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FarmaZutical
Posted on: Feb 13 2020, 08:40 AM


Group: Member
Posts: 584

Re the Type C meeting and a Phase 2b:

I think Clinuvel may in fact be aiming for a pivotal
phase 2b/3 and that the Type C meeting will be used
to discuss how to handle the de facto unblinding
that the tanning effect provides. We’ve seen high dropout
our rates and in a Phase III the patients in the placebo arm
might be inclined to drop out, too, because it’s obvious they
don’t they the drug.

So if a normal randomized double blind placebo controlled
trial is not optimal then they might be aiming for an
unblinded phase 2b/3 and no subsequent Phase 3s.

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FarmaZutical
Posted on: Feb 11 2020, 05:29 PM


Group: Member
Posts: 584

I highly recommend spending 30 minutes on reading this
very comprehensive report:

https://www.iqvia.com/-/media/iqvia/pdfs/in..._=1581405249861

About the Report

The development of innovative medicines has evolved dramatically over the past decade. This study assesses the activity and landscape of research and development (R&D) in 2018, the productivity levels of the clinical development process and how key trial-trends will transform clinical development over the next five years. The features and development path of both newly launched therapies and pipeline therapies are examined along with shifts in the companies bringing these drugs to the market. This report puts forth a proprietary Clinical Development Productivity Index that reflects changes in trial complexity, success and duration over time. Eight key trends driving change in clinical development are explored and their expected quantitative impact on productivity through 2023 are discussed.
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FarmaZutical
Posted on: Feb 10 2020, 05:01 PM


Group: Member
Posts: 584

Yes, Clinuvel never actually stated that they had requested a Type C meeting.
On several occasions they have said that they intended to to so after FDA approval.

“ After the FDA’s outcome on EPP, a Type C meeting will be sought with the Division of Dermatology and Dental Products to request their input on the protocol design and advanced development pathway for SCENESSE® to the US market.” (January, 2019)

I expected that they had already done so and I’m a bit surprised that they haven’t
gotten to it until now. But to be fair, they aren’t being disingenuous on this one.
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FarmaZutical
Posted on: Feb 9 2020, 06:14 AM


Group: Member
Posts: 584

Don’t forget the part time realtor in Palo Alto.
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FarmaZutical
Posted on: Feb 8 2020, 06:46 AM


Group: Member
Posts: 584

One thing is being an investor in Clinuvel, but
try being an EPP patient. I can only try to imagine
the frustration these people are going through.

https://www.facebook.com/groups/AmericanPor...46873875338757/

The best thing that could probably happen for them
at this moment is a buyout so the drug could be
distributed swiftly and efficiently. I used to see a buyout
as a tragedy for shareholders, but with the non execution and
non communication I’m beginning to see it as a
good exit.
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FarmaZutical
Posted on: Jan 11 2020, 03:32 PM


Group: Member
Posts: 584

My feeling is that Dr. Wolgen is punishing the investors who have been
so rude as to write letters to IR requesting information about
the various things that have been buried. I myself
have written numerous letters where I respectfully ask them
to clarify I.e. what happened to the promised cosmetic line, the VP
trial that was suddenly postponed a year and various other aspects
of the company. I’m also amongst those investors who were against
Wolgen’s Christmas present and I have recommended modernizing
the communication strategy so that the company can
attract new investors and garner trust with a more open
attitude.

The only answer I and many others have received is the public
statement from the previous chair that we are “uncivil” and that
we don’t live up to our “responsibilities.”

That tells me that the company is now actively punishing us
by letting us know even less. In my view it’s only fair that
investors demand to know how the company is planning to
monetize the recent FDA approval and which steps are taken to
ensure a swift roll out. We know from a Facebook post from the
American Porphyria Association that the company is now
gathering information from them regarding the location
of the US EPP patients. That’s pretty much the only
piece of information we have 3 months after the historic
approval of Scenesse.

Dr. Wolgen wants investors to have blind faith in his strategy but
that’s not how it works unless you run a private company. I have
faith. Quite a lot, actually. But it’s not blind and I dislike being
regarded as uncivil when I ask legit questions about
aspects of the business.

Over the years I’ve been wondering, why Clinuvel
ran their IR and PR this way. First, I though it was due to the
lack of funds. Then I figured they were terrified of
competition. Now, I’m convinced it’s because they just don’t
give a flip. When investors get not reply or even an acknowledgment of
receipt to respectful and relevant letters sent to IR, then
there can only be one explanation: The don’t care.

I’m not overly concerned that they are covering something up and
I don’t think anything has gone wrong and that they are in
full panic mode behind the curtains. I just think they are sending
a message: Stop bothering us or we will just stop
giving you any information whatsoever about your investment.
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FarmaZutical
Posted on: Dec 20 2019, 07:51 AM


Group: Member
Posts: 584

Since the company keeps the average investor in the dark
regarding the strategy, one can only speculate. Which I have done.

We all know most of the pieces in the puzzle, but how do they fit ?

I think the OTR trial is still alive and meant to be a cornerstone
in the puzzle. A follow up period of 5-10 years would be
a tremendous advantage if they can prove that the patients
are indeed protected against AK and SCC. Follow up periods
that long are not uncommon when dealing with cancers.

XP is obviously also a big piece with DNA repair.

EPP seems more and more like a stepping stone.
The company probably asked for the non REMS
to keep off generics from entering the market.

Now they want to hit as many EPP patients as possible
by establishing centers close to where they live. Smart move
since two exclusion criteria in the MT7117 Phase 2 were
prior use of Scenesse and prior exposure to MT7117.

How will M. Tanabe be able to find +100 patients for a
Phase 3 that fits that bill ? Close to impossible 12
months from now. Which is why it is also crucial that
Scenesse is marketed soon in Britain, since M. Tanabe is
also planning a new trial there.

Breakthrough for XP should be possible if the upcoming
short trial is positive.

What happened to VP ? I think it was canned due to
bad results. But they don’t have the balls to admit it.
This won’t matter much financially if XP is marketed.

Vitiligo could also be a major revenue driver. But probably more
importantly, it will bring Scenesse to hundreds of dermatology
centers throughout the US. Then, the democratization
of Scenesse can begin building on the (hopefully) good
results from XP, EPP, Vitiligo and OTR. Cosmetics ? Who knows...

Blijdorp bought wish.com for pennies and sold it off
at a much higher price. He seems like the person who
only does the big stuff. And Wolgen is greedy. Will
Blijdorp and Wolgen pull this off by 2022 ? I think
they have a plan, and that it may work. It’s frustrating that
we are left to guess but the contours of their plan
are in sight.

The only thing that worries me is a possible acquisition of
another company or product. I hope they won’t go
down that route.

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FarmaZutical
Posted on: Dec 9 2019, 07:34 PM


Group: Member
Posts: 584

One of the clinical trials that I have been most
interested in throughout the years is
CUV011 with 200 participants aimed to evaluate
Scenesse in AK/SCC in organ transplant recipients.

https://clinicaltrials.gov/ct2/show/NCT00829192

It had an end date in 2012 but results were never reported.
I’ve wondered for a long time if it was classic Clinuvel behavior
burying bad results or if there was indeed a strategic reason
for not reporting.

The principal investigator was / is Günther Hofbauer and in this article from
December, 2014 he states, that “studies are currently underway,” suggesting that
the trial was ongoing at that time.

https://serval.unil.ch/resource/serval:BIB_...87D78D.P001/REF

With the renewed focus on DNA repair and general protection against skin
cancers the AK/SCC OTR trial could be a centerpiece, I think.

Was it a failure, was it a success, was it still ongoing in 2014, is it still ongoing
today, was it finished and just waiting to be published at the right moment ?
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FarmaZutical
Posted on: Dec 3 2019, 04:52 PM


Group: Member
Posts: 584

Yes, and we are still wondering.
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FarmaZutical
Posted on: Dec 2 2019, 03:44 PM


Group: Member
Posts: 584

I think the latest CEO letter is comical given the fact that we just had an AGM
which was the best stage he could have asked for. But did he step up and tell investors
what they could now expect after the great FDA hurdle has been overcome? No.

Shareholders have flooded Clinuvel’s feedback form with valid and reasonable
questions about the direction of the company but no clear
roadmap has been presented. Still, we’re offered only vague statements about
how immense an undertaking execution of the commercial plan will be.

Well, newsflash, execution is always though. But the reason why the share price
is plummeting is that shareholders have no idea about what execution will look like.
And, hence, they doubt it will happen.

If management had been more clear about when EPP will reach the US market, when
and how Vitiligo trial(s) will happen, what happened to the VP trial, OTC / cosmetics,
topicals and all other aspects of “execution,” then this latest CEO letter would not have
been needed and shoring would have been something we would laugh at. Sadly,
the CEO letter brings no clarity so the share price can continue the downwards spiral.

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FarmaZutical
Posted on: Nov 16 2019, 07:36 AM


Group: Member
Posts: 584

Clinuvel - Qui audet adipiscitur
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FarmaZutical
Posted on: Nov 9 2019, 07:24 PM


Group: Member
Posts: 584

I think it’s appropriate to bend the truth in very few select situations.
Not handing secrets to competitors is one of them. But what the drug master file
suggests is a company that seems to have no
scrupules about releasing fictional statements only to cover their own
mistakes up. For a company that even resorts to Latin phrases to
tout their high ethical standards, it simply appears hilarious if it weren’t
so serious. Yes, they saved shareholders some paper money. But they
sold their soul. I can forgive a management that make mistakes. Everybody
does and it’s part of being a young company. But it’s simply outrageous
to cover them up if you’re trying to appear MORE ethical than other companies.

I applaud management for getting us to where we are now. But I don’t think there are
many excuses for how it happened. On this board, many have trashed the FDA but
now it’s clear for everyone to see, that the FDA has in fact carried Clinuvel on its back in the
interest of patients in need. Grave mistakes were forgiven because US patients
we’re already flying to Switzerland and the FDA didn’t want more delays.

On the positive side, we have a drug that is so miraculous that the FDA is willing to
forgive a whole catalogue of mistakes in order to get it to marked. But I think it’s
fair to ask, whether a more professional management team wouldn’t indeed have been
able to obtain the same ? In any case, and I think this is very crucial going forward,
I see absolutely no justification for the ludicrous gifting of extra shares to the CEO after
having read the master file and cross referenced it with the public statements that we
have been presented with over the past years.

I think it’s time for the company to live by the ethical standards they
claim to promote. Stay humble, be sincere and never get greedy.
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FarmaZutical
Posted on: Nov 7 2019, 05:14 PM


Group: Member
Posts: 584

If you send this to the company, make sure your get an acknowledgement of receipt.
Many letters to IR seem to go into a spam folder.
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FarmaZutical
Posted on: Nov 6 2019, 05:28 PM


Group: Member
Posts: 584

I have no doubt, everything that is submitted through the online form is sent directly to
a spam folder. I think the only way of getting
their attention right now is through the outgoing chair.
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FarmaZutical
Posted on: Nov 6 2019, 03:38 PM


Group: Member
Posts: 584

Clearly, there has been a bigger than usual push back against the
enrichment plan this time. Otherwise the new chair wouldn’t have
had to write that bizarre letter.

I have unanswered letters on Mr. Bull’s desk and I know that goes for
other shareholders as well. IR is a sham and the company in general
despises shareholders. None can afford not investing in Scenesse
and eventually I think they will get it right. But it’s tough to
endure the blatant discontent they have for retail.

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FarmaZutical
Posted on: Nov 3 2019, 05:27 PM


Group: Member
Posts: 584

The incentives plan is starting to get public attention.

This guy has 32,000 followers.

If you have tried to engage with IR or others about your
concerns, what’s your experience ? My experience is, that
emails are even left unanswered or get arrogant
replies that are of no use at all.

As for the recession clause, I does think it warrants an
actual revolt.



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FarmaZutical
Posted on: Oct 31 2019, 03:45 AM


Group: Member
Posts: 584

This is a post by CUV101 of Hotcopper. It reflects my sentiment exactly.

“ Lets look at those other goals and events along the way.

PC1 - The $7.5B target is for appearance only, 100% of performance rights can be granted without getting anywhere near this target, if there is a recession in US or Aus, then Clinuvel share price outperforming a biotech index (of the boards choosing) by 9% will replace this $7.5B target - quite different. Market cap may even go down!

PC2 - Having cash in the bank. OK, its good and sensible but it hardly encourages R&D and/or spending on growing the company.

PC3 - Buying another business that generates revenue. NOT profit. CSL did it years ago and it worked well for them so it must be a good idea. I’d be happy with this if it was based on a more objective assessment of value to Clinuvel.

PC4 - Performance rights for US sales is not performance. It has already been approved, it has already been reimbursed by US insurance companies for US patients getting treated in Europe for the same price! Also more rights for 10% growth in second year! Pretty easy to achieve when you control the speed of year 1 rollout!

PC5 - OTC launch and $250,000 in sales. This launch was promised to us previously with a launch date given, this was delayed due to supplier issues (was this a lie?). Now they want performance rights to reward their missed promise.

PC5 - First topical melanotropic formulation tested on animals. “Formulation work has commenced and Clinuvel expects the first formulations to be available for clinical testing in Q1 2011.” this quote is from 2010! It was again promised in the 2020 vision at the 2018 AGM, with a study to be completed mid 2019! Once again Clinuvel are being rewarded for non performance over a long period of time.

PC5 - Paediatric formulation, probably fair enough

PC6 - Vitiligo (or any other indication) development. The previous US vitiligo trial reported 2012. 7 years of preparation for this one. Performing trials and meeting with FDA is sort of what the company is supposed to be about.

PC7 - TGA filing - 212,500 rights for approval in Australia. For an Australian company to get approval with TGA AFTER EMA and FDA this is not an extraordinary effort, in fact it is a slam dunk. It will also bring little, if any revenue to Clinuvel as PBAC will be unlikely to recommend reimbursement.

PC8- 116,250 at the Boards’ pleasure- exceptional and unexpected performance.

Look, I think the granting of these performance rights to Wolgen and senior management with such soft conditions is weak. Wolgen has already been granted around 7% of the company, worth over $100M at todays share price. He has consistently been the highest paid Biotech CEO in cash terms on top of this. However, shareholders are all in the money and that is what he is ultimately there for so good on him. If all of these soft performance rights were substituted with a single hurdle of market cap of $4-5Billion in three years then good luck to them all (I think that this will happen). But there is no way they should be approved in their current form. I’d probably be happy if they added a performance condition for engaging with retail shareholders, rather than just ignoring us. Blijdorp’s letter today was bizarre.”
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FarmaZutical
Posted on: Oct 30 2019, 08:30 PM


Group: Member
Posts: 584

If I were Clinuvel, I would pay very much attention to the push back against the performance rights. And I would ask
myself if there could be more to it than just shareholders being opposed to handing out free shares.

Basically, if I distance myself from the past 14 years as an investor, I have no issue with Wolgen
being compensated handsomely for a job well done. I do agree with JohnnyH, though, that the
recession clause is a slap in the face. But could I support the rest of the package without further ado ? Yes I could.
He gets rich - I get rich. Not a problem.

I do think there is more to it, though.

If Wolgen and the company in general treated shareholders with more respect, I think they could get away with
a lot more without having to endure negative posts on ShareCafe.

But years of shady PRs, timelines not kept, rewriting of history as Frogster also mentions,
burying of trial results when it suits them, arrogance towards retailers and an IR department that doesn't
answer basic questions adds to a general resentment towards the company. EVEN in a situation
where they could be lauded as heroes for obtaining FDA approval and basically doing everything we ask of them.

It all comes down to attitude.

If long time shareholders felt more appreciated, I think they could get us to vote for a corporate yacht.

I would vote yes, because it's obviously the easiest way to motivate Wolgen in a time where we still need him.
But it doesn't FEEL right.

