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royco
Posted on: Sep 26 2020, 05:25 PM


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https://www.google.com/amp/s/www.bbc.com/ne...siness-54261382
  Forum: Investment Discussion

royco
Posted on: Jul 16 2020, 09:13 PM


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https://www.bmj.com/content/368/bmj.m810/rr-57
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royco
Posted on: Jul 1 2020, 04:41 AM


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Clinuvel has gone quiet for a while now... Let's hope some news will come out soon apart from the quarterly report and no news letter etc.
The FY 2019_20 has officially ended.
Rien ne va plus
All sales booked, all revenues accounted for.

EU sales growth might have stalled due to covid19 and slow take up of new countries and centers.
Pricing stability I hope and also for manufacturing I don't expect a big cost jump.
So based on that we should be looking at similar numbers as last year in revenues and profit.
But now we have about 50 working days with 3to5 centers in the USA to add first implants at the global price level.
And initial Chinese sales too.

So much news we are now waiting for until the end of the year.
The next 6 months is going to be a busy time for cuv to live up to the expectations and secure future growth.
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royco
Posted on: Jun 23 2020, 11:26 PM


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what about the draconian epp follow up and safety measures?
will regulators suddenly provide scenesse a free passage for covid19?

can the evonik factory provide the implants in indistrial amounts?
who can distribute scenesse worldwide on an indistrial scale? (not clinuvel I presume)
how about safe administration of the implant to patients?
(I know that any nurse could do it but look at all this training and certification blabla regulators forced cuv into)

anyway our management did not spend one word on this option until now and my guess is they did not do any specific actions related to possible covid19 treatment.
a pie in the sky.


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royco
Posted on: Jun 23 2020, 10:36 PM


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How can clinuvel solve the scenesse for covid 19 pricing and production/distribution conundrum and come out a winner?
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royco
Posted on: Jun 23 2020, 04:06 PM


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Posts: 2,985

Will it be so that one day in the not so far away future we will all be grateful for shorters?
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royco
Posted on: Jun 20 2020, 11:26 PM


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Posts: 2,985

what a board this is...so much relentless research brought into the picture.
my sincere thanks to all contributors.

Would it not make sense for cuv to buy this board/sharecafe or at least help some members to contribute more?!
it is by far their oldest, most visited and most knowledgable information outlet today.

I read the effort made by the new pr guy in the latest presentatiom and I could read straight through it how inexperienced the newby was and how almost all was hearsay/debriefing of what he was told when joining.
It just couldnt convince me.
Many on this board and uho of course have over a decade of in depth knowledge on scenesse, clinuvel and its management.
We could do a better job, even if it would be answerring some questions of new investors.

What a joy to be a long term investor in this fantastic company holding one of the most disruptive technologies since they found aspirine.
glta
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royco
Posted on: Jun 11 2020, 07:37 PM


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I believe clinuvel and vallaurix are at an important cross roads.

Since 2016 we have seen strong sales growth until 2019.
The sp increased significantly in the wake of that with an ATH last autumn with a milestone FDA approval.

Since then the sp halved because we had profit taking, the usual EU winter micro sales season dip followed by a the announcement of a very slow roll out in the USA and the final covid 19 blow early 2020.
Non of this would justify an increasing sp imho.

Today things look differently and for me the outlook has probably never been better.
Clinuvel has a very healthy financial status as it is, a very comfortable situation.

I expect a significant sales increase compared to last quarter with the EU spring and summer season starting and most centers opened despite the pandemic. Together with the first US sales in April that leaves still 2 months of EU and USA sales combined. We also know the US roll out was moved significantly forward and seems to be going better than anticipated. The global implant price level strategy seems to be maintained.

Also July-Sept quarter could be a very strong one. USA sales might even go on during Northern winter with 6 implants allowed and this would overcome a part of the winter sales dip.
Not to forget the further roll out in the EU (France?), the approval and roll out in Australia, the further developments in China, the label extension and new indications in the pipeline.
I wont even mention those vitiligo trial preparations.
But I will mention the Vallaurix laboratory opening in August and probably including a part of the cosmetic line. It is my hope that the cosmetic line will be an important sales driver during the Northern winter.
Maybe not in the first year yet but hopefully over the next years.

After years of waiting for singular events like the start of new trials, the final results of trials, the EMA dossier filing, the ema decision , the FDA dossier filing, the fda decision I have never been waiting for so many things in such a short time. Clinuvel had the bad reputation to be late with all expected milestones but at least they achieved all crucial milestones eventually.

I say our management should stay for a few months more at least!
The next 12 to 24 months should be extremely exiting times for clinuvel.
X-ray ending: I wouldn't mind a take over by some big US or EU pharma eventually.

glta
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royco
Posted on: Jun 5 2020, 05:09 PM


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https://www.morningstar.com/stocks/xmun/ur9/ownership
No important shifts it seems:

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royco
Posted on: May 26 2020, 07:59 PM


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Posts: 2,985

Some big kahunas are in pole position having collected heaps of shares at low risk (fda approved) at low cost (thx to profit taking, covid and shorters) and largely under the radar.
Why did they do this? What fo they expect from this small company?

cuv exhibited a very small revenue from operations during the last quarter with winter sales dip, so surely no reason for the sp to move up. The us sales were first expected at the very end of the year, another reason for no sp North movement.

In the current quarter(s) the us sales will have to speak and much growth should be forthcoming from both the us and eu spring sales.
Next quarter we should have the singapore labs opened and get cosmetics on the rails. Maybe China will also be contributing some by years end. Ozzieland might surprise us all with a real fast track ( for once in cuv history), France might also start it seems.
label extensions?
new indications?
new products?
new trials?

bring it on cuv!
This is the "Cambrian explosion" we all were waiting for such a long long (=not short) time.
glta



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royco
Posted on: May 19 2020, 10:07 PM


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Opening of the Singapore lab facilities is now foreseen in August due to covid19 delays.
Ok, I can live with that!
:-)
Still hope we can get some kind of DNA repair trial going before we start the vitiligo phase II.

What an optimistic tone in this newsletter.
We are all set for very strong expansion over the next months and years.
Now let's see how the numbers for the quarter will hold up.

Growth, growth and growth...that's what it is all about.

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royco
Posted on: May 18 2020, 10:12 PM


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cuv has to come up with ever better revenues to overcome the eu scenesse sales stall and winter dip in sales.
If they can increase sales from the usa and roll out the cosmetic line that would help a lot.
I'm not counting on uk or France. Vitiligo is still a pie in the sky until we get further news. China is a question mark if we will move fast or not.
DNA repair trial has gone quiet again.

Every quarterly we should be surprised by yet another increase for 2 years in a row just on epp and cosmetics.
glta

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royco
Posted on: May 12 2020, 11:32 PM


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The value is in the blockchain and the distributed ledger, the crypto part is used to make sure the integrity of the blockchain is kept intact and the fact that it is distributed means no single entity (like a government) can mess with the numbers. Like the libor scandal and an endless string of bigger or smaller scams.

Integrity and trust in a counterpart of an economic transaction and in the currency has extremely high value.
That is why BTC is still here after 11 years, the code is tangible/visible and the coins can be used to pay for real things. Before long the fiat -currencies were also holding tangible value in gold of the actual coin or by gold reserves kept by the central bank but those days are far behind us.





  Forum: Investment Discussion

royco
Posted on: May 12 2020, 07:54 PM


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Posts: 2,985

AVITA Medical Limited
Proposed redomiciliation to the United States of America –
registration of Scheme Booklet with ASIC and financial reporting relief granted by ASIC
Valencia, Calif., USA, and Melbourne, Australia, 12 May 2020: AVITA Medical Limited (Company) (ASX:AVH, NASDAQ:RCEL) is pleased to announce that the Australian Securities and Investments Commission (ASIC) has registered the scheme booklet (Scheme Booklet) in relation to the proposed scheme of arrangement under which AVITA Therapeutics, Inc. (Avita US), a newly-formed company incorporated in Delaware in the United States of America, will become the parent company of the Company and its subsidiaries (Avita Group) for the purposes of effecting a redomiciliation of the Avita Group from Australia to the United States of America (Scheme).

Quo vadis clinuvel?
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royco
Posted on: May 8 2020, 07:48 PM


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It's good to read the thoughts of our chairman every once in a while.

Clinuvel has been a single focus company for over a decade, not expanding in any other way than the progress towards approval.
With FDA and EMA approval in the bag and a new chairman they have been preparing change towards an expanding commercial company with a high growth through sales of own products and in house development of a complete product line.

It's all happening and doesn't seem to slow down despite the current pandemic crisis situation.
The recent flurry of excellent news has been unusual for this small enterprise.
Big and small steps towards strong growth.
He is absolutely right that shorters and worries about shorters should not really be a focus of any management.
Delivery of milestones and growth will make shorters evaporate as the company value increases.

Dedication to the tasks ahead and delivering on expectations are the focus.
The EU roll out seems to mature and some countries seem still unwilling to allow SCENESSE despite the EMA approval in 2014.
But in the mean time clinuvel has prepared the US roll out and they will start to produce revenues as we speak, probably putting the EU revenue in the shadows within 24 months.
Not to speak about China epp start, the soon to be launched new lab and cosmetic range, the DNA repair trial that was announced, the vitiligo US trial that is being prepared right now.

Clinuvel has been shifting gear since the FDA approval and is moving forward at what I believe is the right speed.
After 15 years of holding clinuvel this current speed is warp factor 9 Mr Sulu!
https://www.youtube.com/watch?v=zP9PLYJxjaM

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royco
Posted on: May 7 2020, 10:40 PM


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I hope they are going to give some news on the DNA repair trial.

Let's also see how fast they can implement the vitiligo trial protocol together with the fda.
Both should progress significantly before they open the new lab facility in Singapore.

As I expect the expensive lab and staff will not be allowed to become a dead weight in the accounts and so the new productlines should be launched and commercialized in short order around the time of opening.
Sound financial management indeed.

exciting times!
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royco
Posted on: May 1 2020, 06:12 PM


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Looks like cuv has put scenesse on track to be the first systemic photoprotecting drug helping vitiligo patients.
This fda meeting was a major milestone for 2020.

If my memory serves me well cuv mentioned the lasting effects 6 months or 1 year post treatment in the Singaporean trial.
CURATIVE
scenesse+uv treatment +topical (hand+feet) could be a curative treatment for vitiligo.
DNA repair effects included I guess.

For me the EU and us phase 4 study results are a crucial element.
Safety will be clear and please the regulator but also DNA repair effects and related health benefits must come forward.
EPP patients should come out with a better qol, more sunlight exposure time And all additional benefits from DNA repair...
Possibly only scientifically visible after a decade or two of measuring parameters.

Shifting gears in the race to unlock the full potential of scenesse.
What a ride!
Glta
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royco
Posted on: Apr 30 2020, 10:55 PM


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the big question is: quid the fda meeting yesterday?!?!
When will we learn about the outcomes?

The answer we got from the fda must fundamentally impact the market value.

Next big thing on the agenda is the start of the DNA repair trial.
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royco
Posted on: Apr 28 2020, 09:08 PM


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https://youth-investment-group.com/2020/04/...cket-this-week/
Our friends from wallstreetonline found it.
maybe posted here before already
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royco
Posted on: Apr 27 2020, 10:30 PM


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prenumbra patent filed, could it mean that all is on track to start with a dna repair trial as announced earlier?
an important week starting.
incredible newsflow lately

Asian roll out might be much faster and bigger than anyone could imagine.
The ema had put a lock and chain around scenesse and cuv exiled the further development to singapore.
The fda was very slow in accepting the application but might take a quick turn for vitiligo.
The chinese were the last in the row but I expect them to move so fast they will overtake the us roll out and naturally also the still extremely slow eu market.
gung ho


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royco
Posted on: Apr 24 2020, 08:13 PM


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Scenesse to be distributed to 10 patients in China.

It's in the category of totally unexpected news for me.
I had no clue that they were working towards this since 2 years.
Personally I think it is a major achievement and finally they are not going at it alone for once.

The use of a partnership is the best and maybe (was) the only way to do this I guess.
It mitigates some risks and gives a lot of advantages in speed of access to the hospitals and other administration.
All of this comes at an undisclosed cost and no clue if that is balanced or not.
Number of patients? Reimbursements? insurance? copying the implant? Off label use?

Clinuvel is bringing out positive news in a quick succession now despite of the economic and health turmoil.
That is quite something! I hope the numbers will follow too.

Next week we have the FDA meeting.
The first quarter results coming up

I would hope the TGA will really speed up things and not need until the end of the year to give green light.
Eventually we might hear something about Japan too.
The UK...mmmh no, don't thinks so.
The labs will be opened in Singapore in early July.
And hopefully they can still start this DNA repair trial without too much delay.

If 2020 numbers growth follows this news flow crescendo we should be ready to understand why those big instos have been accumulating shares lately.
glta





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royco
Posted on: Apr 20 2020, 07:24 PM


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Same source for Institutions:

Capital Research and Management Company +1,199,104

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royco
Posted on: Apr 20 2020, 07:22 PM


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Posts: 2,985

https://www.morningstar.com/stocks/xmun/ur9/ownership

Some have been accumulating over the first quarter it seems, not only Goldman Sachs:

American Funds SMALLCAP World A +849,979
Vanguard Total Intl Stock Index Inv +45,785
American Funds IS® Global Small Cap + 228,722
Goldman Sachs Intl Sm Cp Insghts Ins + 177,276

Total for the top 20: +1,358,952 per March 31.
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royco
Posted on: Apr 19 2020, 11:09 PM


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What a great little company this is.

