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seeva222
Posted on: Feb 15 2019, 11:00 PM


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Anyone want to look back and see how similar stocks performed during the GFC? My guess is that they all got crushed, but those with strong balance sheets did 50% better. Just a guess
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seeva222
Posted on: Feb 13 2019, 06:23 PM


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Are we still looking good for ASX?
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seeva222
Posted on: Feb 13 2019, 08:29 AM


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This has always been the case. Repigmentation starts in the follicle. When you see no pigment in the hair, it’s usually dead.
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seeva222
Posted on: Feb 8 2019, 12:24 AM


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As exemplified previously, we have seen the need for us to change our infrastructure to be able to compete in years to come, this requires investments in technology and, at opportune times, in further expansion of the Group through acquisitions.
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seeva222
Posted on: Feb 5 2019, 01:31 PM


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Joe Rogan
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seeva222
Posted on: Jan 29 2019, 12:54 AM


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No more so than not inviting the crazy person who begs on my street corner.
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seeva222
Posted on: Jan 28 2019, 10:48 AM


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Who says you’re inviting confirmation bias? More numbers is not better. It doesn’t take many people to keep diverse perspectives
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seeva222
Posted on: Jan 27 2019, 12:19 AM


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More Florian

https://www.florianhommlongshort.ch/produkt...harmaceuticals/
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seeva222
Posted on: Jan 25 2019, 12:44 PM


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Your are insane
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seeva222
Posted on: Jan 25 2019, 04:39 AM


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I don’t know that I or II darken that much. You don’t need to be dark.
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seeva222
Posted on: Jan 24 2019, 01:46 PM


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The Vitiligo studies were on Fitzpatrick IV and V I believe. I would guess EPP patients would be I and IIs
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seeva222
Posted on: Jan 24 2019, 11:36 AM


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You sold out at 3. It’s 7x that. Advice from a loser...
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seeva222
Posted on: Jan 22 2019, 09:20 AM


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$9mm would send us a nice run one would think. Numbers people like doubling revenue.
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seeva222
Posted on: Jan 21 2019, 11:36 PM


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2018 vs. 2017

Q1: 3,480,000 vs. 1,597,000 + 118%
Q2: 10,388,000 vs. 6,247,000 + 66%
Q3: 10,705,000 vs. 5,638,000 + 89%
Q4: ________ vs. 4,199,000

Looks like a good bet to top 30mm on the ann
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seeva222
Posted on: Jan 20 2019, 09:56 AM


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Posts: 1,163

Someone must be buying if iggy is back. He sold his stock at three (according to him) and claimed cimetide was effective. Now it’s at 22 and he’s touting 7117. Its a schtick.

Cimetide is an ant-acid. Who needs 7117 with Cimetide?
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seeva222
Posted on: Jan 16 2019, 11:02 AM


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Posts: 1,163

1. We do not want off-label use. And CUV has made it clear it’s not interested in that route.

2. Speculating about off-label usage is certainly not helpful to shareholders in any way.
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seeva222
Posted on: Jan 16 2019, 01:43 AM


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Clinuvel controls the distribution therefore They can prevent off label use. I believe they’ve given the FDA and the EMA guarantees.
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seeva222
Posted on: Jan 16 2019, 12:56 AM


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What were the side effects?
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seeva222
Posted on: Jan 15 2019, 12:09 PM


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Do stocks normally soar after FDA approval? The few I looked at didn’t do much. Nor did I see a Nasdaq bump. Small n. Or so my wife says.
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seeva222
Posted on: Jan 15 2019, 04:12 AM


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All time high in Europe. 14.21.

I’d gladly take 250/share
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seeva222
Posted on: Jan 11 2019, 06:47 AM


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Anyone know the % of drugs that received a PDUFA date that were approved?

We’re chasing a $300-million opportunity on EPP in Europe.
A $300-million opportunity on XP in Europe.
A $150-million opportunity on EPP in the US.
A $_________ opportunity on EPP in OZ and Japan.
A multi-billion $ opportunity on Vitiligo.
A _________ OTC opportunity.
CNS, anti-oxidant and other indications down the road.

It’s an almost completely derisked stock and undervalued on EPP Europe alone.

This looks like a $2.5 B market cap to me with conservative assumptions and a 10x multiple.
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seeva222
Posted on: Jan 10 2019, 09:39 AM


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I just shit my pants
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seeva222
Posted on: Jan 10 2019, 01:47 AM


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It doubles the market size in Europe. Theoretically it’s a $600mm market with VP
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seeva222
Posted on: Jan 9 2019, 05:48 AM


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Same wiht CLVLF
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seeva222
Posted on: Jan 3 2019, 04:07 PM


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Prediction time:

2018 vs. 2017

Q1: 3,480,000 vs. 1,597,000 + 118%
Q2: 10,388,000 vs. 6,247,000 + 66%
Q3: 10,705,000 vs. 5,638,000 + 89%
Q4: ________ vs. 4,199,000

Looks like a good bet to top 30mm on the ann
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seeva222
Posted on: Dec 28 2018, 12:59 PM


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Posts: 1,163

The thing with this stock is that it hard to overlook the drumbeat of increasing earnings and profit.
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seeva222
Posted on: Dec 27 2018, 11:31 AM


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2018 Recap:

> Sharply increased revenue AND earnings
> Stuffed NDA submission
> Very encouraging Vitiligo results
> Expanding countries and centres for EPP, still massive expansion available for current geographies
> Lighter reporting protocols
> Two otc products in prelaunch mode with seemingly assured distribution
> Singapore expansion
> NICE rejection and successful appeal
> Announcement of a new indication that doubles the TAM
> NASDAQ Prep underway
> Dividend distribution started
> More positive safety data
> 130% growth in stock price
> Big new shareholder with giant retail presence
> 0 debt, 44mm war chest, very low cost structure

That about right?
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seeva222
Posted on: Dec 24 2018, 11:52 AM


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Betting on a delay?
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seeva222
Posted on: Dec 23 2018, 11:43 PM


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Post from vitty Facebook page. Lots of these really sad.