If I were them, I would show shareholders a little more love.
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FarmaZutical
Posted on: Oct 30 2019, 09:17 AM


Group: Member
Posts: 584

No, I don’t know. I’m not very well versed in TA so I was just
asking someone who might know what usually happens with a gap like ours.


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FarmaZutical
Posted on: Oct 29 2019, 05:54 PM


Group: Member
Posts: 584

I only know basic TA but what is the educated guess about the $28 gap. I read that
9/10 gaps are closed. Will this be the case here as well before we head up ?
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FarmaZutical
Posted on: Oct 26 2019, 06:25 AM


Group: Member
Posts: 584

I agree. But I think it will happen in 3 years. I don’t really think they
want to take the company private, although it would spare
them of having to deal with us. I just don’t see how they could
go to Nasdaq either. They have never liked retail and they want to
still be able to bury stuff. Like what happened to the mysterious
cosmetic like that actually had a launch date and then was delayed
due to supplier issues. That was almost 2 years ago. There might be
a good explanation for them lying, but lying is just a bad concept when
you’re Nasdaq listed.
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FarmaZutical
Posted on: Oct 26 2019, 04:46 AM


Group: Member
Posts: 584

They would have to comply with all sorts of rules and they would have to treat shareholders
very differently. I’ll bet you that they won’t list on Nasdaq at all. I think the chance of them
taking the company private is bigger than an uplist to Nasdaq.
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FarmaZutical
Posted on: Oct 25 2019, 05:13 PM


Group: Member
Posts: 584

Since the company doesn’t recognize CLVLY holders as actual shareholders
and hence won’t grant us access to an AGM or let us wote, I went through the hassle
and bought a few thousand CUV.AX to be part of the real family. Now, it seems
that I need a SRN number to access Compushare. I have no written communication
with the company regarding my buy nor a certificate. Only my the shares electronically
in my online account. Does anyone know how to get the SRN number? IR is a waste of time.
Thanks

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FarmaZutical
Posted on: Oct 23 2019, 06:45 PM


Group: Member
Posts: 584

I’m curbing my enthusiasm. A Type C meeting takes 3 months and another month until the
minutes are released. And I sincerely doubt that they will be able to
treat the first US patient this year. Perhaps a few of the
fly-in patients from Switzerland but that doesn’t really count. And I don’t even
expect that to happen.
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FarmaZutical
Posted on: Oct 22 2019, 07:30 PM


Group: Member
Posts: 584

The same was the case in Norway, where Clinuvel didn’t file the required
documents for more than a year. Helse Bergen, the EPP center at the regional hospital,
had to initiate the appraisal unilaterally.

Now, it seems Denmark is about to evaluate Scenesse, but Clinuvel isn’t
involved in this process, either. If it didn’t seem so crazy,
I would say that it looks from the outside as if Clinuvel is
deliberately stalling reimbursement in various EU countries.

As stated here before, it’s probably because they’ve been too busy
taking about the incentives plan for the CEO.
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FarmaZutical
Posted on: Oct 19 2019, 01:42 AM


Group: Member
Posts: 584

The fluctuating share price also annoys me but I try not to pay attention to it since it is irrelevant
to my long term plan.

Some thoughts about XP:

If new clinical trials were unethical in EPP, I think clinical trials in XP
would be even more unethical, since a randomized placebo controlled
trial would cause cancerous lesions and great pain among the patients in the
placebo arm.

I think, Clinuvel was waiting for EPP approval to advance XP without a
regular phase 3 but rather an accelerated approval or breakthrough designation
with surrogate endpoints and a post marketing phase 4.

In fact, I think it would be very unethical not to provide Scenesse to the 3-400
known XP sufferers in the US, now that it’s approved.

Hailey Hailey would be pretty easy to advance through a normal phase 3
and obtain a label extension. But not XP.


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FarmaZutical
Posted on: Oct 16 2019, 11:18 PM


Group: Member
Posts: 584

It's interesting to go back and read previous statements. At this stage, I think the chair's January 2018 letter is interesting:

"At this critical point in time the Board considered it absolutely essential to persuade our Managin Director to sign one final employment agreement to prepare the company
for a handover by 2021"

- so I reckon this newly signed agreement is the final final ?

"Clinuvel will attract a wider audience in 2018, not at least by diversifying its product offerings to new markets (...) Clinuvel will launch its premiere non-pharmaceutical product lines under private label.
These dermatological products will be complementary to Scenesse."

- So will Clinuvel manufacture a product for another company who will then launch it under private label, og will Clinuvel launch a product from another
manufacturer under private label ? If they launch a dermatological line under the Clinuvel name, that's not considered private label. And if
the won't market it under the Clinuvel name, how will it then benefit the general Clinuvel brand ? In any case it's not clinical.


https://www.asx.com.au/asxpdf/20180111/pdf/...rc9jg0q1s5d.pdf
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FarmaZutical
Posted on: Oct 16 2019, 10:04 PM


Group: Member
Posts: 584

The questionnaire is outdated since they sent it out. I
hope Clinuvel is supplying the HAS with the same
efficacy data, that the FDA relied on in their approval.

Clinuvel ought to shout it from the rooftops.
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FarmaZutical
Posted on: Oct 16 2019, 03:34 PM


Group: Member
Posts: 584

This is a stab in the dark since there are so many variables. My numbers a probably way off but still
it should be obvious, that Vitiligo would be extremely profitable for the company either way.

Here are my thoughts:

Prevalence is app. 50 m. world wide.

Let’s assume that the price per implant drops significantly. Let’s use $2000 and 4 required implants in the combination therapy that’s $8000 per patient.

With app. 3.200.000 Vitiligo sufferers in the US let’s say that 5 % in total (mainly FP IV & V) would want to use Scenesse in combination with narrowband UVB.
Let’s assume half of that target population can actually pay for the treatment.

That’s 80,000 patients yearly and $640,000 m. in revenues.

After taxes and expenses we would have have app. $450 m. and using a 25 P/E (because at that
stage we’d still be a growth company with other indications being developed) that’s
$11,2 bn. market cap and $229 pps. Use a very conservative 10 P/E and and the pps is $92 based on
Vitiligo alone. My numbers may be off but they do point in a direction and they could also be way too low.
Uptake could be slower but at a higher price. And this is US only.

Now, Vitiligo is also a way to get the lotions to market. A lot of “cured” Vitiligo patients will probably
require the Singaporean lotion Chivere of Tsumoyle as a maintenance therapy. That’s added revenues but
also a way to get the lotions out there and eventually to a broader market.

PW once talked about how he is inspired by Malcolm Gladwell’s book “The Tipping Poin” and
I believe Vitiligo would take us very close to exactly that. Once the price is lowered, we are treating patients
in the thousands, label extensions are sought and hopefully granted, the EPP core business is expanded
substantially in both EU, USA and Japan, off label is happening and lotions are about to hit the market,
then we are a totally different company and talking a pps in the hundreds.

EPP alone is much more interesting than I expected some years ago.
With the news efficacy data I don’t see why we shouldn’t be able to reach
2000 patients in fairly short time once we have both EU and US up and running.
Down the road that could double. 2000 patients x $15,000 per implant x 4,5
implants per patient (average) x 0,7 x 25 P/E / 49 m. s/o = $49 pps.
That’s for 2000 patients.

Put in your own numbers and play around with the models. In any case
I’ve never been more optimistic than now. The next 5 years will be fun.
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FarmaZutical
Posted on: Oct 16 2019, 05:38 AM


Group: Member
Posts: 584

Miami based doctor (www.drresnik.com) says he
will advocate for Scenesse off label for Vitiligo.


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FarmaZutical
Posted on: Oct 15 2019, 04:17 PM


Group: Member
Posts: 584

Thanks for sharing. A few points from PW that I note:

- Photo protection for the general population. EPP is only a proof of concept.

- 4500 EPP patients in Europe and the same in the US.

- Slow growth in Europe but a lot more to come


PW is eloquent and sharp. But the big question is, does he
use the implant or one of the new lotions? His tan is amazing.
Scenesse doesn’t affect grey hair, though. Our CEO does
look older.
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FarmaZutical
Posted on: Oct 13 2019, 02:50 PM


Group: Member
Posts: 584

I think you numbers are reasonable, but to reach 1500+ patients in the US, many will have to be diagnosed first.
There are app. 500 known EPP patients in the US today as far as I understand and I expect a swift uptake in most of
this population. Awareness will rise and more patients will probably be diagnosed over the coming years but I don’t think
we can expect 1000 patients right off the bat. However, I think 6 implants are likely in the US.

UK has app. 350 known EPP patients and if NICE surrenders I’m expecting around half of them to be
eligible for Scenesse during a managed access agreement unless the new PASS data gives us a better
QALY measure and full access. I think 3-4 implants will be maximum in rainy Britain.

My expectation is that we will reach 1000 patients treated in Europe soon.
NICE will have to accept the new efficacy data, and the Scandinavian countries
will follow. Denmark, Norway, Sweeden have app. EPP 100-150 eligible patients in total.
Germany will continue to grow and probably reach 500 patients treated soon.
Currently, only 4 patients are treated in Austria but the Ombudsman has requested
broader access so maybe we can get to 30-40 patients there, too. Switzerland and
Italy will also expand and The Netherlands are probably already maxed out. France is evaluating Scenesse for reimbursement as we speak. Spain could also
deliver 100+ patients. This is my short term base scenario for Europe. 1000+ patients at an average of
3 implants which results in US$45 m. revenues.

Add the 3-400 patients who I think we will be treating in the US within a year and we
have minimum 1300 patients of whom 300 will be getting up to 6 implants. Let’s assume the US patients will
be granted reimbursement for 5 implants in average and that’s US$ 22 m. per year short term.

So my most conservative estimate is US$ 67 m. in revenues short term which would result in
US$ 25 pps with a 25 multiple which I find reasonable.

After FDA approval Clinuvel is de-risked and the rest of the pipeline should also begin to
get some option value. Today, I don’t think Vitiligo, lotions, Enfance, XP or any
other aspect of Clinuvel than EPP in the EU or US is being given any value at all.

Australia and Japan as imminent targets for EPP should at least be given a risk weighed
value of something. Especially Japan is huge. When we are fully up and running in
Australia and Japan my EPP numbers double !

And if we move into one or two phase 3 trials for Vitiligo, the market will have to
begin seeing some value here, too. Vitiligo could be an enormous for the company and
even with 20 % risk weighted value being ascribed to Vitiligo today that ought to
add US$ 200 m. to our market cap. Imagine if we were a pre approval company with ONLY
Vitiligo but good results in Phase 2 and now moving into Phase 3. Such a company
could easily be trading at a market cap of 200 m. We have FDA approval for the drug
now so Vitiligo expectations has to begin adding some value, soon. And then there is the
rest of the pipeline.

My best estimate of fair value today is US$ 35 pps. which corresponds with
Sphene and Moelis’ 12 month targets of AU$ 50-58.

If all stars align and we get a move on, I think US$ 100 pps. is
possible within 2-3 years. When I dream, I see the company being acquired
at that stage at a 100 % premium which would give me an easy exit at US$ 200.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 04:09 PM


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No mentioning of the VP trial that was supposed to begin last spring. But they are working on a strategy.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 04:06 PM


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Now mentioning acquisitions. Could happen tomorow or take time. But they are scouting.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 04:02 PM


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Maybe it was a stretch. But that's how I decided to hear it.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 04:01 PM


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WOLGEN:

Topicals ready for clinic in a year.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 03:56 PM


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Wolgen:

NICE:
We won the NICE appeal, but NICE has not responded. But I'm confident that we will combat NICE through a review.

VITILIGO:

We are now seeking a Type C meeting with the FDA
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 03:55 PM


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Wolgen extending a heartfelt and warm thanks to long term investors. That's us, girls.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 03:52 PM


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Wolgen:

Reinitiate Vitiligo development in USA. News in the next weeks. Regulatory and ethics clearance are being sought as we speak.

Singapore is key to organic growth. News at the AGM

Expanding the company without spending extravagantly
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FarmaZutical
Posted on: Oct 9 2019, 01:57 PM


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So just a quick re-cap:

No restrictions on numbers of implants prescribed per year. So 6 is possible.
Calls for a new valuation of the US market.

EMA will probably follow and allow 6 implants, too, soon.

No draconian PASS obligations in the US but Clinuvel seems to
actively want to copy the European setup. Probably because it
adds tremendous value through the new data that’s collected.

Australia and Japan will follow. Partnership for Japan ?

Clinuvel will intensify communication with the FDA and EMA about
new indications (per Wolgen). Swift label extensions ? VP / XP ? New trials ?

We are debt free and have a pile of cash so watch out for
Vitiligo trials soon.

Cosmetics ?!? Bring them on. I’m buying.

Pediatric / ENFANCE. Hopefully soon. And it will add two
years to the market exclusivity.

NASDAQ ?

NICE capitulation. With the FDA basing approval on the Phase IV
efficacy data, NICE will have to re-calculate their QALY for Scenesse
and start reimbursement. France, Norway and all other reluctant countries, too.
6 hours ?!? Wow.

Acquisition of a new product or a company ?

New chairman soon.



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FarmaZutical
Posted on: Oct 9 2019, 06:10 AM


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Double post. But still happy...
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 06:10 AM


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Incredibly happy tonight. For the EPP community, my friends and family who bought in, my kids and myself of course. And for
everybody who has been and still is part of the journey. Wolgen and Co., the ShareCafe community, Uho, investors around the
world who stayed the course.

This is a historic day.

Now we can move on to all the fun stuff. Growth. And to treat more people
in need with this truly amazing drug.

Congrats all.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2019, 12:27 AM


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Probably no need to exhaust your index finger spanking that F5 key.
I think we will hear it first from Clinuvel.

Good luck everybody.
Attached thumbnail(s)
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FarmaZutical
Posted on: Oct 7 2019, 06:23 PM


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Posts: 584

A few thoughts about the incentives:

(i) Unless this covers XP and not VP, Wolgen will probably be cashing in on this one pretty soon
if they did begin the VP trial as announced. However, we don’t know because they stopped
talking about it.

(II) So they were ready to launch the cosmetic line more than a year ago
and then suddenly encountered supplier issues (per Wolgen in a news letter)
which led to a “delay.” We haven’t heard anything about this alleged
supplier let alone a new launch date. Hence, they are lying about the supplier issue
and now Wolgen will be compensated for doing what he was supposed to have done
more than a year ago. This is probably the biggest red flag I have ever
seen in my time as an investor.

(III) Hopefully this is one of the Singaporean lotions progressing to In Vivo.

(IIII) Here they talk about a license or collaboration agreement. Not regulatory approval. Are they
contemplating not going it alone in Australia and Japan ?

Where is Vitiligo ? Why wouldn’t Wolgen want to cash in on Vitiligo progressing
to phase III, positive result of a phase III or even lodging an NDA ?


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FarmaZutical
Posted on: Oct 4 2019, 04:20 AM


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Sorry. Wrong link. Here’s the right one:

https://www.parlament.gv.at/PAKT/VHG/XXVI/I...name_749847.pdf

Page 77
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FarmaZutical
Posted on: Oct 4 2019, 01:09 AM


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4 patients are currently being treated with Scenesse in Austria.
The ombudsman asks that more patients be included.
25-60 patients could benefit from Scenesse in Austria.

Page 73

https://volksanwaltschaft.gv.at/downloads/e..._20190321-2.pdf
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FarmaZutical
Posted on: Oct 3 2019, 02:41 PM


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In the meantime at Clinuvel: Let’s retweet this 🤦🏼‍♂️

https://twitter.com/juliaskripkaser/status/...0772244480?s=21

https://twitter.com/juliaskripkaser/status/...8291781639?s=21
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FarmaZutical
Posted on: Oct 2 2019, 05:12 PM


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“Nothing materially has changed in our outlook,” writes Dr. Wright. The company has a very clear picture of the odds for approval at this
stage, and they are still expecting a positive outcome.

