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


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

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


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new quotation in Germany:
Quotrix Düsseldorf
https://www.wallstreet-online.de/aktien/cli...ceuticals-aktie
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royco
Posted on: Jul 24 2019, 01:03 AM


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


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


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


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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

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


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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

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


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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.



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


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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


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100% sure not on 6 October...it is a Sunday?!
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royco
Posted on: Jun 3 2019, 08:34 PM


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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.""Vyleesi™, 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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

Waiting again
  Forum: By Share Code

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


Group: Member
Posts: 2,929

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

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


Group: Member
Posts: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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

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


Group: Member
Posts: 2,929

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: 2,929

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: 2,929

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: 2,929

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

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


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Posts: 2,929

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: 2,929

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: 2,929

"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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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: 2,929

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.

  Forum: By Share Code

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


Group: Member
Posts: 2,929

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
  Forum: By Share Code

royco
Posted on: Feb 17 2019, 04:49 PM


Group: Member
Posts: 2,929

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: 2,929

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.
  Forum: By Share Code

royco
Posted on: Feb 3 2019, 06:08 AM


Group: Member
Posts: 2,929

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.
:-)
  Forum: By Share Code

royco
Posted on: Feb 1 2019, 07:59 PM


Group: Member
Posts: 2,929

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



  Forum: By Share Code

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


Group: Member
Posts: 2,929

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.
  Forum: By Share Code

royco
Posted on: Jan 18 2019, 02:35 AM


Group: Member
Posts: 2,929

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.
  Forum: By Share Code

royco
Posted on: Jan 16 2019, 12:22 AM


Group: Member
Posts: 2,929

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.




  Forum: By Share Code

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


Group: Member
Posts: 2,929

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


  Forum: By Share Code

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


Group: Member
Posts: 2,929

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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Posts: 2,929

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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Posts: 2,929

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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Posts: 2,929

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!

  Forum: By Share Code

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


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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.
  Forum: By Share Code

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?
  Forum: By Share Code

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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Posts: 2,929

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.
  Forum: By Share Code

royco
Posted on: Oct 29 2018, 11:46 PM


Group: Member
Posts: 2,929

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
  Forum: By Share Code

royco
Posted on: Oct 29 2018, 07:55 PM


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Posts: 2,929

Clinuvel should be treating 700 patients by now with 1.5 implants per quarter in summer.
But still expect sub 10 mln aud revenues.
  Forum: By Share Code

royco
Posted on: Oct 29 2018, 07:40 PM


Group: Member
Posts: 2,929

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: 2,929

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



  Forum: By Share Code

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


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Posts: 2,929

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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Posts: 2,929

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.

  Forum: By Share Code

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
  Forum: By Share Code

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!
  Forum: By Share Code

royco
Posted on: Oct 15 2018, 06:13 PM


Group: Member
Posts: 2,929

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.
  Forum: By Share Code

royco
Posted on: Oct 13 2018, 12:23 AM


Group: Member
Posts: 2,929

benchmark:6,050,921 views on cuv sharescene page
Lets see on Mondayglta
  Forum: By Share Code

royco
Posted on: Oct 12 2018, 10:28 PM


Group: Member
Posts: 2,929

9.5 MLN AUD

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


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Posts: 2,929

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
  Forum: By Share Code

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

  Forum: By Share Code

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


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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.


  Forum: By Share Code

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


Group: Member
Posts: 2,929

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: 2,929

For years i thought the controlles release was only about the implant, now i know its about the share price roo
  Forum: By Share Code

royco
Posted on: Oct 10 2018, 02:51 PM


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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.