Hello all, btw my nick name : romi, from : indonesia...

I cant think anything about my real life with vitiligo on my face.
I need support *maybe
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seeva222
Posted on: Dec 21 2018, 09:13 PM


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Posts: 1,163

is he paid to try to knock the price down or to drum up traffic? The old farmer Epp stuff was pretty hilarious.
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seeva222
Posted on: Dec 21 2018, 12:01 AM


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Systematic and long lasting are the keys here. I could see a six-month regimen every Couple of years. If the worst problem is that it makes your contrast worse for six months I’m OK with that. You have no idea how bad the current treatments are and what a pain in the ass this thing is to keep up with.

If they could find a topical that’s actually worth of shit to go along with this, That would be a huge boon. I’ve been applying steroid creams for 20 fucking years It just gets worse every year.
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seeva222
Posted on: Dec 20 2018, 01:28 PM


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Can you distill down your argument?

A. It works, but this study won’t support approval
B. I can’t even tell if this works.
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seeva222
Posted on: Dec 19 2018, 03:44 PM


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Posts: 1,163

I probably wanted to see this happen more than a PDUFA date. It’s a big market and Clinuvel will actually make it bigger (due to cost). This thing will halt Vitiligo in its tracks. The safety record is being validated every day by EPP.

Phase III, if I read it right, is about replicating phase II and showing that it’s better than commonly used treatments. That seems highly likely given the terrible options that are out there. A systematic treadment for someone with non-segmental vitiligo is a huge boon.

This is big news.
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seeva222
Posted on: Dec 19 2018, 12:41 PM


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https://globenewswire.com/news-release/2018...et-to-2024.html
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seeva222
Posted on: Dec 18 2018, 11:16 AM


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Give me a heads up
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seeva222
Posted on: Dec 18 2018, 11:16 AM


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Give me a heads up
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seeva222
Posted on: Dec 18 2018, 11:16 AM


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Give me a heads up
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seeva222
Posted on: Dec 13 2018, 02:23 PM


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“As the number of European centres and countries is expanding, we are looking forward to a successful year whereby more EPP patients will gain access to the innovative medication.” Any insight into the new centres and countries coming on line?
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seeva222
Posted on: Dec 13 2018, 12:27 PM


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Scratch
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seeva222
Posted on: Dec 11 2018, 05:15 PM


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You are good comedy... the penguin and you were quite the dynamic duo. Both blathered incessantly about ridiculous things, both claimed you sold out absurdly low and then having no shares, you both moved on to other things.

I’m trying to think if your herpes like re-emergence is a sign that there’s a buyer or it’s a sign that there’s low traffic here. Help me, help you.
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seeva222
Posted on: Dec 11 2018, 03:07 PM


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You should sell your shares - the horror. Cimetide’s revenge on an old farmer trying to do good in the world
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seeva222
Posted on: Dec 8 2018, 01:56 AM


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Posts: 1,163

While every day of delay seems excruciating remember every day this company is ramping up revenue. If the FDA delayed the decision for two years, we’d still see a rise on Europe EPP alone. Then there’s OTC and new indications which will double the market size
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seeva222
Posted on: Dec 5 2018, 02:39 AM


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"I suffer from EPP. The approval of Afamelanotid is vital as there is NO other viable treatment for this genetic level condition. EPP is life limiting. As well as the pain and limitations on daily life. We suffer psychologically. Career choices are restricted and my own career path has been highly influenced and restricted by EPP. In addition I cannot viably visit friends and family who live in 'sunnier' countries.

Bearing in mind the weight of scientific evidence demonstrating the effectiveness of Afamelanotid, its low risk the approval process needs to be swift and efficient. If it goes on much longer I will be too old to benefit of this potentially life changing treatment."

https://www.youtube.com/watch?v=ygBKjreMXOI
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seeva222
Posted on: Nov 28 2018, 09:46 AM


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France and England could go online at the same time
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seeva222
Posted on: Nov 26 2018, 08:22 AM


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Any idea of the number of EPP patients there?
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seeva222
Posted on: Nov 22 2018, 01:37 AM


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So we’re waiting in an inspection?
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seeva222
Posted on: Nov 16 2018, 09:59 AM


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The force is with us, I feel a PDUFA date coming by Monday.

~ Blind Squirrel
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seeva222
Posted on: Nov 14 2018, 03:46 PM


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“The FDA is much more concerned about safety in the long run”

I like the way that sounds given The safety track record.
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seeva222
Posted on: Nov 14 2018, 09:38 AM


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And he owns a lot of shares
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seeva222
Posted on: Nov 13 2018, 12:18 PM


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Doesn’t strike me that going on TV would be a good move If you thought the FDA was going to shut Clinuvel down
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seeva222
Posted on: Nov 9 2018, 03:51 AM


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Could be. Didn’t think about that.
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seeva222
Posted on: Nov 9 2018, 03:22 AM


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Well, it looks like they fudged to me. The Rolling review is so that they can get feedback "before" submission. So, I'm not sure what that has to do with the information request. I would think that these conversations should have been had before submission. It's not unusual for the FDA to ask for information after submission, but is it unusual for the FDA to ask for information after a rolling review?
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seeva222
Posted on: Nov 9 2018, 03:22 AM


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Well, it looks like they fudged to me. The Rolling review is so that they can get feedback "before" submission. So, I'm not sure what that has to do with the information request. I would think that these conversations should have been had before submission. It's not unusual for the FDA to ask for information after submission, but is it unusual for the FDA to ask for information after a rolling review?
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seeva222
Posted on: Nov 8 2018, 10:04 AM


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1-Billion again
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seeva222
Posted on: Nov 8 2018, 04:08 AM


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And he has a great porn name
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seeva222
Posted on: Nov 7 2018, 02:11 AM


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Any thoughts on what will be feasible in 2019? tx
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seeva222
Posted on: Nov 7 2018, 02:08 AM


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They do not have to resubmit the entire application (which happends with an RTF) so I assume the

"required long-term safety data and the pediatric plan information needed to evaluate and approve the manufacturing facilities and proposed manufacturing specifications" were not a problem.