If the FDA changed the PDUFA date due to problems that could lead to
a CRL, Clinuvel would know, and it would be criminal to communicate the opposite.

I was hoping for an early approval this week, but it seems the FDA needs all the time it
can get to get ready. So my best bet is, we will know Tuesday afternoon around 5 PM EST US.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 27 2019, 04:39 AM


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Posts: 584

Press release from the hospital that treated the young guy:

http://www.ouh.dk/wm517270

Google Translate:

First Danes treated for rare photosensitivity
  Joachim - patient with EPP (private image)
Joachim, aged 18, suffers from the very rare disease Erythropoietic Protoporphyria (EPP) - a form of photosensitivity that causes him pain and can damage his skin if exposed to sunlight. As the first Dane, he is now undergoing a completely new treatment at the Skin Department at OUH, and it has opened up new possibilities in his life.
He has always been driven to school with special solar film for the panes, and he has spent school hours in the darkest corner of the classroom behind a screen or closed curtains. Outdoor sports and family trips have only been possible when it has been cloudy or dark, and the attire has always consisted of long sleeves, gloves and a cap.
Throughout his life, 18-year-old Joachim has been used to protecting himself from the rays of light. He suffers from the rare disease EPP, where the skin does not form its natural protection from light. Too much sunlight - even through windows and car windows - means that he suffers pain that disappears only after several days of isolation in the dark at home.
- I can feel when my limit on how much light I can tolerate has been exceeded. The skin starts to burn or swell. Then I know I have to stay in the dark for days before it disappears and I can withstand the light again, Joachim tells and continues:
- Even the light from fluorescent lamps is a problem, although it affects me less than the sun. That's why we've always had to turn off all the light at home when I've got too much. It has sometimes made it really difficult to look after the school.
Now Joachim, as the first Dane, has been given a whole new treatment at OUH. The treatment helps the skin in his cells produce the natural protection from the rays of light so that he can better tolerate them. It has opened up new opportunities in the 18-year-old's life.
- I've always had to cover myself and have never been able to stand in the sun for more than a little hour, and then it has had consequences afterwards. Now, for the first time in my life, I've been playing golf in the sun for three hours in a row. It's a great experience when you've only tried it in the evening in cloudy weather, covered in cap and long sleeves, says Joachim.
Already started in kindergarten
Joachim has been influenced by his light sensitivity pretty much all his life. It really started when he started in kindergarten and came out more and play. Here, the parents quickly discovered that something was wrong.
- We quickly saw a reaction as he began to come out more: His skin swelled up and it hurt him. We got him examined for everything from allergies to cancer, says Joachim's father, Dennis, and continues:
- Fortunately, we came to the Skin Department at OUH, where they found out his diagnosis when he was five years old. Others with the disease have waited much longer before finding out what they were suffering from.
 
EPP Treatment Skin Division I

First in Denmark with brand new treatment
Now Joachim, as the first EPP patient in Denmark, has received a completely new treatment at the Skin Department and the Center for Hereditary and Complex Diseases (CAKS) at OUH.
The treatment consists of an implant with the drug afamelanotide, which is placed under the skin. The drug causes the skin cells to form more pigment, which is the body's natural protection of the skin and the effect lasts for a few months.
You can have a maximum of four implants in one year, and Joachim has managed to get two treatments in June and August this year respectively.
- With the treatment here at the end of August I am covered until the end of October, and then hopefully I can manage the winter without too much trouble. Just that not too much sun or snow comes to reflect the light. Then I hope I can have the next treatment as early as March, when the spring sun quickly becomes a problem, says Joachim.
The limit is still there
The new treatment has pushed the limits of how much light Joachim can withstand, significantly. But even though the medication helps Joachim's body protect the skin cells from the light, his sensitivity to light is not completely gone.
- When we were vacationing in France, I was out for a few hours for a few days in a row, and there I hit the border, so I had to take a few days before doors. So my sensitivity to light is still there, but my limit to what I can tolerate has really moved, says Joachim and continues:
- Now I know some completely different things than before. When I have been given too much light, it will not take so long in the dark until I am ready again. I can still be a little scared to go outside, so I just have to get used to it being okay and of course learn where my boundary now goes. But the medicine has really opened up some new possibilities that I have to try now.
 
About the disease Erythropoietic protoporphyria (EPP):
Erythropoietic protoporphyria (EPP) is a rare genetic disease that causes intolerance to light. The sensitivity to light causes prickly pains in the skin when exposed to especially sunlight. Sustained exposure to sunlight can lead to burning pain, redness and swelling of the skin. Ultimately, it can result in skin forming wounds, thickened skin and scar tissue.
The disease becomes active when patients have two special gene defects. There are less than 100 sufferers in Denmark, which is an extremely rare disease.
EPP is one of several porphyria diseases that can be studied biochemically and genetically at OUH, which houses the national Porphyria center. There are other porphyria forms with skin symptoms, while there are also variants that provide acute attacks with symptoms from the abdomen or nervous system.
 
 
Treatment against EPP at the Skin Department at OUH

The first treatment of EPP in Denmark
The skin department at OUH has treated the first Danish EPP patient with the drug afamelanotide. The drug works by stimulating the production of melanin, which is a natural pigment that protects the skin from the phototoxic reactions to sunlight. Afamelanotide is placed under the skin as an implant having a shelf life of approx. two months.
OUH became aware of the possibilities of the new treatment through the Skin Department's research network and the positive results from a number of clinical trial studies, which include is published in the reputed medical journal New England Journal of Medicine. This led to the first treatment of a Danish EPP patient, which was performed by the departmental doctor Nieves Puente de Pablo at the Skin Department at OUH.
- We have several potential candidates for the treatment, which have not yet been marketed in Denmark. After applying to the Regional Medicine Council, we were given the opportunity to treat the first Danish patient with afamelatonide, and we hope to soon be able to offer the treatment to more patients, says Professor at the Skin Department Anette Bygum.
The Skin Department collaborates with the Center for Hereditary and Complex Diseases (CAKS) at OUH and is part of the PREmedico collaboration, which focuses on personalized medicine at OUH and SDU.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 27 2019, 04:28 AM


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Posts: 584

Danish EPP patient gets Scenesse.

https://www.tv2fyn.dk/artikel/nu-kan-han-ta...ynsk-behandling

Google Translate:

Joachim has lived his life in the dark: now he can withstand the sun - thanks to new fun treatment
18-year-old Joachim from Funen suffers from a rare disease that makes him unable to tolerate light. Now he is the first in Denmark to receive special treatment at OUH, which has given him the sun back in life.

Listen to the article
Listen with ReadSpeaker

Focus
 
18-year-old Joachim has lived in the dark all his life because of extreme light sensitivity. Now new treatment can get him out in the sun again.
Sep 24, 2019, 7 p.m. 11:37

JANNE NYENSTAD
Journalist
Imagine that you could only practice sports in the evening when it was dark.

That you always had to sit for rolled-up curtains when you were in school or sitting in a car.

The skin starts to burn or swell. Then I know I have to stay in the dark for several days before it disappears
Joachim, 18-year-old patient with EPP
Or you had to turn off all the light at home because even a fluorescent tube could cause you unbearable pain in the skin.

This is how life has been for 18-year-old Joachim from Funen. He suffers from the disease Erythropietic Protoporphyria - or EPP, which is a very rare and extreme form of photosensitivity.


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The skin swells
- I can feel when my limit on how much light I can withstand has been exceeded. The skin starts to burn or swell. Then I know I have to stay in the dark for several days before it disappears and I can withstand the light again, Joachim tells in a press release from OUH and elaborates:

WHAT IS ERYTROPOITIC PROTOPORFIRE?

Erythropoietic protoporphyria (EPP) is a rare genetic disease that causes intolerance to light. There are less than 100 sufferers in Denmark.
The sensitivity to light causes prickly pains in the skin when exposed to especially sunlight.
Sustained exposure to sunlight can lead to burning pain, redness and swelling of the skin. Ultimately, it can result in skin forming wounds, thickened skin and scar tissue.
- Even the light from fluorescent lamps is a problem, although it affects me less than the sun. That's why we've always had to turn off all the light at home when I've got too much. It has sometimes made it really difficult to look after the school.

The disease causes Joachim's skin to not form its natural protection from light, as with us. This means that even sun rays through a car window can cause Joachim pain in the skin.

Golf in the sun for the first time
But now, OUH has found a treatment that can help patients like Joachim.

He is the very first in the country to have received the new treatment that helps the cells produce the natural protection from the rays of light so that he can withstand being outside. Even when it's bright.

- I've always had to cover myself and have never been able to stand in the sun for more than a little hour, and then it has had consequences afterwards. Now, for the first time in my life, I've been playing golf in the sun for three hours in a row. It's a great experience when you've only tried it in the evening in cloudy weather, covered in cap and long sleeves, tells Joachim to OUH.


Joachim gets an implant with a drug under the skin. It causes his skin to form more pigment. Photo: OUH press

Joachim is still light-sensitive, but the treatment has pushed his limits significantly on how much light he can withstand, he says.

- Now I know some completely different things than before. When I have been given too much light, it will not take so long in the dark until I am ready again, says Joachim and continues:

- I can still be a little scared to go outside, so I just have to get used to it being okay, and of course learn where my boundary now goes. But the medicine has really opened up some new possibilities that I have to try now.


ALSO READ
Devoted to food section: Steffan and Line said yes among drop stands and cardiac devices

HOW DOES IT WORK?

The treatment consists of an implant with the drug afamelanotide, which is placed under the skin.
 
The drug causes the skin cells to form more pigment, which is the body's natural protection of the skin and the effect lasts for a few months.
 
You can have a maximum of four implants in one year, and Joachim has managed to get two treatments in June and August this year respectively.
Source: OUH / Skin Department and Hereditary and Complex Diseases Center (CAKS)
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FarmaZutical
Posted on: Sep 14 2019, 03:40 AM


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France:

https://www.facebook.com/172707952765628/po...2598102?sfns=mo
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FarmaZutical
Posted on: Sep 13 2019, 06:41 PM


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If Clinuvel hasn’t yet tried to recruit Abdel-Malek they should get on
with it now.

https://onlinelibrary.wiley.com/doi/abs/10.1111/pcmr.12823
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FarmaZutical
Posted on: Aug 29 2019, 09:30 PM


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Posts: 584

I have to admit that I was a bit disappointed to read about the three year extension of Dr. Wolgen.
As much as I respect him, I think it’s time for new leadership in Clinuvel. He has been
instrumental in getting the company where it is now, and it is a success. But others could have
done it, too, and going forward we need a CEO who knows how to commercialize drugs
large scale.

Also, I am tired of the continued communication screw ups and outright cover ups.
What happened to VP ? And the cosmetic line which even had a release date and then
delayed due to a “supplier issue” ? Does anyone believe this bogus explanation ? Does management
think we’re stupid ? It’s a classic Clinuvel thing: They announce something - we wait - deadlines
are missed - we wait - they either never talk about it again or they bury it in a
report as we just witnessed with the VP trial which apparently is not underway
as they had promised.

I appreciate that there are a lot of things they need to keep secret and we are not
better of with competitors knowing stuff they shouldn’t. But why on Earth do they
keep putting out teasers for alle these things, knowing that there is no way
they will follow through ? On the other hand, why do we keep getting
excited when they never meet their own deadlines ?

FDA approval is a big thing. But they keep messing up, and they can’t multi task.
Now, they want an enormous amount of new shares for staying on which means
further delays and new screw ups. I’d like to see a total separation of board and management and
new proven leaders taking over so we won’t have to wait another 14 years.
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FarmaZutical
Posted on: Aug 14 2019, 06:54 AM


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I don’t think Tsumoyle and Chivere are the OTC products. I believe, those are indeed CUV9900 and VLRX001.
But besides from that
the sudden burying of the OTC launch is another example of Clinuvel’s disastrous
communication strategy.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 30 2019, 05:41 AM


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Posts: 584

On Monday March 19 2018 Clinuvel filed a trademark application for
Tsumoyle.

https://trademark.trademarkia.com/ctm/tsumoyle-017877349.htm

On the same day, a Polish company, Uroda, filed a trademark application
for TSR No6 - Telomere Skin Repair.

https://trademark.trademarkia.com/ctm/tsr-n...n-017877331.htm

I have found no connection between the two companies and it could just be a coincidence.
But it’s peculiar nonetheless.
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FarmaZutical
Posted on: Jul 27 2019, 07:39 PM


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Good job. That makes sense 👍🏼
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FarmaZutical
Posted on: Jul 26 2019, 01:11 PM


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https://www.ncbi.nlm.nih.gov/m/pubmed/28017138/

Tsumoyle or how they decide to spell it clearly
refers to SUMOylation - perhaps with an Asian twist.

SUMOylation and deSUMOylation involves small ubiquitin-like modifier SUMO proteins - Sumoylation / Tsumoyle.

These processes have important roles in many cellular processes most importantly DNA replication and repair.

When it comes to our product it seems that Tsumoyle could be the topical that targets XP and skin cancer in general
ad the sumorelated pathways have for a long time been investigated as potential therapeutic targets.
Not only in skin cancer but in lots of different disorders.

Whilst it’s pretty obvious what they are trying to do with Tsumoyle,
I haven’t been able to figure out what the meaning of the name, Chivere, is.
Does anyone have an idea about what that could refer to ?
••••

The Role of Ubiquitination and SUMOylation in Telomere Biology
Michal Zalzman, W. Alex Meltzer, Benjamin A. Portney, Robert A. Brown and Aditi Gupta
DOI: https://doi.org/10.21775/9781912530120.16
Telomeres are a unique structure of DNA repeats covered by proteins at the ends of the chromosomes that protect the coding regions of the genome and function as a biological clock. They require a tight regulation of the factors covering and protecting their structure, as they are shortened with each cell division to limit the ability of cells to replicate uncontrollably. Additionally, they protect the chromosome ends from DNA damage responses and thereby, prevent genomic instability. Telomere dysfunction can lead to chromosomal abnormalities and cancer. Therefore, dysregulation of any of the factors that regulate the integrity of the telomeres will have implications to chromosomal stability, replicative lifespan and may lead to cell transformation. This chapter will cover the main factors participating in the normal function of the telomeres and how these are regulated by the ubiquitin and SUMO systems. Accumulating evidence indicate that the ubiquitin and SUMO pathways are significant regulators of the shelterin complex and other chromatin modifiers, which are important for telomere structure integrity. Furthermore, the crosstalk between these two pathways has been reported in telomeric DNA repair. A better understanding of the factors contributing to telomere biology, and how they are regulated, is important for the design of new strategies for cancer therapies and regenerative medicine.

••••

https://www.eurekaselect.com/148674/article

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FarmaZutical
Posted on: Jul 24 2019, 05:11 AM


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https://www.ema.europa.eu/en/human-regulato...g-authorisation
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FarmaZutical
Posted on: Jul 21 2019, 02:21 PM


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This guy:

https://www.marketscreener.com/business-lea...5M-E/biography/
  Forum: By Share Code

FarmaZutical
Posted on: Jul 4 2019, 05:27 PM


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I’ve looked at some of the past processes and it seems that 6 months from appeal
decision to final determination is a bare minimum. Unless they surprise us with a
decision this month, I expect we will hear something next year.

Even after the meeting, they have to write up everything before it’s made public and that takes
many months, too.
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FarmaZutical
Posted on: Jul 1 2019, 05:23 AM


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Posts: 584

I posted this on GG in 2014:

It turns out that the two founders who are listed as Mr. Kenny B HC and
Louis P Chow on the BLS website are in fact named Beh Hang Chwee and Phun Chow Liat Louis.

