; medicated creams for application after exposure to the sun; pharmaceutical skin lotions; preparations for cleansing the skin for medical use; chemical and biological preparations, substances, reagents and compounds for the delivery and storage of pharmaceuticals which are preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide.



https://www.trademarkia.com/ctm/tsumoyle-017877349.htm

https://registrydb.com/tsumoyle.com

QUOTE
This domain name was registered the 19/03/2018 and update for the very last time the 19/03/2018. The subscription period will finish the 19/03/2020 The tsumoyle.com main IP address is 203.170.80.250 and it's located to Australia, . This domain name was registered with Crazy Domains FZ-LLC


Facebook page: "Health and Beauty"

https://www.facebook.com/Tsumoyle/
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sharelooker
Posted on: Apr 10 2018, 10:38 PM


Group: Member
Posts: 327

yes, you are right. He doesn't mention the name. However, CUV is discussed in the comments section below the video, including links to the coverages of "sphene-capital" and "Minus Sinus". So it's not a big deal to figure out the name.
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sharelooker
Posted on: Apr 10 2018, 07:40 PM


Group: Member
Posts: 327

Mr. Hasler (CEO of Sphene Capital) gives an interview on a youtube channel (100k subscribers). At 8:40 min he talks about CUV.

https://www.youtube.com/watch?v=3atqlIlNztM

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sharelooker
Posted on: Apr 8 2018, 06:36 AM


Group: Member
Posts: 327

Australian Melanoma Research Foundation

QUOTE
Nicoletta Muner
Board Member
Nicoletta is a Pharmacist with 20 years experience in the pharmaceutical industry, where she has had exposure to the entire drug development process.

As a Regulatory Affairs professional she has mostly focused on the introduction of novel medicinal products into international markets. As the Global Director of Regulatory Affairs at a pharmaceutical company, Nicoletta has had broad exposure to clinical research and has been a key member of the Australian team which led to the European marketing authorisation of a first-in-class drug.

Nicoletta is a graduate of the Australian Institute of Company Directors.


http://www.melanomaresearch.com.au/about-us/our-people
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sharelooker
Posted on: Apr 5 2018, 07:48 PM


Group: Member
Posts: 327

This report was written by Mr. David Stanton. He also wrote the report from 2010 .
(http://clinuvel.com/investors/analyst-cove...aaff6763fa75dbe)

Mr. Stanton worked for Nomura. So maybe he wanted to do an update on CUV.
  Forum: By Share Code

sharelooker
Posted on: Apr 4 2018, 09:38 PM


Group: Member
Posts: 327

I think the new products will contain an innovative drug delivery system (e.g. a patented liposomal or nanoparticles formulations) for herbal or simple non-prescriptive molecules that can penetrate in to deeper skin layers. This drug-delivey system can later be used for the new developed melanocortins.

The new product lines containing a new drug delivery system will create brand awareness.

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sharelooker
Posted on: Mar 23 2018, 04:02 AM


Group: Member
Posts: 327

Interesting!

This was posted by ODI01 on 4th of march:

QUOTE
From wallstreet-online.de

https://m.jobsdb.com/en-sg/search.do?JSRV=1...amp;JSSRC=SRLSC

VALLAURIX PTE. LTD. The selected candidate will join a global biopharmaceutical company focused on developing drugs for the treatment of a range of disorders. The company has identified patient populations with specific clinical needs. Personal Assistant to Director 02-Mar-18 jobsDB Ref. JSG400003003540618 Employer Ref. 6330498 We are looking for a responsible Personal Assistant to provide personalized secretarial and administrative support in a well-organized and timely manner. You will work on a one-to-one basis on a variety of tasks related to manager’s working life and communication. Position open to Singaporean only. Career Level:Entry Level Yr(s) of Exp:3 years Qualification: Diploma Industry: Accounting / Audit / Tax Services Job Function: Professional Services > Company Secretary Zonal Segregation: No Fixed Location Salary:Salary provided Employment Type: Full Time


Employer name on jobstreet is "PharmaVenture". Employer Reference, that can be found in the web adress, is the same (=6330498).

https://www.jobstreet.com.sg/en/job/6330498?fr=j
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sharelooker
Posted on: Mar 13 2018, 03:08 AM


Group: Member
Posts: 327

https://smanewstoday.com/2018/03/12/rare-di...linical-trials/

QUOTE
From cystic fibrosis to epidermolysis bullosa, the FDA — with Gottlieb, a physician, at the helm — appears increasingly willing to engage patient advocacy groups in designing trials that incorporate more meaningful endpoints and “real-world” data, as well as natural disease histories. It’s an effort to move beyond the traditional, randomized, and placebo-controlled trials that began before him, but which Gottlieb and the agency embrace.


QUOTE
“We’re still very much in the inception of this revolution, in a sense,” added Melmeyer, whose organization is an umbrella group of 270 patient advocacy groups. “There have not been any therapies approved based on quality-of-life indicators, but there have been ones in which reviews have been substantially influenced by patients and feedback. We’re also talking about the inclusion of patient preference information, patient experience data, and real-world evidence reported by patients.”
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sharelooker
Posted on: Mar 7 2018, 03:36 AM


Group: Member
Posts: 327

QUOTE
Marketing support
As the operator of successful retail outlets, and a logistical contract partner, we have an in-depth understanding of what clients want. And how to provide it. As well as delivering leading brands to clients’ shops, we also help them with a broad range of marketing support. We share our retail experience with clients, helping them develop and grow their business in a variety of ways.