Could be wrong.
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seeva222
Posted on: Nov 6 2018, 11:22 PM


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Aud or Usd? Curious to revisit the EPP numbers in Europe. Anyone know how many were currently treating vs ultimate target?
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seeva222
Posted on: Nov 6 2018, 01:39 PM


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Interesting read if you’re bored. “Once you submit your application, don’t be surprised if you receive information requests from the FDA”. An RTF requires you to resubmit the entire application.

If I’m reading this right, the information requested isn’t about safety or efficacy and Clinuvel does not have to resubmit (required with an RTF). Seems to support the newsletter tone that this is more matter of course than feared.

https://www.fda.gov/downloads/training/forh...s/ucm467898.pdf
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seeva222
Posted on: Nov 5 2018, 02:30 PM


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More importantly, these requests seem benign: “no major outstanding issues had been identified”. Level 2 of 5 levels:
(i) full validation of all modules (comprising the scientific dossier on SCENESSE®); or
(ii) request for additional information on each module; or
(iii) further regulatory recommendations on the data package; or
(iv) advise withdrawal of the submission on the basis that more scientific data are required to make the data package fit for review; or
(v) refusal to file (RTF) on the basis of critical issues found in the scientific dossier.

Tx for the updates
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seeva222
Posted on: Nov 5 2018, 02:19 PM


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So, manufacturing questions and follow-up protocol questions are causing the delay?
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seeva222
Posted on: Nov 1 2018, 06:49 AM


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Vs 960 last year
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seeva222
Posted on: Nov 1 2018, 02:35 AM


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13 $1 Mill
14 $2 Mill
15 $3 Mill
16 $12 Mill
17 $17 Mill
18 $33 Mill *Projected
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seeva222
Posted on: Oct 31 2018, 10:19 AM


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Pointing to a $9 million next quarter. 4,199 last year.
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seeva222
Posted on: Oct 20 2018, 12:06 PM


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Whatever it is will likely leverage centers in Europe if I’m reading between the lines correctly
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seeva222
Posted on: Oct 20 2018, 02:56 AM


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The best strategy with retail investors is to give them just enough information to keep them on the hook and to heavily engage instos that have a shared strategic vision. We are the necessary, but unpalatable unwashed masses in the eyes of corporate leaders.
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seeva222
Posted on: Oct 20 2018, 01:55 AM


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One can never tell with his double-speak. Is their process dependent upon receiving the new data? Stan's stance is unclear.

  • Commercial sales of goods almost doubled 21k to 11k.
  • $5 million in receivables.
  • Expansion of countries with access to Scenesse (is that through the current centers?)
  • Don't expect NICE endorsement without a fight.
  • Vitiligo will focus on people of colour first (these are the people suffering the most and will loudly make the case that this is more than a vanity drug.) Great call as the patient advocasy is very clear here. Some might say black and white if he had a bad sense of humor.
  • The other indications and routes to commercialization are "relatively clear."
  • PAD and FZ should be able to identify the genetic affliction next in line given the 5 year study time frame and "genetic affliction" description. Sounds like it will be in Europe as that's where the infrastructure is.
  • concomitant? Had to go to the dictionary.
  • OTC products are considered important to building Clinuvel's brand as the leader in photoprotective care. A big Skincare company would kill for that branding.
  • I love how they describe the low profile, monotonous but effective strategy with a low cost base. That's the way to build a company.
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seeva222
Posted on: Oct 19 2018, 03:26 AM


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I wonder what conflicts there are, if any. I know someone hinted at that previously

Dr Peter Jackson
ï‚· Mrs Sheela Upadhyaya
ï‚· Mr Meindert Boysen
ï‚· Miss Aminata Thiam
ï‚· Mr Francis Pang
ï‚· Mr Jeremy Manuel
Highly Specialised Technologies (HST) Evaluation Committee Chair
Associate Director – HST, NICE
Centre for Health Technology Evaluation Director, NICE
Technical Lead, NICE
HST Evaluation Committee Member HST Evaluation Committee Member
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seeva222
Posted on: Oct 18 2018, 10:47 PM


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I didn’t know about type 2 diabetes, that would be a monster indication. 1/3rd of the US has it or prediabetes.
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seeva222
Posted on: Oct 17 2018, 09:37 AM


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This is the long tail... which may be bigger than the short tail. Inflammation seems to be a baseline root cause for all sorts of problems. Imagine if you didn’t have to take pills, but were injected with a two month solution for _____ inflammatory issue?

Half the problem with drugs is adherence to regimen.
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seeva222
Posted on: Oct 16 2018, 10:38 AM


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What if they’re waiting in more post-autorization data ?
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seeva222
Posted on: Oct 16 2018, 09:27 AM


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Redacted for our premature gravecdancing
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seeva222
Posted on: Oct 13 2018, 11:59 PM


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Hopeful, but not optimistic. I do like that the appeals committee agreed that EPP is clearly a disability.
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seeva222
Posted on: Oct 13 2018, 12:59 AM


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I wonder if this quarter will be higher based upon new capacity coming online
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seeva222
Posted on: Oct 11 2018, 10:23 PM


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I thought it had to be an RTF?
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seeva222
Posted on: Oct 9 2018, 09:59 PM


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Isn’t this about the length of the ASX bump? Someone modeled it out.
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seeva222
Posted on: Oct 8 2018, 04:13 PM


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The FDA wants more data on manufacturing and the post-authorization process.