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


Group: Member
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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


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Posts: 2,929

1 month since fda update.
  Forum: By Share Code

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


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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


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

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


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Posts: 2,929

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


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Quo vadis FDA?
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royco
Posted on: Sep 29 2018, 07:32 PM


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

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


Group: Member
Posts: 2,929

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


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


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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


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Posts: 2,929

70 AUD
  Forum: By Share Code

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


Group: Member
Posts: 2,929

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

royco
Posted on: Sep 27 2018, 12:27 AM


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Posts: 2,929

https://www.businessinsider.com/forgetful-i...est-2014-9?IR=T
"Fidelity had done a study as to which accounts had done the best at Fidelity. And what they found was..."
"people who forgot they had an account at Fidelity."
F-I-D-E-L-I-T-Y

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royco
Posted on: Sep 26 2018, 05:56 PM


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Posts: 2,929

FDA your results please!!!
  Forum: By Share Code

royco
Posted on: Sep 26 2018, 05:45 AM


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https://m.youtube.com/watch?v=kOFu6b3w6c0
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royco
Posted on: Sep 26 2018, 01:45 AM


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I do anticipate a similar scenario to pre ema approval.
Access to us market will come at a cost.
A jv, a new nasdaq entity...something...soon
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royco
Posted on: Sep 26 2018, 01:07 AM


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Australia has been trying to build a biotech industry since the ninetees and in anticipation to the end of home-minerals exploitation or at least to balance the weight of minerals export.

Similar to saudi arabia building a financial hub for when oil ends.
Clinuvel and afamelanotide did fit in perfectly and was hoped to protect ozzie fitzpatrick4 skin from the damaging effects of abundant Southern sunlight.
Eventually preventing a skincancer epidemic.
Clinuvel did the unlikely and unexpected: they managed to get a new product on the market and be profitable with significat growth lined up.
An exclusive club for ozzie biotech after over 15 years of high risk and no reward.

Wolgen stated recently to build a monolithic Australian organisation.
Blijdorp and Wolgen own vast quantities of shares and so do lagoda, ender1 (sean parker) and Fidelity.
All subscribe to the management strategy and are not in a hurry to monetise.

That’s why I believe an unsollicited take over attempt seems unlikely to succeed.
Not before 2020 and not at this sp but probably a multiple.
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royco
Posted on: Sep 25 2018, 06:56 PM


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Volumes and price tawk...FDA validation imminent?Or is the little bird right?
This increase will end without fundamental upcoming news.Last time I had seen this kind of stacked daily increases without news for CUV was in 2006-2007...

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royco
Posted on: Sep 25 2018, 05:33 PM


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EPP = proof of concept
Vitiligo cure
DNA REPAIR

Cosmetic market




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royco
Posted on: Sep 24 2018, 07:57 PM


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From last weeks CEO presentation in NY we know they seem to be just waiting for a decision and probably have submitted the extra information already. I would think it is just a matter of days before the submitted extra information is reviewed for completeness and they are ready to validate or reject the submission and start the official review.




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royco
Posted on: Sep 24 2018, 05:56 PM


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Ripple up strongly.
XRPan important information in the link below: "it is not a distributed ledger"
https://cointelegraph.com/news/from-a-rippl...ds-to-xrp-surge
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royco
Posted on: Sep 21 2018, 04:41 PM


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Lagoda also might have some rebalancing to do.
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royco
Posted on: Sep 21 2018, 04:38 PM


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Could it be the free cash ticket until today?
Ex dividend??
Maybe ask x-ray whats up
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royco
Posted on: Sep 21 2018, 04:33 PM


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Nasdaq presentation?
Someone in NY made some phone calls maybe.
Or fda nda validation/pdufa coming up today in the usa?
Asx300 inclusion would not make waves like this.
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royco
Posted on: Sep 21 2018, 01:02 AM


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Zero chance.
They will have to wait 6 months for a decision minimum.

