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macgyver
Posted on: Dec 12 2018, 01:56 PM


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Posts: 289

I think an insto is still offloading, the volume has been down considerably when compared with the recent high rise action. Downward pressure abounds, hopefully only for a short while and then straight back up😜
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macgyver
Posted on: Dec 9 2018, 07:10 PM


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That certainly seems very plausible.
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macgyver
Posted on: Dec 8 2018, 05:20 PM


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Lol. Sounds like you’re writing Santa Claus a wishlist for Xmas. I think PW has written him one too, hence the comment on the Your Money program about hoping for an early Xmas present. There it is, we’re all praying to the gods and fairies now. Come down the chimney FDA!!!!
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macgyver
Posted on: Dec 8 2018, 05:16 PM


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Ne’er a truer word spoken that best represents the agony that this company mets out to its investors: excruciating.
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macgyver
Posted on: Dec 5 2018, 06:06 PM


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This is a long shot but lately the FDA are full of surprises. Does anyone think that the manufacturing inspections signify an impending priority review?
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macgyver
Posted on: Nov 24 2018, 02:14 PM


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Delete
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macgyver
Posted on: Nov 23 2018, 09:28 AM


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Attached Image



Insto still offloading?
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macgyver
Posted on: Nov 22 2018, 11:00 AM


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Thank you for your comments. Can you tell us Lachlan: Did there seem to be a noticeable contingent of Asian/Chinese investors in the audience?

The five year roadmap ends in 2024. "Clinuvel 2024"
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macgyver
Posted on: Nov 21 2018, 04:40 PM


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Posts: 289

Frogster's dissection of today's AGM does convey a sense of weariness at the same information being regurgitated over and over again. These AGMs are a lost cause. In the last 4 years there has only been one AGM I can remember that has presented what I would consider new or interesting information.

The problem is very clear: When you have a single product winding its way through regulatory purgatory, of which it takes 2-3 years per country depending on where the company sits regards having adequate trial data etc, the time in between is occupied by filler. To rehash old information/history in another way is a wasted opportunity for the AGM. Whats the point of telling people repeatedly about the imminent arrival of the data from the CUV103 trial when it would be more pertinent to let us know whether the supplier for the OTC products has sorted his shit out and is now on the cusp of supplying to market those goods which were announced for release in July of this year?

I understand the PRs released by Clinuvel throughout the year are a tactic to keep investors hanging on by a thread to hope that something imminent is about to occur, when in actual fact it is just filler to see us through the year. An example of this 'baiting' would be the slide that shows Australia and Japan in the approval stage. Dossiers haven't even been lodged to the corresponding authority in these countries let alone being anywhere near approval. This slide is inaccurate and it sucks.

Of all AGMs, this is the year in which all relevant news (barring any commercially sensitive information and considering the Clinuvel 2020 strategy) should have been laid bare to those shareholders who had the gumption to turn up to the meeting, albeit with a hint of reservation about what they might expect. What is happening regards Japan and Australia? What has happened to the OTC products? Have these products been sidelined as a strategic decision awaiting the outcome of the FDA review? What is happening with the NICE issue? How are preparations for the VP trial progressing?

There is a lot I would like to know, some important and some perhaps trivial to others, and I would have done myself a favour to turn up to the AGM. However, it is my sense of resignation to Clinuvel's secretive strategy that I would not be any the wiser had I stood up and asked those questions directly to PW. I can only hope that if and once FDA approval is in hand, that Clinuvel's communication culture will change dramatically (which I doubt), though it is reasonable to expect that it should change given the two biggest markets would then be in the pocket.
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macgyver
Posted on: Nov 21 2018, 10:53 AM


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Posts: 289

Someone here pointed out reporting obligations being reduced due to certain parameters being met (Frogster or ajshare?), which according to the AGM presentation is to occur in 2019. What effect does this have in general on share price performance, or other factors concerning the company? I would think that such a reduction in reporting would have minimal effect, but I am curious to know if historically there is more speculation from the market given it has less information at hand to work with.
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macgyver
Posted on: Nov 21 2018, 10:47 AM


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The Clinuvel 2020 strategy has been upgraded to Clinuvel 2021🙄🤣
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macgyver
Posted on: Nov 20 2018, 07:34 PM


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Congrats on the all-in my friend. By the way, that is the only motto Clinuvel should stick to: There is no such thing as a safe tan

This motto will be used to entice millions to buy Scenesse for melanogenesis, a browning of the skin as it were (at least that’s what someone told me it was)🤷🏽‍♂️
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macgyver
Posted on: Nov 20 2018, 02:19 PM


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Posts: 289

But the good Doctor Wolgen said in the Your Money interview last week that the FDA is more concerned with safety than efficacy. I find that hard to believe though since the FDA has approved some dubious substances in which you almost have to experience death before you get better. Safety, as Dr Wally eloquently reminds us, is indisputable with Scenesse. Which means it’s a two-trick pony instead of one...
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macgyver
Posted on: Nov 20 2018, 12:26 PM


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Dr Wally, afaik Scenesse does not induce tanning, period. It does however induce melanogenesis. In fact I don’t even know what tanning is. Never heard of it. Is it similar to a tannery?
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macgyver
Posted on: Nov 20 2018, 05:23 AM


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Posts: 289

That’s quite a list of issues to be raised, and rightfully so. Expect PW to get tetchy after about the third question....

Ironically, this year will be my first opportunity to attend the AGM, but I won’t be going. Melbourne traffic isn’t worth the non-info I hear...
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macgyver
Posted on: Nov 17 2018, 09:12 PM


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Single malt Walnut?🥃
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macgyver
Posted on: Nov 17 2018, 12:14 PM


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Given the FDA’s penchant for extending timelines, and how the cogs of bureaucracy turn slowly, FDA approval even with priority review will not occur till second half 2019 at the earliest imho. And I feel that’s being optimistic.

Six months for priority review then 4-8 weeks give or take for finalisation of review and miscellaneous paperwork might see approval granted between August and September 2019. Standard review might see approval in November/December 2019. If Clinuvel have learnt lessons from the European rollout, then I’d expect U.S. rollout to be somewhat expedited but I would think it a job well done to actually have first sales before the end of 2019. Remember, the above hinges on a PDUFA being issued before the end of this year, all in all for U.S sales to be up and running, I think it’s reasonable and realistic to expect that to occur a full year from now at the earliest...
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macgyver
Posted on: Nov 16 2018, 10:47 AM


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Definitely in the next 4 weeks🙏
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macgyver
Posted on: Nov 14 2018, 01:21 PM


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My man. Thanks for this.

Regarding the FDA will give approval, the Your Money headline was inaccurate.