In fact, Phun Chow Liat Louis is very easy to find if you just Google "BioTech lab pte ltd"
Then his public LinkedIn profile comes up, where he states BioTech Lab as his current job. More about that later.

Biotech Lab Singapore incorporated somewhere around December 2013 and February 2014. Their website went live
February 2014 with the info it shows today. No changes have been made to the website.

When you read the two gentlemens resumes it's clear that at least one of the BLS directors, Mr. Kenny Beh, is a very
wealthy man. Mr. Phun must be too. I think Clinuvel wants to protect CUV9900s IP from a hostile Retrophin take over
in a new company called Vallaurix.

With the JV they gain access to the deep pockets of these two gentlemen, who might have heard about Clinuvel and the
potential of melanortins through Clinuvels Vitiligo trials in Singapore or at the conference recently. I choose to see the JV
as a wise move. If the two BLS founders actually do understand the power of CUV 9900 and if they are prepared to
pay for the trials needed to advance a topical lotion, then this deal could be very postive for shareholders. If this is
in fact a move by Dr. Wolgen to cash in by handing over some very valuably IP to a new company, Vallaurix, where he will be
overpayed as the new CEO while BLS just sit back and watch the billions roll in and existing CUV shareholders get nothing,
I will be very surprised. That's not Dr. Wolgens style nor is it what I believe our board to stand for.

Therfore, I believe we got two new significant holders through the JV. Only, they did not get shares the classic way. They
got a good part of the CUV9900 IP and in return they will fund some speedy trials. Quid pro quo and I believe that Clinuvel
got a good deal. The work needed for pediatric has to be done within a certain time frame dictated by the EMA. I believe
the reason why Vallaurix will be responsible for the pediatric dose is that Clinuvel wants BLS to fund it so that
the mothership, CUV, can focus on Vitiligo - which will probably require a second partnership - and thus, hopefully,
Clinuvel will be cash flow positive sooner rather than later. Again: A good deal for us.

It's easy to speculate about the JV and I'm looking forward to hearing what y'all think.

Here we go....

1) Beh Hang Chwee aka Kenny B HC aka Kenny Beh Hang Chwee
Director of BLS.

When I Google Beh Hang Chwee I get a hit on www.wilmar-interntional.com where
a Captain Kenny Beh Hang Chwee is listed as Group Head of Shipping:

Kenny Beh Hang Chwee
Group Head of Shipping
Captain Beh was appointed as the Managing Director of Raffles Shipping Corporation Pte Ltd in November 2008 and is responsible for the shipping operations of the Group. He is the CEO and founder of the Raffles Shipping Group of Companies which has since 1 November 2008 become a member of the Wilmar International Group. He is currently a member of the Singapore Nautical Institute as well as a member of the Singapore Institute of Arbitrators.

This info about Mr. Hang Chwee Beh is pulled from businessweek.com:

Captain Hang Chwee Beh, also known as Kenny, serves as the Group Head of Shipping at Wilmar International Limited. Mr. Beh served as Managing Director of Raffles Shipping Corporation Pte Ltd.

This is some more general info about Wilmar pulled from Wilmars website:
Wilmar International Limited, founded in 1991 and headquartered in Singapore, is today Asia’s leading agribusiness group. Wilmar is ranked amongst the largest listed companies by market capitalisation on the Singapore Exchange.

Wilmar’s business activities include oil palm cultivation, oilseed crushing, edible oil refining, sugar milling and refining, specialty fat, oleochemical, biodiesel and fertiliser manufacturing and grain processing. At the core of Wilmar’s strategy is a resilient integrated agribusiness model that encompasses the entire value chain of the agricultural commodity processing business, from origination and processing to branding, merchandising and distribution of a wide range of agricultural products. It has over 450 manufacturing plants and an extensive distribution network covering China, India, Indonesia and some 50 other countries. The Group is backed by a multinational workforce of about 90,000 people.

Wilmar’s portfolio of high quality processed agricultural products is the preferred choice of the food manufacturing industry, as well as the industrial and consumer food businesses. Its consumer-packed products occupy a leading share in its targeted markets. Through scale, integration and the logistical advantages of its business model, Wilmar is able to extract margins at every step of the value chain, thereby reaping operational synergies and cost efficiencies. Wilmar remains a firm advocate of sustainable growth and is committed to its role as a responsible corporate citizen.

Kenny is also the Ugandan Consul in Singapore according to this site:

http://app1.mfa.gov.sg/pdf/dipconopen.pdf
(Page 296)

http://www.embassypages.com/missions/embassy15177/

2) Louis P Chow aka Phun Chow Liat Louis aka Louis Phun
Director, BLS

Louis Phun states BioTech Lab has his current job on his public LinkedIn profile. Also, he is the chariman of Empire Group, a Hong Kong bedding specialist: www.theoldempire.com

Mr. Phun is also the Managing Director for a bunch of other companies. This is his his public resume pulled from http://www.linkedin.com/pub/louis-phun/16/277/263

Louis Phun

Chairman Empire Group

Summary

A successful entrepreneur with a track record of implementing and monetizing innovative business solutions. A professional with a dense network in Asia. Relies on a strong managerial background with international exposure in manufacturing and distribution in luxury goods and services. Self-driven and follows through mid and long term targets, leads by example and has good interpersonal skills to motivate.

Responsible for successful running of all aspects of the business. Ensuring delivery of high quality projects always within time, cost and quality parameters.

KEY SKILLS AND COMPETENCIES

Having a robust and business-focused approach to running a company. Ensuring that everything works to the highest possible professional standards.
A charismatic but pragmatic leader.
Proven ability to identify new business opportunities.

Can maintain close relationships with external bodies, suppliers and clients.
An enterprising and creative thinker, with a commercial eye, exceptional financial acumen.

Experience

MD at BioTech lab pte ltd

December 2013 - Present (10 months) www.biotechlab.com.sg

MD at SG Properties Holding

January 2009 - Present (5 years 9 months) Chairman at Empire group of companies

January 2009 - Present (5 years 9 months)

2013 - Present
MD
Biotech Lab Pte Ltd

2009 – Present
MD
SG Properties Holdings Pte Ltd Land investment and Development

page1image13920 page1image14080
Page1

2008 – Present
Director
The Visionary Residences Pte Ltd
Construction and development of Luxuries Landed Houses

2006 – Present
Managing Director
Luxe Lifestyle Pte Ltd
Supply and Manufacturer of Interior and Outdoor Furniture

1999 – Present
CEO Asia Pacific
Mitch & Marc Asia
Manufacturer of Luxuries Leather goods and watches
Manage and hold master distribution rights worldwide for Mitch & Marc Australia Travel Retails and Duty Free Industries

1994 - Present
Managing Director
The Old Empire Pte Ltd
Manufacturer , Wholesale, OEM of beddings products for International companies in Middle East, South East Asia , Europe. Hotels Supplies.

MD at Luxe Lifestyle Pte ltd

January 2006 - Present (8 years 9 months)
CEO Asia Pacific at Mitch & Marc Australia

June 1999 - Present (15 years 4 months) M D at THE OLD EMPIRE

July 1994 - Present (20 years 3 months)

  Forum: By Share Code

FarmaZutical
Posted on: Jun 25 2019, 11:40 PM


Group: Member
Posts: 584

PTN falling like a lead coated rock with an elephant sitting on it. Now below $1 / - 18 %y
  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2019, 06:10 AM


Group: Member
Posts: 584

I don’t expect NICE to make anything public until maybe October or November.
First they will hold the meeting in July. Then they will write up
a FED which seems to could take up to 5-6 months. First then is the decision public.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 20 2019, 03:23 PM


Group: Member
Posts: 584

Yes. And I’d much prefer investors looking to take some profit do it now
instead of waiting for the high volumes FDA approval will generate.
Potentially, I think this will make us stronger and perhaps avoid
a “sell the news” scenario.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 18 2019, 05:48 AM


Group: Member
Posts: 584

I honestly don’t know and I have to question whether they actually do
manage the company as competently as you say. It could also be a mix
of luck and perseverance. Wolgen is extremely competent and meticulous but I’m not that
sure about some of the other key personnel. Is it Wolgen writing the communiques
himself ? Probably. But why does he then choose to mislead investors time after time ?
I have no answer. The only thing I have to trust, is that he must have a reason and that
his interests are aligned with mine. The peculiar and probably false explanation about
the cosmetic line and an alleged supplier issue bothers me. I have no doubt that he’ll
get things done, but I’d like to not be taken as a fool while we wait.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 16 2019, 12:07 AM


Group: Member
Posts: 584

As everybody here, I’ve made a nice profit but I’m very binary about this investment. I’m not selling anything at this
moment because I know I’d hate myself for not seeing my original plan through.
I’m not worried about the FDA and I believe we will see a lot of new
initiatives being made public soon after approval. Yes, they never ever
live up to their own timelines and, yes, they bury stuff. What ever happened with
the cosmetic line that was delayed due to a supplier issue ? That kind of
misleading statements, I don’t like. But I’m sure they will eventually get
things done and Wolgen’s interests are very much aligned with ours.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 15 2019, 10:40 PM


Group: Member
Posts: 584

Sphene Capital has done a very thorough evaluation that I mostly agree with.
But I’ve posted my own back of the envelope calculations here many times and I’m
happy to do it again. IMO we’re not overvalued in any way.

I expect NICE to come back with some sort of positive final determination.
GB is is app. 400 patients.

Germany is expanding, Holland is fully online, Austria a few patients and it seems
France could come online soon. Add at least 4-500 patients in the US very quickly
after FDA approval and we’ll be treating app. 1,500 patients within the next year or so.
Clinuvel seems to already factor in 6 implants in the US (per the latest presentation) and
they are trying to expand in the EU as well. Conservatively, I will use 4 implants
in my calculation.

1,500 patients x US$ 64,000 per year = US$ 96 m. revenue / US$48 m. earnings x 25 ratio = 1,2 b. / 49 m. s/o =
US$ 24,4 pps.

This is very conservative.

Here, NOTHING else is part of the valuation. Not 6 implants, not EPP in Australia and especially Japan, not a risk weighed
valuation of any of the other indications, nor the topicals, Enfance, OTC or especially Vitiligo.
Other companies with prospects less promising than Clinuvel and with no approved products
on the market can have higher valuations just based on hopes and dreams.




  Forum: By Share Code

FarmaZutical
Posted on: Jun 11 2019, 11:54 PM


Group: Member
Posts: 584

Clinuvel seems to already factor in 6 implants per patient per year.
In the Jefferies Healthcare presentation they have US$96,000 as
health economic impact. That’s US$16,000 per implant.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 8 2019, 03:54 PM


Group: Member
Posts: 584

Great job. I’d buy one. I also thought about setting up a web shop
with Frilly Wear but I was unsure if it would be a trademark / logo infringement.

Made this cap.
Attached thumbnail(s)
Attached Image


 
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FarmaZutical
Posted on: Jun 5 2019, 04:22 PM


Group: Member
Posts: 584

I’m not that worried about the 3 months extension of the PDUFA and I’m still confident
Scenesse will be approved this year. I’m sorry for all the US patients that will have to
endure more pain, though.

I think the biggest problem right now is trust. I’m in this stock mainly because of two
factors: The product and the CEO. Trust is everything and I still
have a lot of respect for Dr. Wolgen - and I do trust him. But his
style when communication with shareholders is a real problem and
is increasingly wearing on my trust. I know there is only so much you
are at liberty to say, when discussing FDA matters publicly. But throughout
the years we’ve had so many ambiguous PR’s and weird rants that
I’m getting suspicious when they send out statements. That’s a shame,
because, basically, I still trust him. Otherwise, I would sel my shares
and buy a big boat or two.

If Clinuvel doesn’t change course and start sending out clear PR’s
they will leave the company vulnerable to short attacks and hit pieces feeding
on the uncertainty aimed to take the company down once we’re NASDAQ listed.

The SEC won’t tolerate the current state of affairs and, certainly,
the US investors won’t.

I wish Wolgen would adopt a straight shooter attitude. Fewer words, more
clarity, more trust.


  Forum: By Share Code

FarmaZutical
Posted on: May 29 2019, 09:15 PM


Group: Member
Posts: 584

I’m still here. Very busy at work but not planning on early retirement anytime soon 😉.
I still plan to hold on to my shares and be part of the next chapter of this amazing journey.
EPP is just the beginning IMO and for me it’s not only about the money, it’s also about the
journey. Because we’ve been her for so long it’s easy to see FDA approval
as an end goal, but to me it’s merely the beginning. I’m very thankful that I discovered
this company more than a decade ago and that I spent thousands of hours
researching every aspect of it. And it brings me joy to read about fellow investors
who are now able to alter their lifestyle and live their dream. If I’ve contributed
a bit throughout the years, I’m very happy. Thanks to everybody here as well.
Ok. Enough sentimentality. We’re not half way there yet.
  Forum: By Share Code

FarmaZutical
Posted on: May 14 2019, 12:00 AM


Group: Member
Posts: 584

I know. Tried for a long time but it was a pretty lonely party.
Perhaps we could all re post SS posts there to get it started.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 24 2019, 06:40 PM


Group: Member
Posts: 584

I haven’t even noticed I was approaching that milestone :-) Thank you so much.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 24 2019, 06:24 PM


Group: Member
Posts: 584

I agree. It now seems reasonable to assume that Clinuvel is in the absolute final stages of
approval. We will probably see a safety registry comparable to the European
setup under the EMA. Clinuvel is not in the business of pumping the share price up
via overly enthusiastic PRs so this letter from the chair gives me great confidence that
they are not only on track but also about to reveal a bunch of new initiatives some of which
we have been waiting for for a long time. The falling share price is annoying but I really don’t care much.
I’ve never had two digits as my final exit target anyway.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 21 2019, 10:57 PM


Group: Member
Posts: 584

Clinuvel isn’t able to communicate which post-marketing requirements the FDA has now decided on. It’s an
ongoing process and Clinuvel now has to commit to the requirements - if any. In the final NDA approval letter
the FDA will list the requirements and remind Clinuvel that they have accepted them.

Post marketing requirements come in many variations. It can be new clinical trials with specific emphasis on efficacy,
PK or safety. I highly doubt we will be asked to carry out any new trials.

In the EU we committed to a PIP and the Singaporean lab is working on that.
The FDA will also require a pediatric plan and this will probably be outlines in
the post marketing requirements.

The EMA set some strict rules in the PASS. It’s an open question if the FDA will require
a similar registry. If they do, it will be part of the post marketing requirements and we will learn about it
in the final app letter when it’s published online or directly from Clinuvel.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 8 2019, 10:26 PM


Group: Member
Posts: 584

Is the focus on Krabbe Disease on Twitter random or will we see a new indication soon ?

Krabbe is a severe neurological condition. It is part of a group of disorders known as leukodystrophies, which result from the
loss of myelin in the nervous system.

From http://stm.sciencemag.org/content/8/362/362ra146 :

“In inflammation-associated progressive neuroinflammatory disorders, such as multiple sclerosis (MS), inflammatory infiltrates containing T helper 1 (TH1) and TH17 cells cause demyelination and neuronal degeneration. Regulatory T cells (Treg) control the activation and infiltration of autoreactive T cells into the central nervous system (CNS). In MS and experimental autoimmune encephalomyelitis (EAE) in mice, Treg function is impaired. We show that a recently approved drug, Nle4-D-Phe7–α-melanocyte–stimulating hormone (NDP-MSH), induced functional Treg, resulting in amelioration of EAE progression in mice. NDP-MSH also prevented immune cell infiltration into the CNS by restoring the integrity of the blood-brain barrier. NDP-MSH exerted long-lasting neuroprotective effects in mice with EAE and prevented excitotoxic death and reestablished action potential firing in mouse and human neurons in vitro. Neuroprotection by NDP-MSH was mediated via signaling through the melanocortin-1 and orphan nuclear 4 receptors in mouse and human neurons. NDP-MSH may be of benefit in treating neuroinflammatory diseases such as relapsing-remitting MS and related disorders.”
  Forum: By Share Code

FarmaZutical
Posted on: Apr 1 2019, 07:14 AM


Group: Member
Posts: 584

His timeframe is over optimistic but his numbers are not insane.