After all those years of regulatory nono and in the midst of a global pandemic and economic crisis they actually managed to treat the first US epp patients this week.
One word: bravo!
We give hope and access to a better life for all those epp patients.

Looking forward:

First the fda vitiligo meeting
Then the start of the DNA repair trial if not delayed. (should be small scale)
The opening of the new singapore labs.

I don't expect high numbers for the quarterly results at the end of the month.
Growth will be forthcoming fast, that I'm sure.
And I agree that the USA epp market alone justifies double numbers from where we are now.

Go scenesse!
Glta
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royco
Posted on: Apr 5 2020, 05:08 AM


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Eps growth rate becomes negative for the quarter.
🤔
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royco
Posted on: Apr 4 2020, 05:32 PM


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https://markets.businessinsider.com/news/st...20-4-1029063649

April 3rd: Goldman sachs says end quarter eps will slide 123pct, best place to be: tech, healthcare and utilities.

https://www.morningstar.com/stocks/pinx/clvlf/ownership

31 March: Goldman Sachs newly owns 177k clinuvel shares.

They are ready it seems.

T-11
First us sales getting very close now.

Hopefully some fda Skype call will be organised about vitiligo as planned and a
DNA repair trial started soon.

Still waiting for the first official signs that afamelanotide can be helpful with covid19. Or will we have to count on India again?

Glta

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royco
Posted on: Mar 26 2020, 02:05 AM


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the implants are "made in usa" so good for making america great again.
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royco
Posted on: Mar 26 2020, 02:01 AM


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if I could only text or tweet potus about this.
Maybe he might accept it without understanding and for the wrong reasons but who cares.
At least he would decide and get it done.
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royco
Posted on: Mar 25 2020, 09:17 PM


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Posted on: Feb 13 2020, 05:33 PM
Browse to post


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Possibly cuv is ready with the fda roll out preparations/admin.

I see no other option why they request a vitiligo meeting now.
Small team can only do one thing at a time starting with the most important: us roll out.

I suppose us first patient treatments could be in 1 or 2 months.
Recruit patients, pre treatment screening, train and certify epp center, deliver implant and go.
I hope the price agreements are in place for many epp patients.

Glta

This one above I posted on 13 February.

It was followed by the announcement of having first sales expected at the end of 2020.
For me that was a usual clinuvel style extremely cautious news item in a pre-corona time and it fit with the pending this and that lingo previously applied by the CEO.
This "delay" news was quite difficult to understand from my perspective and knowing what we know apart from clinuvel being its extremely cautious self.

The actual distribution starting in April is clearly within my personal expectations.
However the fact that they announce this now is a little weird.
Almost like someone forced them to do this and deviate from their usual very conservative approach.
Maybe they wanted to send positive news out to counter the share price downturn to please investors. (and themselves)

Especially because this roll out will probably take place right in the middle of the worst part of the corona situation in the US and possibly a kind of lock down, unseen measures expected.
So as to talk about roll out in the USA in 3 centers starting from 15 April is taking quite a leap of faith and (over-) confidence.
I do think they are ready but I also fear that corona measures will impact.

This could trigger some new announcements of delays in treatment distribution and delays in payments.
Both EU and USA will be impacted I think.
If they have to announce this (in the coming weeks) it will impact seriously on the share price.
I agree with Wally that the FDA should find a way for EPP patients to obtain treatment in a more elegant way compared to the currently foreseen manner.
"extremis malis extrema remedia"

Desperate times call for desperate measures.
(hippocrates and Erasmus)

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royco
Posted on: Mar 23 2020, 08:11 PM


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2335 patients in the USA according to the latest clinuvel ppt.
If they can reach 1000 to 1500 patients over the next 24 months that would be great.

3 major centers to open in phase I of the distribution.
After 15 April USA EPP patients can apply to the co payment savings programme.
The start of a long journey to full distribution of SCENESSE across the USA.
Finally on the move.

Now up to the vitiligo progress and the start of the DNA repair trial this springtime.
Clinuvel will also suffer some delays and even a slower distribution in the EU these months.
Only to catch up in the EU and US summer and to come out of this year with an absolute top level
revenue stream and positive financial results.

Let's see with the next few quarterlies how clinuvel is doing and how it compares to the rest of the market.
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royco
Posted on: Mar 19 2020, 12:38 AM


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our super duo blijdorp and wolgen could have a big impact:

1) buy a significant amount of shares of clinuvel
2) explore and explain if there is any chance of scenesse being helpful with covid19.
3) explain the status of the us roll out and how it is impacted by covid19 (how, not if)

earn your salary PW!
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royco
Posted on: Mar 18 2020, 02:36 AM


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from what I understand the global economy is going into a recession that might last years and in total will be worse than the GFC a decade ago and possibly any crisis before that.

The central banks will again do "everything it takes" as they usually do.
Translated that means they will probably increase liquidity and create enormous amounts of extra money at an unseen scale.
Interest rates will not go further sub zero as the effects of that are totally unknown and possibly destructive to the entire financial system.

As we know BTC will always become more difficult to mine and is limited in number.
Therefore the price in traditional USD/EUR could skyrocket over the next 24 months.

Just my five cents.
  Forum: Investment Discussion

royco
Posted on: Mar 18 2020, 02:20 AM


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Posts: 2,985

recessive dystrophic epidermolysis bullosa (RDEB)
https://www.dailymail.co.uk/femail/article-...gue-Italia.html

Could this be an interesting next orphan target?

Although I also advocate clinuvel does first fully eplore all possibilities for SCENESSE to be helpful with covid19.
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royco
Posted on: Mar 14 2020, 03:04 AM


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I see a crucial role for clinuvel, evonik, WHO and both ema and fda to communicate on the issue and take bold action if there is the slightest option that scenesse could help save lives from corona infected.
Better to be blamed for taking action than for not even trying.
I don't mind if cuv has to spend all savings on an ultra fast and large trial.

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royco
Posted on: Mar 14 2020, 02:45 AM


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You wonder why clinuvel had to exile afamelanotide development to Singapore "vallaurix" just weeks before ema could "untangle" the dossier and approve.
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royco
Posted on: Mar 14 2020, 01:00 AM


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still cannot grasp why no word is said in the media and by the medical word about existing medication that could help the healing process with covid19 or the flu.
not even a test...nada
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royco
Posted on: Mar 12 2020, 07:56 PM


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from the chair letter to shareholders:

"I know that one new technology can reach galactic value"

????
And what could that be?
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royco
Posted on: Mar 12 2020, 05:14 PM


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NL. Netherlands
MC. Monaco
Vallauris is in france close to Monaco if I remember well.
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royco
Posted on: Mar 10 2020, 07:19 AM


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Maybe the fda realised they just approved a drug that could save lives of corona covid19 infected.
Only they should make it easier to obtain....
No comprendo why they don't look any further into afamelanotide to be helpful with corona.
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royco
Posted on: Mar 5 2020, 08:55 PM


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The scenesse.com website is really a great testimony that it is really happening now all elements are put in place to have
SCENESSE distributed in the USA.

Still difficult to grasp how great this is after all those years of maybe, pending this or that and delays of all sorts.
Imagine the anticipation that all those EPP patients feel right now.
Over the next 24 months most of those patients will finally be able to achieve a much needed treatment.

Now let's see how the company will tackle the vitiligo and if the combination therapy will be curative after all.
Yes, imagine a cure for vitiligo.


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royco
Posted on: Mar 3 2020, 08:45 PM


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cuv should find a partner for vitiligo asap after the fda meeting if the outcome is positive.

to go alone for this one is lunacy in my opinion.

too big, too expensive, too time critical.
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royco
Posted on: Mar 3 2020, 06:49 PM


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clinuvel is in great shape despite the sp downfall of late.
Blijdorp and Wolgen are doing a great job to work in the shadows and grow this little gem.

Many big companies and blue chips will have to downgrade the expectations for the year due to the corona-flash crash.
Many were expecting to see an economic crisis appearing in 2020, nobody expected the corona virus to be the cause.
Where do investors find growth, dividends and stability?

Clinuvel will have the upside of the Northern hemisphere summertime sales season.
Return to massive profitability, imminent US roll out for EPP.
Clinuvel/FDA hopefully will announce the results of the FDA type C meeting for vitiligo shortly after 29 April.

A perfect outcome of the April FDA meeting would be the preparation of the phase IIb and phase 3 vitiligo studies in the US.
I expect these trials to be auto-financed but happening in concerto with the roll out in the USA to balance the extra costs.
I do expect clinuvel to partner up with another pharma for vitiligo commercially.

Not even mentioning the opening of the new singaporean labs July 2020 and my expectation that they will soon after be launching some products too again to balance for the extra costs made.
Especially this progress with vitiligo is bringing back some semi justified fantasy in the cuv valuations.


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royco
Posted on: Mar 1 2020, 12:36 AM


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Uho came already years ago with the idea that afamelanotide could be helpful with outbreaks of ebola.
The link was to the anti inflammatory properties back then
WHO knows about afamelanotide. (Peter Piot was the main scientist those days)
They did not do anything, scenesse was not approved yet.

For the current outbreak the Urgency seems to be different but scenesse is now approved EU and USA.
The benefits to general health of using afamelanotide must be apparent in the long term use data generated by clinuvel for ema.

I don't expect Any actual help from a regulator to see if scenesse could be tested with covid19.



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royco
Posted on: Feb 28 2020, 05:28 AM


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Not exclude the impact of the ema that required cuv to change wording on the website and was reading boards like this.
Ema takes the protection of the EU markets seriously as we learned over the years.
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royco
Posted on: Feb 28 2020, 02:00 AM


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first us distribution expected at the end of 2020.

I wonder what the apf and us patients feel with that news.
Spending another summer in darkness even while approved since October.
I hope that despite the announcement scenesse is available in the usa by summer 2020.
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royco
Posted on: Feb 27 2020, 04:02 AM


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Clinuvel knows for years that there is little implant demand this season.
The cost restrictions were self-imposed and kept results from sliding too far of the mark.
This year with the "unfortunately late" timing of the fda approval and the cost increases following cuv got hammered with thick double digit profit decrease.

They should find a solution for thiswinterdip.
Nobody wants to live through another kebab_store like sales season (courtesy to our wallstreet online friends clinuvellians).
This is a pharma company and a business, the management should come with solutions ASAP to have a more steady revenue stream.
No so called biotech high risk company growth company can afford this kind of (planned) drop in already minuscule profits without the markets taking action.

At the same time solid US sales report in the short term could send this sp back into the stratospheric market cap regions.
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royco
Posted on: Feb 27 2020, 02:47 AM


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i think it is high time for clinuvel to announce a significant implant price increase to the global markets.

They have enough reasons to do so:
-manufacturing costs increased
-usa roll out comes with similar draconian measures as eu
-peadiatrics development will be costly too
-r&d cost increasing with new trials expected
-very -strong decrease in profits over the past half year

I still find this ceo incentive plan recall and timing quite enigmatic.
(but most welcome)
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royco
Posted on: Feb 26 2020, 08:47 PM


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"cost increases from commercial manufacturing of SCENESSE® implants have been passed on to the Group by its implant contract manufacturer"

80% cost increase for Drug formulation R&D, manufacture & distribution

My guess is that this is not due to an increase in orders for the US market or R&D costs or distribution costs.
My fear is that the contract manufacturer has significantly increased the production price of the implant.
Clinuvel probably has no other manufacturing options available in the short term and so has to shut up and accept it.
Not really clear but it seems it has taken a big bite out of the already thin profits.
Maybe we forgot that Evonik has a monopoly too. (Is that THE contract manufacturer?)


Again just a guess.
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royco
Posted on: Feb 26 2020, 08:29 PM


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I wonder why they are so unclear about the investments in the singapore laboratories
"expanded through both a new biological and analytical laboratory"

Not sure but these will not be bringing any production for commercial distribution, just research? Maybe I am reading this wrongly.
So from July the first when the officially open the lab facilities they will be a considerable extra cost while vallaurix has zero income?

I find it highly unlikely that clinuvel management will allow the vallaurix singapore operations to become a significant cost factor in the clinuvel results.
So my guess is that the opening in july will go hand in hand with the announcement/roll out of the first commercial (OTC?) products from Vallaurix.
It just doesn't fit the cautious (financial) management otherwise.

All in all I am glad clinuvel still managed a small profit over the last 6 months while gearing to achieve approval and then to prepare US sales.
I expect the burden on the 1Q20 results to be quite heavy still since the revenues will still be in hibernation modus while the implant production for the US should be ordered/paid with the contract manufacturer in the first quarter to start distribution in the second quarter.
Just my guess.

Painful sp collapse indeed.
Fundamentals have not shifted much. (apart from more investments in future commercial growth)
glta





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royco
Posted on: Feb 20 2020, 05:42 PM


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keeping an eye on the big picture:

fda approved ema approved
eu market took 2 years to enter but is now a solid revenue generator.
usa could be much faster i e possibly 6 months to 1 year post green light.
cuv will not stop until the last available us and eu patient is receiving treatment at the uniform price.
growth in revenue will follow
the shorters will retreat, longs will prevail.
who would have thought 4 years ago about shorters at 25aud to be a problem?
In a few years someone will complain about shorters pushing cuv from 200 to 150aud
auch!
glta
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royco
Posted on: Feb 13 2020, 05:33 PM


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Possibly cuv is ready with the fda roll out preparations/admin.