These include:

Concept positioning and customer profiling
Shop spacing concept and design
Research and selection portfolio according to target group
Project operation and team management
Sales optimization
In-store communication, advertising and promotions


https://www.bs-gg.com/en/bs-retail
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sharelooker
Posted on: Feb 21 2018, 05:27 AM


Group: Member
Posts: 327

A lecture by Jasmin B.Link found on the german wallstreet-online board:

https://www.youtube.com/watch?v=DuZfiSGM848

https://www.wallstreet-online.de/diskussion...neuster_beitrag
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sharelooker
Posted on: Feb 13 2018, 10:17 AM


Group: Member
Posts: 327

From the newsletter:

QUOTE
Finally, depending on the financial performance during the next calender year, we will be formalising CLINUVEL's dividend policy and strategic objectives associated wit it.
  Forum: By Share Code

sharelooker
Posted on: Feb 9 2018, 04:29 AM


Group: Member
Posts: 327

Macquarie called the epp centers in germany:

QUOTE
Münster plans to provide EPP patients without limitation of the treatment places, dear ODI! Start as in Chemnitz March/April. I assume that we can reach a penetration rate of more than 90% of German EPP patients in Germany by 2019 at the latest.


https://www.wallstreet-online.de/diskussion...-ltd#newPosting
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sharelooker
Posted on: Feb 5 2018, 05:15 AM


Group: Member
Posts: 327

Maybe the "skincare solutions" will be distributed trough the B&S (https://www.bs-gg.com/nl) channel?! Bleidurps former company!

Any thoughts on this?
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sharelooker
Posted on: Jan 19 2018, 08:46 AM


Group: Member
Posts: 327

Comments on fb regarding SC:

QUOTE
soooo awesome!! I would love to get out to Switzerland!!


QUOTE
I have 2 grown children that need this so bad. They both been through the trials. One got the meds and one didn’t. I know how it would improve their lives. Pray this gets approved soon


QUOTE
Thanks to all for their stories. Perhaps the FDA will move forward with positive results for all of us soon. I was in Phase 3 of the US study and received the life altering drug. I expressed many times to the FAD about my results.


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sharelooker
Posted on: Jan 18 2018, 11:27 PM


Group: Member
Posts: 327

QUOTE
One dinner, one rare disease, one voice: FDA, please accelerate approval for Afamelanotide.

They say a picture is worth a thousand words. This picture represents a sliver of those affected by Erythropoietic Protoporphyria (EPP). Gathered after the incredible 2018 Heme Biosynthesis and The Porphyrias Scientific Conference, the folks at this table tell a tale of the immense need for the approval of Afamelanotide in the US. Everyone at this table has seen the incredible protection Afamelanotide provides for those who receive treatment. Gaining access to treatment in the US is the ultimate goal for every person with EPP. Fight on Shadow Fighters until access is available to ALL with EPP.

Amy is a physician and she has EPP. As a child, she experienced many painful reactions from overexposure to light. Common to many who suffer from EPP, most doctors had no idea what was causing her so much pain – one doctor instructed her parents to “take her home and spank her as she was clearly seeking attention” after he erroneously determined there was nothing medically wrong. Amy has never had Afamelanotide but she has seen the difference it makes in those with EPP who have been fortunate enough to be treated with Afamelanotide. She has recently become an integral part of the EPP community, advocating for her peers and working to help patients get insurance coverage and advocating for FDA approval of Afamelanotide.

Gayle’s 23 year old son, JT has EPP. He has been traveling to Zurich, Switzerland since August, 2015 to receive implants of Afamelanotide. JT’s life has been completely altered by the life changing, powerful protection Afamelanotide provides. The fact that he will be making his 11th trip next month is testament to the effectiveness of this drug. As you can imagine, getting to Zurich is a major expense and time commitment. Going back to life without the protection of Afamelanotide is not an option.

Prof. Minder, MD is the Swiss physician extraordinaire who for the past 10+ years has been providing Afamelanotide for patients with EPP from around the world. She is a renowned porphyria expert, speaks at conferences, symposiums and in front of government bodies internationally. She is the unmatched champion and fighter providing life changing protection by treating her patients with Afamelanotide.

Jennifer has EPP and has recently been traveling to Zurich for treatment with Afamelanotide. Jennifer is an occupational therapist and her work requires her to travel to her patients. Her sensitivity had become so acute that she was either going to have to quit her job and go on disability or find the funds, and time to travel to Zurich to receive this vital treatment with Afamelanotide. Jennifer will be making her 4th trip to Zurich next month and has been able to maintain her job and live pain free now that she is receiving Afamelanotide. Not having access to Afamelanotide is also not an option for Jennifer as evidenced by the lengths her entire family has gone to get her this treatment.

Zoe is Jennifer’s daughter and she has seen first hand the incredible difference in her mother now that she is being treated with Afamelanotide. She has seen her mother go from having to be completely covered up, even while indoors and wearing gloves to protect her hands from the light of her telephone screen to a mom dressed like every other mom and living life pain free. No going back.

Andrew has EPP and has been receiving treatments of Afamelanotide in Zurich since 2015. Andrew is very involved in advocating for the approval of Afamelanotide in the US. He is one of the first (if not the first) US EPP patient to travel to Zurich for treatment. Andrew was part of the Phase II trials in the US and that experience unequivocally proved to him the incredible effectiveness and level of protection Afamelanotide provides. Like JT and Jennifer, not having access to Afamelanotide is not an option.

Kristen’s 12 year old son Brady has EPP. Brady was diagnosed at a young age and Kristen has been a fierce advocate ever since his diagnosis. Kristen is actively involved in lobbying Congress, attending hearings, symposiums and conferences around the world and most recently, is serving as Director of Development at the APF. Brady is too young to receive Afamelanotide but Kristen has seen the protection this drug provides and will be seeking treatment for Brady as soon as he turns 18.

Dr. Barman-Aksozen has EPP and is the Head of the Clinical Chemistry Laboratory and Porphyria Diagnostics at Triemli hospital in Zurich, Switzerland. Like most with EPP, she endured years of pain, suffering and misdiagnosis. She actually diagnosed herself and despite her doctors reluctance to run the test to confirm diagnosis because he believed there was no way she had EPP. The test came back positive for EPP. She has been receiving Afamelanotide for six years.

John is the father of JT, the 23 year old EPP patient mentioned above.

Ana is the mother of Rocio, a 19 year old college student who has EPP. Ana’s husband and other daughter also have EPP. Ana’s husband was part of the US trials and experienced the incredible protection Afamelanotide provides. At college, Rocio was facing a losing battle trying to manage the painful effects of EPP. Ana raised the money necessary to cover the cost of a single implant and this past October, Rocio received the gift of a new life free from pain. Rocio and her father will be returning to Zurich next month. Like all of the others above, not having access to Afamelanotide is not an option for Rocio. The family is working toward getting treatment for Ana’s other daughter and husband as soon as possible.