A quick back of the envelope calculation (mid term):

2000 EPP patients (EU + US): $ 120 m.

2000 EPP patients Japan (5000 total): $ 120 m.

VP: about the same numbers as EPP

500 XP patients (EU + US): ~ $ 50 m.

4000 XP patients Japan: $ 360 m.

Vitiligo: Estimated 300k Fitzpatrick V / VI sufferers in the US.
10 % penetration = 30k patients per year x $ 5000 per treatment: $ 150 m.
(This one is tricky and I’m very conservative here)

Cosmetics: No clue

Total: ~ $ 1 bn. X 0.75 x 25 P/E / 48 m s/o = US $ 390 pps

That’s roughly 23 x today’s pps.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 17 2019, 08:29 AM


Group: Member
Posts: 584

Delete
  Forum: By Share Code

FarmaZutical
Posted on: Mar 17 2019, 08:29 AM


Group: Member
Posts: 584

Nothing wrong with FCK
  Forum: By Share Code

FarmaZutical
Posted on: Mar 15 2019, 02:36 PM


Group: Member
Posts: 584

I expect it will take at least 4 weeks. In the meantime, NICE will probably
post the ECD on their homepage while consultées provide their input.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 14 2019, 03:41 AM


Group: Member
Posts: 584

Evaluation consultation document (ECD) if produced

The Evaluation Committee makes its provisional recommendations in the ECD. An ECD will be produced only if the recommendations from the Evaluation Committee are restrictive. A restrictive recommendation will be one that is more limited than the instructions for use that accompany the technology. Consultees and commentators have four weeks to comment on the ECD. The ECD is also made available on our website so health professionals and members of the public can comment on it.

Final evaluation determination (FED) produced

The Evaluation Committee considers the comments on the ECD if produced, then makes its final recommendations in the FED on how the technology should be used in the NHS in England. Consultees can appeal against the final recommendations in the FED.

Guidance issued

If there are no appeals, or an appeal is not upheld, the final recommendations are issued as NICE guidance.

SOURCE: https://www.nice.org.uk/about/what-we-do/ou...logies-guidance
  Forum: By Share Code

FarmaZutical
Posted on: Mar 13 2019, 11:50 PM


Group: Member
Posts: 584

I still don’t think we should expect a final decision at the upcoming NICE meeting.
The agenda shows that they will discuss and agree on a new Evaluation Consultation Document (ECD).
This document then needs to be sent out to stakeholders for comments so I reckon we will
have to go through numerous meetings before we have a final outcome.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 8 2019, 06:38 AM


Group: Member
Posts: 584

Fair point. Perhaps the March meeting will indeed be final. Fingers crossed for a positive outcome no matter what.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 8 2019, 06:16 AM


Group: Member
Posts: 584

NICE update. The next meeting will not be final. Another meeting is already scheduled for April 11th.

https://www.nice.org.uk/event/hstec-march-2019

Highly specialised technologies evaluation committee meeting

14 March 2019

NICE, Level 1, City Tower, Piccadilly Plaza, Manchester, M1 4BT

Final agenda
The meeting will start promptly at 10:00 and is expected to finish at approximately 15:00

Please note that this agenda is final and is subject to change before the meeting.

  1. Welcome and introduction to format of meeting – Part 1 only (open session)
  2. Code of conduct for members of the public attending the meeting – Part 1 only (open session)
  3. Apologies – Part 1 only (open session)
  4. Any other business – Part 1 only (open session)
  5. Evaluation of Afamelanotide for treating erythropoietic protoporphyria [ID927]
    5.1. Declarations of interest – Part 1 only (open session)
    5.2. Introduction by the Chair, Dr Peter Jackson– Part 1 only (open session)
    5.3. Presentation by the Chair, Dr Peter Jackson – Part 1 AND part 2 (open and closed session)
    5.4. Agreement on the content of the Evaluation Consultation Document (ECD) – Part 2 only (closed session)
To print an agenda, please right click and select 'Print' from the menu.


Date, time and venue of next meeting
The next meeting will take place on Thursday 11 April 2019 at 10:00am, at NICE, Level 1A, City Tower, Piccadilly Plaza, Manchester, M1 4BT

Please note all timings are approximate.



  Forum: By Share Code

FarmaZutical
Posted on: Mar 2 2019, 06:26 PM


Group: Member
Posts: 584

I agree. It’s painful.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 1 2019, 11:48 PM


Group: Member
Posts: 584

Another solid report. Great Work, Peter. However, the numbers on page 5 don't seem to be correct.

Total EPP market is estimated to have 4,443 patients in the US and 500 in Asia / Australia. My numbers indicate that it's actually the other way around.

Japan's population is 126 m. and an EPP prevalence of 4:100.000. That's app. 5000 EPP patients in Japan. Australia's population of 24,6 m. (great people) should result in 100-200 EPP patients. In the US, i expect app. 600-1000 patients based on the official numbers and how many known patients the Porphyria centers are currently treating.

It doesn't change the final and total market volume but IMO the regional numbers are not correct.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 26 2019, 11:52 PM


Group: Member
Posts: 584

No. EPP alone is worth far more once Europe, US, Australia and Japan are up and running.
VP and XP x 2 and even though still in the works those indications are not even reflected risk weighted in
the current share price. Same goes for Vitiligo. I’d consider selling for US $100 today. Maybe.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 19 2019, 04:08 AM


Group: Member
Posts: 584

I sincerely believe Delaney is Wolgen
  Forum: By Share Code

FarmaZutical
Posted on: Feb 14 2019, 11:22 PM


Group: Member
Posts: 584


FDA Helps Streamline Approval Process for Supplemental Drug Indications

By Margot J. Fromer
December 25, 2017

ADVERTISEMENT

Get Permission

As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients.

The U.S. Food and Drug Administration (FDA) has been making efforts over the past several years to expedite drug approvals. How to streamline the review-and-approval process and, in turn, create more and better treatment options for patients was the overarching question posed recently in a panel discussion at the Friends of Cancer Research Annual Meeting held earlier this year in Washington, DC.


We need constant updates about how drugs and devices are performing, and we need to incorporate more real-world evidence into the regulatory process.
— Scott Gottlieb, MD

Tweet this quote
FDA Commissioner Scott Gottlieb, MD, said the agency and all its stakeholders have to think differently about how to apply regulations to new products. “We need constant updates about how drugs and devices are performing, and we need to incorporate more real-world evidence into the regulatory process.”

He added that the FDA’s Oncology Center of Excellence, headed by Richard Pazdur, MD, is applying new ways of thinking about drug development and regulation. The Center attempts to expedite oncology and hematology drugs and devices and to support an integrated approach in their clinical evaluation. “We have a dynamic regulatory environment,” said Dr. Pazdur. “There’s lots of back and forth with sponsors.”

What Happens to a New Indication

Every time a biopharmaceutical company (as a “sponsor”) seeks approval of a new indication for an already-approved drug, the FDA requires a supplemental new drug application (NDA) that consists of the same quality and content as the drug’s original new drug application. Its review and assessment are similar to the original dossier, but the process may not add much value to what the agency already knows about the drug’s safety and efficacy.


We have a dynamic regulatory environment. There’s lots of back and forth with sponsors.
— Richard Pazdur, MD

Tweet this quote
Panel members agreed that the wealth of high-quality data amassed for the original new drug application, plus what has been learned from postmarketing experience, should be considered when the drug is presented to the FDA for an additional indication.

How to Accomplish the Goals

George D. Demetri, MD, Quick Family Chair in Medical Oncology, Dana-Farber Cancer Institute, noted that the FDA approval is the gold standard for drugs all over the world. “We want to preserve that position while at the same time expand what that approval means and how it is accorded.”

George D. Demetri, MD
George D. Demetri, MD
More and more approved drugs are being used in multiple indications, and increasingly, supplemental new drug applications are being submitted using an intermediate endpoint as clinical benefit because the need is so critical.

“A supplemental new drug application can entail either a regular or accelerated approval,” said Amy McKee, MD, Supervisory Associate Director, FDA Office of Hematology and Oncology Products. “The agency may now grant full approval to a supplemental new drug application using an intermediate endpoint on a case-by-case basis. One reason is because we weigh the urgency of an unmet clinical need.”

Amy McKee, MD
Amy McKee, MD
For example, said Dr. McKee, daratumumab (Darzalex) was first approved for multiple myeloma in November 2015; a supplemental new drug application for another indication showed similar response rates, resulting in a second approval 1 year later—and a third only 7 months after that. “We were very comfortable with the speed at which all this happened. All the approvals were based on excellent response rates or progression-free survival.”

The panel discussed a framework that could analyze the characteristics that have led to full approval of drugs based on intermediate endpoints for a new indication.

Shanthi Ganeshan, PhD, Vice President and U.S. Head of Oncology Regulatory Affairs, Novartis, listed the benefits of using intermediate endpoints for drug approval: It streamlines and systematizes the process; there may be no need for confirmatory studies; preclearance for promotional materials is not necessary; and it encourages more supplementary applications.

Unmet Clinical Need

Urgency for filling a medical gap is a primary reason to approve a new indication. That is, how serious or life-threatening is the disease in question? How rare is it? What are the current treatment options, and how effective are they?

Shanthi Ganeshan, PhD
Shanthi Ganeshan, PhD
For example, a single-arm trial of the combination of daratumumab with pomalidomide (Pomalyst) and dexamethasone resulted in its approval for patients with refractory multiple myeloma who had received at least two prior therapies including lenalidomide (Revlimid) and a protease inhibitor such as bortezomib (Velcade). Of patients in the study, 89% were refractory to lenalidomide and 71% were refractory to bortezomib, with 64% of the group refractory to the combination of those two drugs. These patients were about out of treatment options. However, 59% of patients in a single-arm trial of the daratumumab-based combination achieved a response, with a median duration of 13.6 months, demonstrating a significant efficacy outcome.

Natural History of Disease

Understanding the natural history of a specific disease is critical when attempting to expand the use of an approved drug in a new setting. New molecular technologies can help in this effort because genomes, epigenomes, and transcriptomes can be unique to a single tumor type or shared across several tumors driven by the same or related pathogenic mechanisms.

For example, multiple oncogenic driver mutations and rearrangements have been identified in lung cancers and are currently targeted with different therapies, such as kinase inhibitors that have produced greater clinical benefit than platinum-based chemotherapy.

Drug Actions in Different Diseases

To expand a drug’s use, one must understand its pharmacokinetics, pharmacodynamics, and interactions with other drugs—as a single agent and in combinations. For example, dabrafenib- -(Tafinlar) and trametinib (Mekinist) are kinase inhibitors that modulate two independent targets in a particular pathway. Together they have been successful in treating BRAF V600–mutant metastatic melanoma and metastatic non–small cell lung cancer (NSCLC). However, when the combination was used in BRAF-mutant metastatic colorectal cancer, it conferred a poor prognosis and only a modest response rate, according to the panel.

Thus, although the mechanism of action of these kinase inhibitors was well understood and efficacy had been demonstrated in previous controlled trials, a more detailed preclinical investigation of the drug’s pharmacodynamics and tissue-unique mechanisms of resistance showed how the drugs performed in a new indication.

Safety Issues

Supplemental new drug applications require sponsors to submit a safety profile in the new population as well as provide comparisons with previously approved indications. A supplemental new drug application is more likely to be approved when safety data mirror the original indication, thus demonstrating that the drug behaves similarly in both settings.

Dabrafenib and trametinib, used in combination, was granted full approval in metastatic NSCLC, in addition to metastatic melanoma, in part because of the similar safety profile observed in both diseases. ■
  Forum: By Share Code

FarmaZutical
Posted on: Feb 13 2019, 04:38 PM


Group: Member
Posts: 584

Liaison Manager
Leatherhead 12/02/2019 (11:35) Just Added Randstad Strategic Accounts
Apply Now Liaison Manager - Pharmaceuticals

Location: Leatherhead, Surrey

Job Type: Permanent

Salary: £35,000 per year

We are seeking a Liaison Manager to help facilitate the post-marketing distribution of SCENESSE across Europe.

They will be required to oversee the end-to-end delivery of SCENESSE to patients under an agreed post-authorisation safety study protocol as well as identifying new potential opportunities for the company.

They will require skills in clinical trial logistic, knowledge of specific markets (including linguistic skills) and the ability to maintaining existing, and build new relationships with expert treatment centres.

Purpose of the role:

* Manage the contacts with external customers in order to facilitate the European distribution of SCENESSE.

* To facilitate delivery and training logistics for SCENESSE post marketing.

* To maintain awareness of SCENESSE through liaison with KOLs worldwide.

Knowledge:

* Knowledge of European Healthcare Systems, structure and decision making processes.

* Experience/knowledge of orphan drugs.

* Maintain current awareness of ethical, health economic and regulatory requirements.

* Interest in the pharmaceutical development and related business issues: anticipation of future industry trends and opportunities.

* Research skills - ability to source information and to review and summarise scientific literature.

* Ability to analyse, interpret and present scientific data.

* Report writing skills.

* Attention to detail.

* Language skills - German is a bonus.

Qualifications:

* University degree - scientific/ pharmaceutical.

Randstad Business Support is acting as an Employment Agency in relation to this vacancy.
Type
Permanent
Start Date
01/03/2019
Contract Length
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FarmaZutical
Posted on: Feb 3 2019, 09:35 PM


Group: Member
Posts: 584

I hope, the FUD comment wasn't aimed at me. And if it was aimed at Helse Bergen, I sincerely doubt that a public hospital in Norway is in the business of creating FUD through PR. The reason why I find their PR disturbing is because of Clinuvel's history of non-disclousure. France could in fact have rejected Scenesse without us knowing it. I don't think thats realistic, though, so the PR from Helse Bergen was probably just based on wrong info. I wish Clinuvel would keep us informed about which countries they are negotiating with and what the negotiations result in. That would prevent all the uncertainty.

Regarding the many poephyria centers throughout Europa and wether Scenesse can be purchased there. Clinuvel has to train the staff at each individual center and certify them. I don't think a Spanish or Swedish EPP patient can just purchase treatment out of pocket at their regional center as long as Clinuvel hasn't trained the staff, and why should they bother doing so before the national reimbursement is up and running ? Patients can travel to Switzerland and pay out of pocket - that we know for sure.




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FarmaZutical
Posted on: Feb 2 2019, 02:49 PM


Group: Member
Posts: 584

PR from Helse Bergen concerning the Norwegian NO to Scenesse.
It claims that Sweden, France and the UK have also rejected Scenesse for reimbursement which
puzzles me. UK we know about, but Sweden and France?!? It also claims that the only
countries where Scenesse is available are Holland, Switzerland and Italy which is not true,
so perhaps they are generally misinformed. I don’t like the prospects of France saying no, though.

https://helse-bergen.no/nasjonalt-kompetans...ei-til-scenesse

No to Scenesse
The health trusts do not want to cover the costs of the drug Scenesse. Norwegian patients with EPP must therefore not use this medicine which is the first of its kind for this patient group.
Published 31.01.2019
Last updated 31.01.2019


Thumbs down


Too little effect and too expensive
In the Norwegian Medicines Agency's report, which forms the basis of the decision in the Decision Forum, it appears that in clinical studies it has not been possible to show that the treatment increases the time one can spend outdoors to a sufficient extent. Nor does one find a marked increase in quality of life.

Both individuals who have used the drug and clinical experts have stated that the drug may have benefits that cannot easily be demonstrated in the type of study design used here, but this can be difficult to emphasize in such an assessment process.