In the mean time an expanded access program is not excluded.
It could help the worst cases to be treated without further ado.
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royco
Posted on: Sep 20 2018, 09:27 PM


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https://www.bloomberg.com/news/articles/201...world-quicktake
https://www.pwc.com/mt/academycalendar?gcli...AyAAEgJo8vD_BwE
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royco
Posted on: Sep 20 2018, 08:05 PM


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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4763516/
FDA: Expanded Access ProgramImplemented since 1997

"It was seen that the mean time from EMA approval to commercial availability varied from 88 days to 392 days. It is under such situations when marketing authorizations are received in a staggered manner, that EAPs can be implemented.[10] EAPs can be also implemented for rare and orphan diseases like acute myeloid leukemia."
I do not exclude that they allow access to SCENESSE for EPP just after validation of the NDA and prioirity review award.
After all, what is the risk?Maybe our price to pay would be the initiation of a follow up program similar to EMA PASS study with the main aim to assure safety and control distribution to avoid off label availability.It certainly fits into the extra information asked about production and patient details from the EU commercial use data.thinking positively of course but just hoping one of these days the NDA will be validated with or without Priority Review.
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royco
Posted on: Sep 20 2018, 07:47 PM


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https://www.bloomberg.com/news/articles/201...h-unit-jma4u8ol
A little big for us to take over but maybe they could be a great JV partner.
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royco
Posted on: Sep 19 2018, 10:53 PM


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https://cointelegraph.com/news/how-australi...tions-and-plans
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royco
Posted on: Sep 18 2018, 07:48 PM


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In all developed countries people are preparing for the use of blockchain technology as the best way for distributed ledger security for transaction and value storage. (as compared to the current system with centralised databases and fiat-currency) One clear signal is the rising number of blockchain courses offered at universities or other training institutes. According to their marketing they expect the demand for IT-blockchain related jobs to explode over the next 3 years.

The number of robotic transactions is booming since years, just think about the algo-trading and high speed trading on financial markets.
No humans touch this any more.
Who speaks blockchain speaks distributed ledger, who speaks distributed ledger speaks about Bitcoin (and Ether) that are the two cryptocurrencies with own blockchains that are actually having enough "network" power to achieve the distributed ledger. All other currencies seem to either derive their value from the BTC or ETH blockchain or become actually centrally controlled databases anyway because they have a mining network that is centrally controlled.

Because of the need to verify the increasing amount of electronic/robotic transactions, the demand for mining will highly likely follow and increase exponentially over the next years. Therefore the bitcoin/ETH will increase in price (of production) and attract more miners willing to invest for a hefty return. There it is not important to have another tulip bubble growth pattern but to achieve steady growth. As time goes by the gap between the two or three cryptocurrencies that have a sizeable network will most likely increase further in stead of decreasing. Eventually other cryptocurrencies might completely disappear as they simply do not fulfil any distributed ledger requirement on a big enough scale, hence no actual advantage over a centralized database system.

This steady growth might by obtained through a balance between the exponentially rising demand and the weakness of the technology and lack of network power. Together with the built in increase in mathematical difficulty it should nurture steady increase not exponential growth. Therefore also achieving a cryptocurrency that will steadily grow in value with some intermezzo of strong growth or decline. As these parameters find a balance eventually the cryptocurrencies might become a more stable means of value storage and transactionable currency. Since several months the decline is so big that people do not want to receive payments any more with cryptocurrencies. This seems to be more a normal market cycle rather than the actual end of the mania. If unlucky, people who stepped in at the 2017 high might not see their value back until possibly many years later. As you might know, tulips are still big business in Holland and they will remain for many years to come.
  Forum: Investment Discussion

royco
Posted on: Sep 18 2018, 07:06 PM


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if sp could tawk it would possibly say: FDA news coming very soon!
glta
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royco
Posted on: Sep 15 2018, 12:18 AM


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Slide 8:
Cuv controls distribution and quality in the eu “And shortly in the us”

Choice of words “shortly” strikes me as odd and not pointed towards late 2019 or worse.


Confirmed that Friday opening slide says bulletpoint: “waiting fda pdufa.”