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sharelooker
Posted on: Jan 14 2018, 10:03 PM


Group: Member
Posts: 327

Updates from ther german EPP support group:

January 2018

Patients in the UK need all our support!
NICE has announced in a preliminary decision that it does not want to allow Scenesse to treat EPP in the UK! We must all make our contribution to ensuring that this does not happen. We all have a big goal:" Light for everyone"!
We from the Board of Directors Self-help EPP e. V. have translated and commented on James Rawnsley's appeal. Leads here the call of James Rawnsley
http://www.epp-deutschland.de/mediapool/21...-BPA-Aufruf.pdf


Our member Carina gave an interview for the magazine LEA!
Up to date and close to the skin: Carina has a rare Stowechsel disease "The sun is my greatest enemy".
In the next issue of the magazine LEA you can read the article after!


The UKD Düsseldorf is making its promise.
From 01.01.2018 there will be a permanent doctor's office for the treatment of EPP. Thereby treatment appointments are made! This step is exemplary and recommended for imitation!

http://www.epp-deutschland.de/
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sharelooker
Posted on: Jan 14 2018, 11:31 AM


Group: Member
Posts: 327

"Plutos Multi Chance Fund" with 4.17% of Clinuvel:

https://www.plutos.de/plutos-multi-chance-fund/

The CEO of Plutos (Mr. Käsdorf) was a co-author of different books written by Homm.

Maybe they are still accumulating.

https://www.plutos.de/
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sharelooker
Posted on: Jan 10 2018, 03:56 AM


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Posts: 327

A new interview with Florian Homm in the magazine "FOCUS-MONEY", which is very popular in germany!

https://www.focus.de/finanzen/boerse/boerse...id_8271930.html

QUOTE
FOCUS-MONEY: Because you could earn your money more stress-free. Your past is so adventurous that many film producers will probably pay a fortune for the rights to the screenplay. Ever thought of that?

Homm: You will laugh. There are indeed plans to do business with Netflix or Amazon.


It's likely that a main part in this movie will be about the history of Clinuvel and Homm's involvment! This will cause enormous publicity.
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sharelooker
Posted on: Jan 9 2018, 10:34 PM


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Posts: 327

Massive buying pressure at all german exchanges the last days. Today: 6.100 EUR +0,40 +7,01% (Tradegate)!

In my opinion, Homm's last interview on youtube has influenced many germans to buy clinuvel shares. It was extremely successfull (105k views within six days).

https://www.youtube.com/watch?v=Rv8rSMvOm-U
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sharelooker
Posted on: Jan 9 2018, 09:37 AM


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Posts: 327

http://www.ema.europa.eu/docs/en_GB/docume...WC500241018.pdf
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sharelooker
Posted on: Jan 4 2018, 11:10 AM


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Posts: 327

Yes definitively! He still has his network of millionaires and billionaires that follow his stock recommendations. Once he said that the success of his market letter will depend on the stock performance of CUV. So he will do everything to bring the sp to a fair value, which is 17-20 AUD according to him.
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sharelooker
Posted on: Jan 3 2018, 09:51 PM


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Posts: 327

Great interview with Mr. Homm. He talks about Clinuvel at 28:30.

https://www.youtube.com/watch?v=Rv8rSMvOm-U
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sharelooker
Posted on: Jan 2 2018, 09:36 AM


Group: Member
Posts: 327

Afamelanotide is listed here:

https://lovdata.no/dokument/SF/forskrift/2017-12-20-2257
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sharelooker
Posted on: Dec 24 2017, 09:15 PM


Group: Member
Posts: 327

BPA is pushing!

QUOTE
SCENESSE® update (24 Dec 17)
NICE have published a provisional evaluation for making Scenesse available on the NHS. The evaluation follows the appraisal meeting held on 23rd Nov and is now available on the NICE website. This takes the form of an Evaluation Consultation Document (ECD).

NICE are proposing that Afamelanotide (Scenesse) is not recommended for use in England. The BPA is incredibly disappointed at this news. This recommendation is made despite acknowledgement of the enormous impact and severity of EPP. The reasons for the decision are based largely on health economics grounds.

Please take time to read the documentation which is available at NICE – Afamelanotide Appraisal ID927. This decision is not yet final and the BPA is currently formulating an appropriate response to the document.

NICE is seeking further evidence and clarification by 24th January 2018. The evaluation committee is interested in receiving comments on the following:

Has all of the relevant evidence been taken into account?
Are the summaries of clinical effectiveness and value for money reasonable interpretations of the evidence?
Are the provisional recommendations sound and a suitable basis for guidance to NHS England?
In order to make sure your voice is heard please contact the BPA with any comments on the documentation in relation to the above points.

Amongst other things, we are currently seeking advice from Genetic Alliance (www.geneticalliance.org.uk) an umbrella charity for many rare disease charities. They have experience in actively campaigning on issues of policy and practice to influence governments, policy makers, industry and care providers such as the NHS.

For further information on the recommendation, please also see Clinuvel’s latest press release at http://clinuvel.com/investors/news/announcements

In the meantime, we will continue to support EPP patients and keep members informed.


http://www.porphyria.org.uk/?page_id=2619
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sharelooker
Posted on: Dec 7 2017, 04:10 AM


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Posts: 327

In my opinion, lago will soon start to promote the stock via stock analysts. Hey Iggy, where are you?
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sharelooker
Posted on: Nov 30 2017, 08:51 AM


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Posts: 327

Where can i find the most up-to-date bid and offer price of CUV? I've noticed that there are differences between yahoo finance, asx website and asx app (mobile version).
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sharelooker
Posted on: Nov 30 2017, 04:25 AM


Group: Member
Posts: 327

QUOTE
Florian Homm: Our market letter has been available since November 1,2017 and is edited by five other employees in Switzerland. In our view, Clinuvel Pharmaceuticals has a high share price potential and is expected to perform very well until the end of the next financial year. Our stock letter subscribers can read why this is the case.


https://www.wirtschaftsforum.de/interviews/...-macht-gewinnt/
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sharelooker
Posted on: Nov 28 2017, 02:19 AM


Group: Member
Posts: 327

Nice to see CLVLY: 7.17+0.19 (+2.70%).
However on low volume!
  Forum: By Share Code

sharelooker
Posted on: Nov 25 2017, 06:16 AM


Group: Member
Posts: 327

CLVLY: $6.98-> 10-year high!!

