Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome To The ShareCafe Community - Talk Shares And Take Stock With Smart Investors - New Here? Click To Register >

7 Pages (Click to Jump) V   1 2 3 4 > » 

seeva222
Posted on: Yesterday, 12:20 AM


Group: Member
Posts: 1,298

My only concern on efficacy is that the EMA used patient voice. I agree it doesn’t look like a hurdle right now.
  Forum: By Share Code

seeva222
Posted on: Aug 17 2019, 06:50 AM


Group: Member
Posts: 1,298

Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies’ conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application.
  Forum: By Share Code

seeva222
Posted on: Aug 16 2019, 02:55 PM


Group: Member
Posts: 1,298

Two questions: When did this start treatment? Is this the one previously announced? Tx
  Forum: By Share Code

seeva222
Posted on: Aug 14 2019, 12:50 PM


Group: Member
Posts: 1,298

One more week by my estimate. 5% shorts is a disproportionately huge amount of the liquid trading volume given how closely this is held.in another week this gets dicey
  Forum: By Share Code

seeva222
Posted on: Aug 14 2019, 02:57 AM


Group: Member
Posts: 1,298

No mention of Tsumoyle
  Forum: By Share Code

seeva222
Posted on: Aug 13 2019, 06:01 AM


Group: Member
Posts: 1,298

Based on some documents that have been revealed by user Johnny H on sharecafe.com.au through a FOIA request, reason for the delay has been some missing documentation of the manufacturing process at Evonik in Birmingham, UK. As they could not provide updated information prior to the original PDUFA deadline, I consider this the probable reason for the delay. While, of course, the FDA decision outcome stays unpredictable, this seems to be fixable quite easily for a professional company as Evonik (OTCPK:EVKIY).
  Forum: By Share Code

seeva222
Posted on: Aug 13 2019, 12:03 AM


Group: Member
Posts: 1,298

This is the kind of PR I like. Penguin weeps
  Forum: By Share Code

seeva222
Posted on: Aug 11 2019, 04:01 AM


Group: Member
Posts: 1,298

Predicting that price ignition starts in 9 days (barring overall decline). Get your bets in
  Forum: By Share Code

seeva222
Posted on: Aug 10 2019, 01:01 AM


Group: Member
Posts: 1,298

Well, they might. looks like the others will make money.
  Forum: By Share Code

seeva222
Posted on: Aug 9 2019, 01:38 AM


Group: Member
Posts: 1,298



https://journals.sagepub.com/doi/10.1177/23...eShareContainer

Abstract
Patient representation during the evaluation of medicines by key decision makers such as regulatory agencies, Health Technology Assessment bodies, and healthcare payers is increasingly considered to add value to the appraisals and empowers patients, which means that they gain a more powerful voice over decisions and actions affecting their own health. As I myself suffer from the ultra-rare condition erythropoietic protoporphyria (EPP), I have participated as a patient expert in several discussions on access to afamelanotide, which currently is the only treatment for EPP and was approved in the European Union (EU) in 2014. As a molecular biologist with a PhD in EPP research, I consider myself having the necessary requirements to meaningfully contribute to such assessments. In this article, I share my personal experiences with regard to the discussions on access in Germany and England at the respective national competent authorities, the Federal Joint Committee, and the National Institute for Health and Care Excellence, respectively. In addition, I discuss the insights of the International Porphyria Patient Network, a group of highly empowered EPP patients effectively supporting national patient communities in their efforts to enable access to the afamelanotide treatment in their countries.
  Forum: By Share Code

seeva222
Posted on: Aug 8 2019, 12:11 AM


Group: Member
Posts: 1,298

ITs down 5%
  Forum: By Share Code

seeva222
Posted on: Aug 4 2019, 02:28 AM


Group: Member
Posts: 1,298

CUV is bring hamstrung by success, IMO. The evaluations are being made on EPP rather than look at EPP as the indication that pads the balance sheet for expansion of indications and expansion into other areas (like topicals/cosmeceuticals).increased dosage could be from 2-3 or 3-4.
  Forum: By Share Code