The total cost of using Sceness, ie three implants per year and administration costs is estimated at NOK 415,000 per patient per year (excluding VAT) and the treatment has not been found to be cost-effective compared to poorly documented effect.

Like many other countries in Europe
Health trusts in several countries in Europe, including Sweden, England and France, have made similar decisions and will also not cover costs for treatment with Scenesse. So far, this preparation is only available for use in Switzerland, Italy and the Netherlands.
New opportunities ahead of time
If new information about patient safety, cost-effectiveness, price, similar products or otherwise comes, the decision-making forum can reconsider the application.

Studies in progress
Everyone who is currently being treated with Scenesse must be closely followed up on their country's porphyry center. Both the therapist and the patient must record the effect and side effects in a common European database.

The timing for the publication of the first results from this database is unknown, but it is allowed to hope that good effect of the drug can be shown here so that a refund can be sought again.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 1 2019, 05:44 AM


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And Norway is not budging one bit. They’re basically saying that Clinuvel is opportunistic, cherry picking and untrustworthy.
If it weren’t for those 40 Norwegian EPP patients who will be left in the dark, I’d say screw Norway.
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FarmaZutical
Posted on: Jan 27 2019, 05:38 AM


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“Don’t let the melanocortin denier get under your skin”
- Old Chinese Proverbs
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FarmaZutical
Posted on: Jan 20 2019, 10:09 PM


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While we wait for news about all the exciting stuff thats going on, I'm especially looking forward to XP hopefully being announced as the new indication. IMO XP could be much bigger than most may think. Prevalence is very significant in Japan with app. 5000 sufferers from this horrible disease, and once Scenesse is approved by the PMDA for EPP it probably won't take much to obtain regulatory approval for XP or even reimbursed off-label use. In the US, I think XP is a very good candidate for breakthrough designation once EPP is approved and the first XP trial underway. But Japan could be a game changer faster than we expect.





Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.
Shimazawa R1, Ikeda M.<h3 style="-ms-zoom: 1;">Author information</h3>1Graduate School of Biomedical Sciences, Nagasaki University, Japan. r-shima@nagasaki-u.ac.jp
Abstract

BACKGROUND:
Although approved elsewhere, many drug indications remain unapproved in Japan. Many of these unapproved indications are off-label, which, despite strong supporting evidence, are not covered by the Japanese health insurance system. To address this situation, the Ministry of Health, Labour and Welfare of Japan announced in 1999 that, under certain conditions, it would approve a new supplement for a drug indication without clinical trials. This approval scheme involved application evaluation using literature-based evidence; however, the type of indications and the kind of evidence used in practical applications remain to be clarified.


OBJECTIVE:
This commentary sought to investigate the factors that contribute to the approval of individual applications through an analysis of review reports and to assess the outcome of efforts to facilitate the approval of off-label drugs by this approval system that has been used for over a decade in Japan.


METHODS:
Data from 80 approvals granted under this scheme were obtained from the official review reports of the Japanese regulatory agency. The following criteria were selected for the analysis of individual applications: review time, therapeutic class, application category under Japanese regulations, international approval status, postapproval monitoring plan, and variety and quantity of literature evidence. The literature used as a source of evidence was categorized into 4 types: (I) standard textbooks, (II) standard guidelines, (III) reviews, and (IV) application dossier submitted to the foreign regulatory authorities.


RESULTS:
The number of approvals and applications per year showed no consistent trend. The median (SD) review time was 16.4 (9.0) months, which was not affected by the international approval status or the literature evidence. This approval scheme was applied to not only a new indication (56 applications [70%]) or dosage (9 [11%]) but also a new route of administration (13 [16%]). Of the 80 applications, 46 (58%) had been approved in the United States, the United Kingdom, or both; 11 (14%), in other countries; and 23 (29%), in no country. For 2 approvals, the review reports were not released; the other 78 were based on either standard textbooks or guidelines, while 67 (84%) were based on both. The variety and quantity of literature evidence provided in the application showed no consistent trend with respect to international approval status.


CONCLUSIONS:
Prior approval by foreign authorities, although important, did not appear to be essential for approval in Japan. However, substantiating safety and effectiveness of agents by means of standard textbooks or guidelines was used consistently to obtain approval for off-label use.




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FarmaZutical
Posted on: Jan 16 2019, 12:21 AM


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According to patient testimonies MT 7117 seems to have a positive effect with limited unwanted effects.
They are currently in phase 2 but apparently they are struggling to recruit.
I don’t like the competition but I think that once Scenesse is on the market in both the US, Europe and hopefully Japan,
there won’t be a huge need for MT 7117 and possibly they will never be able to recruit for a phase 3. If they do advance MT 7117 into phase 3
and if the get NDA approval it could hurt Clinuvel because an oral pill is so much more convenient.
But it won’t happen within the next 3-4 years and by then, hopefully, Clinuvel will have multiple indications and several products on the market.
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FarmaZutical
Posted on: Jan 15 2019, 09:54 PM


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PW will do whatever is in his power to prevent off-label and he should. Credibility is everything for Clinuvel and
right now they actually have it. Off-label use of Scenesse in a broader population right now is
not what we want. What I would like to see is a much more aggressive strategy pursuing new indications and label
extensions. I’d like to see partnerships for new indications, too.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 3 2019, 03:15 PM


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I think Clinuvel might be amongst the lucky few who are still in process but as this article describes there may
be aspects of the review that are struck by the shutdown anyway.


https://www.fiercebiotech.com/biotech/at-en...rnment-shutdown


We saw a major milestone in FDA approvals in 2018, but a political deadlock that led to a partial government shutdown before Christmas could take some of the shine off a golden year.

Scott Gottlieb, M.D., FDA commissioner and President Donald Trump’s pick for the job, took to Twitter over the holidays after the shutdown took effect on Dec. 22, showing those FDA staffers still turning up to work.

But he admits the ongoing political disagreements in Washington are hampering some drug review efforts, tweeting on Dec. 29: “Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can't collect FY 2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.”

In a thread, he added: “We have questions re: drug review work that’s not user fee funded and won’t continue during shutdown. CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under sec. 361 of the PHSA.

“2/2: For our Center for Drug Evaluation and Research this also includes pausing all OTC monograph drug activities. Only emergency work related to these products will continue.

“3/4 The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.

“4/4: However, new emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.”

According to the Alliance for a Stronger FDA, 59% (10,344) of FDA employees have been retained and 41% (7,053) furloughed during the shutdown.



On the question of how much of the drug and device product review programs will continue during this phase, the group mused: “The last number we saw, perhaps a year or two ago, is that about 30% of the drug review process is paid for by appropriations. Therefore, logically, some part of the drug review process will not continue during a shutdown. The same would be true of devices, except that a larger percentage of the costs are paid from appropriated funds.

“NDAs/BLAs/PMAs have their own product user fee. Companies that have filed and paid the fee can expect FDA to continue the review, even during a shutdown. [W]hile reviews continue, there is a risk that agency time frames may slip. Also, while we can think of no specific examples, it is possible that a product review could require some activity or input unavailable in the absence of appropriated resources. Additional insight can be gleaned from 2013 guidance.

“Based on past shutdown planning, products on which user fees have already been paid (e.g., NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown.”

‏The partial shutdown, which has continued into the new year, comes amid a political impasse over funding for the president’s wish for a wall that would run along the US-Mexico border.

With this political logjam, hundreds of thousands of federal employees have been hit, having to either take unpaid leave or not knowing when they will get paid. This includes Internal Revenue Service workers, customs and border staff, National Parks and housing department workers as well as those at FDA.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 2 2019, 05:35 PM


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But the pigment she was given back stayed for 3 years according to her statement.
That’s encouraging. It’s impossible that we will ever see 100 % repigmentation in all patients but this lady
regained 50 % and apparently it remained. My vitiligo patch on my left leg doesn’t bother me much, but
I would very much dislike having face patches so I understand why she’s happy about her result. Perhaps the
lotion will be beneficial in those areas where implant / nb uvb falls short in some patient.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 2 2019, 07:10 AM


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The lady says it herself:

https://m.youtube.com/watch?v=iqM0mKCFwcw
TC: 7:48

I simply found the old pictures from the trial to prove that it’s the same person.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 1 2019, 07:04 PM


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And the woman in the video was indeed treated with Scenesse if there was any doubt.

She is Case #3:
https://pdfs.semanticscholar.org/47ba/a489d...2488.1546332622

Note the pattern on her left eyelid.

So at least we know that this one person retained her color
3 years after being treated with Scenesse.
Attached thumbnail(s)
Attached Image

Attached Image



 
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FarmaZutical
Posted on: Dec 31 2018, 06:00 PM


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Article about the Vitiligo ph2:

https://pink.pharmaintelligence.informa.com...n-Patients-Wary

Happy New Year to all. 2018 was interesting, indeed. But I think 2019 might
be even more fun.
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FarmaZutical
Posted on: Dec 12 2018, 06:38 PM


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I actually hope we won’t hear anything from the FDA until sometime in January.
That would prove, that Dr. Wolgen was truthful and sincere in the newsletter where he
stated that Clinuvel didn’t receive an RTF. If the upcoming news coincides with the date
that - logically - would be the new day 74, it would disappoint me a lot.
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FarmaZutical
Posted on: Nov 28 2018, 08:00 AM


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I’m surprised it’s not March 2020.
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FarmaZutical
Posted on: Nov 25 2018, 06:31 PM


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Thanks a lot. We can’t know when Clinuvel applied for reimbursement in France but it seems that the average
time is 6 month for appraisal. April seems like a possible deadline unless they filed several months ago.
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FarmaZutical
Posted on: Nov 22 2018, 03:46 PM


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Interesting article that seems to apply to our situation related to the manufacturing issue and current FDA delay.
The good thing is that they discovered the issue now so we are not getting a CRL on that basis later.

https://cen.acs.org/articles/95/i20/complet...r-mail-one.html
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FarmaZutical
Posted on: Nov 5 2018, 03:12 PM


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This is probably the best written Clinuvel communique ever. Concise and easy to read as every PR ought to be.
Assuming that everything stated is true (the reason for the OTC delay seems odd) it actually answered all the questions
we have raised here. Most importantly, no RTF. It seems that Clinuvel together with possibly ICON answered all additional questions
and are now waiting for validation of the dossier if no further questions arise. I think we’re fine.

Bravo, Dr. Wolgen. And thank you.
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FarmaZutical
Posted on: Nov 1 2018, 04:07 AM


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Could be the case. Product availability is one of the FDA is looking at.
You need to be able to prove that you can deliver a stable flow of finished product
to the assessed patient population. Does anyone know what the production cost per implant is?
  Forum: By Share Code

FarmaZutical
Posted on: Oct 31 2018, 09:58 PM


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Those trials will only comprise a few handfuls of patients.
It would have to be something else, I think.
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FarmaZutical
Posted on: Oct 30 2018, 07:21 PM


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I’ll go back and re-listen Dr. Wolgens presentation at the Nasdaq online event to
be 100 % sure. I remember I said it there.
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FarmaZutical
Posted on: Oct 30 2018, 05:40 PM


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But will we get a clear answer to the question: “Was there a RTF or not?”
It takes a persistent investor to get an answer. Who’s going and who will do it ?
And who will be filming ?
  Forum: By Share Code

FarmaZutical
Posted on: Oct 30 2018, 05:16 PM


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This could be the case:

They decided to do an unjustified trade halt to get PR when they filed the last module of the NDA.
It would be very embarrassing and humiliating having to admit that the NDA was incomplete and that they received a RTF only weeks after.
Also, it would have jeopardized ASX300 inclusion at that time.

Therefore, Wolgen and Clinuvel lied about the real reason for the delay and they can’t dial the lies back now.

It would explain why they still expect the decision about Priority Review to be made after the FDA reviews
the requested info. Usually, that decision is made quite early in the validation period.

However, the company has also stated that they already delivered the additional information to the FDA and that they are now
waiting - and that the FDA has provided no additional timeline. That’s odd. Either they are lying or the FDA is handling their case
in a way that is highly unusual. My colleague who deals with the FDA told me that it’s not impossible that the FDA didn’t issue a RTF but it does seem very
strange. A normal company would issue a clear statement but all we get is misleading bs PRs in the form of eassays.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 29 2018, 03:40 PM


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What a nonsensical crap PR. Doesn’t serve any purpose.
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FarmaZutical
Posted on: Oct 29 2018, 07:33 AM


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What ever happened to the news about Vallaurix that was supposed to be know before annual report was out?
Boy, they really know how to mess up even the simplest communication task.
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FarmaZutical
Posted on: Oct 20 2018, 07:37 AM


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5 years aligns fine with HHD but my guess is that they are aiming for XP. Clinuvel want to establish themselves as leaders in optical physics and photo protection and HHD doesn’t fit very well in that branding strategy. They long term goal has always been to develop a general protectant against skin cancer. XP fits much better as a stepping stone to reach that goal eventually. HHD would be a lucrative opportunity short to medium term but in the long run XP is much more valuable because it adds to the strategy that began with EPP.

I think HHD will be one of the indications that will be perused down the road but first we need to build a portfolio that is narrowly dealing with photopeotection. Hence also the focus on OTC cosmetics.

Just my guess.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 18 2018, 07:05 AM


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I had a chance to discuss the possible RTF situation with a colleague who deals with the FDA all the time. He says it’s not common
to ask for additional data the way it’s happening now during the validation process. On the other hand, orphan and rolling cuts us some slack.
It seems there might not be issued an RTF and that the FDA is causing the delay - not Clinuvel. The FDA is overburdened right now and even
though Clinuvel filed the additional data the FDA may not have the capability to review it in a timely manner. That could be the reason for no RTF.
The bad news is that it can take months to review and validate especially the manufacturing process if the FDA found a small issue they want clarification on.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 16 2018, 06:51 PM


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Simply correcting the sloppy work by Rachel Jones in the first segment and article. They fixed the article
and erased the filmed segment. Normally, you would apologize and make the reader aware that the media
published false information. It seems these guys just bury it.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 13 2018, 04:27 PM


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That should be NO bylines.
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FarmaZutical
Posted on: Oct 13 2018, 08:17 AM


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I’m almost certain that Giles Delaney doesn’t exist. Any experienced journalist would show up in a Google search.
There are no articles by him anywhere. My bylines. Besides that the content on Clinuvel’s website is so weird. Clinuvel
should not be a MySpace for obscure journalists.
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FarmaZutical
Posted on: Oct 12 2018, 05:13 AM


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Clinuvel isn’t going to get a voucher. They might get priority review but that can’t be sold off.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 12 2018, 05:12 AM


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We should get drunk together some day. We could write a book :-)
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FarmaZutical
Posted on: Oct 12 2018, 02:18 AM


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I concur. But what puzzles me is that the chair even said that the recent request for additional data was “expected.” Why would they expect
an RTF ? Again, either they lie or there is a loophole in the rules that I haven’t seen applied before.

Also, they pulled a trade halt on us when they lodged the final module. Therefore, I would think
that it is a material event when they receive an RTF and hence something they are obliged
to communicate.
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FarmaZutical
Posted on: Oct 11 2018, 11:04 PM


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I’m very puzzled about this, as well. Logically, Clinuvel received an RTF and will have to re-file.
However, during the presentation the CEO said that the FDA would decide on a PDUFA “shortly.”
The way the company has presented the delay does not at all infer an RTF.
Either the company is disingenuous, which wouldn’t be the first time, or the FDA
is bending a lot of procedural rules to accommodate Clinuvel.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 10 2018, 01:48 AM


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In any case, I expect the reassessment to take between 8-12 months so we might even be past FDA PDUFA before hearing anything from NICE again. American EPP patients are likely to get access to Scenesse well before British sufferers.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2018, 04:44 PM


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Which is why it makes perfect sense with Mr. Blijdorp as our future chair:

“Being recognised for his expertise in merger and acquisitions and leadership, in 2014 Mr Blijdorp was awarded the Ernst & Young Entrepreneur of the Year in the Netherlands.”