Fasten your seatbelts!
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sharelooker
Posted on: Nov 21 2017, 06:17 AM


Group: Member
Posts: 327

Clinhope, could you please post the book? Thanks!
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sharelooker
Posted on: Nov 21 2017, 05:33 AM


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Posts: 327

Can i also attend the meeting with german UR9 shares? Or is it only for CUV holders?
  Forum: By Share Code

sharelooker
Posted on: Nov 20 2017, 06:23 AM


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Posts: 327

Do you guys think that "Priority Review" will be granted by the FDA?

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sharelooker
Posted on: Nov 18 2017, 02:13 AM


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Posts: 327

Florian Homm in the news:

https://www.welt.de/finanzen/article1700615...och-na-los.html
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sharelooker
Posted on: Nov 6 2017, 09:41 PM


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Posts: 327

Offer: 6.055 EUR at Tradegate!!!!!!
  Forum: By Share Code

sharelooker
Posted on: Nov 5 2017, 09:50 PM


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Posts: 327

I think all of this is organized by Mr. Homm! His market letter came out on 1st of November. Since then, the volumes of CUV, UR9 and CLVLY have exploded.

You may think, that the germans are now buying Clinuvel shares. However, no german would buy shares on the asx due to the strong home bias!
  Forum: By Share Code

sharelooker
Posted on: Nov 5 2017, 09:23 PM


Group: Member
Posts: 327

Lago is done with accumulating!They now have around 11% of CUV shares. Iggy and the other plants, who worked for lago haven't posted here since the sudden sp rise.

Hopefully the FDA process won't interfere with the recent activities of Mr. Homm.
  Forum: By Share Code

sharelooker
Posted on: Nov 4 2017, 08:01 AM


Group: Member
Posts: 327

An interesting theory about the recent jump in sp from walltrader over at wallstreet-online:

deepl translate:

QUOTE
Homm is bloody intelligent!Probably smarter than all of us together! I believe that his "Buddies" buy shares to push the price to make the stock look more attractive. He plans such actions years in advance.

The steep rise in the share price, which we are currently seeing, is noticed by many stock screeners worldwide, which means that people are getting information about Clinuvel. And that's exactly what Homm wants: to put it mildly, he is doing IR (Investors Relations) indirectly.

When people look at CUV's balance sheet, they will notice that the company is extremely undervalued.


Source: https://www.wallstreet-online.de/diskussion...maceuticals-ltd
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sharelooker
Posted on: Oct 31 2017, 08:15 PM


Group: Member
Posts: 327

from wallstreet-online (walltrader2014)

deepl translate:

QUOTE
I am convinced that Homm and/or his buddies have been at work in the last two days. The day before yesterday 71k shares on the ASX, today 41k shares. Lagoda has a completely different trading pattern. CUV 4% in the plus at the beginning of the day and -0.6% towards the end of the trading day. This is the typical Homm's trading pattern.

This strategy of "price maintenance" is also mentioned in his documentary (https://www.youtube.com/watch?v=5HrkYu68IjQ&t=807s). Also the new number of active members here in the forum is clear indication that Homm sends his "men" to heat up the share.

His goal is that at the start of his newsletter:
a) that the liquidity of CUV/UR9 appears to be high
b) that the trading forums for CUV are active and have as many members as possible
c) that the price is rising

All three points have been reached and Homm can release his market letter tomorrow.


Source: https://www.wallstreet-online.de/diskussion...-ltd#newPosting
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sharelooker
Posted on: Oct 25 2017, 03:55 AM


Group: Member
Posts: 327

40k now!!!!! A maniac is buying!
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sharelooker
Posted on: Oct 25 2017, 03:55 AM


Group: Member
Posts: 327

40k now!!!!! A maniac is buying!
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sharelooker
Posted on: Oct 25 2017, 03:41 AM


Group: Member
Posts: 327

36k!!!!! Germany is out of control!
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sharelooker
Posted on: Oct 25 2017, 02:55 AM


Group: Member
Posts: 327

I totally agree with you! Not to forget, it will be his 10-year anniversary. Back in 2007 he pumped the stock from 2 euro to 7 euro!
  Forum: By Share Code

sharelooker
Posted on: Oct 25 2017, 02:29 AM


Group: Member
Posts: 327

In germany, the party has already started!!! Stuttgart Exchange +8% .

35k+ traded shares in total!
  Forum: By Share Code

sharelooker
Posted on: Oct 25 2017, 01:10 AM


Group: Member
Posts: 327

10-12 mln AUD!
  Forum: By Share Code

sharelooker
Posted on: Oct 24 2017, 02:42 AM


Group: Member
Posts: 327

20k+ shares in germany, today! It seems that everyone is preparing for the big party starting on friday smile.gif
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sharelooker
Posted on: Oct 23 2017, 08:54 PM


Group: Member
Posts: 327

I think that he will pump his fund with a lot of CUV shares!
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sharelooker
Posted on: Oct 23 2017, 08:23 AM


Group: Member
Posts: 327

Florian Homm will start his own investment fund!