seeva222
Posted on: Aug 3 2019, 05:25 AM


Group: Member
Posts: 1,298

It took two months to recover last time. August 20th closes that window
  Forum: By Share Code

seeva222
Posted on: Aug 1 2019, 12:59 PM


Group: Member
Posts: 1,298

Uhm. He gave you documents. Nothing to “believe”
  Forum: By Share Code

seeva222
Posted on: Aug 1 2019, 05:20 AM


Group: Member
Posts: 1,298

Hey you dope. He just shared very good news. The holdup is a QC/CMC issue not efficacy or safety. That means is a matter of when not if. You should go open up another credit card and buy more.

For F sake, he went through a lot of trouble and is giving you valuable intel and you’re acting like a Douche.
  Forum: By Share Code

seeva222
Posted on: Aug 1 2019, 01:30 AM


Group: Member
Posts: 1,298

Great to see those margins as we pad a healthy balance sheet. But a $3M increase doesn’t mean much against a mkt value of a billion +
  Forum: By Share Code

seeva222
Posted on: Jul 31 2019, 01:52 AM


Group: Member
Posts: 1,298

The flyer here is that were now getting paid earlier so we could see next quarter’s cash receipts coming this quarter.
  Forum: By Share Code

seeva222
Posted on: Jul 28 2019, 08:43 AM


Group: Member
Posts: 1,298

Can someone summarize?
  Forum: By Share Code

seeva222
Posted on: Jul 28 2019, 07:14 AM


Group: Member
Posts: 1,298

I would have thought we’d drift lower. The fun starts this week. Followed by the 60 day pre pdufa window. Good times.
  Forum: By Share Code

seeva222
Posted on: Jul 26 2019, 12:32 PM


Group: Member
Posts: 1,298

I think the name has Asian significance.

https://finance.yahoo.com/news/85-bn-cosmec...-142900205.html

85 Bn Cosmeceutical Market - Global Growth, Trends and Forecasts 2019-2024 - ResearchAndMarkets.com
Business Wire
Business WireJune 27, 2019, 2:29 PM UTC
DUBLIN--(BUSINESS WIRE)--

The "Cosmeceutical Market - Growth, Trends and Forecasts (2019 - 2024)" report has been added to ResearchAndMarkets.com's offering.

The global cosmeceuticals market is forecasted to reach USD 85 billion by 2024 growing at a CAGR of 8.81% during the forecast period (2019-2024).


Countries, such as the United States, Canada, United Kingdom, Germany, and other European countries held a prominent share in the global cosmeceuticals market. China, India, and Vietnam present considerable growth opportunities for the market players, primarily due to the growing millennial population.

Furthermore, raising awareness regarding cosmeceutical and cosmetics products, such as anti-aging, sun care, and hair care products, is expected to drive the growth potential in the near future. The introduction of new products with bio-active ingredients play a crucial role in driving the demand for cosmeceutical products across the world, especially in the Asia-Pacific region.

Scope of the Report

The global cosmeceuticals market offers a wide range of products broadly categorised under skin care, hair care, lip care, and oral care. Also, the market covers the products available across distribution channels Supermarket/Hypermarkets, Convenience stores, online stores, speciality stores, others. Moreover, the study provides an analysis of the cosmeceuticals market in the emerging and established markets across the world, including North America, Europe, Asia-Pacific, South America, Middle East & Africa.

Key Market Trends

Growing Ageing Population

Consumers, especially the ageing population, are increasingly looking for methods and products to maintain and improve their appearance to look youthful and beautiful, more so with the rising awareness about anti-ageing products. The middle-aged people are increasingly witnessing ageing anxiety, due to the high prevalence of extrinsic signs of ageing. Anti-ageing skin products are known as cosmeceuticals, as they overlap the distinction between cosmetics and pharmaceuticals. Over the past two decades, declining fertility and mortality rate has resulted in a sustained rise in ageing population across the region, especially in China and Japan. Strong desire among men and women to retain youthful appearances has groomed and nurtured the cosmetic industry across the region.