I see no other option why they request a vitiligo meeting now.
Small team can only do one thing at a time starting with the most important: us roll out.

I suppose us first patient treatments could be in 1 or 2 months.
Recruit patients, pre treatment screening, train and certify epp center, deliver implant and go.
I hope the price agreements are in place for many epp patients.

Glta

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royco
Posted on: Feb 5 2020, 09:01 PM


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The benefits of being and remaining a long term shareholder of clinuvel are clear.
After the 2006 and 2007 rise and collapse in sp years of flat-lining followed around 1 and 2 AUD.

In 2014 the flat-lining was shortly interrupted with the EMA approval push to even 4 AUD and quick profit taking and sp collapse.
Only to be followed by years of semi flat-lining and a glacial roll out speed in the EU with an unexpected number of extra regulatory roadblocks and other NICE stories.

From 2016-17 onward the ride upwards brought us above 10 and in 2018 just under 20 AUD.
Cuv became profitable and created some small but robust revenues from the handful of EPP patients treated in a handful of EU countries.
Yet it became clear that clinuvel has a lack of revenues in the winter months where it almost goes out of business so to speak.
Cost control was a great help to achieve profitability but that limitation also means that there was no more development worthy to speak about and competitors are catching up.
A micro-dividend was unexpectedly created. (I still don't understand why)

2019 we quickly went above 20 AUD and had the all-time greatest achievement of the FDA approval followed by an approval spike to 45 AUD that was again followed by a decline towards pre-FDA approval levels at about 25 AUD today.
We are slowly getting out of the worst revenues quarters for clinuvel in the european winter months. As a result of the FDA preparations costs have gone up significantly exactly in the low revenue season.
Though luck.

It is sometimes hard to take another sp beating after all those hopeful developments over the last few years where it went from almost out of business with no product to a profitable biotech with a slow but steadily growing revenue stream.

Now what will follow?
The 2020 revenue season is about to start and bring profits back.
Me thinks the company is busy gearing up to be ready for the future and it will keep growing revenues from the EU and the US for years while remaining profitable with strictly controlling costs.
I see a lot of potential revenue growth over the next 24-36 months with USA, Australia, UK and France markets opening up slowly.
Clinuvel should focus further on the EU and US roll out which is at a high profit rate.
Maybe no spectacular jumps in revenues but a steady grinding increase with an unfortunate winter dip not.
New indications, new products are all in the charts for the next years and will take a large bite out of the cuv money pile before they start to generate pie-in the sky revenues or maybe even some profits.

In my view the new chapter has started with clinuvel's USA approval.
Its much more fun to wait for the next quarterly report and revenue growth numbers than to make another loss and wait for the next phase II trial results.
Or to wait for the announcement of the dividend in stead of waiting for the next capital increase.
Its much more fun to wait for vitiligo progress while you know the drug is already EMA and FDA approved with a great safety record.
Its much more fun to wait at 25 than at 2.5 AUD, 15 AUD.
So much more fun to wait for the ASX100 while in the ASX200 already.
Its a different ballgame and we are still in it!

Back to sleep mode now.
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royco
Posted on: Jan 30 2020, 10:45 PM


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Not very high expectations of the EU winter revenues.

I just hope the revenues are not less than last year around this time and they still make a mini-profit thanks to the lack of investing in any progress outside of SCENESSE for EPP.
Unfortunately clinuvel management has not yet worked away the seasonal revenues fluctuations, they know this for years already and never seem to bother that the winter revenue stays very low.

Clinuvel have almost nothing invested in any R&D over the past years as the numbers clearly show and the lack of new trials also clearly indicates.
They have enough revenues, organic growth and money in the bank to start investing heavily in progress on new molecules, indications, trials, products and methods etc.
Another year of actual development standstill would be extremely bad from almost all points of view.

We have now 3 months since the US approval...what are they waiting for?
The only real news we got since that time is the application for the Australian approval.
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royco
Posted on: Jan 20 2020, 06:44 PM


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https://www.forbes.com/sites/billybambrough...0/#4abbbb4191cb
  Forum: Investment Discussion

royco
Posted on: Jan 19 2020, 10:59 PM


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Chill bros &sistas
Smooth sailing from now on.
All indicators green for growth.
For years to come.
Cuv have all what iT takes to execute.
Next to lookout for quarterly results.

Personally I hope that we can build further during 2 -5 years before the inevitable take over.
Glta clinuvelians
May the afamelanotide be with you.
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royco
Posted on: Jan 16 2020, 06:04 PM


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So the usa is also demanding a similar draconian follow up.
The plan had to be reviewed until now.
Cuv had to make changes to the wording on the website following Ema complaints about unauthorized advertising?!
They are monitoring formal and informal communicatief Chanels?!
Cuv sticks to the uniform pricing despite entire pharma is going in the opposite direction.
Big pharma must hate them: they got a systemic tanning agent approved and now Apply uniform price on all matkets.
I have little doubt they had to ban the word cosmetic.

Hunt down, silence and take out.
How long more Will they allow this rogue outfit to go on?
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royco
Posted on: Jan 14 2020, 08:00 PM


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6 per year, 6 months evaluation.
Looks like a fair deal.

That is big news for many US patients!

I think we could/should see some sp adjustment to this news.
Less risk, more value.

I hope clinuvel will comment this breakthrough (tomorrow).
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royco
Posted on: Dec 19 2019, 12:06 PM


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2019 marks the year of the fda tipping point since the discovery in the 80ties.
2020 I expect the start of the cambrian explosion for clinuvel and afamelanotide.
Happy festive season to all!

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royco
Posted on: Dec 14 2019, 01:23 AM


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https://www.forbes.com/sites/billybambrough...gher-heres-why/
  Forum: Investment Discussion

royco
Posted on: Dec 13 2019, 06:02 PM


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At the very end he said The USA market entry should double or tripple the results.
What I was missing: patiënt focus, epp patiënt stories, other patients suffering from other diseases that could be helped by SCENESSE or any of the new products in the pipeline.
Too much talk about the past and how well they did.
The share price is still up a lot since 5 years and the shorters have a point that many biotech do fail to capitalise and execute post USA market approval and entry.
Going at iT alone for epp in the USA.

Hoping for Some real news soon.
Glta
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royco
Posted on: Dec 5 2019, 11:26 PM


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50 AUD would be underwhelming for myself.

I am convinced that our chairman has something else in mind than to sell off at a handful of times the initial value of his holding.
His previous endeavor B&S holding took him a lifetime to develop into what it is now, this is a man with patience and dedication.
From what I read he still owns about 50pct of this B&S company today and the stake is much more important in absolute value and percentages when compared to his current Clinuvel holding.

Whatever is his situation exactly I read into this that clinuvel is also a "long term" play for him and that he wants to sit it out until the OTC and cosmetic line is available to make sure his B&S holding can benefit to the maximum from it. The B&S holding has the perfect fit international prime location market access and marketing/sales position to form a perfect match with clinuvel's future OTC portfolio.
If they can find the right balance for the pricing and out-licensing distribution and sales, both his clinuvel stake and B&S holdings can benefit optimally and grow significantly in the long run.

So i have no doubt that WB will want the CEO and CUV to continue down this path for the next 36 months at least.
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royco
Posted on: Dec 4 2019, 05:18 AM


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"how clinuvel enters its final chapter"

Further to the end of the ceo letter its all about the last part of the strategic trilogy.
But reading it again... The choice of words strikes me as odd especially at the start of the letter.
After the final chapter a book is finished and can be put on the shelf (to be sold).
A final chapter before a take over can be realised within acceptable financial reward for the ceo maybe?

Let's repair the uv induced dna damage ASAP and get this over with.
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royco
Posted on: Nov 29 2019, 05:39 PM


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The only pills I need are sleeping pills.

The Train is on rails for multiple revenue growth.
36 months from next destination: a biotech with a diversified product portfolio, sustained profit, dividends, growth.
I have no doubt this team Will eventually execute all steps and Will not stop at a failure or delay but always Carry on.
The markets Will do their work and reward the winners.

Walking with New confidence thanks to the fda approval.
Maybe in 36 months we are discussing disappointment and finding excuses because iT had been trading at 150 to fall back to 100 ozziedallars.
glta
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royco
Posted on: Nov 25 2019, 11:24 PM


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unlimited validity...

That is a breakthrough!
It was conditionally approved until now by EMA with the data to be presented yearly to the committee.
I guess that means that they will not have to convene and re-decide any longer based on the outcome of post marketing obligations and research data.

So could it mean that clinuvel and the hospitals/patients in the EU can slowly abandon this extra work?

Clinuvel should bring this positive achievement out in the open, where is the news-release?
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royco
Posted on: Nov 22 2019, 08:17 PM


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Maybe this was already discussed but I consider B&S group (profit 2018: EURO 71mln) a potential target for clinuvel.
They could buy a distributor for its topline otc products.

To build a similar channel from scratch doesn't make sense, especially not with Blijdorp as a chairman of clinuvel.
Clinuvel likes to keep things in tight control so if they don't build it in house they could buy one.
B&S is profitable and has global reach.

Clinuvel is currently maybe still too small and the products not ready yet.
This time next year I expect the market cap could be double or more, revenues should have grown significantly, cash pile should be big and also the OTC product line should be ready for roll out.
Possibly with a capital raise and quotation of the new shares on NASDAQ paying for a part of the expansion.
glta


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royco
Posted on: Nov 20 2019, 02:23 AM


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A metronomic ceo remember.

I expect a boring agm as always.
Nothing special to report, all decisions passed by majority.
The ceo ppt as usual containing no new information.
Chair recap of the history of cuv and thanks to ceo.

Clinuvel Will not change into a dynamic pr and sales vehicle.
The ceo stands for steady progress in the creation of value in the long run.
In 10 years from loss making, no product but debt free towards profitability with approved product and cash-rich dividend paying status.
The next stage is increased profitability and a multi product and market company.
The 2019 fda approval Marked the start towards this next level.
The ceo has 3 years to bring us en route in what should be the more easy part of the journey.
After that I expect HIM to become chairman of the board and own 10pct of what hopefully will be a company of 4 to 7 bn aud.
Another 5 years onwards could double this again.

I dont see how any investor could be against.

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royco
Posted on: Nov 6 2019, 11:20 PM


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I think he plans to never sell any single share and collect Growing dividends ever after.
So you might have to wait a mighty long time wpw.
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royco
Posted on: Nov 6 2019, 09:40 PM


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Leaving?
If all Goes well he might OWN around 5mln shares so he remains deeply involved even if he is no longer ceo.
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royco
Posted on: Nov 6 2019, 07:34 PM


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Dilution happened today with the new shares issued.

Cuv did not file for the Australian regulator yet, they announced that they plan to do it by first quarter next year.
We all know how well cuv is keeping timelines and we all know the value of "expedited" review etc.

The ceo incentive plan will again create significant dilution and will be voted on 20 November. My guess is that they have it already covered with enough votes by the major and sophisticated shareholders.
They might have noticed some headwind from some medium to minor shareholders and they want also those on board for a bigger majority in favor.
By the time this proposed dilution happens at its highest level nobody on this board will have ANY troubles with it since the market cap will be 7.5 BLN AUD. Even if the sp retreats 10% on the same day as the shares are awarded nobody that is here today will find that a problem.

As you see in the example below the NICE had made a secret price deal with the company after 4 years of time wasted.
For clinuvel the problem is that the price is known and equal throughout the EU and many countries regulators only want secretive price deals as to give them "perceived" benefits compared to other EU countries.
So clinuvel is fighting an uphill and lonely battle that leads us to our current semi- stand-still of delayed or negative decisions in many countries.

What I find more difficult to grasp is that even in a low-ball US EPP patients only scenario clinuvel has basically doubled the revenue potential with obtaining the US approval.
Possibly the roll out will be as slow as it was in the EU but even then we are looking at a double digit increase of revenues over the next months towards a 100% growth of current revenues in let's say 23 months from now. Clinuvel is known for its strict financial controls and I strongly believe the profitability will stay at a very high level compared to today.
There are risks but they are minimal compared to before the FDA approval.
Clinuvel management should now come up with a new and clear plan for development and they should start to announce many long awaited milestones.
Many of them before or at the AGM, some before the end of the year and some early 2020. In 5 months time clinuvel is entering the next high revenue half year and should have a very good idea on the increase in revenues from the US market. We should have progress on all other fronts reported too.
I guess clinuvel must now significantly grow in number of employees driving those costs up. (hopefully non have the CEO pay scale)
The implant production costs must also increase for the us roll out.
Some extra marketing and IR/PR costs for sure.
Hopefully also some extra costs for R&D (eg vitiligo trial etc) .
Possibly some costs for production facilities in Singapore.

The CEO has kept us afloat in those dark days pre approval by not spending on anything but what was necessary for EMA and FDA approval.
The company has come to an actual R&D stand-still for years now and this might cost us dearly if not turned around quickly.
We cannot remain a one trick pony forever.