I liked his dig at Shkreli spending 7 years in prison.
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macgyver
Posted on: Nov 13 2018, 01:45 PM


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Posts: 289

I watched it as well, at the bottom of the screen there was a headline saying " Wolgen: Clinuvel product will get FDA approval". Cant recall him saying that exactly so I hope the Your Money team didn't jump to conclusions or take what he said out of context. Trying to upload a photo I took of the headline but Sharescene won't let me upload. Besides, PW is too clever to make an unguarded statement like that I reckon...
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macgyver
Posted on: Nov 13 2018, 11:36 AM


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Posts: 289

This comment from the same Instagram post. Curious.
QUOTE
crystin_linares17#I'mCured!!! Oh my God😱 I'm So Excited I Can't Believe Herbs Could Cure Herpes I had for 5 years! This worked like magic to me. I'm forever grateful.
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macgyver
Posted on: Nov 11 2018, 03:32 PM


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Posts: 289

Don’t understand how their filing was accepted for review in 60 days when compared to Clinuvel’s scenario. I can only imagine their two Phase 3 trials must have been very successful, and that the submission was watertight. Something to aspire to...
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macgyver
Posted on: Nov 10 2018, 08:33 AM


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Posts: 289

Maybe the clock was started again. Do they need to give themselves a full 60 days to analyse new information? If so then I would expect a response or confirmation of acceptance of submission for review to be forthcoming no later than the end of January. Any later than that would be plain annoying and a travesty...
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macgyver
Posted on: Nov 9 2018, 03:02 PM


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Posts: 289

Happy wedding anniversary JohnnyTech. Hope you can buy your lovely wife that Rolls Royce Wraith she’s been pining after this time next year wub.gif
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macgyver
Posted on: Nov 9 2018, 09:49 AM


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Posts: 289

Hope the PDUFA date isn’t a bone of contention devilsmiley.gif
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macgyver
Posted on: Nov 9 2018, 05:48 AM


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Fair. I wasn’t sure what was going on to be honest, I was just hoping there wasn’t an RTF issued. Now, I’m more confident of approval than ever.
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macgyver
Posted on: Nov 8 2018, 09:43 PM


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Posts: 289

I think Johnny H wants to chat privately with you, which is cool by me. No big deal.

Johnny H and Johnnytech were adamant about the RTF. I think even Farma was pretty sure about it too. If you’re a stickler for the rules then by rights an RTF should’ve been granted. But really we were all in the dark about this, however PW clarified everything in the newsletter and showed us the FDA has discretion and levels of protocol dependant on the individual submission. That PR was the antidote to the speculation surrounding the possibility of an RTF.
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macgyver
Posted on: Nov 8 2018, 11:04 AM


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A new possible indication I read about on BBC: trichothiodystrophy.
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macgyver
Posted on: Nov 8 2018, 10:48 AM


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I imagine the distinction between standard and priority review is based on a very critical unmet need e.g serious life threatening diseases. The odds don’t look promising based on the record of the Dermatological Dept of the FDA. With that I’m assuming standard review will be granted even if Scenesse does meet statutory requirements.

The anticapation of an announcement regarding acceptance of submission for review is getting palpable, as evidenced in the rising share price. Surely we must hear something before the end of the year, no?
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macgyver
Posted on: Nov 8 2018, 10:07 AM


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Posts: 289

0.0001% for margin of error? devilsmiley.gif
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macgyver
Posted on: Nov 8 2018, 01:02 AM


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Bottlenecks. Invaluable patient data. Structure in place for further indication trialling. PASS has been a blessing in disguise...
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macgyver
Posted on: Nov 7 2018, 08:56 PM


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Posts: 289

X-Ray is faithful to the takeover...
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macgyver
Posted on: Nov 7 2018, 01:45 AM


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You’ve might have taken this out of context. The FDA has asked specifically about manufacturing and product, this says information about efficacy and safety, long term safety plan and paediatric information leading to evaluation and approval of manufacturing and product processes. I think there’s a difference in that the FDAs requests for info is not related to efficacy and safety concerning the drug, merely the manufacturing/product process itself. With that there is still discretion available to the FDA I believe.
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macgyver
Posted on: Nov 6 2018, 04:45 AM


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Posts: 289

Not sure why there seems to be this rigid adherence to regulation and law from some posters regarding an RTF. It’s completely feasible that there is flexibility in the way the FDA deals with individual submissions. Perhaps the rules are guidelines only, with the FDA being a large bureaucratic organisation it would be extremely wasteful of resources to issue an RTF simply because a reviewer requires more information about a less than critical component of the submission dossier.

I have more trouble believing PW’s story about the OTC delay rather than the FDA delay.
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macgyver
Posted on: Nov 5 2018, 03:04 PM


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Posts: 289

You're right, I place too much emphasis on timelines regards Clinuvel. I should know better, my bad. I'll go and sit in the corner...

P.S: I feel the vitiligo results from Singapore will be a blockbuster, considering its taken months to analyse the results from all 6 patients. A trove of data that cannot be analysed overnight, 6 patients is quite the workload... devilsmiley.gif
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macgyver
Posted on: Nov 5 2018, 02:49 PM


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Posts: 289

QUOTE
Due to unforeseen circumstances incurred by our suppliers, a knock-on effect was seen to CLIUVEL’s timelines for the new OTC product line and impacting the launch. We are confident that these issues will be resolved to ensure the registered product line can be launched in the New Year.


Don't see how this could've happened. PW announces new OTC product launch for sometime in July 2018. You wouldn't do this if you weren't confident you didn't have ample supply. The launch is now delayed by 6 months minimum. 6 months?? There is some other reason that PW is not telling us about, or he decided at the last minute to can it until the FDA accepts the submission for review.

To note, its quite possible we will see the famed vitiligo trial results from Singapore within the next 3 years....
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macgyver
Posted on: Nov 5 2018, 02:31 PM


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Posts: 289

If an RTF was to occur, it would've happened by now. An RTF should indicate that the submission was less than adequate in more than one important aspect. This newsletter, if it is to be believed, implies that the submission is more or less satisfactory in most areas.

Product and manufacturing are non-issues for me. If the FDA was asking for more data from EPP patients then that might indicate a problem with efficacy or safety, the biggest factors concerning the success of a submission or market approval. Since that hasn't occurred (yet), then essentially, the submission is about to be accepted for review.
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macgyver
Posted on: Nov 5 2018, 10:56 AM


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Posts: 289

Silly stock....🙄
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macgyver
Posted on: Nov 5 2018, 09:30 AM


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Posts: 289

Attached Image

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macgyver
Posted on: Nov 1 2018, 08:07 AM


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3Q18 beat 2Q18 dollarwise, sustained and improved compared with 2Q & 3Q 17. Very positive sign.

1Q19 over $5-6 million would be very impressive and indicative of increasing patient numbers, even through the winter months. The clinics could be starting to turn the tide regarding bottlenecks...
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macgyver
Posted on: Oct 31 2018, 03:45 PM


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Posts: 289

I’ve been trying to rationalise today’s trading. Doing so will lead to insanity, in which it appears you’re halfway there. Welcome to the club!!🤪🤪🤪
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macgyver
Posted on: Oct 30 2018, 10:27 AM


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Posts: 289

Attached Image



A lot of NXXT in there...🙄
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macgyver
Posted on: Oct 30 2018, 10:13 AM


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Posts: 289

Agreed, buying orders nearly matching sell orders.
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macgyver
Posted on: Oct 30 2018, 09:17 AM


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There’s no rationale for the current trading the way it is. The share price would be in free fall regardless. I figure the instos drove the price up to a price where they could start to offload all the way down to x amount. Watching the trades this morning, it’s clearly obvious someone (shorters?) is intent on driving it down. Why sell x amount of shares 50 cents below the last trading price? Knowing this I’m comfortable with the knowledge that this stock is still capable of being manipulated anyway the players see fit. It doesn’t change the outlook based on the fundamentals one iota...
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macgyver
Posted on: Oct 29 2018, 03:46 PM


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Posts: 289

I only really discerned 3 things from that PR:

- They're building a building.