QUOTE
At the same time, he will launch his own investment fund, which also promises price gains in the event of a correction on the exchanges. Homm told the WELT AM SUNDAY. "The financial system is facing a tough crisis," the investor said. "The question is not whether that will happen again, the question is only when it will happen."


https://www.welt.de/finanzen/article1698991...anzmaerkte.html
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sharelooker
Posted on: Oct 21 2017, 09:40 PM


Group: Member
Posts: 327

Only figures will tell the truth! I'm expecting a nice sp run-up until thursday, followed by spikes on friday, tuesday and wednesday!
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sharelooker
Posted on: Oct 21 2017, 07:24 AM


Group: Member
Posts: 327

Only six days left until the (record) annual report will come out! I'm really interested in the shareholder section.It will reveal who has sold so many shares to lago!
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sharelooker
Posted on: Oct 20 2017, 10:12 AM


Group: Member
Posts: 327

I can only see 3,658 shares traded so far!
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sharelooker
Posted on: Oct 20 2017, 06:26 AM


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Posts: 327

https://www.itv.com/news/wales/2017-10-19/a...skin-condition/
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sharelooker
Posted on: Oct 19 2017, 09:39 PM


Group: Member
Posts: 327

What about a FDA run-up?
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sharelooker
Posted on: Oct 19 2017, 03:19 AM


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Posts: 327

CUV is reading here!!

The website http://www.spijko.com/clinuvel_prod/index.php has been closed! Now you need a password to enter.
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sharelooker
Posted on: Oct 17 2017, 09:55 PM


Group: Member
Posts: 327

http://www.southwalesargus.co.uk/news/1560..._for_treatment/
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sharelooker
Posted on: Oct 17 2017, 08:16 AM


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Posts: 327

Newsletter is out!

http://www.asx.com.au/asxpdf/20171017/pdf/43n91r0vk7j9d7.pdf

Key points:

- PW is relatively cofident about FDA apporval
- PASS protocol will be revised
- New strategy annoucement at the AGM
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sharelooker
Posted on: Oct 16 2017, 10:57 PM


Group: Member
Posts: 327

Iggy ist eine arme Haut. Ich habe fast Mitleid mit ihm. Es ist offensichtlich ,dass er innere Aggressionen gegen sich selbst hat. Iggy versucht seine Probleme in den Griff zu bekommen, in dem er andere Menschen angreift und beleidigt. Solche tiefgreifenden psychologischen Schäden beruhen meist auf einer schlechten Erziehung der Eltern! Somit trägt er im Endeffekt keine Schuld.
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sharelooker
Posted on: Oct 15 2017, 09:07 PM


Group: Member
Posts: 327

Yes, scenesse and its positive effect on life quality is mentioned extensively. It's clearly a campaign for accelerating the access of the implant. Especially for austria, where they still have problems.
  Forum: By Share Code

sharelooker
Posted on: Oct 15 2017, 01:47 AM


Group: Member
Posts: 327

12. OK. 2017 - Two affected people report on their lives with EPP in an impressive and moving film - After a short time in the sun (usually only a few minutes), the disease causes incredibly painful combustion reactions and leads to a life of isolation and pain - Conny and Mischa talk about it.
www.eppaustria.at
www.epp-deutschland.de
www.porphyria.ch

https://www.youtube.com/watch?v=DWAlzCaDnbM
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sharelooker
Posted on: Oct 13 2017, 05:59 AM


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Posts: 327

why?
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sharelooker
Posted on: Oct 13 2017, 01:52 AM


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Posts: 327

I agree with you! This is Homm-Style. I think that he is buying large parcels of UR9 and CUV at the moment. Then, when his market letter will be published on 1st of November, he expects that the stock explodes which gives him a nice profit.

Like in his old days when he worked for ACM ! wink.gif
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sharelooker
Posted on: Oct 11 2017, 04:40 AM


Group: Member
Posts: 327

There will be a german online congress from 14.-17.November. One of the Keynote speaker is Mr.Florian Homm. It's free if you register within the next five days. This congress is very popular and has 50k participants.

https://finanzkongress.de/
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sharelooker
Posted on: Oct 11 2017, 03:50 AM


Group: Member
Posts: 327

Tradegate: 12.130
Stuttgart: 6.000
Frankfurt: 2.790
Lang & Schwarz: 1.025
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sharelooker
Posted on: Oct 11 2017, 12:18 AM


Group: Member
Posts: 327

Almost 22k shares in germany!!!!!!!!
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sharelooker
Posted on: Oct 10 2017, 11:20 PM


Group: Member
Posts: 327

Last friday night i told you about a guy who placed UR9 in oder to lower the sp. He is back today!! UR9 is almost -5% with a relatively high volume of about 15k shares. At the end of the day, this guy will raise the price to its normal level!

Crazy times!
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sharelooker
Posted on: Oct 9 2017, 10:13 PM


Group: Member
Posts: 327

I strongly agree with you! According to the chart, the year 2018 must deliver a 2-3 bagger!
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sharelooker
Posted on: Oct 8 2017, 09:07 AM


Group: Member
Posts: 327

I think a sp run-up is starting now. When you have a look on several down-phases in the long-term chart you can see that each down-phase (approx. 1 year) is followed by a one year run-up.
  Forum: By Share Code

sharelooker
Posted on: Oct 8 2017, 08:27 AM


Group: Member
Posts: 327

Catalysts in the next 3-4 weeks:

-record quarter results
-record annual report
-record market letter
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sharelooker
Posted on: Oct 7 2017, 10:49 PM


Group: Member
Posts: 327

Hey folks,

does Clinuvel have to pay VAT in each european country?
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sharelooker
Posted on: Oct 7 2017, 08:52 AM


Group: Member
Posts: 327

google translate:

QUOTE
The light design
In the past she fought against roll-clichés, today against health insurance companies: the medical doctor Elisabeth Minder has developed the only medicine against a light sickness.

She loves the sun, likes to be outdoors in the garden. During the holidays she moves to the desert, the Middle East or North Africa. For many of the patients of Elisabeth Minder a horror show. There is little that they fear more than before the sun. When their rays hit them, they bend in pain and burns in exposed places. It is like fire under the skin, say sufferers.

"The patients are traumatized by the pain, comparable to torture or accident victims," ​​says Elisabeth Minder. She sits in her simply furnished living room where we meet her for a coffee. It is one of the few specialists worldwide for the rare metabolic disease Porphyria. At Zurich's Triemli Hospital, where she was the first woman to receive a doctor's office in 1993, she led the only consultation for porphyria patients in Switzerland. To this day, although she has been retired for three years.