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royco
Posted on: Nov 4 2019, 05:37 PM


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The good thing is that Spain has only a handful epp patients.
I suppose they could go abroad for treatment using crowdfunding etc.

30 seems to be the new 20.
Im ready for the next swing to the 40 level.

Now I wonder what is the opinion of HoMM on this ceo rewards package?
Also from uho on gg no reaction yet.

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royco
Posted on: Oct 30 2019, 05:23 PM


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I think they thought the fda approval would not take that long hence the optimistic tga timing.

PW and cuv are not know for putting accurate timelines but for achieving 2 main milestones and all the little ones in between.
How could they have done things faster when the regulators dictate all?
In hindsight I think this was probably the shortest and most likely only path to regulatory approval.
Along the way they secured enough funding avoided a hostile take over and achieved a viable commercial plan leading to profitability, a dividend and a strong financial situation.
Bravo!

I voted FOR for all points on the agenda because I agree to award him those shares if the market cap reaches those astronomic values in just 36 Months.
5 times current valuation.
Five times.
36 months (or less)
Those extra shares also mean his commitment to the company success increases to almost unhealthy levels.

And yes, I was there in 2004 and 2005 seeing my investment dwindle and hopes fade untill the turnaround.

PW and WB are all that stand between a bright future and a lowball take over.
I opt for the bright future allthough a take over might come regardless.
Glta
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royco
Posted on: Oct 23 2019, 04:42 PM


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Anybody a guess for the quarterly result?
I hope results are at a new all time high.
Most news should be out in the next month until the agm.

A very long list of things to do.
Vitiligo fda meeting outcome?!
If they can start a us phase 3 that would be a game changer.

With a first patiënt usa treated this year and increased distribution in the eu and us I suppose they could double the results over the next twelve months.
Great times for cuv investors and patients.
Glta
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royco
Posted on: Oct 9 2019, 06:35 AM


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Congrats to chairman Stan Mcleish retiring soon.
Well deserved.
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royco
Posted on: Oct 9 2019, 04:37 AM


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Alia jacta est
We exited the wormhole.
What a journey. 16 years for me.
Congrats to all here and especially happy for the US epp patients.
Onwards and upwards.
All future developments are easy compared to what was achieved today.
Thanks for all posters for your efforts to turn every (mile) stone and measure every (news) letter.
A movie script.
Please don't forget to share your fortune and be generous to those in need. (but avoid taxes;~)
Glta
October 8th clinuvel rebirth.

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royco
Posted on: Oct 2 2019, 10:28 AM


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https://images.app.goo.gl/tmqWnJ4CTdv2xrdn8
New logo?
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royco
Posted on: Sep 16 2019, 06:10 PM


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Im going in black out comms mode until approval.
See you all on the other side!
glta
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royco
Posted on: Sep 16 2019, 04:08 AM


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Any day now...
Expedited priority orphan fast track delayed for 3 months after 2 years of review

They could give a few days now dont you think?!
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royco
Posted on: Sep 11 2019, 08:06 PM


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Not a take over...
A run over.
Rabbit vs headlights kind of stuff.

something was brewing pre Ema approval.
Same pot is on the fire again?!
An offer pre Fda pdufa?
Unlikely
Post fda?
A lot cheaper if the starting point was 24 And not 34 aud.

Personally i see more in a usa vitiligo partnership.
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royco
Posted on: Sep 11 2019, 04:15 PM


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Hold, hold, hooold!

https://m.youtube.com/watch?v=FaF5MAY1Wow
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royco
Posted on: Sep 10 2019, 11:33 PM


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Posts: 2,985

Don’t let those tree Shakes and last trade of the day games fool you: value is being created @cuv.
The fda decision Will come in less than a Month.
Time and frustration is the price we pay for seeing this opportunity early on.
Cuv is standing before a decade of growth and prosperity.
Blijdorp and Wolgen Will see iT through.
sit Back, relax and enjoy the ride!
Glta

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royco
Posted on: Sep 4 2019, 04:24 PM


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My expectations are that cuv Will achieve us scenesse approval in a few weeks.

I expect this monster bull run to continue with the following actions in quick succession:top results for current quarter, us roll out start, solid eu sales increase, Japanse filing, ozzie filing, VP trials start, a new indication announced, vitiligo fda path to market announced.
Cosmetic line launched. Vallaurix progress with new products. Nasdaq?!: a new record sales and profit Higher,
Higher dividends announced.

12 Montes from now we Will be a lot wiser.
There Will be two cuv: the one we know today and the one after fda approval.
Bigger better faster.
Glta
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royco
Posted on: Sep 4 2019, 01:23 AM


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Crunch time for cuv.

I dont expect any news from the labelling and follow up requirements.
I expect comms black out by cuv.
Wild swings of sp?!?

If the fda or cuv would issue news about this iT would be quite a precursor to actual approval.
Cuv has 4 weeks to set up the necessary infrastructure to be ready when approved?!
And then followed by a negative opinion?!?

Highly unlikely.
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royco
Posted on: Aug 27 2019, 04:50 PM


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Im glad its almost over with this fda/Ema endless review saga.

This week final results of the FY, dividends news.
Next week fda labelling requirements.
Then 4 weeks of information vacuüm I suspect until the
Fda decision time and hopefully followed by a long list of actions that where announced for this year but never materialised.

Japan
Australia
Vitiligo
Topical line
New orphan drug disease
New trial start
...
Before we dive back in the winter sales dip quarters.
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royco
Posted on: Aug 21 2019, 04:22 PM


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What I dont get is the time the fda leaves cuv to put in place the labelling and follow on requirements..

Previously these were supposed to be released no later then April with a pdufa set for July 8th.
Now early September for early October pdufa.

1 month compared to 3 months.

The latest newletter says cuv is unaware but expecting an Ema copy of draconian follow up.
How can they put this in place within 20 working days? Hire, train peiple and document what is not an exact copy and paste of eu follow up.
After all this is clinuvel and iT is in a virtual timezone as we know.
Probably the mass impact of scenesse is causing a wobble in the space time continuüm when close enough to market gatekeepers.

If really eu-similar I would count on 3 to six months needed before commercial roll out start in the usa.
My guess would be this has to be audited by the fda prior to pdufa.
Hence further delayed pdufa.
Then pdufa met within 3 days and perfect stats.

First us sales around half 2020??

Other option: eventually very little follow on misery required since the fda dont want to put out a “bad” example of how iT approves drugs(not).
Other option: cuv u turn and strategy change. Eg. Us partnership, take over, Nasdaq entity, prior to the September release.
And Many more options for sure!
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royco
Posted on: Aug 19 2019, 04:22 PM


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Im optimistic scenesse can be approved on pdufadate or with another minor delay.

Knowing that history repeats and knowing the regulatory history of scenesse with the fda and Ema I would think further delay is the most likely scenario.
The sp evolution since the previous delay seems to walk the talk.

I expect also Some last minute clinuvel organisational shake up just before the fda gives the nodd.
Likely to happen before the fda unveals the labelling and post marketing requirements.
Because Once Those are out approval must be a slam dunk.
Unless evonik and clinuvel fail to comply with the fda expectations within 30 days.

Possibly another audit end of September.
Small problem and another extra month delay?!

My guess is a big crack in the monolithic australian company structure could appear in the next three weeks.
Or a take over offer of course.



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royco
Posted on: Aug 18 2019, 02:33 PM


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https://www.ccn.com/mystery-bitcoin-invento...eveal-identity/
Satoshi nakamoto aka ???
  Forum: Investment Discussion

royco
Posted on: Aug 7 2019, 04:08 PM


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Voluntary action indicated
No regulatory importance iT seems
All systems go for launch
https://www.registrarcorp.com/fda-inspection-dashboard/

VAI
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royco
Posted on: Aug 3 2019, 05:25 AM


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Should have read pw newsletter.
It explained the fda delay due to incomplete data.

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royco
Posted on: Aug 1 2019, 04:13 PM


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One thing in this fda evonik story’s does not ADD up: clinuvel seems to be totally ignorant about this problem.
Totally surprises and disappointed reaction to the fda delay.
No explanation given to sh...weird.
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royco
Posted on: Jul 31 2019, 04:34 PM


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Solid Numbers.
Sustaines growth.
Product manufacturing cost estimates and Numbers from last year indicate we have an equally big quarter ahead.
Cash rich.

I expect a solid dividend increase to be announced in August.
But to be honest all eyes are on the September/October fda decision and the 2020 usa roll out.
If that materialises we have several years of strong growth ahead.
Probably one of the best growth stories around.

Now how to put all that cash at work in the best way?
Vitiligo?
Tsumoyle?
Chivere?
VP?

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royco
Posted on: Jul 30 2019, 05:31 PM


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Last moments before the parameter changes occur:
Earnings per share up
Price earnings down

Strong growth should be followed by a strong dividend announced later in August.

Imho somewhere between 10 and 15 mln for the quarter would be great.
Anything above: awesome!
  Forum: By Share Code

royco
Posted on: Jul 26 2019, 06:00 PM


Group: Member
Posts: 2,985

Belgium situation update:
About 50 patients registered
Possibly final decision on reimbursement in September.
So hopefully those people can be treated throughout 2020.

  Forum: By Share Code

royco
Posted on: Jul 26 2019, 05:46 PM


Group: Member
Posts: 2,985

new quotation in Germany:
Quotrix Düsseldorf
https://www.wallstreet-online.de/aktien/cli...ceuticals-aktie
  Forum: By Share Code

royco
Posted on: Jul 24 2019, 01:03 AM


Group: Member
Posts: 2,985

Maybe the missing piece of the puzzle for the fda.
If they want to allow marketing without Many obligations (what i expect) while the eu Ema is having draconian follow on meassures in place, both look in contradiction.
In case of a real emergency the fda would look terrible.
Maybe I see too much in this but its extremely good news still!
  Forum: By Share Code

royco
Posted on: Jul 22 2019, 04:17 PM


Group: Member
Posts: 2,985

Who does pw stay in Singapore with vallaurix?

Newswise good times coming up:

In a few days the Results for fy18-19
Dividends announced end of August
Labelling news first week of September
Fda decision first week of October
And last but not least: dividend payment early October
AGM October
An item every month, I like iT


I guess all other announced progress is deferred until after fda and more likely next year.
I hope coverage in the usa Will be high from Northern summer usa onwards.
They should be ready to treat allregistered from year one.
They had plenty of time to prepare!
  Forum: By Share Code

royco
Posted on: Jul 10 2019, 12:21 AM


Group: Member
Posts: 2,985

Our ceo explained cuv would remain a monolithic ozzie Company.

Me thinks the fda cannot approve until Some serious shake up in the commercial model and clarity on how to make money in the us.
Partnerships, take overs?
Jv? Nasdaq quoted new shares?
Many options, little time left.
In my personal view the approval has become inevitable and its imminent as we know.
As Some Said here already the fda s options for delay are running out.(and they even outlasted the extreme Ema timelines)

At Some point someone Will have to put the card on the table.
Soon the Numbers are coming out ,hopefully top again.
  Forum: By Share Code

royco
Posted on: Jun 25 2019, 07:23 PM


Group: Member
Posts: 2,985

I think cuv's days in the shadows are over.
The current sp is already bringing us in a very respectable level for what is still a company with a very small quarterly revenue (see last two quarters in Northern wintertime) but important growthlevels.
Growth if forthcoming ans with fda approval I think we have ourselves around 75-100 million in annual sales guaranteed for the next 10 years on epp only.

With the ASX200 inclusion there will be a ton of new investors that are looking into and analysing this company for the first time.
FDA approval is what will mean substantial de-risking and is needed to help unlocking the immense potential of the drug platform and also trigger a number of important actions from the company with regard to the further development of the drug SCENESSE and the other related products including cosmetics.
My guestimate would be between 50-70 AUD in the following months until the end of the year.
Towards this time next year and with further expansion according to plans I hope for 70-100AUD.

Compared to previous percentual growth levels that is not spectacular but by that time we could be a 4 bln AUD marketcap company.
I still have some hopes for a substantial take over bid or clinuvel taking over another company or announcing an important joint venture for US distribution.
Just like what happened before the ultimate EMA green light I expect this to materialise just before the US approval.
Hard to believe that clinuvel would go all alone to develop and market the drug platform in the US market and rest of the world.
It makes sense to partner up and share the burden rather than to develop what nobody else is waiting for: a completely new US sales and marketing machine.
Possibly Blijdorp and B&S are instrumental for this scenario and ideally positioned at least for the more cosmetic part of the platform.