- The building will house new analytical methods/tools.

- The sp dropped an enormous amount today.

Also, correct me if I'm wrong, did they say when they set up Vallaurix and did some studies that they discovered CUV9900? I thought they already had that before Vaullaurix was established. I dont know, its all getting murky again....
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macgyver
Posted on: Oct 29 2018, 03:18 PM


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Posts: 289

Lagoda and FIL did alright I think...
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macgyver
Posted on: Oct 29 2018, 02:21 PM


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Posts: 289

Is today the biggest one day loss ever?? FML...
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macgyver
Posted on: Oct 29 2018, 10:23 AM


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That announcement wasn't material to anything. It was pure rubbish. As stated, there is other more important news we could be updated on. Wouldn't hurt PW to actually tell us what he thinks the current time frame is for the FDA to review the information recently requested. Or some tidbit. I didn't find the mention of new analytical tools inspiring.

I need some soothing SP rise ointment....
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macgyver
Posted on: Oct 29 2018, 09:46 AM


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Wow, what a catastrophe...🤷🏽‍♂️
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macgyver
Posted on: Oct 26 2018, 09:53 AM


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Off market trade? Its usually recorded somewhere on a trading platform. Special rule allowing trades to go through off the books so to speak?
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macgyver
Posted on: Oct 26 2018, 09:46 AM


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Posts: 289

LevelHeaded, whilst I appreciate your efforts to assuage the anguish I feel at not having bought at the bottom, it cannot diminish the reality that most gamblers experience when they regret the timing of their bets.

That aside, I am confident Clinuvel's sp will be right back up over $25 in short order. However, in every instance regardless, I like to win.
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macgyver
Posted on: Oct 26 2018, 07:15 AM


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Damn, I should’ve bought shares today...
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macgyver
Posted on: Oct 24 2018, 02:14 PM


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25% slide? Yes, I'm thankful its not 50%.

I should waited till today instead of yesterday to spend my super on Clinuvel shares. What a bugger...
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macgyver
Posted on: Oct 20 2018, 07:06 AM


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Posts: 289

I’m ashamed to say this, but XP would be more lucrative than HHD, although I have longed hoped that HHD would soon become an official indication given its particularly nasty characteristics.
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macgyver
Posted on: Oct 20 2018, 07:02 AM


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Posts: 289

He’s self administering to test its effects on autism, if X-ray is to be believed that PW is indeed a savant.
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macgyver
Posted on: Oct 19 2018, 08:11 PM


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Lol
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macgyver
Posted on: Oct 19 2018, 06:17 AM


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I’ll be contributing to that short squeeze. As of today. I’m going all in with my SMSF on Clinuvel, and if all goes well I’ll live well till I retire and when I retire I will still be living well 😉💵💵💵

Ladies and gentlemen place your bets, the ball is spinning🎲♥️♣️♠️♦️
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macgyver
Posted on: Oct 18 2018, 04:30 PM


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Nice work. I thought this was happening but I was unsure especially after the shake last week. Now we have proof. Onwards and upwards smile.gif
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macgyver
Posted on: Oct 16 2018, 07:41 PM


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I see CUV9900 is breaking out and making a run to the finish line. What’s going on there??
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macgyver
Posted on: Oct 16 2018, 03:28 AM


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I can’t queue higher than $25. Sad...
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macgyver
Posted on: Oct 15 2018, 07:47 PM


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Outrageous, they’re selling themselves short!!
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macgyver
Posted on: Oct 15 2018, 11:34 AM


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Tiddlywinks..
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macgyver
Posted on: Oct 13 2018, 09:03 PM


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“North Korea nuclear naughty boy Kim Jong Un”

“Dr Doom”.

Can someone ask who Giles Delaney is at the AGM? 🤣🤣🤣
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macgyver
Posted on: Oct 13 2018, 08:54 PM


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Thank you for posting, a very interesting read. An insight into how the reimbursement was negotiated in other European countries, the first time I had seen PW mention anything directly about how the pricing was worked out regarding patient number thresholds.

And he is exactly right: if it’s good enough for the EMA then it’s good enough for NICE. What’s the point of having an EMA? (Pre-Brexit that is😈)
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macgyver
Posted on: Oct 12 2018, 03:18 PM


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Not too bad today, all things considered.
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macgyver
Posted on: Oct 12 2018, 03:32 AM


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Posts: 289

An RTF is a material event, and one that should be communicated accurately to shareholders. Clinuvel could be sued for not doing so as it could result in investors losing money no matter how short the time frame is. Clinuvel are expert at presenting information in a very grey manner at best and utterly fudging the truth at worst so I wouldn’t be surprised if this was the case on this occasion.

But as mentioned already, several statements about impending PDUFA dates and “expected information” could imply an unforeseen loophole, or perhaps since it is mostly technical information the FDA is waiting for there could be an allowance for Clinuvel to submit without affecting the status of their submission, even more so if the FDA has already accepted 80-90% of the content of the rest of the NDA which contains “ the guts” of it, so to speak..
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macgyver
Posted on: Oct 11 2018, 11:09 AM


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Don’t worry too much Yolo, I have faith in Clinuvel.
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macgyver
Posted on: Oct 11 2018, 06:39 AM


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Particularly if it’s overvalued....
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macgyver
Posted on: Oct 10 2018, 08:12 PM


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Well, I’m always learning... I didn’t know what EPP was 10 years ago, and I also used to ignorantly think EPP sufferers could just “stay out of the light”. I reckon 95% of Australia’s population doesn’t know what EPP is. That’s why porphyria groups should keep fighting the good fight and educating folks, such is the rare and strange nature of this disease.
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macgyver
Posted on: Oct 10 2018, 04:42 PM


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Posts: 289

I think it’s less a corruption problem and more an education problem concerning the NICE members. While it was very poor form for that doctor to say that EPP patients could stay out of the light, it could be said that he, like many others before who have eventually come to understand this disease and the psychology of its sufferers, is just simply not up to speed with it. This means he should be chastised not once but twice: once for making a dipstick comment, and again for making an assumption without knowing the facts!
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macgyver
Posted on: Oct 10 2018, 05:23 AM


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Posts: 289

A confluence of factors may affect the share price over the next 3 weeks:

- The ASX experiencing consecutive drops to the point where it is approaching technical support,

- Continual rebalancing by certain instos,

- Volume still averaging higher compared with three months prior,

- CLVLY and UR9 opened lower yesterday but finished higher with what could be labelled fair volume. Interesting to see whether the recent spruiking of Clinuvel by PW and Co draws more attention to the these stock codes,

- Jitteryness concerning FDA NDA and when it starts,

- General economic conditions approaching similar indicators with the recession of 2008.

I’m expecting a PR concerning the NDA and the requested information within or at the end of the next 3 weeks (60 days total from date of request/relevant PR). I do expect the sp to be volatile regardless of PDUFA being announced especially if priority review is not granted. Overall I do expect the sp to climb gradually towards PDUFA date, this stock is not overvalued yet.