My guess:
No rtf
Answers provided
Waiting pdufa again
No further questions received until today
PR is likely
I see some options open for early access and fda allowing epp access per direct to be ready for the spring/summer 2019 distribution.
Fda looking for double insurrance in production and patient details because large® scale distribution is imminent.

Very optimistic on Fridays.
Glta
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royco
Posted on: Sep 14 2018, 10:40 PM


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Half yearly I thought.

Also the news release said “details” about the eu patient data ( commercial distribution)
So I think it is not “latest” or “updated” eu patient data.

Also the presentation of last Friday states clearly cuv is waiting for pdufa date somwhere in bullet point of first slides i thought.
So I suppose they submitted the extra documentation and now wait for an answer or further questions.

Maybe today we get fda feedback, who knows?’
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royco
Posted on: Sep 14 2018, 08:42 PM


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from the 5 September FDA update news:
"although at this stage further timelines have not been provided by the FDA"

Anybody any idea what timelines we might eventually be looking at?
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royco
Posted on: Sep 13 2018, 06:58 PM


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https://cointelegraph.com/news/breaking-new...ryptocurrencies
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royco
Posted on: Sep 13 2018, 06:57 PM


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https://www.independent.co.uk/voices/bitcoi...r-a8534746.html

A Rolls-Royce dealership in Houston, Texas, has just announced that it will sell you a new one for Bitcoin – 55 of them reportedly, though if Bitcoin keeps falling, they might want a few more. I suspect, since its outgoings are in dollars, it would convert the bitcoin into dollars pronto.
  Forum: Investment Discussion

royco
Posted on: Sep 13 2018, 12:56 AM


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Can anyone imagine where the sp would have been today if FIL would not have made this amount of shares available?
And this is just volume without news.
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royco
Posted on: Sep 13 2018, 12:54 AM


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https://www.trademarkia.com/ctm/tsumoil-017877362.htm
was registered in the EU on 27 August
not sure if this was posted already.
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royco
Posted on: Sep 12 2018, 12:52 AM


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Slide 8 of the Friday NY biotech newsmakers presentation:


"and we areaware of a growing number of EPP patients crossing the Atlantic to seek treatment who are prepared to pay, and in some cases receive already reimbursement from US healthcare insurers."


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royco
Posted on: Sep 10 2018, 11:47 PM


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Going up without news has happened in the past too and was always followed by a downfall without news after. Or worse with bad news or further delays etc.

Anyhow, my expectation is that the upward surge will continue for a few days more and end well over 20, maybe even closer to 30.
Possibly with another 20% day somewhere in between and upon actual good news coming through.
I expect the FDA PDUFA news any day before end of September. If "bad" it could be a show stopper.

We are suddenly in the headlights and if we stall, we could end up roadkill too.

Fidelity was smart to lock in profits before the FDA news and hedge for delays or bad news.
I suppose they are on the sell side now also.
Blijdorp was smart to buy shares at 10 AUD.
He will not sell for years to come I suppose.

Who will be the next chairman?
Wolgen or Blijdorp?
The CEO was too busy to comment on the FDA news and he sent LAchlan to NY to do the talking.
Maybe he is too busy with internal politics and positioning towards the AGM.
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royco
Posted on: Sep 10 2018, 04:38 PM


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Definitively established: racehorse

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royco
Posted on: Sep 7 2018, 08:02 PM


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not forgetting uncle uho for a wide array of investment and scientific information on CUV:

https://groups.google.com/forum/#!categories/clinuvel

Probably more information on afamelanotide than to be found on the clinuvel website.
Took years of relentless searching and carving to establish.

For clinuvel it is important to know that it's history was just a long drawn out passage through the regulatory and trial minefield with all involved suffering and getting much older.
We made it through EMA's minefield in 2014 and probably also through the FDA minefield soon. We will have to wait until 2019 to find out.