Being a clinuvel shareholder I am very familiar with delays. It is almost natural to expect delays with anything on the path of SCENESSE and CUV. Trials, regulatory decisions, cosmetic roll outs, product developments. The only time they got something earlier than expected was the 2010 Italian early access scheme. 9 years ago, anything else was stretched to the breaking point. Longest ema review ever, two extra phase II or III trials needed in the EU... waiting endlessly for the US phase II results, waiting years for the vitiligo phase IIb results...EMA opinion delays....months and years gone.
Now just the fda has added 3 months to the longest ever fast track orphan drug, expedited and rolling review. Forgetting the delays to market in the UK...
Clinuvel people just never give up and seem to outlast the regulatory roadblocks and virtual reality.
I wonder if the US EPP community will have to go and protest at the FDA offices this month with help of the EU bunch and similar to what they did when EMA just could not decide.
glta

  Forum: By Share Code

royco
Posted on: Jun 19 2019, 04:26 PM


Group: Member
Posts: 2,985

Great times for cuv investors :

June actual ASX200 inclusion
July best results ever and steep increase of EPS/ decrease of p/e ratio
August announcement of dividend
September fda news labelling etc
October fda decision and quarterly results

Im still expecting a last minute action prior to the pdufa date with Nasdaq quotation or jv or something big in the usa.
A take over offer is always possible too of course.
Glta

  Forum: By Share Code

royco
Posted on: Jun 7 2019, 04:15 PM


Group: Member
Posts: 2,985

I like to see the timeline on there.
IT just shows the mockery of a review:

Orphan drug status 2008
Fast track 2016
patiënt meetings 2017
Rolling module submission review then 6 months wasted since initial submission in July 2018.
Jan 2019 priority review awarded 6 months pdufa
Now 3 months extra delay without explanation.

Patients Have the right to go mental.
Maybe the fda should approve Some psychotropic substance for patients waiting the approval.



  Forum: By Share Code

royco
Posted on: Jun 5 2019, 12:19 AM


Group: Member
Posts: 2,985

https://www.ccn.com/bitcoin-is-still-at-an-...e-part-of-the-1
https://www.kitco.com/news/video/show/Kitco...-James-Altucher
  Forum: Investment Discussion

royco
Posted on: Jun 3 2019, 11:26 PM


Group: Member
Posts: 2,985

100% sure not on 6 October...it is a Sunday?!
  Forum: By Share Code

royco
Posted on: Jun 3 2019, 08:34 PM


Group: Member
Posts: 2,985

https://www.palatin.com/research-focus/fema...anotide/"A New Drug Application was submitted in March 2018, with acceptance of the filing in June 2018. The PDUFA (Prescription Drug User Fee Act) goal date for completion of FDA review of the Vyleesi New Drug Application is June 23, 2019.""Vyleesiâ„¢, the trade name for bremelanotide, is a novel melanocortin 4 receptor agonist under investigation to help restore a natural sexual desire in premenopausal women with HSDD."
Let's see if this "all American sister melanocortin" will be further delayed. (I doubt it)

I also come to think that the FDA is actually struggling with the labelling and post-marketing commitment that were overdue since April 8th.
And more in detail with the post-marketing commitments since the labelling/production issues were probably promptly solved long time ago.Safety is not an issue since a long time. Efficacy is crystal clear looking at the EU data with patient return rates in the high 90%.So the only thing left is approve it and make sure nobody can get it apart from a lucky handful of EPP patients.The EMA did lock up all commercial and off-label potential through the PASS study system.

I believe that if the FDA would implement the same draconian EMA post marketing requirements it would send a shock-wave through the US pharma business. It would send a totally unwanted and counter-productive signal from the regulator towards the industry.Massively rising development costs and actually adding years of research before full approval for new molecular entities.The US drug-development would be quickly lost to China also?
Also counter intuitive to the orphan drug status.

Yet they don't want to let is pass just like that because of the "tanning" side effect.What to do if you have nothing negative left to say....delay!


  Forum: By Share Code

royco
Posted on: Jun 3 2019, 04:21 PM


Group: Member
Posts: 2,985

In September I expect a last minute decision to organise an advisory committee.
+6 months

Ema all over again.
Priority review orphan drug, pristine safety, not carcinogenic, Ema approved
Yet fda do the Longest short track ever.

Patiënts know what the F stands for in F-DA.
Another season without protection.

Cuv Will not annaunce anything before the fda decision.
Where are my sleeping pills.

  Forum: By Share Code

royco
Posted on: May 27 2019, 08:37 PM


Group: Member
Posts: 2,985

https://www.google.be/amp/s/www.cnbc.com/am...ne-therapy.html
Paediatric oorhangers drug, genetherapy...trial not always successful.
Possibly lethal (not confirmed yet)

Concerning fda approval I think cuv Will not give up unless approved.
The last newsletter was clear.
Rtf, crl or delays wont matter cuv Will push further.
I trust this resolve (see also the ema approval) and believe scenesse Will eventually be approved for epp.
That puts the odds at 99.99% for me.
(The 0.01% is when something disrupts cuv between now and approval)

Glta
  Forum: By Share Code

royco
Posted on: May 24 2019, 04:30 PM


Group: Member
Posts: 2,985

With the last month of the FY starting soon cuv must have a very good idea of earnings/sales.
Before uk nice and fda decide the books will show what I expect an almost double eps number.
About end of July these new numbers will be officially known.

The company has toured some big cahuna conferences lately so the word is out in big finance.
14 June asx200 news
08 July fda news
31st July quarterly/FY results

If asx200 becomes real and the fda decides positively at pdufa date with a revenue growth of 50% or close announced just a few weeks later...
we r looking at a seriously hazardous explosive sp situation.
It could also all go wrong of course.
Glta !
...
  Forum: By Share Code

royco
Posted on: May 21 2019, 04:29 PM


Group: Member
Posts: 2,985

48 days until fda pdufa
24 until asx200 rebalance announcement

I don’t expect any other news from cuv prior to the fda decision.
Unless fda labelling and follow up news maybe
Or something from uk nice?

  Forum: By Share Code

royco
Posted on: May 19 2019, 08:39 PM


Group: Member
Posts: 2,985

https://www.google.com/amp/s/www.cnbc.com/a...our-family.html

Life changing investments...2009-2019
Sleeping pills needed because cuv still has a long way to go before reaching uber levels.
Glta
  Forum: By Share Code

royco
Posted on: May 17 2019, 10:34 PM


Group: Member
Posts: 2,985

Waiting again
  Forum: By Share Code

royco
Posted on: May 17 2019, 10:31 PM


Group: Member
Posts: 2,985

8912 transactions on asx cuv today...botparadise
  Forum: By Share Code

royco
Posted on: May 16 2019, 04:11 PM


Group: Member
Posts: 2,985

Double leverage:
-milestones lining up
Earliest next week asx200 and earliest June (expedited review) but more likely July fda news(hopefully not a delay)
-Same time as instos start to buy nobody wants to sell in what could be the biggest sales quarter on record for cuv)

Only 48mln shares.
After fda news a high number of long awaited actions will be triggered.
(NASDAQ, cosmetic line, new indication, start vp trial, vitiligo meeting tia, Japan filing, Australian filing...)

Avita medical and clinuvel could better join forces to cure vitiligo.
Wait and see.
Gita
  Forum: By Share Code

royco
Posted on: May 15 2019, 07:10 PM


Group: Member
Posts: 2,985

https://avitamedical.com/uploads/pdf/AVH-CF...e-14May2019.pdf
not the right board I know but just days after BNYM becomes a major shareholder in both clinuvel and Avita in Melbourne the Avita CFO decides to move out.

  Forum: By Share Code

royco
Posted on: May 14 2019, 04:41 PM


Group: Member
Posts: 2,985

https://www.businessinsider.com/bitcoin-pri...5?r=US&IR=T
  Forum: Investment Discussion

royco
Posted on: May 10 2019, 05:45 PM


Group: Member
Posts: 2,985

German board digging deeper in avita.

Avita got approval from fda last September for the recell technology to treat burn wounds with spray on skin cells grown from own skin.
Results look amazing.

They plan to use the technology for vitiligo in a trial to start this year.
They combine therapy with melanocyte treatment in at least one patient.

It would be great to combine the vitiligo treatment trial.
Use the regenerative and melanogenesis features of afamelanotide.
A merger in the making?

It fits with the timing of the 2014 pre ema approval joint venture shake up.
  Forum: By Share Code

royco
Posted on: May 7 2019, 10:23 PM


Group: Member
Posts: 2,985

https://www.nature.com/subjects/sumoylation
"Sumoylation is a post-translational modification process. It is analogous to ubiquitylation in terms of the reaction scheme and enzyme classes used, but rather than conjugation by ubiquitin, sumoylation involves addition of SUMOs (small ubiquitin-like modifiers). Sumoylation can affect a protein’s structure and subcellular localization."
https://www.trademarkia.com/ctm/ctm-company...1-2T'Sumoyl
Goods & Services: Skin care preparations; cosmetic preparations for skin care; cosmetic preparations for skin care, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; cosmetic oils; skin creams (cosmetic); skin care creams (cosmetic), lotions (cosmetic) and oils (cosmetic); wrinkle removing skin care preparations; sunscreens; waterproof sunscreen; sunscreen preparations; sunscreen creams and lotions; cosmetics for protecting the skin from sunburn; sunblock; sun barriers (cosmetics); sun creams; cosmetic preparations for protecting the skin from the sun's rays; sun care lotions; compounds for skin care after exposure to the sun's rays; after-sun milks, creams, lotions and moisturizers; sun bronzers; sun-tanning preparations;
cosmetics for tanning the skin including preparations for tanning without sunlight, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; self-tanning preparations (cosmetic); self -tanning creams (cosmetic) and lotions (cosmetic); suntan creams, lotions, oils and gels; skin rejuvenation preparations; skin rejuvenation products with and without analogues of alpha-melanocyte stimulating hormone (alpha-MSH); antiaging skincare preparations; antiaging creams, lotions, moisturizers, gels, balms and serums; cleansing creams, lotions, milks, foam, gels and masks.
  Forum: By Share Code

royco
Posted on: May 2 2019, 08:09 PM


Group: Member
Posts: 2,985

That's some interesting news!Also the date is important: valid from 1st of July...that is BEFORE the pdufa date.Me thinks we could see expedited approval early June and start of sales in July. (as predicted here before)
Could it be that clinuvel almost doubles its patient number from the next quarter onwards?There has been an fda emphasis on production and the ability to provide the medicine once it is on the market.Also they now have two providers/manufacturers it seems.

Towards the numbers for the current quarter and the full FY2018-19 I expect a significant rise in the eps ratio. We must be getting a serious increase from the current 0.332 AUD.

https://www.barrons.com/quote/stock/au/xasx...mod=DNH_SLagoda and Fidelity still in according to this site but possibly not updated for the current month.Vanguard market indexes are moving in big time.Also noticed a high number of newcomers on the list.
We are set for defining moments in the clinuvel history that will unfold soon.My hope now is that FDA approval will come first, then we will get some extra attention from the ASX200 index inclusion and this will be followed by the steady influx of more and more investors. While this avalanche takes shape clinuvel will hopefully start to unveil progress on their other projects and aims that had been promised for a longer time.They have been listed here before so I will not put them again.
Also nice to read that the CEO remembers his own words about the April 8th date for the fDA to give news on the labelling and post marketing requirements. They are probably too busy...
I think that the company feels a lot more pressure from new investors that are actually reading and analysing the company news and comparing it to their actions. Under-promise and over-deliver...and careful with timelines!
buy, hold or sell?
Better take a sleeping pill and come back in 24 months or so before doing something really stupid.:-)




  Forum: By Share Code

royco
Posted on: Apr 30 2019, 04:28 PM


Group: Member
Posts: 2,985

Great result
Veritas in numeris
Prediction cited 1.8 mln manufacturing costs for the current quarter.
Now get the USA on board and we increase growth again.


  Forum: By Share Code

royco
Posted on: Apr 25 2019, 02:57 AM


Group: Member
Posts: 2,985

The Ema pass data is crucial for cuv to understand its own product better.
It is probably better and more detailed then the actual trial data.
And it is an extra insurance for a safe development.
Some limitations with roll out and continued gathering of real life data will also make sense in the USA.
  Forum: By Share Code

royco
Posted on: Apr 24 2019, 05:40 PM


Group: Member
Posts: 2,985

Big thanks to Stan for all These years as our chair!
I think hè sensed the moment of his farewell is arriving very fast.
Better get a final letter out quickly!
  Forum: By Share Code

royco
Posted on: Apr 24 2019, 05:36 PM


Group: Member
Posts: 2,985

We all expected feedback from the fda/cuv on labels and post marketing requirements
no later then April 8.
I guess this is it...
Gung ho!
  Forum: By Share Code

royco
Posted on: Apr 9 2019, 04:24 PM


Group: Member
Posts: 2,985

Fda post marketing Safety monitoring looks quite different from Ema pass.
Deels the fda puts the focus in labelling and advertising rather than extra studies.
Any other approved (fda) drug with ema pass-type (like scenesse in the eu) in the usa?
Would clinuvel be doing the same type of study of the fda do not require iT?
What about the costs for this?

So what are we waiting for in the short term?
-new indication
-start VP trial
-aquisition (usa distributor?)
-Nasdaq quotation
-quarterly result
-asx200
-fda decision
-new chairman
-Japan faling
-Australian filing
-UK NICE agreement
-vitiligo fda meeting end of phase2/Path to Market
-development of vallaurix products
-launch of cosmetic line


  Forum: By Share Code

royco
Posted on: Apr 5 2019, 12:58 AM


Group: Member
Posts: 2,985

When Will we See the first sign of a Nasdaq quotation and/of an important usa aquisition?
My Guess: prior to July 8.