Asia-Pacific Dominates the Global Cosmeceuticals Market -

Though the term cosmeceuticals' started gaining momentum in China recently, it has now become one of the most preferred product categories in the country. Busier and stressful lifestyles of consumers in the country, as well as worsening environmental conditions, created more concern around skin conditions amid consumers who seek products for skin rejuvenation. This has led to an increase in sales of cosmeceuticals. Moreover, the population of Japan is among the most prolific consumers of cosmetics, placing it among the top five national markets for personal care products. From the viewpoint of not only size but also the trends and market demand, Japan can be regarded as a gateway to other Asian markets. Success in the Japanese market can raise product/brand profile and visibility, particularly in other Asian markets.

Competitive Landscape

The most active companies in the market include key players, such as Procter & Gamble, Unilever, L'Oreal SA, Shiseido Co. Ltd, and The Estee Lauder Companies Inc. L'Oreal SA is one of the most active companies, with numerous brands offering a broad range of cosmeceuticals, across the world. The company has spent considerably on improving quality, product innovation in terms of ingredients, functionality, and packaging. Moreover, these active companies have adopted strategic acquisition as their key strategy, to increase their geographical presence and customer base.

  Forum: By Share Code

seeva222
Posted on: Jul 26 2019, 06:32 AM


Group: Member
Posts: 1,298

Not only that, but of intention to become a skincare company and pending M&A. Big beauty is getting into cosmoceuticals and that market is exploding. CUV is going the other way.

Mr Blijdorp is an international entrepreneur who has helped build privately owned B&S International NV, one of the largest global trading houses, over the past three decades. Mr Blijdorp has led B&S’s growth, with the Dutch group focussed on the wholesale and international trading of luxury and fast moving consumer goods and pharmaceutical products. Formerly B&S’s CEO, Mr Blijdorp now focusses on the group’s development and expansion strategy

n 2014 he was recognised for his expertise in merger and acquisitions and leadership as the Ernst & Young Entrepreneur of the Year in the Netherlands. Since joining CLINUVEL in 2014, Mr Blijdorp has been actively involved in the Group’s long-term strategy for product commercialisation, growth, and development.
  Forum: By Share Code

seeva222
Posted on: Jul 24 2019, 02:32 AM


Group: Member
Posts: 1,298

Yup, I think we jumped the gun.
  Forum: By Share Code

seeva222
Posted on: Jul 24 2019, 12:17 AM


Group: Member
Posts: 1,298

Well done CUV. Centers felt scenesse was a money waste(they weren’t making $) because of the protocols which limited opening of new centers.
  Forum: By Share Code

seeva222
Posted on: Jul 21 2019, 12:54 PM


Group: Member
Posts: 1,298

David John Lewis? Of Tesco?
  Forum: By Share Code

seeva222
Posted on: Jul 18 2019, 11:03 PM


Group: Member
Posts: 1,298

Iggy sold at below 5, fixed his EPP with cimetide and still comes back? Someone is buying
  Forum: By Share Code

seeva222
Posted on: Jul 17 2019, 12:34 AM


Group: Member
Posts: 1,298

Thanks, I'm interested to see what impact early payments have as both the coming quarters are the largest.
  Forum: By Share Code

seeva222
Posted on: Jul 16 2019, 08:57 AM


Group: Member
Posts: 1,298

Any guesses on receipts with faster payments? We were up 66% this quarter last year. Are there new centres on line?
  Forum: By Share Code

seeva222
Posted on: Jul 15 2019, 02:23 AM


Group: Member
Posts: 1,298

So, theoretically we could just manufacture in Europe and kill the CMC issue?
  Forum: By Share Code

seeva222
Posted on: Jul 14 2019, 10:22 PM


Group: Member
Posts: 1,298

where are they being manufactured for Europe now?
  Forum: By Share Code

seeva222
Posted on: Jul 14 2019, 12:15 AM


Group: Member
Posts: 1,298

+ 45 day run up before PDUFA
  Forum: By Share Code

seeva222
Posted on: Jul 13 2019, 02:41 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Jul 13 2019, 12:58 AM