From 2019 and with FDA approval in the pocket...forget about the clinuvel history: look at the future!
And be happy to be part of it. Only a handful investors are at this stage.
Everyone will want your shares soon enough and say in hindsight it was logical this would become a great drug some day.
Only pity they missed out.
glta clinuvellians
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royco
Posted on: Sep 7 2018, 06:23 PM


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https://cointelegraph.com/news/goldman-sach...k-are-fake-news
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royco
Posted on: Sep 6 2018, 07:29 PM


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Yes, I am seeing delayed quotes. Thanks for posting the data.
My funny bid/ask numbers were appearing just at close of market and right before the 40k extra shares traded after market closure.
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royco
Posted on: Sep 6 2018, 07:27 PM


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Oct--Nov-Dec18-Jan-Feb-March19
6 months roughly with PR.

:-)
Could be half February if expedited delivery of goods before end of September...
As someone said before this is not about a bonus for management so probably later than earlier!
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royco
Posted on: Sep 6 2018, 04:34 PM


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Get ur point not an ANDA procedureso scrap 7 days.
Maybe cuv noticed they could not answer yet within two weeks after day 60, hence the news release day 60+14.
I sure hope they can do it in days and not weeks or months.
Glta
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royco
Posted on: Sep 6 2018, 04:26 PM


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Bid and ask jump wildly
Bid now 15.740
Ask 13.420
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royco
Posted on: Sep 6 2018, 03:59 PM


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From the post below...
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royco
Posted on: Sep 6 2018, 02:59 PM


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I think the fda has reviewed ALL modules and found 2 documentation shortcomi.gs.
clinuvel has 7 days to answer and keep rolling review.
why else would the fda.come up with two items.in two modules? the last one on eu patients and an other on production.

Why would they do this?
my guess; early access might be granted next to PR and pdufa March 2019.
a life changing drug with no alternative effective treatment and high patient demand.
patient voice heard.

New target date is next Wednesday?!
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royco
Posted on: Sep 6 2018, 12:22 AM


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"The latest FDA documentation request represents a further step in the review of the submission, which was made under “rolling review” of the NDA. It is anticipated that after submission of the additional documentation, all information requested will be sufficient, after which the Division of Dermatology and Dental Products will take a decision on Priority Review."

I guess this is one of the advantages of the rolling review and once these documents are delivered (any day I suppose) the FDA PR and validation decision will be made public right afterwards. I could be a matter of days since clinuvel already knew this information request on day 60 and it don't seem like a huge task to deliver this extra data.

I start to think it is indeed just a safeguard for the FDA to accept the dossier and allow marketing for a controversial drug without clear enough trial results (p values and size of trial) but with very a strong patient demand. Here the extra EU patient data/details sounds like they want to be extra sure on the latest patient values too. (ie after June 2017) Possibly they needed some extra safeguards about dangers for mass production and the famous off label market.

Supposedly the next statement will be the FDA validation and PR decision...and it wont take too long either. I guess before end of September. Suspense!!
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royco
Posted on: Sep 5 2018, 11:28 PM


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they took 60 days to review the final module on completeness and added the problem they still had with one of what I suspect was the one of the earliest modules (production data).

Outcome: they need more details on the EU patient data and implant production.
They said this to clinuvel on day 60.
Clinuvel got to work and spent the last two weeks to get the job done. After today they received the official wording from the FDA and they could communicate to us.
No RTF and as "the source" said: can be submitted at any point.

Hopefully sooner and according to dr Wright the PR decision and validation should come right after this extra documentation is submitted with pdufa data and start review clock.
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royco
Posted on: Sep 5 2018, 05:55 PM


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Good times for asx300 trackers to but cheaper cuv for a while...hope they will be included by 21 Sept...
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royco
Posted on: Sep 5 2018, 04:23 PM


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"I am confident the fda will analyse this additional data as a final step before taking a stance on PR"

So dr Wright thinks this is it, no more questions or delays after cuv bring the data and fda analyses it.
From the news it seems this data is not vaste but mere details.