Maybe a last minute take over offer?!
  Forum: By Share Code

royco
Posted on: Apr 4 2019, 08:18 PM


Group: Member
Posts: 2,985

What puzzled me a bit with the lagoda holdings is the 31.51% of assets.That is incredibly high...
  Forum: By Share Code

royco
Posted on: Apr 4 2019, 04:58 PM


Group: Member
Posts: 2,985

Money season arrived with European spring.
Last days prior to the fda feedback.
A precursor to the game changing fda decision.
Glta

  Forum: By Share Code

royco
Posted on: Apr 4 2019, 12:46 AM


Group: Member
Posts: 2,985

https://finance.yahoo.com/news/bitcoin-brie...8-KmPCodx0zYAFL
  Forum: Investment Discussion

royco
Posted on: Apr 2 2019, 05:25 PM


Group: Member
Posts: 2,985

Monday is fda day.

IT Will be a major indicator of things to come.
Nog entirely sure what I prefer:
-no need for follow up or need to follow up ei style.

I expect soon after the new indication Will be made public.
Maybe the can start the VP trial in the Meantime.
End of the month its results time again.
Any predictions?

Great times for clinuvel investors.
  Forum: By Share Code

royco
Posted on: Apr 1 2019, 09:46 PM


Group: Member
Posts: 2,985

https://www.barrons.com/quote/stock/au/xasx/cuv
Lagoda Investment Management LP2.39M4.99%-1.02M31.51%10/1/18
  Forum: By Share Code

royco
Posted on: Mar 29 2019, 08:52 PM


Group: Member
Posts: 2,985

a news item came up but not the one expected...
So there goes the first quarter and their promise to deliver a new indication for SCENESSE.My guess: too busy with the FDA in the crucial days before the 8 April news.So I don't think we will learn anything about a new indication until after 8 April.
Clinuvel quo vadis?
  Forum: By Share Code

royco
Posted on: Mar 29 2019, 05:26 AM


Group: Member
Posts: 2,985

Ready for Some newsflow today.
What About that new indication?
  Forum: By Share Code

royco
Posted on: Mar 26 2019, 10:44 PM


Group: Member
Posts: 2,985

I have decided to handover my responsibilities as Chairman of this Board upon FDA’s granting of marketing authorisation for the use of SCENESSE® in the US. Stan McLiesh stepping down in July latest. Who will replace him??

Stan Mc Liesh


  Forum: By Share Code

royco
Posted on: Mar 26 2019, 08:15 AM


Group: Member
Posts: 2,985

The company "announced" this imminent announcement just three weeks ago...at an investor briefing.
So why now suddenly wait for the fda?

For the
Cosmetic line launch I understand its better to wait.
Even if it is done by vallaurix in singapore.

  Forum: By Share Code

royco
Posted on: Mar 25 2019, 11:19 PM


Group: Member
Posts: 2,985

"2nd indication Q1’19"
Investor briefing March 2019 slide 6
4 days left to have this announced within their own timelines.
8 April FDA news on labelling and post marketing follow up
30 april quarterly financial report
I am also expecting the announcement of the start of the Variegate porphyria trial during the first half of this year.
First half of this year should see some news on the UK NICE and UK distribution, French reimbursement feedback etc.June: ASX200 rebalance8 July FDA PDUFA31 July full year financial report
Maybe some news on the Japanese and Australian filing too.
April, May and June we should see some updated investor briefings posted on the website too as they do their roadshow in Sidney, NY and London.
I would also hope that we will get a dividend reinvestment plan in the first half year followed by an announcement of the 2019 dividend somewhere end of August like last year.
For the second half of 2019 I would expect some update on the Vitiligo path to market/trial(s) agreed with the FDA.

  Forum: By Share Code

royco
Posted on: Mar 18 2019, 08:33 PM


Group: Member
Posts: 2,985

Martket cap of 1 BN USD attained.cuv is passing this important milestone of credibility.What a journey.
In my opinion cuv is worth double today based on the growth figures from the recent past and those expected for the near future.The profitability is great, they have zero debt and a nice pipeline of new products or applications in preparation.
The FDA decision is a next turning point for credibility and visibility but also the starting point for cuv to increase the speed of development on many fronts.
What I do not understand is how the FDA can issue a decision on the labelling and post marketing commitments by April 8 and then wait another 3 months before the 8 July overall marketing decision.
Scenario 1:
8 April the FDA communicates the labelling and post marketing commitments to clinuvel.Then I can only deduct that SCENESSE will be approved. Why else go through the efforts to let them prepare all of this if not to start marketing in 3 months time? I presume the 3 months are meant for clinuvel to get their ducks lined up before marketing starts.

Scenario 2:
8 April the FDA does not communicate any labelling or post marketing commitments to clinuvel.By logical deduction the FDA thinks the product is safe enough and well labelled as it is presented in the EU currently.
So how on earth would it then come to any other conclusion then to approve in July? Hence, why do they need 3 months more?

In other words I presume that the April 8 news or no news from the FDA concerning the labelling and post marketing commitments is all encompassing for the July 8 decision. By doing a little more work on the why and how you can find out that approval chances are VERY close to 100% and you have the information 3 months ahead!
I would find it more logical that if the FDA would issue no news on April 8 they should decide very shortly after on the marketing of SCENESSE in case there is no further need for labelling and post marketing adaptions.

There is also a third scenario: delay




  Forum: By Share Code

royco
Posted on: Mar 12 2019, 08:51 PM


Group: Member
Posts: 2,985

https://www.newsbtc.com/2019/03/11/winklevo...n-lead-to-this/
  Forum: Investment Discussion

royco
Posted on: Mar 7 2019, 08:07 PM


Group: Member
Posts: 2,985

If you keep holdings balanced between usd clvly, eur ur 9 and aud cuv your exchange risks are limited.

Cuv will always have majority of revenues either in eur and usd.
I dont know what their internal strategy is to avoid exchange ridks.
Supposedly they keep revenues in base currency and transfer moderately to aud on need for cash to cover costs.
Most/all of that is euro from the start.

Obviously the control of this risk is Only valid in a moderate exchange rate evolution scenario.
Janet and Mario are always busy to avoid shocks.

Not an expert, just learned by doing.


  Forum: By Share Code

royco
Posted on: Mar 7 2019, 10:09 AM


Group: Member
Posts: 2,985

And the best thing is cuv have zero debt and only <50 !
million shares to divide the revenues over the lucky holders.
Revenues set grow over the next 10 years.
Cuv will be gathering multi billion revenues over the years.
How much you want to put on the table to get your share?
  Forum: By Share Code

royco
Posted on: Mar 7 2019, 10:09 AM


Group: Member
Posts: 2,985

And the best thing is cuv have zero debt and only <50 !
million shares to divide the revenues over the lucky holders.
Revenues set grow over the next 10 years.
Cuv will be gathering multi billion revenues over the years.
How much you want to put on the table to get your share?
  Forum: By Share Code

royco
Posted on: Mar 6 2019, 05:56 PM


Group: Member
Posts: 2,985

Great times for cuv sh and epp patients.
From my side I feel very grateful and I will share a significant part of this new wealth with those in need and less lucky.

The sp of cuv can be in tripple digit territory within the next two-three years.
Only showstopper could be a take over.
That would be a real pity since this company has the potential to become an investment that could span generations in our family.

And what a great pass time to read up on cuv here and on other boards!
Thanks to all here for your many useful contributions.
Glta
  Forum: By Share Code

royco
Posted on: Mar 5 2019, 04:08 AM


Group: Member
Posts: 2,985

In fact some of those 2010 swiss patients will know by now, first hand.
The question is if someone is speaking out, if someone is listening and taking note.
Best would be a scientist/medical practitioner and patient in 1 and the same person.
I can think of some already.
  Forum: By Share Code

royco
Posted on: Mar 5 2019, 04:04 AM


Group: Member
Posts: 2,985

Cuv is gaining expertise with every implant, every day and every patient treated in the eu.
The data gathered is unique, vaste and hopefully wide enough to also capture scientific knowledge on long term effects of scenesse in otherwise healthy epp patients.
I presume that if any more protective effects exist they will become apparent when comparing this subpopulation to the entire population..
EPP patients on scenesse should have an overall better health, qol and eventually higher life expectancy than the population in general.
Time (years)will tell, cuv will know first.
  Forum: By Share Code

royco
Posted on: Feb 27 2019, 07:06 PM


Group: Member
Posts: 2,985

anybody read the half year report?
Seems like it completely passed under the radar while the numbers are quite impressive although not unexpected.Also some important ratios have been updated on ASX. (eps)I suppose all models than recalculate and give buy/sell orders accordingly.
Looking at the sp it has been hanging around 20-22 AUD for over 6 months now since it had risen 100% from around 10AUD over the first half of 2018.My guess is that we are in for a new sp growth period depending on the expected catalysts that should materialise over the next 5 months.
In any case the all encompassing future determining binary FDA outcome is what is needed to unlock or kill the universe of options open to clinuvel.
I would also think that the higher sp would be a great moment for clinuvel to do a capital raise and combine it with a new entity with NASDAQ quotation.We should be well cashed up to start the expensive vitiligo pathway to a curative treatment.
  Forum: By Share Code

royco
Posted on: Feb 27 2019, 12:28 AM


Group: Member
Posts: 2,985

Blijdorp or Wolgen will NOT let go of cuv below tripple digit sp imho.They know very well it is only a matter of a very limited amount of time until they have that without a takeover, so why hurry?
The volumes are just the pre-cursor to a lot of news coming our way in 2019.MarchASX200 inclusion
NICE decision EPP
French decision EPPApril
FDA news on follow up protocols
JulyFDA decisionI expect after September-December:Japanese filing EPP
Australian filing EPP
Launch of cosmetic linestart VP trialsextra indication announcedVallaurix products announcedVitiligo FDA meeting and pathway announced (trial preparation start)

Is there a remote possibility that the FDA will decide earlier than the PDUFA date?Especially since the production trepidation seems to be resolved.

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royco
Posted on: Feb 22 2019, 04:37 AM


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Just reminded myself about the intensity and anticipation of this period before the fda.

Never again will we be in this enviable situation again with clinuvel.
From July there will be before and after the fda.
It is totally surreal after 15 years of black snow, dolldrums, money rounds, dilutions,trials, new management, failures, agms, ppt, newsletters ema opinions, delays,

I try to savour this moment.
Just before the inevitable tipping point.
All great expactions depend on July and the f-d-a
And we sit and wait.
Glta
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royco
Posted on: Feb 17 2019, 04:49 PM


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https://www.investinblockchain.com/nasdaq-i...hereum-indices/

Feb 25th
  Forum: Investment Discussion

royco
Posted on: Feb 8 2019, 05:57 AM


Group: Member
Posts: 2,985

Tipping point
After 15 years
Enjoy the ride
If there is no take over to spoil the fun we are set for a decade of substantial growth.
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royco
Posted on: Feb 3 2019, 06:08 AM


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Lets not forget that until today cuv never stopped at a no or non.

Cuv had a big nono/jamais from the start, everywhere. The fda sent them walking, ema sent them in hyper space several times. Cuv has a viable safe treatment for epp and they know it.
Look at the uk, cuv will keep fighting until all uk epp patients receive treatment.

Imho the pricing of scenesse is fair and the benefit for patients is apparent and significantly so.
If not the ema half year reports would have already resulted in withdrawal.
Did anyone ever read a report from a patient saying scenesse has no significant (positive) impact on their life?
Never written.

Back to narcosis.
:-)
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royco
Posted on: Feb 1 2019, 07:59 PM


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Posts: 2,985

The good thing about the last quarterly is mostly that we are already in the next!:-)This is 2019 folks, already 1/3 of the new quarter is gone, springtime -orders start to roll in again.We have fast track, priority review, PDUFA date in 5 months, GMP inspections probably ongoing.
Manufacturing costs were up 3-fold of the past quarter (593 vs 186) and that is a very good sign for the current quarter since payments seem to be nicely aligned with delivery these days.
April-June quarter 2018 445.
Jan-March 2018 878
Oct-Dec 2017 697
Lots of things to watch out for this year:-UK NICE outcome
-ASX200 rebalance
-launch of cosmetic line
-start of trial VP
-announcement of new indication-Japanese filing-Australian filing-lowering of EMA follow on requirements-increase of the maximum number of implants to 6
-news on the FDA requirements post commercial (no later than April)
-FDA decision-I do not exclude a pre-FDA decision NASDAQ quotation with extra shares issued.-vitiligo FDA meeting (after July)-start of commercial sales of SCENESSE for EPP in the USA-FY 2018-19 results-return to profitability-2019 dividend announcement
-dividend reinvestment plan
probably I missed some.Take a tea and enjoy or better a sleeping pill and wake up on the other end of 2019.glta



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royco
Posted on: Jan 18 2019, 10:58 PM


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https://www.bogleheads.org/wiki/John_BogleJohn C. (Jack) Bogle (1929 - 2019), after whom the Bogleheads® are named, was founder of the Vanguard Group and creator of the world's first retail index mutual fund.
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royco
Posted on: Jan 18 2019, 02:35 AM


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Some will want and need 6 implants but Every individual patient is different in symptoms severity and strenght of the positive effects of scenesse so 6 implants are not always needed I suppose.
If I remember well all italian patients in the early sponsored access were treated all year round.
The implant price seemed to have triggered the more conservative max 4 implants approach by the regulator.
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royco
Posted on: Jan 16 2019, 12:22 AM


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The implant was used because injecting a liquid solution directly into the bloodstream had too many side effects. The key for minimal side effects was in the optimum dosage (16mg) that was delivered over a period of a few days into the bloodstream.