In the case of porphyry, the production of the red blood dye does not work properly. Intermediates accumulate in the body, which in many subforms leads to abdominal pain, sometimes also to liver problems or neurological deficits. Especially in a variant, the so-called erythropoietic protoporphyria (EPP), patients suffer from painful photosensitivity. Without treatment they lead a life in the shadow, dressed in clothes and with umbrella. Sunscreens do not help them.

It is full of ideas

EPP has become the focus of the public in recent years. Although in Switzerland no more than 80 patients suffer from it, the light sickness to date still keeps health insurance funds and authorities busy. It is a prime example of how patients are at the mercy of pharmaceutical companies and health insurance companies.

Actually, there has been the drug Scenesse for a few years, which greatly reduces the sensitivity of the affected persons and allows them an almost normal life. But then the Australian manufacturer Clinuvel tripled the price for the treatment to around 70,000 francs per year in 2016. The health insurance companies felt they were being blackmailed by the small producer company, and every second stopped payments. For those affected, many of whom had been able to live almost without pain for several years, a disaster. "The reaction of the funds has hit the wrongs," says Minder. For the price increase of Clinuvel, she understood: "In the Netherlands and in Germany the same price was recognized by the state institutions." Furthermore, the company had previously provided the drug for studies for a long time free of charge and subsequently at a reduced price.

Whoever meets the doctor for the first time underestimates them. It exudes a sense of austerity and modesty. Also her house: built at the end of the 80s, it stands in a quiet residential quarter of Adliswil ZH and is simple and practical furnished. On the walls are prints with Egyptian hieroglyphs and a drawing as a thank you from their patients.

"For me, the price increase was also a shock," says Elisabeth Minder. The irony: she herself was decisively involved in the fact that the drug is now reality. Thanks to it the waves have smoothed. In countless conversations and exchanges, she was able to convince those responsible. "I've become a lawyer," she says. Today, almost all funds are paying, the only exception being the CSS.

The Baslerin still remembers well, as it has begun with the light protection drug Scenesse. In 2006, she drew attention to the small Australian company Clinuvel. This announced on the website a new EPP drug - a bit full-bodied, as later turned out, because larger studies with it did not exist yet. "The following Sunday morning, I contacted the company by e-mail and received an immediate reply," says Minder. Three months later she submitted the application for the first clinical study with EPP patients to the Ethics Committee. "I will never forget the moment," said Minder. She had worked together with the leaders of Clinuvel around the clock at Studiendesign. The study became a success. Patients tolerated the sun much better and had hardly any side effects. Further studies followed in Switzerland, the USA and Europe. A personal fee has never been referred to Minor by Clinuvel. Consciously not, she emphasizes.

Minder is an initiative, takes the matter into his own hands in case of problems, stays tuned and goes through. And it is always full of ideas for new projects. "I have to take care that I do not overrun others." Your team is generally well-managed. "I was fortunate that I always had fantastic employees," says Minder. Obviously she also had a good hand for finding the right people. "The knowledge and motivation the employees are the largest capital, "says the medical doctor.As a woman is an exotic woman, Elisabeth Minder grew up in the city of Basel, in a co-operative settlement with terraced houses on a small street and many children. Although her parents were not academics, she soon wanted to study like her three brothers. It was supposed to be medicine, which was unusual for a woman. The parents and the teachers advised in vain. "I've always been somewhat rebellious," says Minder. After studying, she specialized in internal medicine with additional clinical pharmacology and finally landed at the University Hospital of Zurich. There she soon began to deal intensively with porphyries. They established methods of analysis, with which the different subforms could be diagnosed. Later, her team succeeded in deciphering a gene mutation that led to a patient with a severe liver complication to EPP.Minder was always encouraged during her career. But as a woman, she was an exotic woman in the male-dominated world of science and medicine until the 1980s. "They knew me at the congresses like a colorful dog," she says. Perhaps this development has helped Elisabeth Minder to win the trust of her porphyria patients. However, a role plays with certainty that since her childhood she suffers severe migraine attacks and knows what pain can mean. "Because of their many negative experiences, the EPP patients usually only open when they realize that they know what they are talking about," says Minder. She hopes that "a secure, longer-term treatment will now be granted to her".


https://www.tagesanzeiger.ch/wissen/medizin.../story/25640910
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sharelooker
Posted on: Oct 7 2017, 05:44 AM


Group: Member
Posts: 327

QUOTE
The next BPA Autumn Conference is being held at the Holiday Inn – CARDIFF North M4 (Jct. 32), Merthyr Road, Tongwynlais, Cardiff, CF15 7LH, on Saturday 7th October 2017 (09.30 – 16.15).

The programme is yet to be fully finalised, but will include both doctor and patient talks (as well as our brief AGM). There will be updates from Clinuvel and Alnylam (Clinuvel have developed a treatment for EPP and Alnylam are developing one for acute porphyrias), as well as patient experience talks on both acute and skin porphyrias. There will be plenty of opportunities to speak with other patients and members.

The Autumn Conference is free to attend, however booking is essential. If you would be interested in attending, please forward the names of anyone wishing to come with you to sue.burrell@porphyria.org.uk or liz.gill@porphyria.org.uk or call 0300 30 200 30 to confirm your attendance. Please see the information pack for more details.

Travel bursary: The BPA do have some funds to help support people to attend meetings. If you would like to apply for funding please get in touch (funding available up to: £50.00 for travel and £50.00 for hotels).


http://www.porphyria.org.uk/?event=autumn-conference-and-agm
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sharelooker
Posted on: Oct 7 2017, 04:57 AM


Group: Member
Posts: 327

Hm....the volume at the german stock exchange "Tradegate" is still rising! Almost 20k shares in sum now! I've noticed this trading pattern some weeks ago. It was also on friday evening (german time). UR9 is down almost 4 %. Right before market close the stock price will go up again.