Group: Member
Posts: 1,298

So, iggy is the dipstick for a shorter? That makes the most sense.
  Forum: By Share Code

seeva222
Posted on: Jul 12 2019, 11:10 PM


Group: Member
Posts: 1,298

And there is less liquidity with fund holders via the ASX
  Forum: By Share Code

seeva222
Posted on: Jul 11 2019, 11:22 AM


Group: Member
Posts: 1,298

Can you translate?
  Forum: By Share Code

seeva222
Posted on: Jul 10 2019, 12:58 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Jun 25 2019, 04:26 AM


Group: Member
Posts: 1,298

Whenever the ASX effect dies down, I expect us to languish till cash receipts come out.
  Forum: By Share Code

seeva222
Posted on: Jun 22 2019, 07:21 AM


Group: Member
Posts: 1,298

After a 3 month delay
  Forum: By Share Code

seeva222
Posted on: Jun 22 2019, 02:01 AM


Group: Member
Posts: 1,298

There are some problems, including compromised immune system and the fact that the effects do not last. Still, it's promising.
  Forum: By Share Code

seeva222
Posted on: Jun 14 2019, 07:37 AM


Group: Member
Posts: 1,298

Wasn’t the cutoff may31?
  Forum: By Share Code

seeva222
Posted on: Jun 4 2019, 11:48 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Jun 4 2019, 02:49 PM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

seeva222
Posted on: Jun 4 2019, 02:46 PM


Group: Member
Posts: 1,298

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

  Forum: By Share Code

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


Group: Member
Posts: 1,298

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?
  Forum: By Share Code

seeva222
Posted on: Jun 4 2019, 12:09 AM


Group: Member
Posts: 1,298

so, does scenesse help with the production of eumelanin ?
  Forum: By Share Code

seeva222
Posted on: Jun 3 2019, 10:37 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Jun 3 2019, 09:40 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 31 2019, 10:06 PM


Group: Member
Posts: 1,298

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

Where’s Iggy?
  Forum: By Share Code

seeva222
Posted on: May 30 2019, 01:51 AM


Group: Member
Posts: 1,298

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!
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 10:35 PM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 02:02 PM


Group: Member
Posts: 1,298

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?
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 01:55 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 08:06 AM


Group: Member
Posts: 1,298

Just a reminder that FDA approval lights a pretty big fuse to Vitiligo and other indications
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 03:57 AM


Group: Member
Posts: 1,298

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

Someone had it. Tx
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 02:24 AM


Group: Member
Posts: 1,298

Last time we had these discussions the stock tanked
  Forum: By Share Code

seeva222
Posted on: May 29 2019, 01:08 AM


Group: Member
Posts: 1,298

I remember fretting over $5 prices.
  Forum: By Share Code

seeva222
Posted on: May 27 2019, 07:30 AM


Group: Member
Posts: 1,298

We’re in the double window, < 45 days from PDUFA, < 20 days from ASX 200
  Forum: By Share Code

seeva222
Posted on: May 24 2019, 11:33 PM


Group: Member
Posts: 1,298

AUD. At least mine was.
  Forum: By Share Code

seeva222
Posted on: May 24 2019, 01:19 PM


Group: Member
Posts: 1,298

I'm at $45/$18
  Forum: By Share Code

seeva222
Posted on: May 24 2019, 12:54 PM


Group: Member
Posts: 1,298

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?


  Forum: By Share Code

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


Group: Member
Posts: 1,298

BTW, what does their 50% liquidity number mean?