They want Wolgen to stay on till 2021. What happens in 2021 ? (Cue drumroll).
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2018, 02:03 PM


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On the positive side I think this one is significant:

“it was unreasonable for the committee to state that the trial results show small benefits“

However, some of the other important appeals were dismissed.

It’s great that some of the appeals were upheld and that it now goes back to the NICE committee,
but will it be enough to change the outcome? I don’t know.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2018, 01:53 PM


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NICE appeal decision:

https://www.nice.org.uk/guidance/gid-hst100...appeal-decision

Conclusion and effect of the appeal panel’s decision
121. The appeal panel therefore upholds the appeal on the grounds IPPN 1a.1, CLINUVEL 1b.1, IPPN 1b.1, BAD 2.2, BAD 2.3, IPPN 2.2. The appeal is dismissed on all other grounds.
122. The evaluation is remitted to the evaluation committee who must now take all reasonable steps to address the following issues:
i) The failure to include an IPPN representative at the second committee meeting (IPPN 1a.1).
ii) The failure to demonstrate adequate consideration of the legal duties and obligations placed on it as a public authority under the Equality Act (CLINUVEL 1b.1 and IPPN 1b.1). The appeal panel considers that this is likely to include express consideration of whether the methodology used in the evaluation discriminates against patients with EPP and if so what reasonable adjustments should be made.
iii) The appeal panel's conclusion that it was unreasonable for the committee to state that the trial results show small benefits with afamelanotide (BAD 2.2 and 2.3, IPPN 2.2).
123. There is no possibility of further appeal against this decision of the appeal panel. However, this decision and NICE’s decision to issue the final guidance may be challenged by applying to the High Court for permission to apply for a judicial review. Any such application must be made within three months of NICE publishing the final guidance.
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FarmaZutical
Posted on: Oct 1 2018, 01:34 PM


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Choosing VP as the new orphan indication is a brilliant move. I was expecting XP, but this makes much more sense from a business perspective.
First, they will use the established framework of the EPP centers in Europe to conduct the trial(s). Likely, they will do the same in the US for the pivotal
phase 2/3 or 3 that will follow the initial 2a. This is less costly and scientifically easier than stating all over in XP where they have
no network yet. If they follow the same strategy, they will probably initiate XP trials in Japan once Scenesse
is approved for EPP there in a year to two.

Also prevalence is much higher for VP than in XP. VP = 1:100.000 (much higher in South Africa) and XP 1:1.000.000.
That gives us at least app. 6000 patients in Europe and 3000 in the US. 15.000 in South Africa.

They will dose VP patients every 28 days mirroring the dosing cycle in treating Vitiligo. It seems they plan to use
the data collected during the upcoming VP trials to also support the future NDA for Vitiligo. Smart move using synergies.

Even if they cut the price per implant down to $6000 that’s a very significant business case. We don’t know how many implants
they plan to administer yearly to VP patients but let’s assume 6 to be conservative.

Uptake will probably be fairly high since there is no alternative, so let’s assume we can treat 4000 patients in Europe and 2000 in the US
which is probably still conservative.

6000 patients paying 6000 USD 6 times a year = 216 m. USD. In my book that represents <60 USD pps. Add South Africa and that number
explodes but I will leave that out for now. Also, they may not lower the price per implant at all and then my numbers double (!).

Add EPP at the new lower price per implant administered 6 times a year (which is probably coming up) to 3000 patients coming up
and that’s 108 m. USD = < 30 USD. Add Australia and Japan and the number is even higher.

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

The FDA and EMA are very likely to approve an sNDA and I expect the best possible scenario is a PDUFA for VP sometime in 2021 but
already now it should represent a risk weighted value of somewhere between 10-30 %. If they show good results in the phase 2a
which I expect they will the value will be higher also given the fact that the likelyhood of regulatory approval is extremely high for
a second indication.

At the current price per implant stand by my previous calculations and think that EPP is worth at least
50 USD in Europe and the US combined short to medium term. That number will go down if they lower the price per implant, of course.

I’d say that neither Vitiligo nor any of the other opportunities are reflected in today’s pps. Enfance, topicals etc. Right now, the pps
merely reflects the opportunity for EPP in Europe and we’re still on the very low side. VP ought to add a few Bucks today and 5-10 USD when the market realizes that it’s
a less risky endeavor than gaining regulatory approval for a new drug.

There’s still a lot of work to be done and it will be interesting to follow the work with VP and hopefully soon also Vitiligo.

My 12-18 months target is 50 USD. By then, we are either approved in the US or very close to be approved. VP trials
have hopefully been successful in Europe, the cosmetic line is underway, Vitiligo is revived, regulatory approval in Australia and
Japan is underway and Enfance for treating the pediatric population is hopefully also moving along.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 27 2018, 10:23 PM


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62 USD plus shares in the acquiring company.
The value of EPP in the US and Europe plus a 25 % premium.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 26 2018, 07:51 PM


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It says something about management’s shares being taken out of the calculation when determining the market cap neede for the ASX200.
Do you know more about this and if that changes anything for us ?
  Forum: By Share Code

FarmaZutical
Posted on: Sep 9 2018, 08:25 PM


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It seems Clinuvel deleted the two Facebook pages for Chivére and T’sumoyle.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 7 2018, 06:56 PM


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New investors and funds,

Welcome to the Clinuvel family. Now that we’re getting new cousins
as part of the ASX300, you might want to know some more about
us. This analyst report is the best way to get to know us:

http://www.sharescene.com/index.php?act=at...st&id=49929

Sincerely,

Uncle Farma
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FarmaZutical
Posted on: Sep 7 2018, 04:44 PM


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Thanks a lot. Can you post the pdf again ? Didn’t seem to be attached.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 5 2018, 05:07 PM


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Feel free to do so 🙂
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FarmaZutical
Posted on: Sep 5 2018, 04:21 PM


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I share your frustration and you’re right in many ways.
But it could in fact be a 23 year old FDA inspector who’s
causing the RTF.

Once Clinuvel submitted the application the review team received
the different modules and started determining wether to validate or not.

The deficiencies might be enough to cause a delay but I’m not
overly concerned that this ties into the overall push back against Scenesse.

  Forum: By Share Code

FarmaZutical
Posted on: Sep 5 2018, 03:28 PM


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Posts: 584

Clinuvel has received a refusal to file letter - RTL

They received this information no later than 60 days
after submitting the NDA; hence August 22nd or 23rd.

They deliberately held this information back from the market until
now unless the FDA is in violation of its own rules to communicate
the RTF within 60 days after submission.

It could be, that Clinuvel was hoping to buy some time
while submitting the additional information.

But could it also be that a drop in SP two weeks ago would
have impacted ASX300 inclusion negatively and therefore
they kept the market in the dark making us think we were waiting for
the day 74 letter ?

In any case, the information that the FDA requests is not catastrophic.
RTFs have increased over the past years and have no impact on wether
the FDA is likely to approve the NDA or not when the deficiencies are corrected.

As I mentioned many times:

Rolling review is not a rolling review.
Fast track is not fast.
Priority review says nothing about approvability.

But also:

A RTF is not catastrophic
A CRL does not mean that the NDA can’t be approved at a later stage. Sometimes within only days or weeks after the CRL.

Come on Clinuvel. Play by the book and get this solved by tomorrow.
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FarmaZutical
Posted on: Sep 5 2018, 05:32 AM


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That’s a very modest wish :-)
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FarmaZutical
Posted on: Sep 5 2018, 02:55 AM


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A friendly word of caution: Hybris is a bitch. And I’m superstitious.
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FarmaZutical
Posted on: Sep 4 2018, 03:59 PM


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“Would you not think the “rolling review” process was a complete sham and a total waste of time and effort if Scenesse was to be rejected?”

Yes and no. From a personal standpoint, yes. But when you know how the FDA operates, no.
Rolling review is in its essence more about frequent communication between the sponsor and the FDA more so
than being an actual review of the modules as they roll in. Upon lodging the final module of the NDA all the modules are sent
to the proper offices within the division and first then, begins the actual validation and subsequent review. During the review there might
be an adcom. That’s also a potential pitfall. And the FDA makes it very clear that fast track, rolling review, priority review and all the other
paths don’t equal a better chance of approval.

Do I think it’s fair to assume and to I hope that our situation bodes well for approval? Yes indeed.
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FarmaZutical
Posted on: Sep 4 2018, 02:57 PM


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It’s very important to remember that priority review does not equal certain approval of the NDA.
I’m not saying this to downplay how awesome it would be to get priority review but merely
to emphasize that NOT getting priority review does not equal a lower chance of approval, either.
In both scenarios the chances of approval are very high and just having the NDA validated
is a tremendous step forward.
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FarmaZutical
Posted on: Sep 2 2018, 02:13 AM


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If the division ever had a valid reason to grant priority review it would be now.
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FarmaZutical
Posted on: Aug 31 2018, 09:02 PM


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It’s 14 calendar days.
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FarmaZutical
Posted on: Aug 31 2018, 12:40 AM


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Scenesse is reviewed by the dental and dermatology division.
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FarmaZutical
Posted on: Aug 30 2018, 03:04 AM


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I know that you're a seasoned bioinvestor so you probably know the procedure and suggesting an RTF just because we haven't heard from them yet is not fair.

The validation period is 60 days, indeed. But the timeframe for the Day 74 letter is an addtional 14 days. Most recently, Evoke Pharma got their Day 74 letter two weeks after the validation period which is normal.

I'm sure we will hear from the company on the day (or the following Australian time) they receive the Day 74 letter. We may not get priority review but we will live without.

As for the 24 months review timeframe it's correct that the derma divison of the FDA is known for slower reviews and 24 months is not unusual. Again, your attack is not totally fair.
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FarmaZutical
Posted on: Aug 30 2018, 12:09 AM


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But there will be. I’m just curious as to how Clinuvel will react. Probably not
a bad idea to remain on the ASX right now.
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FarmaZutical
Posted on: Aug 29 2018, 05:59 PM


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Many interesting points. One of which is him talking about an end game which according to this could be
as near as 2021. I wonder what their internal plans for an “end game” are. I would love to see Mr. Blijdorp as new chair.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 24 2018, 02:34 PM


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It can take longer. Most recently, Starpharma announced the submission of their final module on April 30th. The FDA
validated the NDA on July 9th and confirmed priority review. That’s 60 + 10 days and within the day-74 limit.
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FarmaZutical
Posted on: Aug 23 2018, 06:35 AM


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It seems increasingly likely that Chivére and Tsumoyl are indeed CUV009 and VLRX001 and not the new cosmetics as I thought.
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FarmaZutical
Posted on: Aug 22 2018, 05:03 AM


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Yes, but after 2016: "Since then..."

"Scenesse was approved by the European Medicines Agency (EMA) for the prevention of phototoxicity in adult patiens with EPP in December 2014, with the first patients receiving the drug under the marketing authorisation in June 2016. Since then CLINUVEL has facilitated the treatment of EPP patients in six EU countries...."


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FarmaZutical
Posted on: Aug 22 2018, 04:24 AM


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Another question: Which are the last two of the six EU countires they are referring to ?

Netherlands, Germany, Austria, Italy, ????? and ??????
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FarmaZutical
Posted on: Aug 22 2018, 03:21 AM


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The deadline for validation is tomorrow but the FDA has another 14 days to communicate the decision to the sponsor. Hence, it's called a Day-74 letter. It might come earlier, though.

The recent PR seems like an attempt to put some informations out there about the company in anticipation of an imminent decision by the FDA that will, evidently, put Clinuvel in the limelight.

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FarmaZutical
Posted on: Aug 15 2018, 04:38 AM


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You're on to something.




Sumoylation is a covalent protein posttranslational modification that conjugates the small ubiquitin-like peptide SUMO to substrate. Sumoylation is critically implicated in multiple biological processes, including cell proliferation, differentiation, senescence and apoptosis, etc. Therefore, it is not surprising that dysregulation of sumoylation has been implicated in tumorigenesis and different types of cancer were found to be addicted to functional sumoylation pathway. The potential role for sumoylation as a therapeutic target in caner is emerging.


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FarmaZutical
Posted on: Aug 14 2018, 04:47 PM


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Both Chivére and now also Tsumoyl are now registred trademarks.

https://www.trademarkia.com/ctm/tsumoyl-017877352.htm
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FarmaZutical
Posted on: Aug 9 2018, 02:36 AM


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Either Clinuvel is applying extra pressure while the appeal committee is
preparing its decision or the appeal was dismissed and they are
now venting their frustration on instagram.

I expect they will take it to High Court if it is dismissed.
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FarmaZutical
Posted on: Aug 9 2018, 12:49 AM


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Wauv
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FarmaZutical
Posted on: Aug 8 2018, 06:07 PM


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To add to your list: Japan and Australia. Combined 150 m. population and 500-1000 potential EPP patients.
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FarmaZutical
Posted on: Aug 7 2018, 06:05 PM


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Although the deadline for validation is August 22nd we might get to wait another 14 days.
The FDA has 14 days to let the company know wether the NDA is validated or not. Hence, it’s called a 74-day letter.
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FarmaZutical
Posted on: Aug 1 2018, 01:56 AM


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Many of my friends spend countless hours on watching baseball and other sports. I have to admit I don't care much for that. The time I spend on DD is less than what my friends spend on watching TV. I don't watch TV. They day Clinuvel is sold, I will have way too much time on my hands and the need for a new hobby. Perhaps a Sunseeker Predator 50 will do.


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FarmaZutical
Posted on: Jul 31 2018, 09:09 AM


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They are part of the appeal process.
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FarmaZutical
Posted on: Jul 31 2018, 07:50 AM


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Today, NICE published all the documents related to the appeal. It’s a real thriller.

This is the link to the main page where you’ll find everything:

https://www.nice.org.uk/guidance/indevelopm...10009/documents

In the company’s appeal letter, Clinuvel describes how a member of the committee is blatantly disqualified
as the company had discussions with him at an earlier stage about using him as a consultant. They turned down
his offer and had no idea he would turn up on the NICE committee. This is outrageous.

You’ll have a good hour of reading if you go throug all the documents.

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FarmaZutical
Posted on: Jul 30 2018, 08:07 PM


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From NICE homepage:

11.1 What is the timescale for the appeal decision?

In both the oral and written appeal processes, the Appeal Panel will aim to send its decision in writing to NICE within 15 working days of the appeal. There may be circumstances in which more time is needed. The appeal decision is then considered by the Guidance Executive. The Guidance Executive consists of the NICE Senior Management Team and is chaired by the NICE Chief Executive. Figure 3 summarises the appeal process from the release of the appeal decision to its publication as well as the publication of the guidance.

11.2 Outcome of an appeal

Appeal upheld and final draft guidance returned to the advisory committee

If 1 or more of the appeal points are upheld and it is necessary for the final draft guidance to be returned to the advisory committee, the Guidance Executive will aim to consider the appeal decision within 15 working days of receipt. The Guidance Executive will decide how to act on the decision of the Appeal Panel. The appeal decision is normally published within 10 working days of its consideration by the Guidance Executive. Consultees (including appellants) and commentators are informed of the appeal decision and details of when the final draft guidance will be reconsidered by the advisory committee, 2 working days before publication of the appeal decision.

The technology will be returned to the relevant programme and work will start on reviewing the guidance as advised by the Appeal Panel and agreed by the NICE Guidance Executive.

The advisory committee will meet to consider the Appeal Panel's decision for review. The advisory committee will then produce revised final draft guidance. When the final draft guidance is produced, it will be distributed to consultees and commentators. Consultees will then have a further opportunity to appeal or to identify any factual errors.