NICE is proving to be a pain in the neck and I have compartmentalised it already as being lost to Clinuvel. Bigger fish to fry somewhere else.
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macgyver
Posted on: Oct 9 2018, 02:51 PM


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I think you're spot on.
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macgyver
Posted on: Oct 9 2018, 02:36 PM


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On further reading, it remains to be seen whether the appeals upheld will be enough for NICE to approve.

Appeal by International Porphyria Patient Network (IPPN)
Appeal point Ground 2.1: The committee failed to act fairly by not acknowledging the evidence provided in patient testimonies and by expert physicians on the overwhelming clinical benefit.

- Appeal point was not upheld. A somewhat critical factor considering patient testimonies were used in the EMA's approval decision.

- Not sure how Clinuvel could capitalise on the fact that NICE was unreasonable by stating afamelanotide provides small benefits. If Clinuvel were to be successful in the final NICE decision, I think their argument hangs tentatively on this aspect. Patient testimonies no longer play a part moving forward.

- The other possibility for Clinuvel is the discrimination aspect against EPP sufferers, in that there is no other treatment available and NICE's decisions/behaviour denies EPP patients access to treatment. With this I guess NICE and Clinuvel could come to an agreement with the managed access scheme, however NICE would negotiate the hell out of the pricing way down to a level that Clinuvel possibly won't accept.

- The appeal panel's judgements seem fairly weighted without further analysis. Two options then: Agree on a lower price for Scenesse with full discretion possibly lower than the lower end of the pricing band agree in Germany OR straight to the High Court.
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macgyver
Posted on: Oct 9 2018, 02:09 PM


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edit
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macgyver
Posted on: Oct 9 2018, 10:37 AM


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Still waiting on one for going too fast to $22🤣
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macgyver
Posted on: Oct 9 2018, 10:28 AM


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Instos giving themselves some headroom to offload post haste, could still be a few weeks left of this kind of action.
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macgyver
Posted on: Oct 9 2018, 09:33 AM


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Tree shake...
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macgyver
Posted on: Oct 8 2018, 04:08 PM


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Its a problem I have with the current strategy. Regardless of whether Clinuvel obtains FDA approval, they still have work to do in Europe. This intense singular focus on the FDA blindsides Clinuvel to anything else. FDA approval is not contingent on keeping a low profile across the globe. It's approved in Europe for God's sake!

I understand meeting requirements to list on the NASDAQ, but like I mentioned before, theres a whole lot of money burning a hole in Clinuvel's bank account that needs to be put to work. Otherwise I'm going to give my crusty old friend Carl Ichan a call and get him down to the AGM to agitate for change!!!
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macgyver
Posted on: Oct 8 2018, 02:22 PM


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Including the requisite increase in share price of course Mr LevelHeaded....
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macgyver
Posted on: Oct 8 2018, 08:59 AM


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Copy that, makes sense now.
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macgyver
Posted on: Oct 8 2018, 08:59 AM


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Posts: 289

Investor presentation Sachs 18th Biotech in Europe

https://www.asx.com.au/asxpdf/20181008/pdf/...1lz45q14r6h.pdf
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macgyver
Posted on: Oct 8 2018, 08:54 AM


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Edit: 2.7 % of shares not 2.7 million.
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macgyver
Posted on: Oct 8 2018, 08:39 AM


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I'm curious about the status of ACN 108 768 896 Pty Ltd. This entity is supposed to be a subsidiary of Clinuvel, formerly known as EpiPharm (the original Epitan holding company?). It holds 8% of Clinuvel's shares. How does a subsidiary hold shares in a parent or holding company? I take it some legal gymnastics has taken place.

Edit: Epipharm was divested back in 2006 by Clinuvel, which possibly means GenePharm Australasia Ltd. is a major shareholder in Clinuvel. However, ACN 108 768 896 Pty Ltd is still registered in Melbourne 3000. Curious....
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macgyver
Posted on: Oct 8 2018, 08:30 AM


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I think it's high time Madman was given a seat on the board should Biljdorp move up to Chairman, his stake plus his superfund puts him up there not far behind PW at 2.7 million shares. Would be good to have another Melburnian on the board besides Ms Shanahan. After all it is a Melbourne company not a European one....
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macgyver
Posted on: Oct 5 2018, 02:56 PM


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Interesting. I wonder if they know something about Priority Review already and they’re setting the stage for Stan’s exit.
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macgyver
Posted on: Oct 5 2018, 11:37 AM


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I knew it was too early🤷🏽‍♂️
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macgyver
Posted on: Oct 5 2018, 10:25 AM


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Correct me if I’m wrong but I’m guessing you have vitiligo?🤷🏽‍♂️
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macgyver
Posted on: Oct 4 2018, 05:35 PM


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Adieu $22, we only knew you for a short while.

Delicious finish today.

Its too early isn't it? Sorry....
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macgyver
Posted on: Oct 4 2018, 01:55 PM


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Lagoda no longer a substantial holder. See announcements.

We’re moving up.
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macgyver
Posted on: Oct 3 2018, 10:09 PM


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I prefer consolation to consolidation, or constellation for that matter🤷🏽‍♂️
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macgyver
Posted on: Oct 3 2018, 05:15 PM


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I’m not a fan of sideways action.
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macgyver
Posted on: Oct 3 2018, 06:30 AM


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Maybe they’re counting on patient testimony for this indication as well...
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macgyver
Posted on: Oct 2 2018, 05:49 PM


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Waiting for someone to burn the shorts.
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macgyver
Posted on: Oct 2 2018, 09:56 AM


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Out of napkins.
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macgyver
Posted on: Oct 2 2018, 01:57 AM


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Never won lotto, too hard.
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macgyver
Posted on: Oct 1 2018, 05:00 PM


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I completely agree with your assessment, particularly with vitiligo and also running parallel indications. Getting over the line with the FDA is key to everything, hopefully it might snowball from there...

Farma I think the U.S for EPP is already starting to factor into the share price. Interesting to see where it ends up by time of FDA approval.

The family of porphyrias to be treated by Scenesse, what is the total number of potential patients? Mind-boggling.

100k shares shifted in the last 13 minutes of open market trade today? 700k or less to go in my napkin calc before the price moves up from $22.
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macgyver
Posted on: Oct 1 2018, 02:33 PM


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Another high quality post, cheers Farma and Levelheaded😄
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macgyver
Posted on: Oct 1 2018, 10:18 AM


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Is this THE second indication?
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macgyver
Posted on: Oct 1 2018, 05:29 AM


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$120?
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macgyver
Posted on: Sep 30 2018, 03:12 PM


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I’m ready for no PR, I expect it actually. Preferably PR is ideal but I can wait. The only thing that would be irritating is dragging out the NDA past it’s 10-12 month timeline as what happened in Europe. This time around there is no excuse to drag it out, there are very clear guidelines that the reviewers follow and the benefit of the doubt should be given to Clinuvel concerning efficacy due to patient retention and safety profile. To go beyond the timeframe is inexcusable.

The odds are not in favour of Clinuvel due to zero percentage of PRs issued from the FDA’s Dermatology and Dental department. Though in saying that, I couldn’t tell you what kind of indications and their severity PR was applied for previously. EPP might very well be a first due to the severity of it but I would be surprised if it was the first of its kind to gain PR. Opportunity for research...

If PR is granted, I’d take that as an approval and I think the market will respond accordingly in the positive.
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macgyver
Posted on: Sep 28 2018, 05:58 PM


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Posts: 289

From Commsec: Not sure if its up to date regarding Fidelity going below 5% threshold.