52 week average volume moved to 132 from 125 last week.
  Forum: By Share Code

seeva222
Posted on: May 22 2019, 09:12 AM


Group: Member
Posts: 1,298

4 days to buy. Now it gets interesting
  Forum: By Share Code

seeva222
Posted on: May 21 2019, 01:58 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 21 2019, 09:57 AM


Group: Member
Posts: 1,298

(That was a Wiggles reference for you Auzzies with kids)
  Forum: By Share Code

seeva222
Posted on: May 21 2019, 04:37 AM


Group: Member
Posts: 1,298

Lachy!
  Forum: By Share Code

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


Group: Member
Posts: 1,298

Cuv presenting tomorrow in NYC

https://www.ubs.com/global/en/investment-ba...ence-agenda.pdf
  Forum: By Share Code

seeva222
Posted on: May 20 2019, 11:28 PM


Group: Member
Posts: 1,298

Started strong, ended weak
  Forum: By Share Code

seeva222
Posted on: May 20 2019, 11:44 AM


Group: Member
Posts: 1,298

Strong volume. 60k
  Forum: By Share Code

seeva222
Posted on: May 20 2019, 05:04 AM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

seeva222
Posted on: May 20 2019, 12:56 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 18 2019, 06:26 AM


Group: Member
Posts: 1,298

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.

  Forum: By Share Code

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


Group: Member
Posts: 1,298

https://www.orthocell.com.au
  Forum: By Share Code

seeva222
Posted on: May 17 2019, 12:03 PM


Group: Member
Posts: 1,298

31.64, you’re getting slow on the draw
  Forum: By Share Code

seeva222
Posted on: May 17 2019, 01:04 AM


Group: Member
Posts: 1,298

chugga, chugga.... and we're still just approaching the lift-off windows for FDA and ASX. The volume (329,856) shouldn't hurt.
  Forum: By Share Code

seeva222
Posted on: May 16 2019, 01:43 AM


Group: Member
Posts: 1,298

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.

  Forum: By Share Code

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


Group: Member
Posts: 1,298

I love their recell technology. Theoretically you could replace your skin in any area you're having a problem.
  Forum: By Share Code

seeva222
Posted on: May 14 2019, 11:00 PM


Group: Member
Posts: 1,298

I wonder if there are laggards ready to be relegated as well.
  Forum: By Share Code

seeva222
Posted on: May 14 2019, 12:32 PM


Group: Member
Posts: 1,298

When is the cutoff for measurement?
  Forum: By Share Code

seeva222
Posted on: May 13 2019, 10:58 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 8 2019, 03:02 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 3 2019, 10:16 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: May 3 2019, 06:40 AM


Group: Member
Posts: 1,298

I was mostly kidding. I suspect it was a message to the FDA to counterbalance Stan’s letter. Wild as speculation
  Forum: By Share Code

seeva222
Posted on: May 2 2019, 09:12 PM


Group: Member
Posts: 1,298

I think he’s letting an institution buy in before approval.
  Forum: By Share Code

seeva222
Posted on: May 2 2019, 04:25 AM


Group: Member
Posts: 1,298

Speaking of

https://www.fool.com.au/2019/04/30/clinuvel...y-sales-growth/
  Forum: By Share Code

seeva222
Posted on: May 2 2019, 12:35 AM


Group: Member
Posts: 1,298

Short covers + insto buys + ASX 200 index buys = Some interesting pressure building outside of approval and numbers (which should be very good for Q4)
  Forum: By Share Code

seeva222
Posted on: Apr 30 2019, 11:47 PM


Group: Member
Posts: 1,298

4x increase in production/manufacturing costs? I've been trying to get my Mom to buy on the dip, maybe this will work.
  Forum: By Share Code

seeva222
Posted on: Apr 30 2019, 10:03 AM


Group: Member
Posts: 1,298

Anyone got the opening depth?
  Forum: By Share Code

seeva222
Posted on: Apr 30 2019, 09:57 AM


Group: Member
Posts: 1,298

I wouldn’t want to be short right now.
  Forum: By Share Code

seeva222
Posted on: Apr 28 2019, 01:40 PM


Group: Member
Posts: 1,298

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.