The regulators never asked for an implant but I do vaguely remember EMA or so asking to have a better device to implant SCENESSE.




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royco
Posted on: Jan 10 2019, 07:24 PM


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The NDA is validated by the FDA.Probably the best news ever in the history of clinuvel and SCENESSE and what a relief for the EPP patients in the USA!
We get priority review and no extra committee meeting is expected.An update of the FDA on the post marketing requirements no later than 8 April.3 months later on July 8th they hope to reach a decision.It seems they want clinuvel to be ready for the roll out of SCENESSE this summer.

What a year this promises to be for clinuvel:
-a new indication announced.-vitiligo progress in the second half of the year (next steps agreed with the FDA)
-March inclusion in the ASX200-March NICE UK decision-Japanese filing-Australian filing-Launch of a cosmetic product line-Start of a VP trial-continued profitability
-dividend and dividend re-investment plan-FDA decision on SCENESSE-start of US sales of SCENESSE-lowering of the PASS requirements in the EU-Vallaurix progressing the pipeline
-a NASDAQ listing must be in the cards also


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royco
Posted on: Dec 29 2018, 07:05 AM


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After 15 years of investment and interest in scenesse we finally end a year over 10 aud.

EU sales are well establixhed and growing steadily since the 2014 approval.
Entry into the asx300.
Profitability seems to have become the new normal.
A dividend paid, no div policy known yet.
An fda dossier filed but not accepted yet.
Hopeful for a commercial launch in the usa no later than 2020.

Tga and japanese regulatory filings within a few months are possible.
A commercial otc topical product launch imminent.
A second scenesse eu indication in the pipeline for early 2019.
Follow up burden lowered in 2019.
A new trial to start soon.
Nice appeal upheld and next step to be announced in March.
Vitiligo results stellar and ready for a phase 2 or 3 tfial in the usa after epp approval.
2 extra products developed and nearing clinical stage.
Possible asx 200 entry 8n 2019.

I hope for steady growth in 2019 and a vitiligo partnership of some kind in 2020.
I hope for close to 50mln aud revenues inthe cuurent FY and a new increased dividend with a reinvestment plan this time.

Glta



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royco
Posted on: Dec 20 2018, 05:13 PM


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The stats are significant!

Just like the us phase 2 stats were.
The drug is very safe as we know from epp, ple, otc, AK and su trials in a few thousand patients.

It remains a very small sample and it is still tricky to claim it will work for everyone with vitiligo (population) although the stats indicate it is a valid drug and results are highly likely not just luck.
Protocol change to an open label is beter because it is impossible to do a (double) blind study as we know from epp.
The vasi score seems to be an exact measure for repigmentation.

My question is if this is highly automated/robotised or a manual work.
To calculate at 7 points a vasi score for 5 to 10k patients would need some form of automation.
The next study should include a topical attempt to repigment the feet for a sub sample.

If that works we have a safe, complete and lasting effect: a CURATIVE vitiligo treatment.
Slam dunk.

We will only find out if and after the fda approves SCENESSE for epp.
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royco
Posted on: Dec 19 2018, 05:39 PM


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Stellar results, lasting effects, safe and well tolerated.

Feet remain problematic and topical/ local side treatment would help.
The inverse of ema/fda regulatory fear: patients drop out because of the skin darkening effects.

Unfortunately USA vitiligo progress hinges on the fda approval for epp first.
Cuv will not advance to phase 3 before.

The long wait continues.
Tga and japan next.

Fda quo vadis?
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royco
Posted on: Dec 14 2018, 09:08 PM


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Left on the end of 2018 promise list of our CEO:-vitiligo singapore results-announcement of a new indication for SCENESSE
Maybe I forgot something but I suppose those are the most important ones.
I do not expect them to come forward with any news without having the FDA validating the file.Now that the CEO has hinted on an advisory committee meeting I fear that the FDA will drag this out deep into 2019 and a decision in 2020.So I expect them to go quiet on the launch of the cosmetic line in 2019.The only thing they are doing at the moment is to increase the EU distribution.



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royco
Posted on: Nov 21 2018, 06:50 PM


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The fda did, is doing or will do a gmp inspection of the production facilities in 2018.
That is news!
Seems everyone is waiting for the fda.
I don’t expect any repoted fda progress in 2018 any longer.
All eyes on 2019.
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royco
Posted on: Nov 20 2018, 01:40 AM


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forgot to mention:
-no news on the Australian dossier filing-no news on the Japanese dossier filing-no news on the situation with NICE UK
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royco
Posted on: Nov 19 2018, 05:21 PM


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Promising prospects for the agm:
- only 3 things to vote
-no news from fda
-no news from singapore trials
-no news on new indication
-no news on cosmetic vallaurix product
- ceo contract renewed?
-cfo contract renewed?
-new trial start?
-dividend strategy?
-dividend reinvestment plan?
-feedback from roadshow?

Yawn
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royco
Posted on: Nov 12 2018, 07:27 PM


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I really do hope the FDA will turn down the clinuvel suggestion for a mirror of the eu PASS follow up. As long as they are provided with the EMA reports all should be ok. I cannot see how the US pharma industry would be happy to see this kind of costly draconian measures becoming FDA fashion.

We must be very close to some news on the PDUFA/PR the dossier has been in the twilight zone for almost 5 months now.More regulatory delays almost inevitably means another summer of suffering for the US EPP patients.


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royco
Posted on: Nov 9 2018, 05:31 PM


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A scenesse certified member of the American dermatology society points to quite forward actions by cuv.
The fda must build in a lot of safeguards that scenesse can actually be manufactured and distributed.
Orphan drug 2007
Carcinogenicity waiver 2016
End of phase 3 meeting/ enough data to file 2016
Patient meeting 2016
Fast track 2016
Rolling review 2016
Eu patient data commercial use provided2018
All modules filed 2018
Clinuvel suggests to copy eu pass protocol
Extra questions2018

I think the fda must be almost ready.

Scenesse manufactured in the usa
Expert centres known
Patients known

2019 should be the start of us distribution indeed!

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royco
Posted on: Nov 7 2018, 09:24 PM


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Posts: 2,985

I think clinuvel also has started or will start discussions to increase the maximum number of implants to 6 so patients can be treated all year round when needed. And they also would look at the decrease of the draconian follow-on administration and research burden on the patient, company and experts. And I still remember the CEO mentioning something about a 2019 price increase. (don't remember where I read this)
Much of the slowness in the increase for the past two years was probably related to the administrative and research burden on any expert centers and patients engaging in supplying SCENESSE to EPP patients.
I am not against this seemingly unreasonable extra burden for this very small patient population at the start of the roll out.The scientific information clinuvel can gather from this could be of crucial importance in the further "shelf-life" of SCENESSE and afamelanotide and it's simply one of those "by products" of pioneering.Hopefully after 3-5 years of safe distribution the regulator really has no further reason for worry and patients would just get SCENESSE without further ado.

I am not for replicating this study and work with US patients though. It would make much more sense to keep providing the science outcomes of the EU PASS to the FDA on a continued basis. Adding those few hundred US patients to the sample would with a very high likelihood not alter the outcomes. (statistical and anecdotal)So my hope is that the FDA will use common/scientific sense and send this clinuvel suggestion to the drawing board.Of course the regulatory demand in the EU was probably largely enticed by their fear for off label and wide spread use.

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royco
Posted on: Nov 5 2018, 10:05 PM


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"Another factor which will perhaps have an impact on the FDA’s decision process is our suggestion of the US post-marketing program in EPP."
That's it! Nobody in the FDA has ever come across this type of request from a commercial company to apply draconian post marketing follow up. They are lost on how to deal with this clinuvel suggestion, they don't have the people or new job-types to answer. So they now gave clinuvel more time to answer (no need for that) but more specially they gave themselves more time to find out how to/who will deal with the clinuvel suggestion.




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royco
Posted on: Oct 31 2018, 07:28 PM


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Our CEO in the Feb 2018 Newsletter:
"The new staged communication strategy aims to be fully implemented by 20 May, when we disclose our complementary product lines and new markets to be served."Not2017 they came up with the clinuvel 2020 strategy, 2018 they built a new website (and called it a communication strategy) but at the end of 2018 there is still no new products. Naturally they did not spend much on the strategy and the website and they are proud of that.They can always blame the FDA for the delays.

Product manufacturing costs expected for the July-Sept quarter were set at 870k AUD in the previous quarterly report, actual result is a meagre 186k AUD.
That is only 20% of what was forecasted!!Actual costs during April-June quarter were 445k AUD. (890k AUD was predicted in the Jan-March quarterly) Again that is only 50% of the estimation.

With the upcoming slow season of 2 quarters they put forward 1,300k AUD product manufacturing costs for Oct-Dec.It seems a totally unreasonable amount based on SCENESSE alone, unless they want to stockpile for next year's treatments or they are simply extremely bad at forecasting. Maybe they expect a lot of receipts from customers paying for previous quarter implants only by the end of the year and they want to balance the production costs with those incoming monies to provide a cushion when the orders start coming in early 2019 and with almost no cash generated. (building 2019 SCENESSE stockpile)

Maybe the previous estimations were including the OTC and other products to be launched and the costs involved that did never materialise at the May 20th as announced.
They might be still hoping to launch something this year, who knows. Still not clear how and when clinuvel will put all those millions of AUD at work after the FDA approval.
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royco
Posted on: Oct 31 2018, 05:22 PM


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Almost 15pct up after open, thats a spike.
It almost seems like the sp is kept to a strict scenario.
There shall be no increase prior to fda outcome.

After 15 years of depressed sp and the 2003, 2007 and 2014 pump and dumps, maybe we owe this 2018 drop to shorters or
maybe there is still not enough demand for cuv shares is my guess.

The first part of the ceo tawk in the annual report was all centred around the 1 bln marketcap.
Just a few days later the sp falls bring us to well under that. He should have thought twice and keep focus on safety data and patient feedback.
Like someone helps to negotiate a less than astronomic contract and salary with pw.

Quarterly results are excellent but only just a tat over expectations. No spectacular increase.
Clinuvel is still treating sub 500 patients I deduct and that is underwhelming.
Expected Production costs go up, but they have been wrong before.
Cuv geared up for a strong current quarter and a double digit increase of FY18-19 receipts compared to last FY.
40 mln aud?
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royco
Posted on: Oct 31 2018, 12:00 AM


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Clinuvels dossier does probably not fall within the 6 points stated and they did not receive an RTF letter.

The extra data that was asked 2 months after the submission of the final module was:
-product manufacturing information
-details from the European post-authorisation use of SCENESSE®.
I suppose especially the last one is based on the review of the final module delivered containing EU data from 2017.
The first one would probably be the result of the actual review of an earlier module and related to recent changes in production (increase) or packaging etc. If they wouldn't have reviewed those 2 modules how could they have come up with these details?Making me believe they actually have reviewed (not formally) all modules over the past 2 years and as submitted.


Since they had years or months to review and ask more information on the other submitted modules it would seem unlikely that they will still come up with missing information on older modules or more missing information on the latest module containing the EU patient data.
From what I read in the recent presentation clinuvel did after the FDA update they are now waiting for the pdufa date and PR decision and dossier validation which implies that the extra data has been submitted within a short time after the FDA requested it.

Me thinks the FDA is far advanced in reviewing/validating (not formally) all modules including the final one delivered and the validation of the 2 recently sent information packages. I think they must ready apart from issuing the PDUFA date, the PR decision and the formal review. My hope is we will learn about this pdufa date before the end of this year.
Just being optimistic.



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royco
Posted on: Oct 30 2018, 11:21 PM


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The review clock typically does not begin until everything is submitted. Nevertheless it is an advantageous concept for both parties – sponsor and Agency. Considering these breakthrough programs are expeditious in nature, it behooves the agency to commence preliminary review as opposed to waiting and receiving one big NDA/BLA bolus. Sponsors are also working with a greater degree of efficiency by sending finished parts while other aspects of their application, such as the clinical portion, are still in progress.
http://theectdsummit.com/rolling-ectd-subm...d-fda-programs/
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royco
Posted on: Oct 30 2018, 10:55 PM


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https://www.thepharmaletter.com/article/new...e-ndas-and-blas
The increased number of RTF actions also points to the evolving complexity in assessing an application’s completeness. This complexity is associated with the enactment of the Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from drug developers to support product review.5The Act’s standards and guidelines for review are intended to secure the allocation of resources towards products that are safe and effective and thus ensure the timely and efficient approval of new drugs and biologics.2Prior to PDUFA’s enactment, RTF actions were typically limited to applications that had extreme deficiencies.1 However, since the Act contains the prescribed deadlines for review actions, the incidence of RTF actions has grown.1
The new guidance informs applicants of what they can do in case that they receive an RTF notification. Applicants still have an opportunity to discuss with the FDA review division the filing of an application that has been protested. Within 30 days following the RTF action, an applicant may write a request for an informal conference with the FDA. During the conference, the applicant can argue for the filing of the document.
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royco
Posted on: Oct 30 2018, 10:51 PM


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RTFs are “based on omissions or inadequacies so severe as to render the application incomplete on its face,” the old guidance states. “To be a basis for an RTF, the omissions or inadequacies should be obvious or at least once identified and not a matter of interpretation or judgement about the meaning of the data submitted.”
https://www.focr.org/news/pink-sheet-refuse...e-not-substance
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royco
Posted on: Oct 30 2018, 10:46 PM


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https://www.focr.org/news/pink-sheet-refuse...ot-substanceFDA lists six deficiencies that will likely draw an RTF, none of which should be surprising to sponsors:

  1. Materially lacking or inadequately organized applications.
  2. The application contains inadequate information for one or more indications when multiple indications are submitted in the same application. In those case, “FDA may accept for filing those parts of an application that represent complete submissions for particular indications but refuse to file those parts that are determined to be incomplete for other indications,” the guidance states. That is unchanged from the 1993 version.
  3. Reliance on a single trial to support approval of an application without adequate justification, and particularly in cases where FDA already formally requested more than one trial, at the end of Phase 2 meeting, for example.
  4. Failure to submit an assessment of studies related to the potential abuse of a drug that are necessary to inform drug scheduling under the Controlled Substances Act and the development of drug product labeling.
  5. Required content is not submitted electronically where the FDA has specified it must be.
  6. For NDAs or original BLAs reviewed under the Program, if minor components agreed upon for late submission are not received within 30 calendar days after receipt of the application.