Morningstar rates Clinuvel as overvalued, even though they have updated their values upwards as the stock price climbs...

Attached Image

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macgyver
Posted on: Sep 28 2018, 03:48 PM


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I’m predicting a $22 finish today.
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macgyver
Posted on: Sep 28 2018, 02:58 AM


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Whoops excuse the language....
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macgyver
Posted on: Sep 28 2018, 02:38 AM


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You've never been here before....

Fuck vitiligo bro.

It'a a 5 year dream....

XP is where its at. Jump on before the Japanese leave you behind....
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macgyver
Posted on: Sep 27 2018, 06:00 PM


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Posts: 289

Today’s trading pattern similar to last 2-3 weeks, before trading begins someone has a price in mind they would like to finish at by the end of the day whilst moving a ton of shares. Uncanny how we land on $22, someone was sniffing around that number all day😝

Maybe Mammon will let it go up tomorrow🤷🏽‍♂️
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macgyver
Posted on: Sep 27 2018, 01:35 PM


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Anyone got the latest insto shareholding numbers?
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macgyver
Posted on: Sep 27 2018, 01:18 PM


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$120
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macgyver
Posted on: Sep 27 2018, 10:44 AM


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Volume is up considerably within the first 45 mins of trading (128k)

Big day coming up, this stock is hitting critical mass.
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macgyver
Posted on: Sep 27 2018, 12:06 AM


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Hell yeah.
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macgyver
Posted on: Sep 26 2018, 10:10 PM


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Sphene is probably more on the money with their napkin calcs, $40 AUD seems quite high based on European EPP. Cobi has pencilled in end of June 2019 so certainly doable👍
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macgyver
Posted on: Sep 26 2018, 04:05 AM


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A long time I take it😥 Even EPP has some way to go before revenue streams have matured in the four markets Clinuvel is targeting. Reinvestment of profits into further development and trials simultaneously in different regions once EPP approvals are established is the only way to go in my opinion.

It’s in PWs interest to take a leaf out of Jeff Bezos’ book and increase expenditure to reach a point where approvals for other indications in different regions are happening in quick succession (I know, this is the pharma industry. Nothing is quick). If we continue at the current rate of progress (regulator obsfucation, lobbying from powerful competitors etc notwithstanding) then PW will be an old man by the time Clinuvel is well entrenched in the industry.

I don’t need dividends (though they are greatly appreciated), I just need $200 a share 5 years from now🤷🏽‍♂️😝
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macgyver
Posted on: Sep 26 2018, 03:49 AM


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A mix of both. Currently the share price is surging in anticapation of FDA approval sometime next year. I foresee similar circumstances occurring with the other indications. Having approval in Europe and the US sets up solid fundamentals for the company to drive expansion expeditiously if not already. The napkin doesn’t take into account CNS indications either.

For the longest time the share price responded only to positive quarterly results and material information. Now investors are anticipating future revenue streams. So I think this will be the case in the near future with other indications. Similarly with oncology drugs and other potentially highly profitable indications, some companies have share prices that the layman would consider unjustifiable given no revenue or the drug in question is only at Phase 2. However the anticapation is there and reflected in a crazy share price. This type of behaviour might drive Clinuvel share price to continual new heights, albeit over a period of time.
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macgyver
Posted on: Sep 26 2018, 02:08 AM


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Based on XP, EPP, vitiligo and cosmetics, this stock is worth in excess of $200 per share. I think recent activity suggests new investors and instos are waking up to this potential. Monolithic....
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macgyver
Posted on: Sep 26 2018, 01:50 AM


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My napkin has conservatively calculated XP to be worth $3.8 billion over ten years from start of sales.

Japan = 1/22,000 prevalence. Pop: 127 million/22,000 = 5772 patients approx. (round down to 5700)

Europe/USA = 1/250,000 prevalence (more for Europe). Combined pop: approx 1 billion/250,000 = 4000 patients approx

(5700 + 4000)/2 = 4850 (divide by half for conservative estimate).

4850 patients at $80k AUD per annum = $388 million AUD per annum.

Exclusivity extended in Europe? Not sure. If not then the $3.8 billion figure comes down considerably. However, experience gained in the rollout in Europe should expedite rollout in the U.S thus leading to a second indication being granted with substantial exclusivity in the U.S and limited exclusivity in Europe. (Another two years minimum before receiving XP approval in Europe leaving 4 years or less. 3-4 years exclusivity in Europe is not to be dismissed and is still rewarding by any measure.)

Europe should be first off the rank concerning XP trials, if only because EPP is already approved and a second indication less difficult to obtain. However, Clinuvel may be required to market Scenesse Enfance first. If so, then I guess the US following FDA approval can commence XP trials. Alternatively, Japan with its higher prevalence of XP patients, smaller geography and developed economy, may be better suited to participating in XP trials because of higher number of available patients.
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macgyver
Posted on: Sep 25 2018, 03:19 PM


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Attached Image
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macgyver
Posted on: Sep 25 2018, 02:53 PM


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I’m hearing ya. Long and strong brother💪🏻
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macgyver
Posted on: Sep 25 2018, 02:39 PM


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What’s to know? We’re going to $30 today mate!🤣🤣🤣


In all seriousness, it’s making me nervous. Anyone derisking?
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macgyver
Posted on: Sep 25 2018, 01:10 PM


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Posts: 289

I don’t see why you couldn’t attend the AGM being a CLVLY holder. Doesn’t seem right to deny entry to our fraternal brothers, and sisters of course🤝✊
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macgyver
Posted on: Sep 25 2018, 12:14 PM


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Healthy appetite for shares still showing....
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macgyver
Posted on: Sep 24 2018, 12:29 PM


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Making fortunes by the minute seems so passé now... devilsmiley.gif
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macgyver
Posted on: Sep 24 2018, 12:13 PM


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Posts: 289

Well, I was premature by two weeks rolleyes.gif

What is happening is exactly how Johnny H predicted it would go. Supply becoming very tight and the potential for substantial gains to be made in a short period of time. Expecting some volatility along the way, however if the share price surges more then it should build up a nice buffer should Clinuvel not get a priority review or some other issue occurs.
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macgyver
Posted on: Sep 21 2018, 04:47 PM


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As Verhaven posted this morning, CLVLY and UR9 made gains last night. I was expecting an announcement this morning but nothing came of it.
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macgyver
Posted on: Sep 21 2018, 04:33 PM


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Posts: 289

I think FIL still offloading (no reason to think they are not) If it was their 1 million shares dumped on the market then the volume for this week might bring their holding down to less than a million, provided the 500k gets absorbed quickly on Monday.

Not long until they’re out then.
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macgyver
Posted on: Sep 21 2018, 04:13 PM


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Posts: 289

FIL pushing through the last tranche sub $19 before Monday perhaps.

Tipping point.
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macgyver
Posted on: Sep 21 2018, 04:04 PM


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Posts: 289

What the...???

Attached Image



1m shares bid for in aftermarket? 👀
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macgyver
Posted on: Sep 21 2018, 11:20 AM


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Mammon is allowing the stock to rise today. Did someone sacrifice a lamb at the altar?