That has nothing to do with the Primary end point.

I suspect they are waiting on more P/A data from Europe which could be awhile. That doesn’t preclude priority review. That seems to be signaled by fast track.

In the meantime, the numbers will do the talking.
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seeva222
Posted on: Oct 5 2018, 11:19 PM


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He also had an interesting answer on vitiligo and concurrent FDA processes. He said they need to focus on one approval and FDA approval on EPP would set the stage for Vitiligo approval. (Paraphrase)
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seeva222
Posted on: Oct 5 2018, 10:35 AM


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Ha. Yes. My over wrought (likely now buried) point is that there will be a lot of vitiligo sufferers buying Scenesse, because the alternatives are very flawed.

My apologies for the million posts.
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seeva222
Posted on: Oct 5 2018, 10:19 AM


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I think I’ve beaten my small point to death.
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seeva222
Posted on: Oct 5 2018, 03:59 AM


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DId I mention I have Vitiligo? From the Vit Newsletter:

In recent weeks we’ve had an influx of requests for support from those experiencing the social stigma that vitiligo brings to so many in the South Asian countries. I am told that in some regions of India, if a single member of a family develops vitiligo, the entire family is often ostracized. Developing vitiligo after marriage can be grounds for divorce.
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seeva222
Posted on: Oct 4 2018, 11:52 PM


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Topicals can definitely work but… Again if you have 30 large lesions it’s a very hard regimen to stick to. I have both Protopic and a steroid and they work but I have a hard time sticking to adherence. My point is that topicals are not a long-term solution, many people with Vitiligo would happily pay more if they could afford it for a systematic cure. Also it’s not just a self-esteem issue. When mine is active it feels like my whole body is being attacked by a slow grade burn. This is not a Wawa post nor are any of these supposed to be Wawa posts. I’m just telling you from the user perspective there’s more juicie here than people think when it comes to fit a lie ago. There’s a lot of pent up frustration. I expect the cream to make a ton of $$$ If it works even a little bit.

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seeva222
Posted on: Oct 4 2018, 04:25 PM


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That will cost you one Ferrari. Epilogue: We shouldn’t undersell Vitiligo’s potential.
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seeva222
Posted on: Oct 4 2018, 03:41 PM


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It takes forever... very hard to keep it going. Not to mention you look like youve been attacked by some flesh eating disease with the bright red spots. I may go back because I’m less compliant with the UVB home treatment.
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seeva222
Posted on: Oct 4 2018, 11:28 AM


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In the areas where it takes, it may actually come back in darker than the surrounding skin. Hyper. But the contrast in the areas where it doesnt take become more pronounced. But here’s the thing, so far repigmented areas have shown some permanence. That’s NOT the case with UVB and topicals. It’s a constant back and forth battle.

Imagine if you have 30 sizable patches that you have to treat with some cream 2x day (that’s 15 minutes of work btw per) AND you have to get UVB 2-3x a week (either a trip to the Dr or a home unit) which makes you orange and blotchy constantly and when you stop... your skin starts de pigmenting again. Really, it’s an almost impossible battle to keep up with.

Now contrast that with getting an implant and UVB that actually has some seeming permanence and may require maintenance of an implant 2x a year with no UVB to keep the gains... if you could afford it, you’d pay for #2.
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seeva222
Posted on: Oct 4 2018, 09:37 AM


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Yup. As long as it’s filling in that’s fine by me. Same thing happens when you use UV light
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seeva222
Posted on: Oct 4 2018, 09:07 AM


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Posts: 1,163

Yes you want the implant, you need something systematic. Topicals do not cover enough area and are too hard to apply in all the areas that you need to apply them.This from a guy who applies them every day.
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seeva222
Posted on: Oct 4 2018, 02:12 AM


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*2* additional indications. Why wouldn't Vitiligo be on the map? It's the indication next closest to commercialization.
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seeva222
Posted on: Oct 3 2018, 10:39 AM


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Cash receipts prediction contest:
Last year: Jun $6,247,000, Sep 5,638,000
This year: Jun10,388,000, Sep 9,349,000 at the same ratio.

1 share from FZ’s stash to the closest prediction


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seeva222
Posted on: Oct 1 2018, 04:56 PM


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There is no primary or systematic treatment for Vitiligo. Scenesse could quickly become the standard as it has long-term effect. Right now it’s creams and UVB and progress quickly reverts. There needs to be a sustainable/systematic treatment.


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seeva222
Posted on: Oct 1 2018, 03:00 PM


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“VP and EPP combined represents a future share price of 100 USD at the very least. 150 - 200 USD if they don’t lower the implant price. ”

Preach brother FZ.

Each new indication is a reason to extend the patent, no? 680 patients in Germany alone where distribution network is strong. Easy money.

Homm is going to have to update his newsletter lol. He went long XP.
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seeva222
Posted on: Oct 1 2018, 10:10 AM


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1/100,000
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seeva222
Posted on: Sep 28 2018, 03:01 AM


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I’m here for Vit and because I know my gradually turning white ass will be first in line.
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seeva222
Posted on: Sep 28 2018, 01:36 AM


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I think you guys are way under shooting this. In his latest update Fromm estimates that XP Japan and EPP Europe alone are worth 50-65 per share. That’s not including FDA approval, OTC products, Vitiligo, and other indications. This all seems perfectly reasonable and highly likely.