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sharelooker
Posted on: Oct 7 2017, 04:45 AM


Group: Member
Posts: 327

With FDA approval a double digit sp is as sure as death and taxes! I hope that we get a nice FDA run up,too!
  Forum: By Share Code

sharelooker
Posted on: Oct 7 2017, 04:12 AM


Group: Member
Posts: 327

I think it's a good sign! I really like the volume of UR9 during the last 1-2 years. UR9 appears to get out of the shadow!
  Forum: By Share Code

sharelooker
Posted on: Oct 7 2017, 03:34 AM


Group: Member
Posts: 327

Unusual trading pattern in germany! Almost 15k shares in sum.
  Forum: By Share Code

sharelooker
Posted on: Oct 6 2017, 06:06 AM


Group: Member
Posts: 327

SCIENTIFIC WORKSHOP ON ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
SUMMARY REPORT
Workshop Date: October 24, 2016

QUOTE
Conclusion
As described in this report, this workshop emphasized the need for increased research and available treatments
for EPP. Through this workshop, FDA learned more about what matters most to patients and caregivers regarding
symptoms, impacts, and aspects of EPP treatments. The participants’ sense of community and their desire to advocate
for current and future generations at risk for EPP were strikingly clear. The scientific component of the workshop
allowed FDA to obtain expert input on the complex issues surrounding drug development and treatment of EPP more
broadly, including clinical trial design and conduct. It is clear that EPP has a debilitating physical, social and emotional
impact on the lives of patients and their loved ones. FDA shares the patient and healthcare community’s desire and
commitment to furthering the development of new safe and effective drug therapies to treat or prevent EPP.



https://www.fda.gov/downloads/Drugs/NewsEvents/UCM579234.pdf
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sharelooker
Posted on: Oct 4 2017, 07:32 AM


Group: Member
Posts: 327

Elie Ishag to retire from Clinuvel board

http://www.asx.com.au/asxpdf/20171004/pdf/43mxvv656vtj5y.pdf
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sharelooker
Posted on: Oct 3 2017, 06:12 AM


Group: Member
Posts: 327

Google translate:

QUOTE
Object:
ID 17F046. Exclusive drug delivery Scenesse implant sc 16mg (active ingredient Afamelanotide) for the Hospitality Company of Padua. Reliance on Clinuvel UK Ltd of London pursuant to art. 63, paragraph 2, letter b) of Legislative Decree no. 50/2016 for the twenty-four month period.

Expected expenditure: 744530,16 €

Content (notes for transparency):
With this measure, the custody procedure in accordance with art. 63, paragraph 2, letter b) of Legislative Decree no. 50/2016 for the supply of the exclusive Scenesse implant sc 16mg (eg afamelanotide) to Clinuvel UK Ltd of London for the period of 24 months


http://service.sanita.padova.it/PubRainbow...ssBrowser23.asp
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sharelooker
Posted on: Oct 2 2017, 10:19 PM


Group: Member
Posts: 327

An upcoming lecture from Dr. Barman on the availability of Scenesse.

QUOTE
The case of the ultra-rare light intolerance erythropoietic protoporphyria (EPP)
EPP is a very rare genetic condition in which even brief exposures to sunlight and artificial light sources trigger severe
and extremely painful phototoxic reactions in all exposed skin areas. Unlike in most other rare diseases, an approved
therapy exists which enables patients to live an almost normal life. Swiss patients were the first EPP sufferers testing
«afamelanotide» in clinical trials and played a crucial role in the EU approval. Until 2016, most Swiss EPP patients
had access to the treatment at a subsidised price, reimbursed by health insurers. However, as a commercial price was
introduced last year, many health insurers stopped treatment reimbursement, forcing patients back into a life in pain
and darkness.
The seminar will address scientific, legal and ethical aspects of the case as an illustration of the challenges in orphan
drug access.


http://www.unige.ch/medecine/ieh2/files/76...9/Affiche_1.pdf
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sharelooker
Posted on: Oct 2 2017, 04:46 AM


Group: Member
Posts: 327

Iggy, your posts are soooo boring!! *yawn*. It almost hurts!
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sharelooker
Posted on: Sep 29 2017, 09:17 PM


Group: Member
Posts: 327

In my opinion, Mr. Homm has created a lot of attention about Clinuvel in his videos, books and interviews! Especially for the german folks! German stock exchanges have taken the lead in terms of volumes. So far today, the volume is 12k on german exchanges

Why the stock isn't going up?Well, i think Lago is the problem. They are controlling the sp by placing orders that bring the sp down. So they can buy cheap shares. Don't unterestimate these guys. They are highly trained traders with more knowledge than we have. When they are done with accumulating, the sp will go up immediately.
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sharelooker
Posted on: Sep 29 2017, 05:15 AM


Group: Member
Posts: 327

Mr. Homm will launch his first market letter on 1st of November. It's verly likely that he will give a detailed analysis of CUV, which could give the sp a boost!

https://www.florianhommlongshort.de/

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sharelooker
Posted on: Sep 9 2017, 07:02 PM


Group: Member
Posts: 327

Great find, RC!

So next week (wednesday), AWMSG will decide about Scenesse. Will they make it public or do we have to wait until october?
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sharelooker
Posted on: Sep 8 2017, 08:35 PM


Group: Member
Posts: 327

Hey folks,

one question: Can Clinuvel find out about my name and address when i own UR9 shares?
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sharelooker
Posted on: Sep 8 2017, 05:34 AM


Group: Member
Posts: 327

Me neither! Something is going on behind closed curtains!

Within the nex days/weeks we should see a storm of asx annoucements!
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sharelooker
Posted on: Sep 8 2017, 03:48 AM


Group: Member
Posts: 327

Again 0 volume in CLVLY and CLVLF. Third day in a row!
Germany (UR9) has taken the lead!
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sharelooker
Posted on: Sep 7 2017, 10:07 PM


Group: Member
Posts: 327

I think there is a new link "Healthcare Professionals" on the top right corner on the Clinuvel website. Never seen this before:

http://www.clinuvel.com/hcp/
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sharelooker
Posted on: Sep 7 2017, 07:07 PM


Group: Member
Posts: 327

Can someone give a summary about this publication? It's in french.

https://saez.ch/de/article/doi/saez.2017.05914/
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sharelooker
Posted on: Sep 7 2017, 05:07 AM


Group: Member
Posts: 327

But how could they get listed on the NYSE or NASDAQ with their bad financials?
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sharelooker
Posted on: Sep 7 2017, 04:42 AM


Group: Member
Posts: 327

Does anyone know why $AXON is allowed to switch to NASDAQ?

http://investors.axovant.com/news-releases...-listing-nasdaq

In comparison to Clinuvel their financials are in a very bad shape! They don't fulfil any listing requirements. Do i miss something here?
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sharelooker
Posted on: Sep 2 2017, 03:16 AM


Group: Member
Posts: 327

I think it's not the classic expensive drug development that is going on at vallaurix. It's rather about to find a clever drug delivery method for the melanocortins. In modern labs peptide synthesis and analysis is pretty cheap and easy. You don't need highly educated pharma professionals.