If an appellant from the first appeal lodges another appeal, the appeal letter must not raise the same points presented in the first appeal or those points presented by another appellant at the first appeal hearing. The Appeal Panel will have already determined the outcome on these points.

If an appellant who did not participate in the first appeal hearing lodges an appeal, the appeal will need to satisfy the Vice Chair of NICE that one or more of the grounds has been met and has a reasonable prospect of success. The appeal process will follow its usual process and continue as either an oral or written appeal.

Only points that directly relate to the aspects of the revised final draft guidance associated with the appeal decision will be considered.

Appeal Panel requests changes to the final draft guidance but no further consideration by the Committee

If the Appeal Panel asks the Guidance Executive to approve changes to the final draft guidance that do not require further consideration by the Committee, the Guidance Executive will aim to consider the appeal decision within 15 working days of receipt of the appeal decision. After the Guidance Executive meeting, editorial changes to final guidance are made if required and the final guidance is normally published on NICE's website within 15 working days. Consultees (including appellants) and commentators are informed of the date of publication, and are sent the Appeal Panel's decision and a copy of the final guidance 2 working days beforehand.

Appeal dismissed

If the appeal is dismissed and the Appeal Panel has not requested changes to the final draft guidance, the Guidance Executive will aim to consider the appeal decision within 10 working days of receipt of the appeal decision. After the Guidance Executive meeting, the final guidance is normally published on NICE's website within 15 working days. Consultees (including appellants) and commentators are informed of the date of publication, and are sent the Appeal Panel's decision and a copy of the final guidance 2 working days beforehand.

11.3 What happens after the appeal decision is published?

There is no possibility of further appeal against the decision of the Appeal Panel. However, this decision and NICE's decision to issue the final guidance may be challenged by applying to the High Court for permission to apply for a judicial review. Any such application must be made promptly and within 3 months of publishing the final guidance.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 28 2018, 03:58 AM


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The only thing that struck me was the mentioning of regulatory
approval of the cosmetic product. Cosmetics are not subject to EMA or FDA
regulation. There are guidelines especially when it comes to sun screen products regarding
the wording of the label etc. but that’s it. How come we need
regulatory approval ?
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FarmaZutical
Posted on: Jul 23 2018, 12:44 AM


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On a différent note and just because it’s Sunday and I have time to
speculate: I think Mr. Blijdorp will replace Stan as chair later this year.
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FarmaZutical
Posted on: Jul 23 2018, 12:42 AM


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Seems like the wording is the problem. They are trying to patent
Afamelanotide as a drug, or inadvertently they are doing so because of poor wording
while actually trying to patent the use for the specific indication.
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FarmaZutical
Posted on: Jul 21 2018, 01:34 PM


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This is an except from a blog post the CEO wrote in 2011.
I think it’s worth re-reading now when we’re approaching
crunch time for EPP in the US. EPP is only the beginning.

By PW:

From a corporate standpoint, Cerezyme is a prime example of why so many large pharmaceutical companies are now focusing specifically on the orphan drug space. Genzyme netted Cerezyme total sales in excess of US$1.5billion over the past two calendar years with estimates that around 5,000 Gaucher’s disease patients are taking the drug, 10% of them without charge. (Those sales included a period in 2010 where Cerezyme manufacture was disrupted, delivering the company lower than expected sales for the drug in 2010 (US$719m).) It’s undeniable that this is a sound business model but the risk lies in exploring an approval system which was primarily intended to incentivise companies to pay attention to rare disorders.
More enticing for many therapeutic developers of late, however, is the potential for their orphan drug technology to be used in broader medical applications; so called ‘translational medicine’. Here, drugs which have multiple potential applications are investigated for indications with the greatest clinical need first (often orphan indications, where there are still so few therapies for more than 6,000 rare and often severe diseases) before being tested for more common indications within the community. This affords a developer (but also the regulator) comfort that it has a level of safety and efficacy data. This staged approach safeguards regulatory acknowledgement before addressing broader applications (which, in turn, could lead to reductions in drug costs due to economies of scale). Here, a translational medicine born out of orphan drug status can not only help a broader patient community, but also provide even greater returns for those who have invested time and money in a high-risk industry. It really is a win-win situation. However, patience is required from investors; they need to understand the long-term view and processes involved.
It is likely that we will see more orphan drug R&D announcements in the future as pharmaceutical companies expand their presence in the space. Hopefully the goals here will remain true to the orphan drug legislation and we can continue to provide new and better therapies to those patients who need them the most.
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FarmaZutical
Posted on: Jul 21 2018, 12:13 AM


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Wolgen said the company hopes to make a topical product for wider consumption; in his opinion, a pill or a drink would be unnecessary and dangerous due to the risk of an overdose. Additionally, it will be another six to 12 months before the FDA finishes reviewing Scenesse for limited use.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 17 2018, 08:42 PM


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I bet it suits PW very well that the SP is not rising right before the NICE appeal and possible FDA priority review.

“Ponimus crescente per fundas feneret ripa usque ridenti” doesn’t really fit the story of a little, humble, altruistic
company.
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FarmaZutical
Posted on: Jul 11 2018, 04:24 AM


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Are you able to re-post ?
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FarmaZutical
Posted on: Jul 9 2018, 09:03 PM


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T’sumoyle and Chivére could be two different products with different MOA but both photoprotectants. The
French sounding product Chivére would be better suited for the Western markets and might
contain ingredients that in some way promote melanogenesis; although it seems very unlikely
since it’s a cosmetic. But Westeners want darker skin while many Asians mostly
prefere lighter skin. T’sumoyle with its apostrophe and slightly Chinese looking name
could be the product for the Asian region and have photoprotective properties while not
making the skin darker.
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FarmaZutical
Posted on: Jul 8 2018, 10:11 PM


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I think it’s more and more likely that Willem Blijdorp and his company B&S International will be
instrumental in distributing Clinuvel’s new cosmetic line and that it will
probably be through tax free retailers in airports; mainly or partly in the Asia Pacific.

Cosmetic giants like Estée Lauder, L’Oréal, Unilever & Procter and Gamble are all very focused
on travel retail, according to this article: http://sc.mp/fJ7SDs

The market is huge and travel retail is exactly what B&S International are experts in.

The article mentions the TFWA international summit in Cannes and how the Tax Free Works Association gathers the
Global travel retail industry in France for this 5 days summit. I’d never heard about TFWA but
apparently Clinuvel attended the 2018 TFWA Asia Pacific conference in Singapore in May: http://clinuvel.com/2007-announcements/ite...gory/776-events

Scenesse isn’t exactly a product for the travel retail market so when Clinuvel attends this
conference it has to be with a different product and scope in mind. Chivere and t’Sumoyle seem
like products that could be a shoe in for this market.



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FarmaZutical
Posted on: Jul 7 2018, 07:17 PM


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I knew you would have a much better explanation. Thanks Frogster. It sounds very plausible. I wonder if Blijdorp is a candidate to replace Stan later this year.
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FarmaZutical
Posted on: Jul 7 2018, 12:46 AM


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I’m sure Frogster and others are more qualified to answer this question
but I find it very unlikely that such a transaction is not pre arranged with
the parties having negotiated price and timing well in advance.
But again it’s not my field.
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FarmaZutical
Posted on: Jul 6 2018, 03:05 PM


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Posts: 584

So it was Blijdorp who acquired those 1,359,973 shares from Lagoda at $10.
Good for him. And very bullish.
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FarmaZutical
Posted on: Jul 4 2018, 06:13 PM


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We don’t know how and when this was negotiated and with whom. It could be pre arranged long ago.
It could be a transfer of shares from a custodial account to a private one. It could be
Lagoda locking in profits to balance off some of their bad investments.
For comparison, Lagoda’s largest holding according to the 13F is Trupanion
at a current value of $23 m. 7 % of Clinuvel represents a current value of $26 m.
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FarmaZutical
Posted on: Jul 2 2018, 06:36 PM


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I have no idea. But it would make sense to await registration of the trademark so I’d say we have to wait another month or two.
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FarmaZutical
Posted on: Jul 2 2018, 06:23 PM


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Ok, August 17th then. Thanks.
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FarmaZutical
Posted on: Jul 2 2018, 04:30 PM


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The Chivére trademark has been approved.

https://trademarks.justia.com/792/17/chivere-79217953.html

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FarmaZutical
Posted on: Jun 23 2018, 04:07 PM


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Monday is World Vitiligo Day. Could that be related to the trading halt ?
During a normal procedure, submitting an NDA only involves the sponsor and the FDA.
No risk of leaks. Everything is confidential. Therefore, I think the trading halt could
be due to a 3rd party being involved somehow. Announcement on World Vitiligo Day would be a good stage.
Speculation on a Friday night.
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FarmaZutical
Posted on: Jun 23 2018, 12:53 AM


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And it works :-) Thanks a lot !!
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FarmaZutical
Posted on: Jun 23 2018, 12:45 AM


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Unfortunately not here. Only getting a blank page. But thanks for the effort.
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FarmaZutical
Posted on: Jun 23 2018, 12:30 AM


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Would you be able to post US level 2 here ? Thanks
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FarmaZutical
Posted on: Jun 22 2018, 04:25 PM


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8. Debt settlement
9. Is there room for my family in my mother’s appartment ?
10. How old do the kids need to be to legally work ?
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FarmaZutical
Posted on: Jun 22 2018, 01:09 PM


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Posts: 584

We should expect a PR within 4 hours before Germany and later the US opens. Otherwise
a trading halt in Australia has no effect.
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FarmaZutical
Posted on: Jun 22 2018, 12:47 PM


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Posts: 584

I have never seen a trading halt only due to an NDA being submitted. Ever.
It’s not uncommon to request a trading halt when the FDA has an advisory committee meeting,
but not at this stage.

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FarmaZutical
Posted on: Jun 22 2018, 06:24 AM


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Posts: 584

Management want the stock to be unloved by the market. It’s obvious that they are actively
un-promoting the company through mumbo-jumbo pr’s, non existent IR and
a despise for retail investors. It’s the end game that counts and in the interim
they’d rather behave like a privately held company to not
drive up the share price too much which could provoke regulators and cause
more pushback. If you hang on as an unloved retail investor, in the end,
you will feel the love when the company is acquired or the revenues
so high that the market will have to react. Until then, PW and Lachlan Hay
will do what they can to keep a lid on expectations, the pps and anything
that could derail Scenesse. It could be done with much more professionalism and with respect for investors
but I do appreciate that there is a need to stay under the radar.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 12:04 AM


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With US approval (most likely) coming up and subsequent reimbursement talks, it would be stupid to budge on the price in Britain. It would lower the fixed price for all countries.




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FarmaZutical
Posted on: Jun 22 2018, 12:00 AM


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Unfortunately not. From a quick glance it seems most of the appeals were finally rejected.


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FarmaZutical
Posted on: Jun 21 2018, 11:19 PM


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https://www.nice.org.uk/about/what-we-do/ou...s-and-decisions

If they don’t win this one the next stop will be high court.
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FarmaZutical
Posted on: Jun 21 2018, 03:37 AM


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Posts: 584

If Clinuvel doesn't file the last module of the NDA by July 1st it will be the last and final evidence, that a Clinuvel deadline can never again be taken seriously. Lachlan Hay and Dr. Wolgen really need to deliver on this one.


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FarmaZutical
Posted on: Jun 16 2018, 12:38 AM


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Posts: 584

I suggest a sweepstake.

Whoever thinks Clinuvel will meet the deadline replies
with a YES.

Whoever thinks they won’t file by July 1st replies with a NO.

The winners will be able to brag about it.
The looses commit to donating $100 to the young
EPP sufferer’s Gofundme.

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FarmaZutical
Posted on: Jun 15 2018, 08:20 PM


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Posts: 584

I concur. It should be fairly easy to forecast only a few weeks ahead.
But to answer your question, where should a new delay come from ?
Management !

I hope I’m proven wrong and that the NDA is filed one of these days.
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FarmaZutical
Posted on: Jun 15 2018, 06:41 PM


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Posts: 584

I think there is 0 % chance that Clinuvel will file the NDA by July 1st.
My expectation is sometime in Q3. Do you remember the quote by Lachlan Hay: “Surely by year’s end.” That was years end
2017 and he said it early 2017.
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FarmaZutical
Posted on: Jun 14 2018, 12:33 AM


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Posts: 584

Bad news is an option. But I think stop-losses being triggered by one or two initial retail sales are the reason. It doesn't take much to start and avalanche with such a thinly traded stock. Homm's pumping has brought in a lot of new investors with only one scope: fast money. Many of them probably don't have the same vision as many on this board and they will have stop-loss orders in place. I don't.




EDIT: The sell off started on the ASX on relatively limited volume but the avalanche spread to Germany (Homm land) and then the US.






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FarmaZutical
Posted on: Jun 13 2018, 03:39 PM


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Relatively low volume sell off. Gap closing.
Time to go above $14 on next leg up.
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FarmaZutical
Posted on: Jun 7 2018, 01:44 AM


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Hey JT,

The Priority Review that Clinuvel may get is not the same as the Priority Review Voucher Program. If we get priority review for Scenesse, it's not a voucher and it can't be sold.
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FarmaZutical
Posted on: Jun 3 2018, 04:17 PM


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Posts: 584

So, Giles Delaney is supposed to be an experienced business journalist.
He has no Twitter account, I have found 0 bylines with his name having spent
a considerable amount of time searching and no Facebook either.

I found an Anne Giles Delaney who is a sports reporter in Florida, but no
business journalist with the name Giles Delaney.

A journalist without a social media presence? Very unlikely.
And why are there no pieces by him to be found anywhere
on the Internet ?

There are many journalists with the name Delaney but no Giles.
Giles Delaney could of course be a pseudonym.

Giles could also be a middle name that he hasn’t used in his
bylines as a journalist, e.g. James G. Delaney or Kevin G. Delaney
but the only business journalists named Delaney I can find don’t
seem like the types that would be for hire by Clinuvel: Arthur Delaney of
Huff Post and Kevin Delaney who founded Quartz.

I don’t think Giles Delaney exists.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 2 2018, 03:39 AM


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Posts: 584

BPA is participating in the appeal in Britain. They published this questionaire online to be used in the appeal. I don't see how it could be of any use, though.

https://www.surveymonkey.co.uk/r/Z8CX5WD

https://www.facebook.com/groups/110926852272162//




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FarmaZutical
Posted on: May 30 2018, 05:22 PM


Group: Member
Posts: 584

I think we are missing the whole point. Clearly, the company wants to stand out from the crowd of streamlined biopharmaceuticals. They are doing so by having the weirdest logo ever. The website is crammed with pseudo scientific and academic information. The blog is something I have never seen elsewhere. They spend a lot of time writing about how to be ethical and less about the wonders of their products. Other companies have streamlined websites with to the point information and flashy catchphrases. I think this company is doing everything to look a little amateurish and with softer edges. It’s not about profits. It’s about patients and the mission. I hope I’m right and that there is actually a thought behind it all. I think there is
  Forum: By Share Code

FarmaZutical
Posted on: May 30 2018, 03:32 AM


Group: Member
Posts: 584

The blog is an odd attempt to appear open to outside "journalistic" scrutiny, although Delaney doesn't write anything that directly relates to Clinuvel and to an even lesser extent anyting that is critical towards the Company.

Also, it's probably an attempt by Clinuvel to seem reflective - by proxy.

I find his blogs harmles and a bit boring. Perhaps if he wrote in Latin, it would spice it up.
  Forum: By Share Code

FarmaZutical
Posted on: May 29 2018, 04:29 PM


Group: Member
Posts: 584

What's in a name? That which we call a rose by any other name would smell as sweet.
We are such stuff as dreams are made on, and our little life is rounded with a sleep.
Fair is foul, and foul is fair: Hover through the fog and filthy air.

Best, Stan
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