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CUV, CLINUVEL PHARMACEUTICALS LIMITED
polyphemus
post Posted: Today, 10:50 AM
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We should receive the preliminary Final report in 2 weeks (end of August).

2 weeks later I expect addition to the ASX300 Index (XKO) - with the other 4 Biotechs being CSL, Sirtex, Mesoblast, Monash IVF

Have to attach the index with CUV inserted as a text file - it should copy paste into a spreadsheet ok for review

Attached File  XKO.txt ( 31.72K ) Number of downloads: 4


I note several of the market data vendors I use, ASX, IRESS, Morningstar, Reuters, Bloomberg all have grossly incorrect information. I put this down to they must use annual and half yearly report for their information vs the quarterly reports. As we use quarterly reports we already know EPS was at 24c on Revenues of 48c with 73c in Cash assets PS.

Reported EPS was 0.149 for last year.

Any way - I assume that when the data gets changes of the random fair value ratings will change. I would expect that inclusion to the ASX300 will also spread the shareholder base a bit more.

Vendor PE EPS ASX 95 $ 0.120 Bloomberg 95.29 $ 0.130 Reuters 101.76 $ 0.120 IRESS 95.24 $ 0.126 Morningstar 84.62 $ 0.143 Poly 50 $ 0.240 From my estimation we are currently undervalued on an Asset basis by about 25-30% so I see this as a buying opportunity on dips


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ajshare
post Posted: Today, 09:55 AM
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Not sure the relevance of this trial done in 2010 to the NDA review. It was submitted /updated this week

Implant Pharmacokinetic and Pharmacodynamic Study

ClinicalTrials.gov Identifier: NCT03634137
Brief Title: Implant Pharmacokinetic and Pharmacodynamic Study
First Submitted : March 29, 2010
First Submitted that Met QC Criteria : August 14, 2018
First Posted : August 16, 2018 (Estimate)
Last Update Submitted that Met QC Criteria : August 14, 2018
Last Update Posted : August 16, 2018 (Estimate)

https://clinicaltrials.gov/ct2/show/NCT03634137

 
Desert Rat
post Posted: Today, 09:33 AM
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In Reply To: Clinhope's post @ Today, 08:31 AM

AMAG is a real company whereas PTN has been mismanaged and self-rewarding for management at the expense of shareholders. There is one drug approved for brem's indication, hypoactive sexual desire disorder, Addyi. However, Addyi completely flopped after approval and is now back in the original developers hands (Sprout Pharmaceuticals). But it has a "killer" Black Box Warning against concomitant alcohol ingestion, esp. if you think about increasing sexual desire w/o a little ethanol. I think the facts of Scenesse bode much better for the EPP indication since there is now a highly-detailed record of safe and effective use in the EU for 2+ years. I just hope the FDA's statisticians will give us a break since the original Scenesse phase III trials were simultaneously developing the relevant clinical endpoints for the EPP indication. The same thing happened in the brem trials wherein different endpoints were "chosen" for the final analysis, although they said it was done with FDA input. But overall, you are right: PTN is not an investable company and AMAG is the play if you believe brem will get approved, IMHO.


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Clinhope
post Posted: Today, 08:31 AM
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In Reply To: Desert Rat's post @ Today, 02:50 AM

There seems to be quite a few people here interested in Palatins Bremelanotide. As an investment opportunity surely youíd be looking at AMAG instead of PTN as AMAG will take exclusive rights of the drug and PTN only recieving royalties...



--------------------
PWC for life...
10am, 28th November 2017 = Final Not So Final Countdown to Blastoff to the moon or soft landing on nearby landing-pad.
https://www.timeanddate.com/countdown/launch?iso=20171128T10&p0=152&msg=Clinuvel+2017+Annual+General+Meeting&font=cursive
 
Desert Rat
post Posted: Today, 02:50 AM
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If Scenesse does not get a priority review at the FDA, we can look at the published review timeline for AMAG/Palatin's, cyclic melanotropin, bremelanotide, as a reference:

NDA filed on 3-26-2018
NDA accepted on 6-4-2018
PDUFA date is 3-23-2019, or nearly one year after the NDA was filed.


The Scenesse NDA was completed on 6-25-2018, and if it is a standard review, that means a PDUFA date in mid 2019, would be comparable to bremelanotide's timeline. Hopefully, we get a Priority Review.





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seeva222
post Posted: Today, 12:43 AM
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In Reply To: investek's post @ Yesterday, 09:59 PM

Did I mention how much I love these plays? The market-size is enormous. Even if they just got tiny traction, the implications are huge. Having a ready delivery channel, an expertise and product focus based upon that expertise that is clearly more than cosmetic is a powerful strategic advantage. They should target dermatology offices as well.


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investek
post Posted: Yesterday, 09:59 PM
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In Reply To: haigoooo's post @ Aug 15 2018, 12:47 AM

Great find!

The article below outlines the pathways from senescence to melanoma and includes MITF sumoylation.
I find it interesting that this was published in August 2017, how much earlier did Wolgen know of or suspect these pathways / mechanisms of action existed? I suppose the trademark was only filed this year so perhaps the sumoylation connection was new to Wolgen?

QUOTE
Pathways from senescence to melanoma: Focus on MITF sumoylation
Abstract
Cutaneous melanoma is a deadly skin cancer that originates from melanocytes. The development of cutaneous melanoma involves a complex interaction between environmental factors, mainly ultraviolet radiation from sunlight, and genetic alterations. Melanoma can also occur from a pre-existing nevus, a benign lesion formed from melanocytes harboring oncogenic mutations that trigger proliferative arrest and senescence entry. Senescence is a potent barrier against tumor progression. As such, the acquisition of mutations that suppress senescence and promote cell division is mandatory for cancer development. This topic appears central to melanoma development because, in humans, several somatic and germline mutations are related to the control of cellular senescence and proliferative activity. Consequently, primary melanoma can be viewed as a paradigm of senescence evasion. In support of this notion, a sumoylation-defective germline mutation in microphthalmia-associated transcription factor (MITF), a master regulator of melanocyte homeostasis, is associated with the development of melanoma. Interestingly, this MITF variant has also been recently reported to negatively impact the program of senescence. This article reviews the genetic alterations that have been shown to be involved in melanoma and that alter the process of senescence to favor melanoma development. Then, the transcription factor MITF and its sumoylation-defective mutant are described. How sumoylation misregulation can change MITF activity and impact the process of senescence is discussed. Finally, the contribution of such information to the development of anti-malignant melanoma strategies is evaluated.

https://www.researchgate.net/publication/31...ITF_sumoylation

Senescence - SCENESSE
https://www.trademarkia.com/scenesse-79088813.html

Sumoylation - TSUMOYL
https://www.trademarkia.com/ctm/tsumoyl-017877352.htm

At least Tsumoyl makes a bit more sense now and I donít just think of Sump Oil when I read it!



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seeva222
post Posted: Yesterday, 08:03 AM
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In Reply To: mrdax's post @ Aug 15 2018, 10:33 PM

Theyíre a meat clever. NICE has been designed to say No unless Yes is the only alternative.

And FTR, I donít blame their thinking.

 
mrdax
post Posted: Aug 15 2018, 10:33 PM
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https://endpts.com/biogens-big-breakthrough...-reimbursement/

QUOTE
Once again, UK regulators have proven that they are unwilling to pay a heavy price for the breakthrough drugs that the FDA enjoys hustling through to quick approvals.

In this case, the UK's NICE is at least temporarily closing the door on Spinraza, Biogen's landmark new therapy for rare cases of SMA, despite discounting the $750,000 US list price for the first year of therapy.

But without a better idea of the longterm impact of the drug on patients, some of whom face a death sentence at the age of 2, it wasn't possible to conclude that the price was justified.

[...] but the very high cost of nusinersen meant it could not recommend the drug as a cost effective use of NHS resources," noted Meindert Boysen, director of the centre for health technology evaluation at NICE.



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seeva222
post Posted: Aug 15 2018, 08:27 PM
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In Reply To: ajshare's post @ Aug 15 2018, 03:30 PM

Do most Derm drugs stop your face from boiling? Itís alreay been fast tracked


Said 'Thanks' for this post: PunkassDerm  mrdax  
 
 


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