Edit: Scrub that, someone is pulling it down🙄
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macgyver
Posted on: Sep 20 2018, 10:32 AM


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Posts: 289

I’ve been thinking about the shift in strategy to XP indication/ DNA repair related indication before commencing with vitiligo. Any clues as to why this is the case?

- Maintain higher pricing per implant? (Shouldn’t be an issue given prevalence of vitiligo patients, even at reduced price per implant)

- OR vitiligo trial results less than adequate or waiting on new delivery method to improve pigementaion such as Vallaurix topicals?

- Easier to obtain approval for XP indication?

- Or is XP a launch platform to treating similar DNA repair- related indications, which maintains higher pricing whilst treating very large pool of potential patients leading to more profitability in the interim versus treating vitiligo?
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macgyver
Posted on: Sep 20 2018, 10:03 AM


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This page is unavailable, or needs updating. An old link perhaps?
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macgyver
Posted on: Sep 18 2018, 06:32 PM


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Past few days definitely increasing incrementally. Possibly more than 2-3 cents at a time.

Attached Image



Not going backwards? Wonderful.
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macgyver
Posted on: Sep 18 2018, 12:38 PM


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Posts: 289

I tried to sell some shares this morning at $100 before the open on the off chance that some idiot had a bid in for $100. I knew it was a long shot😁😁😁

How controlled is the sp rise the last few days?? Are we only moving up in 2-3 cent increments per day?? 🤣🤣🤣
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macgyver
Posted on: Sep 15 2018, 11:03 PM


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This may be relevant. Not sure if Scenesse falls within the five classes. I assume since the U.S health insurers are paying they may have a lawful obligation to front up.

[attachment=50463:998ECD68...07D8DA2C.png]

https://bcht.berkeley.edu/sites/default/fil...ma%20120914.pdf
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macgyver
Posted on: Sep 15 2018, 05:53 PM


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Depends on the type of health insurance package they select? Pay a higher premium to get expansive coverage?
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macgyver
Posted on: Sep 15 2018, 12:24 AM


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60 days for resubmission, approved in October 2010. Doesn’t seem too bad at all...
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macgyver
Posted on: Sep 14 2018, 11:38 PM


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I think you’re wrong, I don’t think we got an RTF at all. As stated by others, how would Clinuvel get all this way with workshops, orphans status, etc just to fall over at the very end? It is incredibly frustrating to think this time money and effort would count for nothing, particularly if Dr Wright’s comment about the requests from the FDA for two seemingly minor issues is what the NDA submission hinges on.

I know Farma states unequivocally that it was an RTF, then another poster (AJShare or yourself perhaps?) posted that there was a procedure in place for the FDA to request further information OR ask further questions about the submission without issuing an RTF. The latter makes sense: it is onerously unfair if the FDA rejects outright a submission if there are a couple of losse ends to tie up and make the submission watertight IMHO.

As clarified by Royco, the FDA is asking about patients coming on treatment, not more data from current patients. Shit, I could be wrong about everything and it’s been setback, but I’m optimistic and take the good doctor at his word. unsure.gif
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macgyver
Posted on: Sep 14 2018, 11:26 PM


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I see. I had a look back through the PRs, Dr Dennis Wright mentions that the FDA is asking for “real world evidence of EPP patients coming on treatment in Europe”. This may mean documentation about new patients including referrals from GPs, registration for treatment etc. That would be positive since the FDA may deem current patient data to be sufficient for the NDA.

I’m sure Clinuvel will take their time to submit requested information, though I don’t believe it should take more than 90 days to provide said information.
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macgyver
Posted on: Sep 14 2018, 10:20 PM


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Good question, how often is the patient data submitted to the EMA? Quarterly?

This request seemed a little open-ended, so for the sake of fairness from the FDA I guess maybe the current quarter only or perhaps the data from the last quarter which may take time to edit and compile for consumption.

Disturbing that all previous patient data submitted to date is not sufficient, or I’m reading it wrong. It’s the only thing that bugs me about the delay. Everything else is easy.
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macgyver
Posted on: Sep 14 2018, 06:14 PM


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Agreed. His job is done.
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macgyver
Posted on: Sep 14 2018, 12:14 AM


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You know how it is at the big end of town. Assume the position.
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macgyver
Posted on: Sep 12 2018, 01:48 AM


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That was reassuring also, I don’t expect reimbursement problems in the US admittedly. No budgetary issues there comparable to the NHS for example. With U.S health insurers willing to pay for Scenesse administered in Europe, this should be one less issue for PW and Co to deal with whilst contributing to an expedited rollout.
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macgyver
Posted on: Sep 11 2018, 09:29 PM


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Looking at the maps in the presentation released the other day, I noticed there were EPP centres in Spain and France. The European Porphyria Network has a map that is essentially identical although it does include centres in Turkey, Bulgaria(?), Moscow and Hungary. Hungary is in the EU though it would be difficult for EPP patients let alone the country to afford payment for Scenesse.

Also of interest to me was the map for the U.S EPP centres. It was my hope based on past experiences with the rollout in the EU that Clinuvel would be thoroughly on top of their game when rollout begins in the U.S. In a way this map provides some assurances that Clinuvel is thinking about the rollout, however I won’t count my chickens just yet.
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macgyver
Posted on: Sep 11 2018, 04:01 PM


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Much more measured buying and selling today. Feels like another FIL offload.
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macgyver
Posted on: Sep 11 2018, 04:02 AM


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Clinuvel is a bit more resilient because of what it sells, usually it’s bucked the market trends.

By the way, I think we’re headed to $25 but no more. Still have to leave a little upside based on Sphene’s $32 estimation😉

As always I’m glad to be wrong if it goes higher.
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macgyver
Posted on: Sep 10 2018, 12:37 PM


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Posts: 289

$20 by close of business isn’t looking so absurd now.

Please PW, don’t smoke any reefers with Joe Rogan.

Lachlan, you need to stop smoking reefers, period.
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macgyver
Posted on: Sep 10 2018, 11:27 AM


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Posts: 289

Would XP be easier to receive a label extension than for vitiligo?

Given the prevalence of XP sufferers in Japan, Clinuvel might be preparing for an assault on the Japanese market with both Scenesse and T’sumoyle.

Very pleased about the strategic focus on XP.
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macgyver
Posted on: Sep 10 2018, 11:07 AM


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Posts: 289

I guess so, it’s not often I see the offer side finish halfway down the list compared with the bids. If demand keeps up I don’t see why the sp couldn’t reach $20 today. That couldn’t happen could it, that’s just absurd😄😄
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macgyver
Posted on: Sep 10 2018, 10:52 AM


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Offers are depleting quickly...
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macgyver
Posted on: Sep 8 2018, 11:55 PM


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I’d guess no, although Clinuvel appears to want to step out into the limelight now (ASX300, NASDAQ) so by rights they should release a presentation on the ASX

Is it too obvious to say that if Clinuvel does have a presentation it will closely mimic a baboon’s ass rather than match the quality of Immutep’s?
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macgyver
Posted on: Sep 7 2018, 01:36 PM


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129,000 on sell vs 61,000 buy yet the sp is currently at $15.25???