Excluding EPP and XP, What does everyone think this would be worth on Vitiligo alone?
On US EPP alone?
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seeva222
Posted on: Sep 27 2018, 10:57 AM


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I’m thinking a floor of 20 until the next quarterly or event.
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seeva222
Posted on: Sep 27 2018, 10:12 AM


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Got it. T
  Forum: By Share Code

seeva222
Posted on: Sep 27 2018, 01:52 AM


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Are we at the end of a cycle if quarterly earnings continue to pop? Tough to cycle down against growing earnings.
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seeva222
Posted on: Sep 27 2018, 01:20 AM


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Buffet: "in the short run, the market is like a voting machine--tallying up which firms are popular and unpopular. But in the long run, the market is like a weighing machine"
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seeva222
Posted on: Sep 27 2018, 01:18 AM


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[dup]
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seeva222
Posted on: Sep 27 2018, 01:18 AM


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For what it's worth, Fromm believes that XT is worth another $30 or so (that's on top of European EPP at $30). So, Europe EPP and Japan XT = $60 a share.
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seeva222
Posted on: Sep 26 2018, 04:05 AM


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Just market sizing Japan 6,000 x 70,000. XP may have a higher usage rate than EPP (more implants) , so 70 might be low. I would expect near 100% adoption if approved.

The fact that there's a semi-well know movie about it in Japan should help the approval cause (this all assumes XP is the next indication.

https://www.youtube.com/watch?v=jFq1nZ6V-JU
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seeva222
Posted on: Sep 26 2018, 01:04 AM


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The XP market is a $400 recurring revenue market. It would have to be a very big number to hit a multiple off of that.
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seeva222
Posted on: Sep 25 2018, 04:06 PM


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Current price completely justified. And UR9 has joined the party +.73
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seeva222
Posted on: Sep 25 2018, 03:57 PM


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Real price should be north of 30 on Euro EPP
+ US EPP
+ XP (4x size of EPP)
+ Vit
+ OTC
+ Antioxidant/Antiflammatories
  Forum: By Share Code

seeva222
Posted on: Sep 24 2018, 11:05 PM


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I thought $6 was too rich... even though I knew the Europe numbers would eventually demand a higher value. Argh

BTW, new numbers come out in a month.
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seeva222
Posted on: Sep 24 2018, 09:34 PM


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Unless they’re waiting in more data from Europe...
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seeva222
Posted on: Sep 20 2018, 01:18 PM


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6k in Japan
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seeva222
Posted on: Sep 20 2018, 12:55 PM


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The problem with Vitiligo is price. XP is a much better way to go to keep current price levels. I don’t think insurance companies in the US will fork Over for Vit lightly at 20k. I make some decent coin and that’s still a ton of money.
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seeva222
Posted on: Sep 20 2018, 04:43 AM


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If you read closer it’s reputational damage and financial impact that they’re worried about neither of which affects Clinuvel.

Neither of the requests addresses efficacy or safety, those would be back to the Drawing board issues. The other way to look at this is that the FDA is essentially sayinf Scemesse is both safe and effective. Or at least those aren’t issues.

“additional information covers product manufacturing information and details from the European post-authorisation use of SCENES
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seeva222
Posted on: Sep 17 2018, 11:40 PM


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New Hi in Germany if it closes here
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seeva222
Posted on: Sep 16 2018, 03:46 AM


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I wonder if there are dividend funds that would be buying CUV as well.
  Forum: By Share Code

seeva222
Posted on: Sep 15 2018, 10:36 AM


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The flight to Switzerland is cheap compared to the cost
  Forum: By Share Code

seeva222
Posted on: Sep 13 2018, 12:04 PM


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Amazing to see this support with such selling pressure. We’re clearly in an entirely ne phase.
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seeva222
Posted on: Sep 12 2018, 11:16 PM


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Do you believe a word he writes? He said he didn’t have a significant position
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seeva222
Posted on: Sep 12 2018, 12:48 PM


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It’s PAD taking profits
  Forum: By Share Code

seeva222
Posted on: Sep 11 2018, 01:29 AM


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Not to ruin the party but has anyone considered the impact on this little stock if a second GFC hits?
FC hits?
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seeva222
Posted on: Sep 10 2018, 11:56 AM


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Oh, If only the penguin were alive to see this
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seeva222
Posted on: Sep 10 2018, 11:24 AM


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6,000 XP patients in Japan I believe. 6,000 x $70,000 =
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seeva222
Posted on: Sep 7 2018, 02:34 AM


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Bingo. They're letting FIL get out.
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seeva222
Posted on: Sep 5 2018, 05:03 PM


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The no new clinical trials part is crucial. Manufacturing and European data ? What more could they want?
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seeva222
Posted on: Sep 5 2018, 03:47 AM


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Hybris makes me break out in a rash
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seeva222
Posted on: Sep 4 2018, 10:26 AM


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The thing is is he don’t really even have to speculate on itt, you know the numbers will come through. Still I’m stuck on my price that I paid for years ago
  Forum: By Share Code

seeva222
Posted on: Sep 3 2018, 06:06 PM


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Two US friends had disfiguring skin cancer... this shouldn’t take that long
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seeva222
Posted on: Sep 3 2018, 03:38 AM


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Also the numbers you have for Vitiligo are likely underrated many people have it and don’t seek out attention for it. I didn’t even know what the heck it was for five years.And if you think it’s a stigma here think about the stigma in India And among African-Americans.
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seeva222
Posted on: Sep 2 2018, 09:50 PM


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Vitiligo is the big kahuna. EPP pays the freight.
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seeva222
Posted on: Sep 1 2018, 10:45 PM


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Those results while under PR, would send it soaring.
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seeva222
Posted on: Sep 1 2018, 08:57 AM


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Congrats all. So, which comes next? ASX, PR, NPA? Btw, did the annual give anyone a heads up in the next quarter numbers?
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seeva222
Posted on: Aug 30 2018, 02:45 AM


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Having an acquisition as a goal is just plain stupid And likely to lead to a bad mistake.
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seeva222
Posted on: Aug 25 2018, 12:53 AM


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Has anyone else noticed that many stocks get no bump for priority review and some went down after FDA approval? Insight into why? Tx
  Forum: By Share Code

seeva222
Posted on: Aug 25 2018, 12:37 AM


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Not at all. Approval just allows Clinvuel to market in the US. Then they have to lobby insurance carriers to include it. Not sure about the Govt reimbursement process. We mostly have private H/C.
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seeva222
Posted on: Aug 25 2018, 12:25 AM