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royco
Posted on: Oct 30 2018, 07:15 PM


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clinuvel should be treating at least 500 patients this year.
So in 3 months of summer that would be 1,5 implants per patient or 750 implants minimum.Sales should be very big, receipts from customers might not reflect this yet as they might be delayed.
Last quarterly they had a 66% increase year on year.Same with this quarter would land us at 9.3 million AUD or just 10pct under the previous quarter of 10.3 mln AUD.
2016: a sp spike in the days before the release of the July-Sept Quarterly and an ASX query following
2017: a sp spike in the days after the release of the July-Sept Quarterly and an ASX query following
2018: ???



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royco
Posted on: Oct 30 2018, 05:32 PM


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At the agm it will be 5 months since they filed the final module.
If there is no news by then there should be a lot of questions asked as to what is going on.
Total deja vu of the endless ema review.
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royco
Posted on: Oct 29 2018, 11:46 PM


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Posts: 2,985

https://trademarks.justia.com/792/17/chivere-79217953.html2018-10-02REGISTERED-PRINCIPAL REGISTER
https://www.trademarkia.com/au/trademark-1878257.htmCHIVERE
Current Status: Registered/Protected
https://trademarks.justia.com/792/19/clinuv...90.htmlClinuvel2018-09-18REGISTERED-PRINCIPAL REGISTER
https://www.trademarkia.com/ctm/tsumoyl-017...tmStatus/Status Date: Registered/Monday, August 27, 2018
https://www.trademarkia.com/ctm/tsumoil-017877362.htm
several variations of TSUMOYL,1 chivere

https://patents.justia.com/assignee/clinuve...icals-limited13 patents
https://patents.justia.com/patent/10076555<h1 class="heading-1">Methods of inducing melanogenesis in a subject </h1>Date of Patent: Sep 18, 2018
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royco
Posted on: Oct 29 2018, 07:55 PM


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Posts: 2,985

Clinuvel should be treating 700 patients by now with 1.5 implants per quarter in summer.
But still expect sub 10 mln aud revenues.
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royco
Posted on: Oct 29 2018, 07:40 PM


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Posts: 2,985

Clinuvel/vallaurix is moving ahead to become the first company out of Singapore to develop a new molecule and bring it all the way to the market.
First one to the clinic very soon would be cuv9900.
This should be a topical product and vallaurix will do all work including production in house in a newly built lab.
It is expected to go through regulatory trials much faster. ( in Singapore?!)

In the mean time the fda validation stall seems to be consolidating into November since a 22 June completion of filing.

Imho
Cuv knows the revenues of last quarter are good enough to justify spending a few millions in Singapore facilities AND keep the company profitable over the 2 slow income quarters we are in now. Cuv is moving towards an integrated drug company( invent, produce, develop, distribute).

My guess is that WB has some foresight into the synergies of distributing the Vallaurix premium cosmetics exclusively via his very own B&S channel.
B&S could possibly buy some cuv shares in the future and become the next major sh, makes sense to do it via a capital increase.

Still waiting for the first vallaurix actual product candidate in the clinic. So this news is somewhat of a pimped no-news yet type of release.
I suppose the fda situation is a factor in the general slow-down of Vallaurix progress towards actual profucts.






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royco
Posted on: Oct 25 2018, 06:05 PM


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Again the same style of difference with the volume on the ASX 68k and on the clinuvel website 104k.That is quite a big difference again.Anybody?

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royco
Posted on: Oct 25 2018, 12:29 AM


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Posts: 2,985

On ASX it says 48,091 volume for the day and on the clinuvel website it says 92k.Any explanation for this difference?



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royco
Posted on: Oct 24 2018, 01:30 AM


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If the fda drags on until 2020 what is clinuvel going to do with all the cash piling up?
Will we get a pdufa date in 2020? Is it possible?
Clinuvel 2020/vitiligo phase 3 on hold and single focus on fda yes but put those millions of aud at work!
To go after vitiligo alone would not be the smartest thing imho.

The fda silence 4 months after filing the final module together with two years of fast track rolling review reminds me of September/October 2014.
Subsequent ema opinion delays after the 2012 filing until
A sudden take over offer
A sudden joint venture in Singapore.
Followed swiftly by a positive opinion.

Let’s see if cuv will undergo some unexpected changes prior to pdufa date or us market entry.

Glta
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royco
Posted on: Oct 19 2018, 04:58 PM


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Page5
At the time of print some news on the vallaurix development should have come out.

Nope

No new indication known yet
No japan or ozzie filing
No vitiligo trial results
No news from fda
No NICE decision
No vallaurix follow on products

I hope they have answers at the time of the agm.

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royco
Posted on: Oct 17 2018, 09:53 PM


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What on earth are the fda people doing with the scenesse/epp file?
Sure hope this round of waiting is not going to drag on another month.
Cuv is more a test of patience than anything else.
QED
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royco
Posted on: Oct 16 2018, 01:12 AM


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As was said here before the checking of the additional documents should not take much longer.

Sure the fda could do it in a shorter timeframe than the original 2 months needed for the full validation.
Cuv said this would be the final questions before decision time.
They are waiting for pdufa since the NY presentation.
We could be very close.

Also for NICE, I like the ceo opinion he can wait weeks but not months for the review of the decision document.
So in latest a month we will have access in the uk or a court case.
Access in the uk would be a great precursor for the fda.
Glta!
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royco
Posted on: Oct 15 2018, 06:13 PM


Group: Member
Posts: 2,985

6,050,921 on Fridaytoday:6,141,138
That is 90k views of the cuv sharescene page over the weekend.Me think sharescene is by far the best information gateway for clinuvel at this point.
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royco
Posted on: Oct 13 2018, 12:23 AM


Group: Member
Posts: 2,985

benchmark:6,050,921 views on cuv sharescene page
Lets see on Mondayglta
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royco
Posted on: Oct 12 2018, 10:28 PM


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Posts: 2,985

9.5 MLN AUD

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royco
Posted on: Oct 12 2018, 09:38 PM


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Posts: 2,985

Quarterly Cashflow report for the period ended 30 September 2017.

The Cash receipts for the quarter were $5,638,000

compared to $6,247,000 for the previous quarter.

Soon we will get the July-September quarterly results.Anywhere close to 10 million AUD would be a great result for me.
Previous 2018 quarter:
Cash receipts from customers for the quarter were
$10,388,000
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royco
Posted on: Oct 11 2018, 11:49 PM


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The first CEO presentation was on 19 September in New York.
It stated clearly: waiting for PDUFA date.The October 4th presentation just confirmed that status.

Meaning that compared to the 5 September FDA Update they had already submitted the extra documentation requested by the FDA by or even before 19 September.
CSO on September 5th:
"I am confident the FDA will analyse these data as a final step before it takes a stance on Priority Review."
So this week they will have had almost 1 month time to assess the new documentation on manufacturing information and details on EU use of the drug. It didn't take long for clinuvel to gather the data and so it can't be a lot to assess either.

"product manufacturing information and details from the European post-authorisation use of SCENESSE"
Doesn't sounds like much more than some nuts and bolts for completing 2 modules. (including the last provided module that had the real world use and latest EU patient information in it)

No timelines provided but I think we are getting very close.
I cannot imagine the FDA people would need two months to look into the new documentation.
And to think that I clearly remember the initial FDA attempt around 2004...To be this close to a pdufa date and start of review is hard to believe.Who cares about PR?! 6 months, 12 months or 24 months is nothing compared to never or 168 months.glta

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royco
Posted on: Oct 11 2018, 08:20 PM


Group: Member
Posts: 2,985

Sure hope the FDA is going to give some kind of feedback before the end of the year.EPP patients in the USA must be going nuts with this regulatory silence.


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royco
Posted on: Oct 11 2018, 07:32 PM


Group: Member
Posts: 2,985

Looking at the trend in the past 24H the cryptomarket is nicely correlated with the rest of the global markets.

  Forum: Investment Discussion

royco
Posted on: Oct 10 2018, 03:45 PM


Group: Member
Posts: 2,985

For years i thought the controlles release was only about the implant, now i know its about the share price roo
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royco
Posted on: Oct 10 2018, 02:51 PM


Group: Member
Posts: 2,985

A ten pct drop whitout news makes doubt spin in many minds.
The molecule is safe, the implant is effective.
Cuv is fighting for every patient to be able to have a choice of treatment.
Nice has been battling scenesse (and epp)since the first ema days, mostly side by side with the french regulator.
Epp could be treated by staying out of sunlight
Clinuvel was after bringing a tanning agent to market
A decade lost in ema-tic delays.

Until the inevitable opinion.
Today released on ec markets since 2 years
Pristine safety
98pct patient return rate

And in final struggles with uk nice.
Waiting out fda delays
Quid Francia?

Scenesse is a great addition to pharma
Cuv team and investors do not give up.
Patients are very satisfied with the treatment result and keep coming back despite the draconic follow on research demanded.
This extra research will eventually be a great asset for cuv.


  Forum: By Share Code

royco
Posted on: Oct 9 2018, 07:39 PM


Group: Member
Posts: 2,985

Maybe also a facto today:
Just paid out about 1mln AUD dividends.
  Forum: By Share Code

royco
Posted on: Oct 5 2018, 01:06 AM


Group: Member
Posts: 2,985

1 month since fda update.
  Forum: By Share Code

royco
Posted on: Oct 5 2018, 12:39 AM


Group: Member
Posts: 2,985

They are presenting now in Basel so the new praentation should be posted.
Hopefully something on fda...F-D-A
Maybe they lost a module or accidentally erased it.
  Forum: By Share Code

royco
Posted on: Oct 2 2018, 07:36 PM


Group: Member
Posts: 2,985

https://www.accessdata.fda.gov/scripts/opdl...fgridkey=263208
  Forum: By Share Code

royco
Posted on: Oct 2 2018, 07:34 PM


Group: Member
Posts: 2,985

May 10 2011https://porphyriafoundation.blogspot.com/2011/05/day-at-fda.htmlMike and Matt visit FDA to explain EPP
August 2, 2013
http://www.porphyriafoundation.com/news/Visit-to-the-FDA EPP patients met with FDA. August 2, 2013 was a memorable day for the APF members, who met at the FDA to explain Erythropoietic Protoporphyria (EPP) and asked that the FDA approve Afamelanotide/SCENESSE for EPP.
October 24, 2016https://www.fda.gov/downloads/drugs/newsevents/ucm530480.pdfFDA scientific workshop on EPP and with patients and other stakeholders involved.

October 2, 2018FDA is still thinking about validation of the SCENESSE NDA.The patient voice is heard but apparently not well understood by the FDA.



  Forum: By Share Code

royco
Posted on: Oct 2 2018, 04:26 PM


Group: Member
Posts: 2,985

Quo vadis FDA?
  Forum: By Share Code

royco
Posted on: Sep 29 2018, 07:32 PM


Group: Member
Posts: 2,985

https://ambcrypto.com/goldman-sachs-and-goo...ayment-startup/
  Forum: Investment Discussion

royco
Posted on: Sep 29 2018, 12:56 AM


Group: Member
Posts: 2,985

My hope that they would be ready this Friday...unfortuantely nothing more.
No can do text.
Glta
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royco
Posted on: Sep 29 2018, 12:29 AM


Group: Member
Posts: 2,985

Still some hours left for the FDA to decide on validation and PR within my 48 hour time window.LEt's hope it is for next week if today doesn't work out.
  Forum: By Share Code

royco
Posted on: Sep 27 2018, 11:38 PM


Group: Member
Posts: 2,985

I would like to see an FDA PR and validation announcement over the next 48 hours with a PDUFA date 29 March 2019.If we see further delays the US EPP patients can forget about SCENESSE treatment during 2019 too.

  Forum: By Share Code

royco
Posted on: Sep 27 2018, 08:08 PM


Group: Member
Posts: 2,985

70 AUD
  Forum: By Share Code

royco
Posted on: Sep 27 2018, 06:53 PM


Group: Member
Posts: 2,985

Last trade of the day: around 50k shares changing hands at 16:29 at 22 exactly.
This is a sophisticated signature, I suppose we will see more big volume days as the ASX300 kicks in and more people read up about SCENESSE.

Hell, what's up with the FDA?
  Forum: By Share Code

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