  Forum: By Share Code

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


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Apr 24 2019, 11:39 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Apr 24 2019, 01:52 PM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

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


Group: Member
Posts: 1,298

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

Wonder Drug
  Forum: By Share Code

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


Group: Member
Posts: 1,298

Which means we could get paid early for 2019 orders.
  Forum: By Share Code

seeva222
Posted on: Apr 20 2019, 02:09 PM


Group: Member
Posts: 1,298

Isn’t this the lowest quarter because it’s out of season? Cash receipts are on a delay.
  Forum: By Share Code

seeva222
Posted on: Apr 20 2019, 10:15 AM


Group: Member
Posts: 1,298

Buy 45 days before, sell 4 days after. In between for us is the ASX announcement
  Forum: By Share Code

seeva222
Posted on: Apr 20 2019, 05:13 AM


Group: Member
Posts: 1,298

That needs all caps. DNA repair and anti-inflammatory are some big kahunas.
  Forum: By Share Code

seeva222
Posted on: Apr 18 2019, 01:14 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Apr 18 2019, 02:01 AM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

seeva222
Posted on: Apr 17 2019, 12:01 PM


Group: Member
Posts: 1,298

Rounding error for you
  Forum: By Share Code

seeva222
Posted on: Apr 16 2019, 05:07 AM


Group: Member
Posts: 1,298

Strike that, nearmap is in.
  Forum: By Share Code

seeva222
Posted on: Apr 16 2019, 03:35 AM


Group: Member
Posts: 1,298

Xmas could come early? I'd love to watch the shorts mess their shorts.
  Forum: By Share Code

seeva222
Posted on: Apr 12 2019, 08:49 AM


Group: Member
Posts: 1,298

https://www.facebook.com/1112753815441338/p...707382?sfns=xmo
  Forum: By Share Code

seeva222
Posted on: Apr 12 2019, 08:49 AM


Group: Member
Posts: 1,298

https://www.facebook.com/1112753815441338/p...707382?sfns=xmo
  Forum: By Share Code

seeva222
Posted on: Apr 4 2019, 12:07 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Apr 2 2019, 10:54 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 27 2019, 05:53 AM


Group: Member
Posts: 1,298

Love you Johnny Tech, but you’re an over optimist.
  Forum: By Share Code

seeva222
Posted on: Mar 27 2019, 01:58 AM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

seeva222
Posted on: Mar 22 2019, 11:33 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 22 2019, 05:24 AM


Group: Member
Posts: 1,298

I’ve looked at 4 stocks none of them popped on approval.
  Forum: By Share Code

seeva222
Posted on: Mar 22 2019, 01:57 AM


Group: Member
Posts: 1,298

Whomever recommended Avita is having a good day
  Forum: By Share Code

seeva222
Posted on: Mar 21 2019, 02:23 AM


Group: Member
Posts: 1,298

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
  Forum: By Share Code

seeva222
Posted on: Mar 20 2019, 02:42 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 20 2019, 11:46 AM


Group: Member
Posts: 1,298

Was hoping this dip might make into the us... wonder if this will short squeeze past 30.
  Forum: By Share Code

seeva222
Posted on: Mar 18 2019, 12:47 AM


Group: Member
Posts: 1,298

Good find. I think the opportunity here dwarfs the prescription opportunity
  Forum: By Share Code

seeva222
Posted on: Mar 17 2019, 02:54 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 17 2019, 12:37 AM