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1. EMA=FDA
2. NICE=Medicare/Medicade

The first is approval to market, the second is will a country pay for it. It's still approved in England, so you can buy it, the government just won't pay for it.
  Forum: By Share Code

seeva222
Posted on: Aug 24 2018, 11:42 PM


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Here's the thing about Clinuvel:

  • The Dollars Will Come
  • The only thing holding back sales is capacity, not demand
  • Fast Annual growth is virtually guaranteed and that investors can't overlook
  • Now couple virtually guaranteed growth with expansion to the US
  • Add in Vitiligo (a huge market)
  • And Tsumoyl Chivarly
  • And then other indications
  • And there's no way this puppy won't grow. I stopped buying at $6, ugh.The revenue numbers from Europ alone will push it up.



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seeva222
Posted on: Aug 22 2018, 10:45 PM


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Some interesting news and trends in skincare.


  • Estee Lauder Is Chasing L'Oreal in a Race for the Lucrative Asian Market: Markets in the APAC region include Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, the Philippines, Singapore, Taiwan, Thailand, and Vietnam. As such, it represents the largest consumer base of any market available to the retailers by population size.
  • The Mibelle Group expands into Asia: The Mibelle Group acquires South Korean dermocosmetics brand Dr. G
  • According to a L'Oréal report, Chinese consumer spending in international tourism on makeup and cosmetics products rose from $55 billion in 2010 to $261 billion in 2016.
Market Trends, Issues & Drivers from the “Medicated Skin Care Products - Global Strategic Business Report”
https://www.researchandmarkets.com/research...l_medicated?w=4

  • Increasing Focus on Wellness and Self-Care amidst Mounting Healthcare Costs Drive Healthy Market Growth
  • Health & Wellness Boosts Demand for Dermocosmetics
  • Aging Population and their Vulnerability to Age-Related Skin Changes: A Strong Growth Driver
  • Major Anti-Aging Ingredients of Cosmeceuticals
  • Popular Cosmeceutical Demographic Statistics of the Global Aging Populace: Unfurling the Market Potential
  • Booming Demand for Anti-Aging Skin Care Products Bodes Well for the Market
  • Common Skin Care Cosmeceuticals
  • Failure of Non-Prescription Products Drive Demand for Physician-Dispensed Skin Care Solutions
  • Innovations for Actinic Keratosis
  • Favorable Trends in the Beauty Industry Spell Opportunities for Medicated Skin Care Market
  • Surging Popularity of Multi-Functional Products Promote Market Expansion
  • Women: The Dominant Consumer Cluster for Medicated Skin Care Products
  • Exponential Increase in Urban Population Promote Higher Demand for Medicated Skin Care

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seeva222
Posted on: Aug 22 2018, 08:45 PM


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My guess is that they’re playing it very safe until fda approval. Once that happens they could easily get a credit facility (they could get a hefty one now ). Of course if they’re going to use that money for an acquisition...
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seeva222
Posted on: Aug 22 2018, 06:10 AM


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I believe they commited to the countries that they held the tests in.
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seeva222
Posted on: Aug 22 2018, 04:38 AM


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Clinuvel conducted clinical trials of SCENESSE® in EPP from 2006 to 2013. During this time the company evaluated the treatment in 352 EPP patients. After completion of the clinical trial program, approximately 130 patients across eight countries (Australia, Austria, France, Germany, Italy, Sweden, Switzerland and The Netherlands) received SCENESSE® free of charge.
  Forum: By Share Code

seeva222
Posted on: Aug 22 2018, 03:43 AM


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How did they leave out revenue growth and NOI?

Anyone know how many of the 44 centers are operational?
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seeva222
Posted on: Aug 18 2018, 12:55 AM


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Buckle up boys, it’s about to get interesting.

ASX 300
Priority Review
OTC
Next round of earnings

  Forum: By Share Code

seeva222
Posted on: Aug 17 2018, 12:43 AM


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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.
  Forum: By Share Code

seeva222
Posted on: Aug 16 2018, 08:03 AM


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

And FTR, I don’t blame their thinking.
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seeva222
Posted on: Aug 15 2018, 08:27 PM


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Do most Derm drugs stop your face from boiling? It’s alreay been fast tracked
  Forum: By Share Code

seeva222
Posted on: Aug 15 2018, 08:27 PM


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Do most Derm drugs stop your face from boiling?
  Forum: By Share Code

seeva222
Posted on: Aug 15 2018, 11:44 AM


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Until priority review, annual and 3rd quarter earnings. Quite ok with that
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seeva222
Posted on: Aug 15 2018, 01:07 AM


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Sorry for repeating myself, but to your Coca Cola point.... CUV has and ENORMOUS brand opportunity here. You can't buy "Leader in Photo-protection", you have to earn it. And what skin care brand wouldn't want that?

BTW, as clunky as the rest of their social media efforts have been, their Instagram looks very good.
  Forum: By Share Code

seeva222
Posted on: Aug 14 2018, 07:27 AM


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Amigos down too
  Forum: By Share Code

seeva222
Posted on: Aug 14 2018, 02:50 AM


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And the stock dropped 8%... odd.

Stock price: ALNY (NASDAQ) $89.37 -8.00 (-8.22%)
  Forum: By Share Code

seeva222
Posted on: Aug 14 2018, 02:50 AM


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And the stock dropped 8%... odd.
  Forum: By Share Code

seeva222
Posted on: Aug 12 2018, 02:09 AM


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The way the translation was structured was confusing. Got it. Thanks
  Forum: By Share Code

seeva222
Posted on: Aug 12 2018, 02:09 AM


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The way the translation was structured was confusing. Got it. Thanks
  Forum: By Share Code

seeva222
Posted on: Aug 11 2018, 04:47 PM


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Can you translate the translation?
  Forum: By Share Code

seeva222
Posted on: Aug 11 2018, 03:56 PM


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6k in Japan? 1. Horrible 2. Quintuples current EPP market in Europe.