I’m going back to sleep, hopefully it’s at $20 by the time I wake up🤣
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macgyver
Posted on: Sep 7 2018, 08:54 AM


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Posts: 289

Salt is becoming scarce.
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macgyver
Posted on: Sep 7 2018, 08:45 AM


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Posts: 289

Great. Clinuvel had all three feathers in their cap and still managed to fuck it up.
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macgyver
Posted on: Sep 7 2018, 08:12 AM


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Posts: 289

Now that it’s official, maybe fund managers might open the faucet a little early? Sorry I should say it’s already started🙄
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macgyver
Posted on: Sep 6 2018, 09:53 PM


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Posts: 289

Many tiny buys trying to keep the sp elevated, usually it’s the other way around. An agreement in place to move some FIL shares aftermarket at circa above $14?

Still strong interest with more to come in my opinion. I think the smart money knows now leading up to ASX 300 to get in quick, regardless of delays with the FDA. We’ve been here before and I don’t foresee any disastrous rejection, it’s a formality.

Fast track, rolling review, patient and expert workshops, orphan status: if it doesn’t get approved with all this behind it I might as well become a eunuch.
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macgyver
Posted on: Sep 5 2018, 03:41 PM


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Posts: 289

“The share price? I corrected it sir”....

Attached Image

Still a lot of interest in this stock, considerable volume with sp coming back somewhat. She’ll be right.
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macgyver
Posted on: Sep 5 2018, 03:36 PM


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Posts: 289

Damn, that’s kaka. I stand corrected.
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macgyver
Posted on: Sep 5 2018, 03:13 PM


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Posts: 289

Not the first time FDA has asked a company for more information. Let’s take it at face value and call it a request for more information. A refusal to file letter? No.

The data request was made under the “rolling review”. Code for : we didn’t get it right.

Manufacturing data? Pfft whatever. Piece of piss.

More data from European EPP patients? This is the sticky one for me. Why this? Just to be sure? I don’t like this request.
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macgyver
Posted on: Sep 5 2018, 10:14 AM


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Posts: 289

SP stabilising.
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macgyver
Posted on: Sep 5 2018, 02:29 AM


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Posts: 289

Puppeteering is an honorable profession, though a Jim Henson only comes along once every so often. Don’t be a miser, pay for the kid’s tutu if that’s what they want to do in life🤣
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macgyver
Posted on: Sep 5 2018, 02:26 AM


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Posts: 289

It’s a good problem to have, only nuclear war or an asteroid striking the Earth is going to plummet the sp from almighty highs to junk status. I’m guessing there will be more pressing concerns when the market has been destroyed in a ball of fire....

I’m seeing it through to my target price or close to, nothing less.
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macgyver
Posted on: Sep 4 2018, 06:45 AM


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Posts: 289

I was anticipating notification this Friday, at the latest that is.
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macgyver
Posted on: Sep 3 2018, 05:02 PM


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Another impressive show of interest if somewhat muted compared with Friday’s action. Perhaps a gradual walk to $20, which is fine.
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macgyver
Posted on: Sep 1 2018, 09:50 AM


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Posts: 289

Ask a broker.
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macgyver
Posted on: Sep 1 2018, 07:53 AM


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Posts: 289

Australians get a 50% tax discount on capital gains if the investment has been held for longer than 12 months. Not sure about about other people on this site, but given the high earning capacity of my usual trade, I usually factor in 25% tax on capital gains. This is the highest I can expect to pay. Yes I wish I had set up a trust for the shares years ago with multiple beneficiaries so I could spread the tax burden but I was too dumb then. Not too dumb to know what to do with the money now😉
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macgyver
Posted on: Sep 1 2018, 06:20 AM


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Posts: 289

If you were foolish enough to sell your shares because of what someone said on this site then I’m sorry, it’s foolish...
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macgyver
Posted on: Aug 31 2018, 12:11 PM


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Posts: 289

Definitely not.
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macgyver
Posted on: Aug 31 2018, 11:42 AM


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Posts: 289

Two things would impress me:

- getting to $15 by close of business today

- Staying there and beyond.
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macgyver
Posted on: Aug 31 2018, 01:05 AM


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Posts: 289

Is that 0% have obtained priority review?? I understand dermatology and dentistry is not quite up there with cancer in terms of expedition, but surely it’s all relevant to each own’s division no?

18 months on average for NDA review? I need a tonic water.
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macgyver
Posted on: Aug 30 2018, 07:09 AM


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Posts: 289

The shares would convert straight over. No foreseeable problems.
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macgyver
Posted on: Aug 30 2018, 07:01 AM


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It would appear there is more to this than meets the eye regarding acquisitions. Obviously the remit for Keamy doesn’t include any random acquisition, it will be strategic and specific to the core strengths of the company. It is an apt goal if it puts to work the money sitting in the bank. It’s burning a hole and it needs to make money very shortly, future vitiligo trial costs aside. I’d like to see a better return than what term deposits currently pay...
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macgyver
Posted on: Aug 29 2018, 09:09 PM


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Posts: 289

VLX001, CUV9900 AND complementary OTC? Maybe the cosmetics are in addition to the molecules. Handy to have an extra arrow in your quiver.

Clinuvel gearing up for ASX 300, and hopefully this will mitigate some of the manipulation we’ve seen for the last few years. More volume, less erratic sp behaviour.

Eccentric leadership indeed. When I heard PW laughing in the interview with the vitiligo journalist Lee Thomas, I realised then he is eccentric...
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macgyver
Posted on: Aug 28 2018, 12:09 AM


Group: Member
Posts: 289

I take it you’re not a fan of removing the requirement to issue quarterly reports as Trump wants. Bless you, you’re not on his team...
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macgyver
Posted on: Aug 22 2018, 05:38 AM


Group: Member
Posts: 289

I thought it was an unusual PR, most of the information contained within seemed fairly uninteresting, as in it was in line with our expectations and not much new information. And the timing seemed unusual as well, right before the imminent priority review decision. A general PR for retail investors and others perhaps when Clinuvel moves up to the ASX300 as the new kid in the block?
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macgyver
Posted on: Aug 14 2018, 03:12 PM


Group: Member
Posts: 289

I’m not expecting much for 15 days, give or take. But as always price might spike or deflate on backroom news... By the way I was just in L.A, happy to kick your balls anytime Johnny👍
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macgyver
Posted on: Aug 9 2018, 03:00 AM


Group: Member
Posts: 289

I wonder if this will set a legal precedent regarding the definition of disability concerning NICE should this make it to the High Court. I have no doubt Clinuvel will win, the question is at what price?
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macgyver
Posted on: Aug 7 2018, 02:03 PM


Group: Member
Posts: 289

You’re right about keeping key people, and Clinuvel’s limitations. BH usually keeps management in place for companies they acquire, those managers know how to run the business better than them. Fortunately BH can afford to buy whole enterprises outright so synergies isn’t a priority. Admittedly it’s not fair to compare BH with Clinuvel, however I’m reticent to base company performance on a dodgy website. Acquisitions might be a hidden strength?
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macgyver
Posted on: Aug 7 2018, 12:21 PM


Group: Member
Posts: 289

Berkshire Hathaway seems to have done alright out of acquisitions.
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macgyver
Posted on: Aug 6 2018, 08:55 PM


Group: Member
Posts: 289

Yeah Clinuvel is poised to takeover Turing and Retrophin🤪
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macgyver
Posted on: Aug 3 2018, 09:23 AM


Group: Member
Posts: 289

These look like places in Mexico🤣
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macgyver
Posted on: Aug 1 2018, 11:29 AM


Group: Member
Posts: 289

Yup I’m thinking the same as well, although the anticipated share price for FDA approval is baked in a little bit in the current share price. Triple revenue is not unreasonable, it’s a question of when so I think a tripling of the current share price is absolutely achievable within a relatively short time frame, all things considered. Suffice to say it’s taken a while to gain traction in the EU, I view it now as laying the foundation for a Europe wide treatment program for EPP patients that was always going to take time to achieve. It’s never been done before, Clinuvel is a trailblazer in this field and is learning and adjusting just as much as we are concerning our investments.