They burned already 2 weeks for having the documentation ready. I hope they are ready to submit or maybe already did a apart.
Why dont they comment on how much time it will take to answer?
They leave sh in the dark...
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royco
Posted on: Sep 5 2018, 02:38 PM


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They had this news already two weeks back?
Letter first refusal ti file etc?
Maybe they already looked up most data by now.
Heck they should have all team ready to find the details on the manufacturing requested and to compile the extra item from the eu patient data.

All in all i think they did correctly lodge the files mdules with a rolling review and including completeness to file feedback from fda etc.
The eu patient data was in the final module and added by initiative of cuv and unusual for fda to receive.
So not unusual they ask another detail.

For the manufacturing it is more surprising because must have been lodged early on.
The factory is audited by ema (NICE)since two or three years of production.
The ema has had identical data.
It must be something changed in production and fda need an update.
I see this as an easy one: ask evonik usa forward of fda question on tech detail and send through the answer as cuv has no clue about production details.

Review and pr decision only start when all requests are satisfied.
24 months time and still they arr not shy to ask more info.
Again I keep a small option it is to dot all i's before allowing PR.
Still disappointing q
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royco
Posted on: Sep 5 2018, 11:29 AM


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Could also b the fda " heroes" are headed for a positive decision on first ever PR for so-called dermatology drug and need to make it look as if they really dug in deep ( cover the back for when criticism comes)

after 24months of delaying what they should be doing (approve), this is disappointing.
I count with at least two months delay from this request alone.

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royco
Posted on: Sep 5 2018, 10:50 AM


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A typical cuv situation.
Consistantly misses timing.

Hope this is not the same stall cuv delay as ema has done before.
They make it sound as if they will deliver quickly some details and then get quick a decision on acceptance and PR.
i also find it funny they post 2016 info about fda saying sufficient data etc.
Fast track, rollng review and regular interaction for 2 TWO years and then this?!?

Could be gone for months of regulatory bladibla just like with ema.
Meanwhile us eppoatients are screwed for 2019 also?!
Apf must be going mad with fda!!

Great timing by fidelity...
NB the product is manufactured in the USA!
Evonik factory and audited by uk nice.
Speak English please!?!

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royco
Posted on: Sep 4 2018, 09:25 PM


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A fair way to enter the nasdaq would be to create about 100-200 mln usd worth of new shares and give existing shareholders rights to sign in first. Depending on the price of the market-shares at that time and the price of the new shares that could mean we could all decide to sell those rights at a bonus in case we are not interested to put more money on the table.

The NASDAQ quotation would also be a possible conduit for actually earning money in the US market after the FDA approval.
I expect a major move by clinuvel in the final three months before start of sales. So this would mean about November/December this year when they obtain priority review on the NDA dossier and have the pdufa date in February 2019. I don't think they would do anything but tawk before the 2018 AGM in November.

The announcement of vitiligo curative trial results would be a nice follow up on the news show lately and this week to come (FDA and ASX300)

Now to look out for when those Singapore Vallaurix products will be launched. This has been delayed from "May 20" to "July" and now "in the future". The cherry on the 2018 cake?
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royco
Posted on: Sep 4 2018, 07:28 PM


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thanks to FIL poring shares on the market they have probably helped to keep the sp in check over the past days.
With all ASX300 tracker funds preparing to invest there is enough demand lined up.

FIL is really into the contrarian trading/investing because they seem to be happy selling important portions when shares are wanted sp goes goes up and good news is flowing.
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royco
Posted on: Sep 4 2018, 04:56 PM


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NDA was delivered on June 22. ( not 25)
So August 22 is the 60 days mark( 2 months)
So today or tomorrow pdufa date by fda I guess.
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royco
Posted on: Aug 29 2018, 07:28 PM


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Exactly my reading: Blijdorp is positioned for taking over the baton from Stan at next AGM.