That’s $400 mill of recurring revenue at $75/year
  Forum: By Share Code

seeva222
Posted on: Aug 9 2018, 11:24 PM


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What is artificial churn? Market making?
  Forum: By Share Code

seeva222
Posted on: Aug 7 2018, 10:13 PM


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Unless youve done it many times(well) how can it be a hidden strength?
  Forum: By Share Code

seeva222
Posted on: Aug 7 2018, 01:23 PM


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So have others. 1. You have to be able to integrate effectively. 2. The cultures have to fit or you need to fire a lot of people. 3. They can't be too far off your strategic capability set. 4. You need to pay the right price and not over extend. 5. You have to make sure you've uncovered any ticking time bombs. 6. You have to retain key people that make the company worth the price. 7. I could go on.

BH has a fully developed capability set and practices needed to do this successfully. Our guys can't get a website designed right. Can it work? Sure. It's also the #3 reason companies fail.


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seeva222
Posted on: Aug 7 2018, 12:16 PM


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Most acquisitions suck. Especially if a small company is hunting for them. One of the top ways to kill a company, especially if it's debt financed. Almost every acquisition is a "bet the company" at this size. But, it's the quickest way to scale.
  Forum: By Share Code

seeva222
Posted on: Aug 6 2018, 10:48 PM


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One price will prove to be one if the smartest moves they’ve made
  Forum: By Share Code

seeva222
Posted on: Aug 6 2018, 10:47 PM


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I believe it’s at the highest close
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seeva222
Posted on: Aug 6 2018, 12:51 AM


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So,X-ray is iggy?
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seeva222
Posted on: Aug 2 2018, 12:28 PM


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What is your probability of certain?
  Forum: By Share Code

seeva222
Posted on: Aug 1 2018, 12:41 AM


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https://www.youtube.com/embed/cZfXod7onG0
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seeva222
Posted on: Aug 1 2018, 12:30 AM


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Bingo, it's a unicorn on EPP Europe alone. If management does nothing but execute on the Europe plan, it should hit a $1 Billion valuation.

Then add in US.
Then add in Vitiligo (I'm waiting here!)
Then OTC.
Then other indications.

I also expect the number of EPP patients to increase as awareness does.
  Forum: By Share Code

seeva222
Posted on: Jul 31 2018, 09:07 AM


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Send this to the BPA
  Forum: By Share Code

seeva222
Posted on: Jul 30 2018, 11:24 PM


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Projecting out at 1.67 multiple. Officially a derisked stock, below like multiples, with many upside plays. Run frilly, run.

7.0
9.5
10.4
3.5
------
$30.4

Numbers game:

Mar 16 .8
Jun 16 1.2 (50% higher than Q3)

Mar 17 1.7 (2x 2016)
Jun 17 6.2 (3.5x Q3, 5x 2016)

Mar 18 3.4 (2x 2017)
Jun 18 10.4 (3x Q3, 1.67x 2017)
________
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seeva222
Posted on: Jul 24 2018, 08:39 AM


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What are we waiting on WRT Vitiligo?
  Forum: By Share Code

seeva222
Posted on: Jul 20 2018, 09:33 PM


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Could be reallocation. Sector rebalancing, better investment opportunities,sector reprioritization, this one no longer meets their criteria(2x vs 5x)
  Forum: By Share Code

seeva222
Posted on: Jul 20 2018, 12:42 AM


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Anyone get the feeling that a penguin committed suicide somewhere in the Netherlands today?
  Forum: By Share Code

seeva222
Posted on: Jul 19 2018, 10:46 AM


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Uh. “Does discount “
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seeva222
Posted on: Jul 19 2018, 04:55 AM


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I'll be happily surprised if so. But if CUV doesn't discount for NICE, that makes their job harder with everyone else.
  Forum: By Share Code

seeva222
Posted on: Jul 19 2018, 01:11 AM


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I think there is zero shot at NICE without a price concession, which would be a mistake IMO.
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seeva222
Posted on: Jul 18 2018, 11:17 PM


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Sale ends July 30th (or thereabouts)
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seeva222
Posted on: Jul 17 2018, 11:13 AM


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Sunscreen ban
https://www.nytimes.com/2018/05/03/travel/h...screen-ban.html
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seeva222
Posted on: Jul 15 2018, 03:48 PM


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Anyone know of similar sized companies that received approval? Curious as to the share impact. Tx
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seeva222
Posted on: Jul 12 2018, 07:33 AM


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I’ve been following starPharma after someone suggested it here and they have been drifting lower and lower after they announced priority review. I think earnings will be the difference for CUV hence July 31.
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seeva222
Posted on: Jul 12 2018, 05:36 AM


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We're in a nice buying window. I would expect that changes on July 31st.
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seeva222
Posted on: Jul 11 2018, 03:15 AM


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I note on Florian Homm. He now claims to have a very large stake in Clinuvel after claiming to have a small position. Buyer beware on his guidance, he won't tell you things are going bad until after he's out.
  Forum: By Share Code

seeva222
Posted on: Jul 9 2018, 12:49 PM


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64B business.

“Beauty products were always important in travel retail, but in recent years they have seen an extraordinary boom,” explains Martin Moodie, founder and chairman of industry news source The Moodie Davitt Report.

“Certain beauty sectors too have boomed. Korean skincare has proved hugely popular with young Chinese travellers; make-up (particularly colour cosmetics) is enjoying a surge of popularity with millennial travellers; and other sectors such as hair care, dermo-cosmetics (a mixture of skin health and beauty) and men’s fragrances are also growing strongly.”

Never heard of Dermo-cosmetics, but Chivre fits the bill.
  Forum: By Share Code

seeva222
Posted on: Jul 9 2018, 01:44 AM


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I really like the chivre play. You can build a big business on the “The worlds leader in photo protection”. Specially when it comes with a distribution channel.
  Forum: By Share Code

seeva222
Posted on: Jul 7 2018, 03:50 AM


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My thinking was just that if you know that an inside Director wants to buy 3% of a company, you might want to hold on.... but rebalancing may take precedence.
  Forum: By Share Code

seeva222
Posted on: Jul 7 2018, 12:18 AM


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Question:

Does Lagoda know who they are selling to at this point? Seems odd that they would dispose of a million shares knowing the buyer, unless it was some sort of pre-arrangement.
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seeva222
Posted on: Jul 6 2018, 11:21 PM


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Tough to imagine a more bullish signal than a director buying over a million shares AFTER a giant run-up. Especially given the nature of his background.
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seeva222
Posted on: Jul 4 2018, 02:23 PM


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As much flak as we’ve given Clinuvel for the logo and absurd news column, the instagram is well done. Simple awareness will bring Vitiligo patients out of the woodwork. I wish they could speed this up.
  Forum: By Share Code

seeva222
Posted on: Jul 3 2018, 11:41 AM


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Numbers game:

Mar 16 .8
Jun 16 1.2 (50% higher than Q3)

Mar 17 1.7 (2x 2016)
Jun 17 6.2 (3.5 x Q3, 5x 2016)

Mar 18 3.4 (2x 2017)
Jun 18 ________
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seeva222
Posted on: Jul 3 2018, 06:27 AM


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Should be a nice buying lull until the receipts are announced. Then it's Receipts/New Products/PDUFA/Annual/Receipts in pretty short order.
  Forum: By Share Code

seeva222
Posted on: Jul 1 2018, 06:54 AM


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And a market cap of 500 with FDA approval and Vitiligo still to come. Good odds
  Forum: By Share Code

seeva222
Posted on: Jun 28 2018, 09:04 AM


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Uniform pricing in the US. Applause.

This and getung patient testimony included are legitimate heavy lifts.
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seeva222
Posted on: Jun 27 2018, 12:05 PM


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So... any bets on quarterly receipts?
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seeva222
Posted on: Jun 26 2018, 11:49 AM


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It was semi amusing once
  Forum: By Share Code

seeva222
Posted on: Jun 26 2018, 07:02 AM


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In other words, it’s very likely to prevent skin cancer

"The innovation developed as SCENESSE® activates an umbrella of melanin which shields patients' skin cells from light sources," CLINUVEL's Chief Scientific Officer Dr Dennis Wright said.

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seeva222
Posted on: Jun 26 2018, 02:10 AM


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Predictably CLVLY is down
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seeva222
Posted on: Jun 25 2018, 10:22 AM


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Starpharma didn’t pop at all on submission and has wafted downward. Hopefully we gat a pop now and when cash receipts are announced.

June: Submission
July: Receipts
August: Priority Review
October: Annual/Receipts

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seeva222
Posted on: Jun 25 2018, 08:04 AM


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Just the limits of the halt I think
  Forum: By Share Code

seeva222
Posted on: Jun 24 2018, 06:09 PM


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Not triggered by approval... or even acceptance of the NDA, though he has no incentive to submit an incomplete or shakey NDA.

Here's one company that had a rolling review and still earned an RTF:

Clarifying more on the FDA verdict, the FDA has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461. In addition, FDA has requested the conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

https://www.briefing.com/investor/analysis/...drug-(alks).htm
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seeva222
Posted on: Jun 24 2018, 12:52 PM


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Thanks. It's just on submission, not acceptance? That seems like a rather ill thought out incentive.
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seeva222
Posted on: Jun 24 2018, 12:00 PM


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After some wine and a little distance...

Triggering a 5-million share dilution seems like the most plausible reason for a trading halt. There was a halt around each previous dilution.

My question is: Does the trigger come after submission of the final module or FDA acceptance? The latter usually results in a PDUFA date.


This halt was for a paltry 8 Mill. Wolgren will get 60 or so.
http://www.clinuvel.com/investors/news/ite...1c6502bd0016b40
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seeva222
Posted on: Jun 24 2018, 07:07 AM


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Okay, prediction time: What will turn out to be the cause of the halt? What will be the ASX close on Tuesday?

NDA Submission
NDA Submission and Priority Review
Surprise PDUFA
RTF Efficacy Issue
RTF Sloppiness Issue
M&A/JV
Surprise early approval to get EPP patients the drug for the summer
Wolgren bought cheap Auzzie Footie Club and Retired
Lachlan hit send too early
New logo revamp with chick shooting the lizard
Trump wants an injectable tan

5,6,7,8,9,10,11,12,13,14,15,were rich
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seeva222
Posted on: Jun 23 2018, 01:46 PM


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One example of a four month review process https://www.zacks.com/stock/news/272346/sea...y-review-by-fda
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seeva222
Posted on: Jun 23 2018, 01:46 PM


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Posts: 1,163

One example of a four month review process https://www.zacks.com/stock/news/272346/sea...y-review-by-fda
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seeva222
Posted on: Jun 23 2018, 12:56 AM


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Posts: 1,163

Well this makes me feel better. Anyone in Germany? Looks like the price hasn't moved much.

CLVLF just hit 10.00
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seeva222
Posted on: Jun 22 2018, 11:20 PM


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Posts: 1,163

It may just be that we didn’t hit the efficacy bar.You would think with the EMA results that the case would be strong…

Celgyne: The biotech reported after the market closed Tuesday that the RTF came through because the FDA determined “that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review” for multiple sclerosis.

https://endpts.com/bad-news-celgene-blasted...peful-ozanimod/
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seeva222
Posted on: Jun 22 2018, 10:38 PM


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Posts: 1,163

Is it even possible to get immediate approval?
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