Hopefully pw and his crew can come up with an innovative patentable formulation that can bring the peptide through the skin.
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sharelooker
Posted on: Aug 31 2017, 08:25 PM


Group: Member
Posts: 327

CUV has some problems in Wales:

QUOTE
NMG advice to AWMSG:
Afamelanotide (Scenesse®) is not recommended for use within NHS Wales for
the prevention of phototoxicity in adult patients with erythropoietic
protoporphyria (EPP).
The case for cost-effectiveness has not been proven.
Key factor(s) influencing the recommendation:
• There are several uncertainties and limitations in the economic model provided
in the company’s submission.


http://www.awmsg.com/awmsgonline/docsnoind...SG%20papers.pdf
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sharelooker
Posted on: Aug 25 2017, 09:41 PM


Group: Member
Posts: 327

UR9 is out of control, today. Almost +12%!
  Forum: By Share Code

sharelooker
Posted on: Jul 17 2017, 09:45 PM


Group: Member
Posts: 327

Sharescene ist getting out of control at the moment! Please calm down and prepare yourself for the newsletter, that will be out tomorrow!
  Forum: By Share Code

sharelooker
Posted on: Jul 15 2017, 11:07 PM


Group: Member
Posts: 327

Do you think that we'll get an asx annoucement next week?
  Forum: By Share Code

sharelooker
Posted on: Jul 15 2017, 10:17 PM


Group: Member
Posts: 327

I think the NDA submission is delayed because of the slow commercial roll out in europe. CUV often said that the FDA wants to have data from the patients register. Now, backroom deals (as we have seen it in italy) are made to accelerate treatments with SC.

So their first focus should be a more efficient roll out in europe in order to get enough data for the FDA.
  Forum: By Share Code

sharelooker
Posted on: Jul 15 2017, 12:37 AM


Group: Member
Posts: 327

I like Frogster's posts! End of discussion!

CUV needs to hurry up! MNK has just completed a phase I with a depot formulation of a melanocortin against DMD.

http://www.mallinckrodt.com/about/news-and-media/2286128
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sharelooker
Posted on: Jul 14 2017, 08:08 PM


Group: Member
Posts: 327

cuv rebound!
Attached image(s)
Attached Image

 
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sharelooker
Posted on: Jul 14 2017, 07:49 PM


Group: Member
Posts: 327

Yeah where is that damn newsletter?! I wanted to read it today while having breakfast!

@Carte Blanche: Do not attack Frogster! He is a loyal shareholder and always posts high quality content!
  Forum: By Share Code

sharelooker
Posted on: Jul 13 2017, 05:31 AM


Group: Member
Posts: 327

Newsletter!
  Forum: By Share Code

sharelooker
Posted on: Jul 13 2017, 03:37 AM


Group: Member
Posts: 327

LETTER!!!!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 06:22 PM


Group: Member
Posts: 327

None. Still accumulating wink.gif
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 06:20 PM


Group: Member
Posts: 327

Newsletter will be out tomorrow. PW had to add a chapter about Chivére.
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 09:21 AM


Group: Member
Posts: 327

Be patient, my friend!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 06:49 AM


Group: Member
Posts: 327

RC, we are now in the exponential phase of CUV. Our human brain can not handle it! SP can be at $25 very soon.
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 06:41 AM


Group: Member
Posts: 327

Nope, i'm still accumulating shares!

2 hours left!!!!!! Fasten your seatbelts!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 05:52 AM


Group: Member
Posts: 327

What a great day, guys! In around 3 hours the market will react!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 02:29 AM


Group: Member
Posts: 327

not to forget "Chivére" as a pure cosmetic product,which will disrupt the cosmetic market. Global players like Beiersdorf will lose a huge market share!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 02:14 AM


Group: Member
Posts: 327

...and this is just the beginning!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 12:32 AM


Group: Member
Posts: 327

What a great find, NewtoCli!! Thank you so much!!

A new product launch (maybe OTC) is imminent! It's obvious that this new product is a topical formulation of a msh-analogue. It will have a huge impact on the cosmetic market!

SP explosion is imminent!
  Forum: By Share Code

sharelooker
Posted on: Jul 12 2017, 12:05 AM


Group: Member
Posts: 327

9 hours left until the gift will be revealed!
  Forum: By Share Code

sharelooker
Posted on: Jul 11 2017, 10:44 PM


Group: Member
Posts: 327

UR9 (FRA) 4,87 € +0,28 (+6,01 %)
  Forum: By Share Code

sharelooker
Posted on: Jul 11 2017, 09:51 PM


Group: Member
Posts: 327

QUOTE
The most recent PLG implant introduced on the market is Scenesse developed by Evonik for the Australian company Clinuvel Pharmaceuticals. It releases the peptide afamelanotide, a photoprotective drug that protects against sunlight damage by increasing melanin in the skin. Scenesse is indicated for the treatment of erythropoietic protoporphyria, a severe skin disorder caused by the body’s inability to protect itself from sunlight.



http://www.pharmtech.com/30-year-history-p...ease-0?pageID=1
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sharelooker
Posted on: Jul 11 2017, 07:41 PM


Group: Member
Posts: 327

IF there is no newsletter tomorrow, shareholders will receive another great gift!
  Forum: By Share Code

sharelooker
Posted on: Jul 11 2017, 07:18 PM


Group: Member
Posts: 327

yeah, but tomorrow there will be a newsletter! I am 100 percent sure!

BTW : The stock is up 10% since i've given the promise of a great gift to all shareholders. So please be kind to me or i will stop being Santa Claus. hypocrite.gif
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