The ultimate target price is $100, the more I stay in the stock that figure becomes more elusive as time passes, the result of delays and revising expectations that go with it. Current projections for the next five years:

- $30 12-24 months after FDA approval is possibly on the optimistic side but I’d be very happy if we meet this initial benchmark.

- vitiligo approval and sales from the new product line: anywhere from $35-45 a share but this wouldn’t occur until 3-5 years from now.

- After that it’s all too far away and I’d probably have jumped out by then. As PD alluded to, there are other things in life to take care of with the profits from investing, which is just as if not more important than being eternally wedded to a stock in which too much time sweat and tears has been invested.

The message: Enjoy the ride but know when it’s time to get off. Take with you the treasure and be grateful for it😉
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macgyver
Posted on: Aug 1 2018, 11:15 AM


Group: Member
Posts: 289

You mean the new Porsche Taycan electric sports car don’t you? wink.gif
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macgyver
Posted on: Jul 31 2018, 01:25 PM


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Posts: 289

$36 million is burning a hole in PW’s pocket. Put it to work Pierre!!!
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macgyver
Posted on: Jul 28 2018, 05:30 AM


Group: Member
Posts: 289

I’m surprised Johnnytech saw what he did in the newsletter. Respectfully, I didn’t see that at all. The new product line is becoming increasingly enigmatic, is it now a product that has afamelanotide in it and requires regulatory approval? I know it’s been mentioned here before about new molecules requiring approval, if this lotion/creme/ointment is used specifically for cosmetic or adjunct purposes which just happens to clear up eczema, psoriasis etc can it bypass the medical use pathway to market? Possibly just standard regulations that cosmetic products have to adhere to before release.
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macgyver
Posted on: Jul 27 2018, 11:32 AM


Group: Member
Posts: 289

QUOTE
The activities around product launch of the new line are under way and pending regulatory and legal clearance the final presentation will follow. In a staged process, websites, product identity and target groups will be shared, whereby targeted distribution channels will act as pilot and feedback on the first product. This staggered approach aims to lend further visibility to the current expertise of CLINUVEL as well as expanding the Company’s offerings
.

In other words, we’re not ready yet. Thanks for the gobbledegook PW.
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macgyver
Posted on: Jul 25 2018, 09:15 AM


Group: Member
Posts: 289

If you think we need to get paid first, PW needs to his A into G and start pressing hard. Do we need an American CEO?
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macgyver
Posted on: Jul 19 2018, 11:22 PM


Group: Member
Posts: 289

That was a nasty surprise!
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macgyver
Posted on: Jul 19 2018, 11:24 AM


Group: Member
Posts: 289

Looks like we’re headed to $11 today🙄
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macgyver
Posted on: Jul 6 2018, 03:20 PM


Group: Member
Posts: 289

Very good news👍
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macgyver
Posted on: Jul 1 2018, 12:15 PM


Group: Member
Posts: 289

Attached Image



Attached Image



Attached Image



Busy six months coming up.

First EPP patient not likely to be treated until end of 2019.
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macgyver
Posted on: Jun 29 2018, 08:02 PM


Group: Member
Posts: 289

Elementary.
  Forum: By Share Code

macgyver
Posted on: Jun 25 2018, 06:59 PM


Group: Member
Posts: 289

Speculation only, but I suspect PW will not move forward in any aspect with vitiligo until FDA approves Scenesse for EPP, that includes not releasing results from the Singapore vitiligo trials (hope not).

I also suspect that vitiligo will be pursued either in the US first, or Asia and the US together. Europe is just too hard it seems, nearly four years later and we still don’t have all EU countries onboard for EPP. (Will Enfance encounter resistance from the EMA and payors as well??)

That’s a problem, better to spend your energy in a potentially less problematic market.
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macgyver
Posted on: Jun 25 2018, 05:18 PM


Group: Member
Posts: 289

Lol are you tripping balls bro?
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macgyver
Posted on: Jun 25 2018, 10:18 AM


Group: Member
Posts: 289

"From final submission". Is this eight months which includes the validation period, or is it 6 months inclusive of validation period?

A big thank you to Odi01 for the post regarding the Swiss patients all receiving Scenesse reimbursement. This news has been put in the shadow by the NDA submission filing announcement and the preceding trading halt. Outstanding news considering Swiss patients had to fight tooth and nail to get reimbursement. Another win for patients and Clinuvel.
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macgyver
Posted on: Jun 25 2018, 10:10 AM


Group: Member
Posts: 289

Attached Image



From our German colleagues at Wall Street online... biggrin.gif
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macgyver
Posted on: Jun 25 2018, 09:53 AM


Group: Member
Posts: 289

https://www.asx.com.au/asxpdf/20180625/pdf/...0mgrl4csb10.pdf

Filing of NDA submission complete.
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macgyver
Posted on: Jun 24 2018, 05:10 PM


Group: Member
Posts: 289

Wow.
  Forum: By Share Code

macgyver
Posted on: Jun 24 2018, 03:17 PM


Group: Member
Posts: 289

Good news.
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macgyver
Posted on: Jun 24 2018, 12:55 PM


Group: Member
Posts: 289

I concur with the number, between 600k and 930k still to be vested. That’s much more palatable.
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macgyver
Posted on: Jun 24 2018, 09:44 AM


Group: Member
Posts: 289

It all makes sense now. Share price dropped $3 so that when PW's 5 million shares are issued, the average price will be lower that $13.56 so as not to incur the wrath of retail investors who will be none too pleased about the upcoming dilution. Or alternatively, the share price was jacked up to $13 so that PW would have a higher average price when his bonus shares are issued.

This means NDA was submitted two months ago, FDA have accepted and issued priority review/PDUFA, and now the attention becomes acutely focused on vitiligo and complimentary/cosmetic products. $20 a share in 12 months.

It's a script.
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macgyver
Posted on: Jun 23 2018, 06:19 PM


Group: Member
Posts: 289

Maybe it wasn’t poor trolling after all. Sorry Iggy.
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macgyver
Posted on: Jun 23 2018, 03:27 PM


Group: Member
Posts: 289

QUOTE
For instance what would be the reaction if an EPP patient in Germany being treated with Scenesse was diagnosed with a melanoma or a brain tumour? A two day trading halt may be required for the professionals to ascertain if there is any connection to the prescribed drug


Poor trolling. You can do better...
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macgyver
Posted on: Jun 22 2018, 09:54 PM


Group: Member
Posts: 289

Correct, we’ve had many delays before without the need for trading halts. And $3 has been knocked off the share price over the last two weeks already so I don’t think Clinuvel would think it necessary to initiate a trading halt for a delayed submission. It has to be news that is positive (NDA submission accepted) OR really fantastic news (approved already🤣)
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