Nice text he wrote, I like the idea of continuity and growth even if we have to pay CFO and CEO a truckload extra.
Remind me a bit of Charlie Munger way of writing.

clinuvel2020 execution would be great.
ASX300 inclusion more likely with a profitable dividend paying company?
And indeed an extra benchmark achieved for those funds that are looking for less risk.

And 5mln AUD trade and other receivables in the books FY2017-18 sounds quite encouraging for the current quarter revenues.
Now it is just waiting for the FDA...
glta
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royco
Posted on: Aug 29 2018, 04:26 PM


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This dr works for NICE?
How is it possible that supposedly well educated people stick to simplistic and short sighted arguments even if facts show the opposite?
Sounds like someone in 2020 warning against the dangers of the hubble space telescope because it might teach us things that could be harmful in the end.
Sigh.
I guess it remains a controversial drug for many and they cannot separate the selftanning effect from other drug features.
At least the ceo talks about it in a cnn related news channel.
I doubt many will read that deep into the article.

We need some gung ho statements soon to get cuv out of the 10-12 dolldrums.

Fda news (until 5 Sep)
Financial report 2017-18 (Friday 31st. Aug)
Vitiligo phase 2 and path to market
Launch of cosmetic line and add on products
Start of phase 1 for cuv9900 and val001?
Start of scenesse trial in new orphan disease?
Scenesse Label expansion?
Scenesse dosage 4-->6 per year
Quarterly report July-Sep
:-)
All expected by Novembet AGM?! With a new chairman presented?
Busy 3 months upcoming(finally)

2019:
Scenesse price increase
Fda decision
Start sales usa.
Cosmetic sales start
Start us phase 2 or 3 vitiligo curative treatment?

Clinuvel2020 in the making.
Glta


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royco
Posted on: Aug 24 2018, 09:04 PM


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Reading the German board I find it hard to understand why cuv is now valued at 12 aud.
A few years back and just a promise of a drug we were valued around 100-200 mln.

To me it seems still almost nobody believes this drug/company is ever going to be bringing any revenues of worth.
Yet the facts are undeniable.
Profitable and ema approved
Treating almost 1000 patients for over 2 years.
At the brink of fda approval with a view on vitiligo curative treatment, label expansion etc.

Two more molecules in the pipeline for topical use and dna repair and possibly oncological use.
Who said something about sunless natural tanning for cosmetic purpose??
If the company continues on this path and develops sustained and growing income we might wake up one day and see tripple digit sp.

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royco
Posted on: Aug 22 2018, 06:07 PM


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It sure also helps to understand that media news on clinuvel looking for a potential take-over candidate.
With an expected 75-100mln in the bank over the next 12 months its a lot more credible than with only the current 36mln.

At an estimated 750 patients treated over 2018 at the maximum 4 implants each and with German/EU pricing levels:
The annual costs of therapy with SCENESSE® range between €56,404 and €84,606 per EPP patient per annum.

https://www.clinuvel.com/investors-21/news/...bitration-board

revenues 2018: 42 mln mln EURO up to 63 million euro
OR 63 mln AUD up to 94 mln AUD
Only ca 15 mln booked over the first half of 2018...is this the bombshell quarter?
bring on the dividends?!
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royco
Posted on: Aug 22 2018, 04:20 PM


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On a second reading it still puzzles me how they added 2800 dosages of scenesse since May-June.

Normally cuv should be well aware of that number.
Last quarterly showed expected payments for commercial goods i.e. Costs for ordering
scenesse implants around 800k aud and almost identical to the actual numbers in that April-June quarter.
So that is a total 1.6 million aud of implant costs since April.

Even if its 2000 implants for 1000 patients it would bump revenues to unexpected levels.

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royco
Posted on: Aug 21 2018, 11:16 PM


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https://www.accessdata.fda.gov/scripts/fdat...riority-reviews

oct-dec 2017 : 3
jan-mar 2018 : 2

:-)
a VERY select FDA club
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