Group: Member
Posts: 1,298

T/O = Takeover?
  Forum: By Share Code

seeva222
Posted on: Mar 16 2019, 09:14 PM


Group: Member
Posts: 1,298

?
  Forum: By Share Code

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


Group: Member
Posts: 1,298

There something so righteous about Clinuvel buying through the shorts.
  Forum: By Share Code

seeva222
Posted on: Mar 14 2019, 05:22 AM


Group: Member
Posts: 1,298

They are clueless,they are stuck an tanning/vit in Asia vs other indications
  Forum: By Share Code

seeva222
Posted on: Mar 10 2019, 03:15 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 8 2019, 11:12 PM


Group: Member
Posts: 1,298

Why is June inclusion guaranteed?
  Forum: By Share Code

seeva222
Posted on: Mar 7 2019, 01:45 AM


Group: Member
Posts: 1,298

Word of the day:
Cimetidine
  Forum: By Share Code

seeva222
Posted on: Mar 6 2019, 11:05 PM


Group: Member
Posts: 1,298

So, the median would put us at Sep?

  Forum: By Share Code

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


Group: Member
Posts: 1,298

This is the big Kahuna. Anti-oxident, anti-inflammatory properties + OTC will get Walnut a real footy team.
  Forum: By Share Code

seeva222
Posted on: Mar 5 2019, 12:44 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 4 2019, 10:20 PM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Mar 2 2019, 01:29 AM


Group: Member
Posts: 1,298

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.
  Forum: By Share Code

seeva222
Posted on: Feb 27 2019, 04:26 AM


Group: Member
Posts: 1,298

Pre index buy
  Forum: By Share Code

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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

seeva222
Posted on: Feb 13 2019, 08:29 AM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298


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


Group: Member
Posts: 1,298

Joe Rogan
  Forum: By Share Code

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

More Florian

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

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


Group: Member
Posts: 1,298

Your are insane
  Forum: By Share Code

seeva222
Posted on: Jan 25 2019, 04:39 AM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

$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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

What were the side effects?
  Forum: By Share Code

seeva222
Posted on: Jan 15 2019, 12:09 PM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

I just shit my pants
  Forum: By Share Code

seeva222
Posted on: Jan 10 2019, 01:47 AM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

Same wiht CLVLF
  Forum: By Share Code

seeva222
Posted on: Jan 3 2019, 04:07 PM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

Betting on a delay?
  Forum: By Share Code

seeva222
Posted on: Dec 23 2018, 11:43 PM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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

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


Group: Member
Posts: 1,298

Give me a heads up
  Forum: By Share Code

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


Group: Member
Posts: 1,298

Give me a heads up
  Forum: By Share Code

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


Group: Member
Posts: 1,298

Give me a heads up
  Forum: By Share Code

seeva222
Posted on: Dec 13 2018, 02:23 PM


Group: Member
Posts: 1,298

“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


Group: Member
Posts: 1,298

Scratch
  Forum: By Share Code

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

"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


Group: Member
Posts: 1,298

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

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


Group: Member
Posts: 1,298

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

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


Group: Member
Posts: 1,298

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

seeva222
Posted on: Nov 16 2018, 09:59 AM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

“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


Group: Member
Posts: 1,298

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

seeva222
Posted on: Nov 13 2018, 12:18 PM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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

seeva222
Posted on: Nov 9 2018, 03:22 AM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

1-Billion again
  Forum: By Share Code

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


Group: Member
Posts: 1,298


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

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


Group: Member
Posts: 1,298

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

seeva222
Posted on: Nov 7 2018, 02:08 AM


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

Vs 960 last year
  Forum: By Share Code

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


Group: Member
Posts: 1,298

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


Group: Member
Posts: 1,298

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

seeva222
Posted on: Oct 20 2018, 12:06 PM


Group: Member
Posts: 1,298

Whatever it is will likely leverage centers in Europe if I’m reading between the lines correctly
  Forum: By Share Code

7 Pages (Click to Jump) V   1 2 3 4 > » 

Cant find what you are looking for? Show all active topics from the last 3 months


New Posts  New Replies
No New Posts  No New Replies
Hot topic  Hot Topic (New)
No new  Hot Topic (No New)



TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING