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seeva222
Posted on: Yesterday, 12:54 PM


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David John Lewis? Of Tesco?
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seeva222
Posted on: Jul 18 2019, 11:03 PM


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Iggy sold at below 5, fixed his EPP with cimetide and still comes back? Someone is buying
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seeva222
Posted on: Jul 17 2019, 12:34 AM


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Thanks, I'm interested to see what impact early payments have as both the coming quarters are the largest.
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seeva222
Posted on: Jul 16 2019, 08:57 AM


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Any guesses on receipts with faster payments? We were up 66% this quarter last year. Are there new centres on line?
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seeva222
Posted on: Jul 15 2019, 02:23 AM


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So, theoretically we could just manufacture in Europe and kill the CMC issue?
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seeva222
Posted on: Jul 14 2019, 10:22 PM


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where are they being manufactured for Europe now?
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seeva222
Posted on: Jul 14 2019, 12:15 AM


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+ 45 day run up before PDUFA
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seeva222
Posted on: Jul 13 2019, 02:41 AM


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A few takeaways:
    A new molecular entity complicates the NDA
    Denial would be due to the risk assessment (not the benefit) which would be based upon CMC, post marketing licensing obligations and commitments, product claims,labeling and longer-term use.
    US labeling could include a "black box" warning as opposed to the "black triangle" classification which requires more vigilance and monitoring.
    A 3-month delay is frustrating, but the FDA has not issued an RTF or recommended withdrawal of the NDA... and that warrants cautious optimism.

In sum, the risk around manufacturing, labeling and distribution are behind the hold-up, not drug benefit or drug safety. One could conclude that none of those is a long-term deal-breaker and that the September labeling requirements will tell the story.
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seeva222
Posted on: Jul 13 2019, 12:58 AM


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So, iggy is the dipstick for a shorter? That makes the most sense.
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seeva222
Posted on: Jul 12 2019, 11:10 PM


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And there is less liquidity with fund holders via the ASX
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seeva222
Posted on: Jul 11 2019, 11:22 AM


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Can you translate?
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seeva222
Posted on: Jul 10 2019, 12:58 PM


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Johnny H just wants CUV to be honest with investors, but he has hundreds of thousands of reasons to want the stock to go up wildly.
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seeva222
Posted on: Jun 25 2019, 04:26 AM


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Whenever the ASX effect dies down, I expect us to languish till cash receipts come out.
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seeva222
Posted on: Jun 22 2019, 07:21 AM


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After a 3 month delay
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seeva222
Posted on: Jun 22 2019, 02:01 AM


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There are some problems, including compromised immune system and the fact that the effects do not last. Still, it's promising.
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seeva222
Posted on: Jun 14 2019, 07:37 AM


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Wasn’t the cutoff may31?
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seeva222
Posted on: Jun 4 2019, 11:48 PM


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Looking at the FDA risk benefit criteria: can we assume that because the FDA didn't request an advisory committee that there is an assumed patient benefit?
We know the risk profile (from Dr. Wally) is extremely low.
IF that's the case, then sloppy filing, CMC and post authorization marketing plan seem like the likely culprits for any delay.

The last ones are all fixable. The first two are not.
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seeva222
Posted on: Jun 4 2019, 02:49 PM


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It's going to go up in 11 days upon ASX inclusion
It's likely going to go up with July cash receipts
It's likely going to go up 30 days before the new PDUFA (actually 45)
It will languish in between (sans new info) with the summer doldrums upon us
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seeva222
Posted on: Jun 4 2019, 02:46 PM


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Can we scorecard this?

Benefit

Effectiveness: Pretty good, but with some hard to quantify results.

Risk
Drug Safety: Excellent
Manufacturing Safety: Dodgy (CMC looks like the culprit here)

Risk Mgt
EMA Protocal: Stringent

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seeva222
Posted on: Jun 4 2019, 12:16 AM


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ASX announcement happens on 6/14. Anyone know how we stack up? We should be darn close.

An aside question: If indexes constantly get rid of shitty companies, wouldn't they almost always go up? How do they account for the losers?
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seeva222
Posted on: Jun 4 2019, 12:09 AM


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so, does scenesse help with the production of eumelanin ?
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seeva222
Posted on: Jun 3 2019, 10:37 PM


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I believe the newsletter stated that they haven’t started on the labeling requirements as they were busy with other activities. There was a hope here that the FDA just accepted it as is.
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seeva222
Posted on: Jun 3 2019, 09:40 PM


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1. I told you guys to stop counting your chickens! Lol

2. Anyone want to read these tea leaves?

“It is not unusual to see the FDA extend its own timelines when it finds that it requires more time for review and to arrive at a final benefit-risk assessment,”

“We will continue to work with the FDA to work at all possible hours to assist the FDA staff to reach a positive conclusion on the scientific review of SCENESSE®. We are sympathetic to the finite resources the US FDA currently has and will patiently wait for the communication on labelling and post-marketing commitments by 6 September,” Dr Wright concluded.
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seeva222
Posted on: May 31 2019, 10:06 PM


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Speaking of Walnut. This latest rise pushed him past $100-million.

Where’s Iggy?
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seeva222
Posted on: May 30 2019, 01:51 AM


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Congrats! Great story. I'm a vitiligo investor as well. Mine is progressing to the out of control stage. I'm turning to an AIP diet.

Now you have to share your business!
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seeva222
Posted on: May 29 2019, 10:35 PM


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FDA approval is the first big stepping stone toward other indications. I didn’t get in this for EPP, though it’s a great engine
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seeva222
Posted on: May 29 2019, 02:02 PM


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Anyone know for what period volume is measured here? (Monthly/annually)
https://www.asx.com.au/asx/share-price-rese...atistics/shares

It’s spiked from 130k to 150k?
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seeva222
Posted on: May 29 2019, 01:55 PM


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Stay hungry my friend. You don’t have to chase the dollar, but most people dislike retirement because the brain is programmed to accomplish.

You’re likely going to want to have a vocation of some sort.

Dying to know his many shares you have. Real FU money where you have zero worries is a pretty high number.
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seeva222
Posted on: May 29 2019, 08:06 AM


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Just a reminder that FDA approval lights a pretty big fuse to Vitiligo and other indications
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seeva222
Posted on: May 29 2019, 03:57 AM


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What is the data on early approvals? Ie What % come early? How many days?

Someone had it. Tx
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seeva222
Posted on: May 29 2019, 02:24 AM


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Last time we had these discussions the stock tanked
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seeva222
Posted on: May 29 2019, 01:08 AM


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I remember fretting over $5 prices.
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seeva222
Posted on: May 27 2019, 07:30 AM


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We’re in the double window, < 45 days from PDUFA, < 20 days from ASX 200
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seeva222
Posted on: May 24 2019, 11:33 PM


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AUD. At least mine was.
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seeva222
Posted on: May 24 2019, 01:19 PM


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I'm at $45/$18
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seeva222
Posted on: May 24 2019, 12:54 PM


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Killing time killing poll:

What’s your price prediction for Jul 9th if approved?

What’s your price prediction for Jul 9th if CRL’d?


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seeva222
Posted on: May 23 2019, 11:06 PM


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BTW, what does their 50% liquidity number mean?

52 week average volume moved to 132 from 125 last week.
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seeva222
Posted on: May 22 2019, 09:12 AM


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4 days to buy. Now it gets interesting
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seeva222
Posted on: May 21 2019, 01:58 PM


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Three candlestick moves up (three soldiers) are followed by a 3-5 session head fake down and a hammer back up. This is what Iearned on wiki today.
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seeva222
Posted on: May 21 2019, 09:57 AM


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(That was a Wiggles reference for you Auzzies with kids)
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seeva222
Posted on: May 21 2019, 04:37 AM


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Lachy!
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seeva222
Posted on: May 21 2019, 03:30 AM


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Cuv presenting tomorrow in NYC

https://www.ubs.com/global/en/investment-ba...ence-agenda.pdf
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seeva222
Posted on: May 20 2019, 11:28 PM


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Started strong, ended weak
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seeva222
Posted on: May 20 2019, 11:44 AM


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Strong volume. 60k
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seeva222
Posted on: May 20 2019, 05:04 AM


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This would be crazy if it works: The advantage for sun protection is that the protection provided by melanin is longer lasting. Missing a spot is less of a worry when applying once a day at most, as opposed to multiple times in the sun while at the beach, etc.

I can’t imagine the demand
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seeva222
Posted on: May 20 2019, 12:56 AM


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Agree, the long-term trajectory is set. I’m still very excited about the topicals. I don’t even know how to value it, but the market is ginormous.
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seeva222
Posted on: May 18 2019, 06:26 AM


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For us not in the know
https://www.investopedia.com/articles/activ...-buy-stocks.asp

Three White Soldiers

This pattern is usually observed after a period of downtrend or in price consolidation. It consists of three long white candles that close progressively higher on each subsequent trading day. Each candle opens higher than the previous open and closes near the high of the day, showing a steady advance of buying pressure. Investors should exercise caution when white candles appear to be too long as that may attract short sellers and push the price of the stock further down.

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seeva222
Posted on: May 17 2019, 11:09 PM


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https://www.orthocell.com.au
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seeva222
Posted on: May 17 2019, 12:03 PM


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31.64, you’re getting slow on the draw
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seeva222
Posted on: May 17 2019, 01:04 AM


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chugga, chugga.... and we're still just approaching the lift-off windows for FDA and ASX. The volume (329,856) shouldn't hurt.
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seeva222
Posted on: May 16 2019, 01:43 AM


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Exactly, currently you can do skin grafting, but imagine if you could just "spray on new skin"? This seems like a crazy good medtech breakthrough. They're focused on burn patients right now.

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seeva222
Posted on: May 16 2019, 01:07 AM


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I love their recell technology. Theoretically you could replace your skin in any area you're having a problem.
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seeva222
Posted on: May 14 2019, 11:00 PM


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I wonder if there are laggards ready to be relegated as well.
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seeva222
Posted on: May 14 2019, 12:32 PM


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When is the cutoff for measurement?
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seeva222
Posted on: May 13 2019, 10:58 PM


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So, stocks start moving 60 days prior to FDA, more strongly 45 days prior to FDA and 20 days prior to ASX rebalance? That makes the last week of May interesting. That looks to be about 20/45 days prior.
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seeva222
Posted on: May 8 2019, 03:02 PM


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We are entering Verhaven's 60 day window where the runup, on average, has been 20% prior to decision-time. Plus we have the added accelerator of ASX 200 (anyone know how we're tracking on that?) in the second half of the window.
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seeva222
Posted on: May 3 2019, 10:16 AM


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I oddly think hard numbers work against us a bit. When everything is rainbows, it’s easy to justify any price. I’ll take the turtle with hare upside any day.
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seeva222
Posted on: May 3 2019, 06:40 AM


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I was mostly kidding. I suspect it was a message to the FDA to counterbalance Stan’s letter. Wild as speculation
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seeva222
Posted on: May 2 2019, 09:12 PM


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I think he’s letting an institution buy in before approval.
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seeva222
Posted on: May 2 2019, 04:25 AM


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Speaking of

https://www.fool.com.au/2019/04/30/clinuvel...y-sales-growth/
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seeva222
Posted on: May 2 2019, 12:35 AM


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Short covers + insto buys + ASX 200 index buys = Some interesting pressure building outside of approval and numbers (which should be very good for Q4)
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seeva222
Posted on: Apr 30 2019, 11:47 PM


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4x increase in production/manufacturing costs? I've been trying to get my Mom to buy on the dip, maybe this will work.
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seeva222
Posted on: Apr 30 2019, 10:03 AM


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Anyone got the opening depth?
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seeva222
Posted on: Apr 30 2019, 09:57 AM


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I wouldn’t want to be short right now.
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seeva222
Posted on: Apr 28 2019, 01:40 PM


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So the fun is about to start.

> Cash receipts numbers next week. If early payments are coming in they could surprise.
> 60 day countdown starts May 7th, prices look to start rising at this point.
> June ASX rebalance on the way
> July 7 PDUFA
> July cash receipts. This should be a strong quarter.


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seeva222
Posted on: Apr 25 2019, 05:44 AM


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I didn’t determine that it was the FDA reading here, it was cause-and-effect. I believe they responded to something written here. I don’t think the chances are of great that it would happen but it doesn’t serve us in anyway to have an off label conversation. Clinuvel seems very careful about it’s wording around strict adherence to protocol.Even if the chance was .5%... why would you do it? I would follow their lead.
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seeva222
Posted on: Apr 24 2019, 11:39 PM


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Clinuvel is controlling the distribution. Drs can say what they want. Again, this isn't a helpful conversation given that the FDA frequents this board.
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seeva222
Posted on: Apr 24 2019, 01:52 PM


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This scares the holy hell out of me: We eye expansion as the next stage of the Company’s organic and inorganic growth.


Newsflash: Bad M&A is the number 1 killer of value. Companies far over estimate "synergies" and far under estimate things like cultural differences, increased complexity and the timeline needed to reap rewards.

Ugh
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seeva222
Posted on: Apr 23 2019, 11:06 PM


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"It gave you a tan, it increased your libido, it suppressed your appetite... "

Wonder Drug
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seeva222
Posted on: Apr 21 2019, 01:48 AM


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Which means we could get paid early for 2019 orders.
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seeva222
Posted on: Apr 20 2019, 02:09 PM


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Isn’t this the lowest quarter because it’s out of season? Cash receipts are on a delay.
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seeva222
Posted on: Apr 20 2019, 10:15 AM


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Buy 45 days before, sell 4 days after. In between for us is the ASX announcement
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seeva222
Posted on: Apr 20 2019, 05:13 AM


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That needs all caps. DNA repair and anti-inflammatory are some big kahunas.
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seeva222
Posted on: Apr 18 2019, 01:14 PM


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It’s low on EPP Europe alone. As long as the safety profile holds up, quarterly numbers will drive it higher regardless of the US outcome.
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seeva222
Posted on: Apr 18 2019, 02:01 AM


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Since I’ve been inhecting the hormone my Melasma and Roseacea have almost completely disappeared. Also, my Rhinophyma has noticeably decreased. Interesting. A few Vitiligo spots are decreaimg. Nothing big yet
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seeva222
Posted on: Apr 17 2019, 12:01 PM


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Rounding error for you
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seeva222
Posted on: Apr 16 2019, 05:07 AM


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Strike that, nearmap is in.
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seeva222
Posted on: Apr 16 2019, 03:35 AM


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Xmas could come early? I'd love to watch the shorts mess their shorts.
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seeva222
Posted on: Apr 12 2019, 08:49 AM


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https://www.facebook.com/1112753815441338/p...707382?sfns=xmo
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seeva222
Posted on: Apr 12 2019, 08:49 AM


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https://www.facebook.com/1112753815441338/p...707382?sfns=xmo
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seeva222
Posted on: Apr 4 2019, 12:07 PM


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Here's one comp (that someone mentioned here) Avita Medical spiked 40% upon FDA approval, was back down within 5 days and dropped below it's pre-approval level by 20% a month later. It finally spiked 6 months after approval. It's now at 3x it's pre-approval price. I'd take it, but it's not the action I would have expected.
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seeva222
Posted on: Apr 2 2019, 10:54 PM


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Is there anything in the past that leads you to expect that there "will be no more excruciating delays"? Ha, ha. I could see a new stance by the FDA in favor of less restrictions given the safety profile and that Orange Trump could be Brown Trump.
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seeva222
Posted on: Mar 27 2019, 05:53 AM


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Love you Johnny Tech, but you’re an over optimist.
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seeva222
Posted on: Mar 27 2019, 01:58 AM


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I don’t think Nasdaq will do anything special in the short term. It’s not like people will be rushing in to buy it simply because it’s on the NASDAQ. It’s more of a long-term institutional play
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seeva222
Posted on: Mar 22 2019, 11:33 AM


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I own a lot of this, so I’m not trying to “talk it down”, but I don’t think many will view this as a blockbuster drug. We have good reason to think that, but I’m not sure many outside here will.
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seeva222
Posted on: Mar 22 2019, 05:24 AM


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I’ve looked at 4 stocks none of them popped on approval.
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seeva222
Posted on: Mar 22 2019, 01:57 AM


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Whomever recommended Avita is having a good day
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seeva222
Posted on: Mar 21 2019, 02:23 AM


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It’s all my fault I started bragging to a buddy about CLVLY last night. 10 minutes later I came back to a message that the stock was tanking
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seeva222
Posted on: Mar 20 2019, 02:42 PM


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agree on the newsletter, it seems to assume FDA approval and continued European expansion. The “we’re working so hard answering fda questions” part could be interpreted many ways. Mine was not positive.
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seeva222
Posted on: Mar 20 2019, 11:46 AM


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Was hoping this dip might make into the us... wonder if this will short squeeze past 30.
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seeva222
Posted on: Mar 18 2019, 12:47 AM


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Good find. I think the opportunity here dwarfs the prescription opportunity
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seeva222
Posted on: Mar 17 2019, 02:54 AM


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If there's a takeover, who's moving to Puerto Rico with me?

100% tax exemption on interest, financial charges, dividends or distributive share on partnership income from international banking entities in Puerto Rico including AMT. 100% tax exemption on long-term capital gains realized and recognized after becoming a resident of Puerto Rico but before January 1, 2036.
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seeva222
Posted on: Mar 17 2019, 12:37 AM


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T/O = Takeover?
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seeva222
Posted on: Mar 16 2019, 09:14 PM


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?
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seeva222
Posted on: Mar 14 2019, 09:06 AM


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There something so righteous about Clinuvel buying through the shorts.
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seeva222
Posted on: Mar 14 2019, 05:22 AM


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They are clueless,they are stuck an tanning/vit in Asia vs other indications
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seeva222
Posted on: Mar 10 2019, 03:15 AM


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In English

Current situation share
Now I can give you more information and my personal view on Clinuvel.
The stock has been going up for months. So if you look at the potential of the products, especially from scenesse, that's not surprising. Clinuvel's top management is very cautious, prudent and conservative. The communication including coverage of a research company is not a priority as long as scenesse was not appoved in the USA. This should be done around mid-2019. By April 6, the FDA should comment on labeling and marketing. I assume that no subsequent deliveries are required by Clinvel. In June, the approval would be due.
Since I know the scenesse well, their effect and their potential, I see no later than mid-2019, a fundamental revaluation of the title. NB know scenesse, because I can have it myself since 5 years and was allowed to start a new life with this implant! Have no side effects at all, not an approach of it and there will be no - just from the composition of the drug, which has been tested for 20 years. But see a lot of potential other health areas and also in the cosmetics industry.
Other products and product candidates as well as their clinical status are recorded on the Clinuvel homepage - I recommend to anyone interested to study them!
With the FDA approval is just a reassessment of this company and that's the big plus, because so far nobody was interested in this company.
Genre I try to answer questions from you. I'm also grateful for all posts here in this forum.
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seeva222
Posted on: Mar 8 2019, 11:12 PM


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Why is June inclusion guaranteed?
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seeva222
Posted on: Mar 7 2019, 01:45 AM


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Word of the day:
Cimetidine
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seeva222
Posted on: Mar 6 2019, 11:05 PM


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So, the median would put us at Sep?

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seeva222
Posted on: Mar 5 2019, 06:45 AM


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This is the big Kahuna. Anti-oxident, anti-inflammatory properties + OTC will get Walnut a real footy team.
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seeva222
Posted on: Mar 5 2019, 12:44 AM


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I don’t think it would’ve been in any of our interest to have a formal IR before this. No management should want to deal with an unwieldy group Of retail investors. You want a small number of highly aligned institutional Investors. I hope that most of their egforts are still aimed against institutional investors. Retail investors suck from an IR perspective.
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seeva222
Posted on: Mar 4 2019, 10:20 PM


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The trick of IR is to make it dumb enough for a 5th grader. Simplicity is the art. You need to make it so that people with no knowledge of your business “get it” quickly.
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seeva222
Posted on: Mar 2 2019, 01:29 AM


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During the following months we expect a steady positive news flow from Clinuvel. Main topics will be announcements regarding (1) the US Food and Drug Administration’s assess- ment of the risk-benefit profile of Scenesse in the prevention of erythropoietic protoporphyria (EPP) symptoms (to be an- nounced on July 8), followed by submissions of New Drug Applications to authorities in Japan (PDMA) and Australia (TGA); (2) the Phase IIa proof of concept study where patients suffering from orphan disease variegate porphyria (VP) will be treated with Scenesse; (3) progress in the upcoming sci- entific vitiligo studies which would give Clinuvel access to an untapped market of substantial size; (4) announcements of a third indication, most likely xeroderma pigmentosum (XP), a disease which is defined by extreme sensitivity to sunlight (and therefore similar to EPP); (5) the appeal against the de- cision of the UK National Institute of Health and Care Excel- lence (NICE) not to recommend Clinuvel’s Scenesse for use by English National Health Service for adult EPP patients (March 14, 2019); (6) inclusion in the ASX 200, the benchmark for Australian equity performance; (7) the potential Nasdaq listing.
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seeva222
Posted on: Feb 27 2019, 04:26 AM


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Posts: 1,275

Pre index buy
  Forum: By Share Code

seeva222
Posted on: Feb 26 2019, 08:00 AM


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That was just to hit submission standards. I wouldn’t tick it off just yet.
  Forum: By Share Code

seeva222
Posted on: Feb 26 2019, 06:36 AM


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Some of our own did the investigative work. I’ve seen it, it’s legit. That’s all I can reveal to protect the innocent.
  Forum: By Share Code

seeva222
Posted on: Feb 26 2019, 04:45 AM


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Some very good news. The NDA delay was not about efficacy; it was solely a production issue(s) that have been resolved. Strap in.
  Forum: By Share Code

seeva222
Posted on: Feb 22 2019, 07:51 AM


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Do you think the markets will factor in future indications? EPP US isn’t worth that much.
  Forum: By Share Code

seeva222
Posted on: Feb 20 2019, 06:23 PM


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NICE is set up to be a meat slicer, not a patient vehicle. Their role is to ration healthcare.
  Forum: By Share Code

seeva222
Posted on: Feb 18 2019, 10:15 PM


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That is exactly their marketing strategy.It’s not a real article - There’s no analysis of the stock price.
  Forum: By Share Code

seeva222
Posted on: Feb 18 2019, 11:15 AM


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100k, high of 24.29. Righteous
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Feb 13 2019, 06:23 PM


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Are we still looking good for ASX?
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Feb 8 2019, 12:24 AM


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Posts: 1,275


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.
  Forum: By Share Code

seeva222
Posted on: Feb 5 2019, 01:31 PM


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Joe Rogan
  Forum: By Share Code

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.
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Jan 27 2019, 12:19 AM


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More Florian

https://www.florianhommlongshort.ch/produkt...harmaceuticals/
  Forum: By Share Code

seeva222
Posted on: Jan 25 2019, 12:44 PM


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Your are insane
  Forum: By Share Code

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.
  Forum: By Share Code

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
  Forum: By Share Code

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...
  Forum: By Share Code

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.
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Jan 20 2019, 09:56 AM


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Posts: 1,275

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?
  Forum: By Share Code

seeva222
Posted on: Jan 16 2019, 11:02 AM


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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.
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Jan 16 2019, 12:56 AM


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What were the side effects?
  Forum: By Share Code

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.
  Forum: By Share Code

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
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Jan 10 2019, 09:39 AM


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I just shit my pants
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Jan 9 2019, 05:48 AM


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Same wiht CLVLF
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Dec 28 2018, 12:59 PM


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Posts: 1,275

The thing with this stock is that it hard to overlook the drumbeat of increasing earnings and profit.
  Forum: By Share Code

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?
  Forum: By Share Code

seeva222
Posted on: Dec 24 2018, 11:52 AM


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Betting on a delay?
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Dec 21 2018, 09:13 PM


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is he paid to try to knock the price down or to drum up traffic? The old farmer Epp stuff was pretty hilarious.
  Forum: By Share Code

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.
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Dec 19 2018, 03:44 PM


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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.
  Forum: By Share Code

seeva222
Posted on: Dec 19 2018, 12:41 PM


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https://globenewswire.com/news-release/2018...et-to-2024.html
  Forum: By Share Code

seeva222
Posted on: Dec 18 2018, 11:16 AM


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Give me a heads up
  Forum: By Share Code

seeva222
Posted on: Dec 18 2018, 11:16 AM


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Give me a heads up
  Forum: By Share Code

seeva222
Posted on: Dec 18 2018, 11:16 AM


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Give me a heads up
  Forum: By Share Code

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?
  Forum: By Share Code

seeva222
Posted on: Dec 13 2018, 12:27 PM


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Scratch
  Forum: By Share Code

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.
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Dec 8 2018, 01:56 AM


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Posts: 1,275

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
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Nov 28 2018, 09:46 AM


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France and England could go online at the same time
  Forum: By Share Code

seeva222
Posted on: Nov 26 2018, 08:22 AM


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Any idea of the number of EPP patients there?
  Forum: By Share Code

seeva222
Posted on: Nov 22 2018, 01:37 AM


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So we’re waiting in an inspection?
  Forum: By Share Code

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
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Nov 14 2018, 09:38 AM


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And he owns a lot of shares
  Forum: By Share Code

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
  Forum: By Share Code

seeva222
Posted on: Nov 9 2018, 03:51 AM


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Could be. Didn’t think about that.
  Forum: By Share Code

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?
  Forum: By Share Code

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?
  Forum: By Share Code

seeva222
Posted on: Nov 8 2018, 10:04 AM


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1-Billion again
  Forum: By Share Code

seeva222
Posted on: Nov 8 2018, 04:08 AM


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Posts: 1,275


And he has a great porn name
  Forum: By Share Code

seeva222
Posted on: Nov 7 2018, 02:11 AM


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Any thoughts on what will be feasible in 2019? tx
  Forum: By Share Code

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.
  Forum: By Share Code

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?
  Forum: By Share Code

seeva222
Posted on: Nov 6 2018, 01:39 PM


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Posts: 1,275

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
  Forum: By Share Code

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
  Forum: By Share Code

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?
  Forum: By Share Code

seeva222
Posted on: Nov 1 2018, 06:49 AM


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Vs 960 last year
  Forum: By Share Code

seeva222
Posted on: Nov 1 2018, 02:35 AM


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Posts: 1,275

13 $1 Mill
14 $2 Mill
15 $3 Mill
16 $12 Mill
17 $17 Mill
18 $33 Mill *Projected
  Forum: By Share Code

seeva222
Posted on: Oct 31 2018, 10:19 AM


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Pointing to a $9 million next quarter. 4,199 last year.
  Forum: By Share Code

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
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Oct 20 2018, 01:55 AM


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Posts: 1,275

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.
  Forum: By Share Code

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
  Forum: By Share Code

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.
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Oct 16 2018, 10:38 AM


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What if they’re waiting in more post-autorization data ?
  Forum: By Share Code

seeva222
Posted on: Oct 16 2018, 09:27 AM


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Redacted for our premature gravecdancing
  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Oct 13 2018, 12:59 AM


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Posts: 1,275

I wonder if this quarter will be higher based upon new capacity coming online
  Forum: By Share Code

seeva222
Posted on: Oct 11 2018, 10:23 PM


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I thought it had to be an RTF?
  Forum: By Share Code

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.
  Forum: By Share Code

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.
  Forum: By Share Code

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)
  Forum: By Share Code

seeva222
Posted on: Oct 5 2018, 10:35 AM


Group: Member
Posts: 1,275

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.
  Forum: By Share Code

seeva222
Posted on: Oct 5 2018, 10:19 AM


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Posts: 1,275

I think I’ve beaten my small point to death.
  Forum: By Share Code

seeva222
Posted on: Oct 5 2018, 03:59 AM


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Posts: 1,275

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.
  Forum: By Share Code

seeva222
Posted on: Oct 4 2018, 11:52 PM


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Posts: 1,275

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.

  Forum: By Share Code

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.
  Forum: By Share Code

seeva222
Posted on: Oct 4 2018, 03:41 PM


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Posts: 1,275

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.
  Forum: By Share Code

seeva222
Posted on: Oct 4 2018, 11:28 AM


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Posts: 1,275

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.
  Forum: By Share Code

seeva222
Posted on: Oct 4 2018, 09:37 AM


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Posts: 1,275

Yup. As long as it’s filling in that’s fine by me. Same thing happens when you use UV light
  Forum: By Share Code

seeva222
Posted on: Oct 4 2018, 09:07 AM


Group: Member
Posts: 1,275

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.
  Forum: By Share Code

seeva222
Posted on: Oct 4 2018, 02:12 AM


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Posts: 1,275

*2* additional indications. Why wouldn't Vitiligo be on the map? It's the indication next closest to commercialization.
  Forum: By Share Code

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