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post Posted: Feb 10 2020, 05:01 PM
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In Reply To: San Diego's post @ Feb 10 2020, 04:11 PM

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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San Diego
post Posted: Feb 10 2020, 04:11 PM
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In Reply To: LevelHeaded2000's post @ Feb 10 2020, 11:17 AM

I see panic is setting in with the price moving upwards, so it’s time to flood the board again. Why would you think that a type C meeting had already been requested when there has been no previous announcement to that effect? Good, bad or indifferent, it’s quite evident that Wolgen’s strategy has been to put all other indications with the FDA on hold after the filing of the NDA. I am confident, or at least very hopeful that management’s focus over the last few months has been with the rollout for EPP. There may be a valid argument that it was a flawed strategy, but it is disingenuous to state that you thought that a type C meeting with the FDA for Vitiligo had already been requested. That is, unless you are completely uniformed with respect to the company, which doesn't appear to be the case.

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post Posted: Feb 10 2020, 03:27 PM
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In Reply To: investek's post @ Feb 10 2020, 01:38 PM

Clinuvel really needs to move to a broader market fast due to its patent / exclusivity situation. For example, it's exclusivity in Europe expires in 2024 (10 years after approval of 2014 there could be a possible 2 year extension opportunity).

It does not make sense to try to drip indications by going for XP (a very tiny population) and delaying vitilgo. It makes much more sense to go as fast as possible towards Vitiligo. Of course the price per implant will have to come down a lot with Vitiligo, but it will hopefully be made up in volume. XP would be a distraction IMO. This management time has never shown the ability to handle multiple tasks at once.

post Posted: Feb 10 2020, 01:38 PM
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In Reply To: Johnny H's post @ Feb 10 2020, 09:59 AM

Is it possible for an sNDA to be granted with anything less than a Phase 3 study?

I did a quick search and the best I could find was an sNDA application in China with Phase 2 data

I’m wondering if the longer gestation period for Vitiligo approval is intentional? Wolgen has a plan and we’ve only been privy to pieces of it? My hypothesis is that once approved for Vitiligo the price/implant would need to fall considerably, I doubt insurers would stump up the 6x $20K AUD (say $85k USD) per patient. I think Wolgen has other plans for short term label extension at the current implant price for say XP etc, I just have no idea how that can be best achieved. Is it possible to allow compassionate/off label use for XP and run a Phase IV (due to ultra low prevalence)?

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post Posted: Feb 10 2020, 11:17 AM
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In Reply To: sharelooker's post @ Feb 10 2020, 09:08 AM

Wow, I was under the impression that the Type C meeting was already requested. It will take many months just for the meeting. Incredible.

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Dr Wally
post Posted: Feb 10 2020, 10:59 AM
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In Reply To: mattho's post @ Feb 10 2020, 10:27 AM

Every opinion posted here can be twisted around and be interpreted as attempting to influence the SP up or down. What can you do about opinions other than to understand that that is all they are, opinions, until proven at some point in time that’s all they’ll ever be no?

I disagree with many opinions here but I totally respect them if I feel they are coming from long term investors of Clinuvel and not day traders or shorters. We all want to profit obviously but day traders and shorters will say anything at any time.

Alls you can do about opinions is form one of your own hopefully through extensive research (if you want an informed one) and either continue investing in Clinuvel because you see insane profits (based on long term proven incredible safety and cancer preventing qualities that cannot be denied and shunned forever) at some point in the not too distant future OR sell because you believe management aren’t up to the task and the drug has the potential for some kind of photo protective tanning abuse and should be feared and never widely used to save the thousands of lives lost to skin cancer each year.

A figure which continues to escalate by the way.

That’s why you need to know the history of posters here. If all of a sudden their message/opinion deviates overnight like some have then you could assume fairly accurately that they might possibly be up to no good.

A levelheaded opinion of a situation should be consistent and if it does ever change/evolve it won’t happen out of the blue spouting the guaranteed super fast approval of a totally unproven product and at a time of market vulnerability to hopefully create mass panic selling for ones own benefits.

A levelheaded person would never do something like that or would they? ph34r.gif
I have to admit I crapped on about how everything would flow in quick time directly after FDA approval. I was incredibly naive in thinking that would mean the end of the irrational resistance to Scenesse. It wasn’t said because I was shorting the company or trying to mislead anyone here.

Wishing everyone the best of luck through these testing times. Hopefully we’ll all be getting back on track towards the end of this incredible year 2020.

Understand the reality of this unprecedented situation but don’t panic.

2020. Year of the germ!

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post Posted: Feb 10 2020, 10:27 AM
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As longer i read here the comments i got more and more confident about, that most of the CUV shorters are very active in this board to play with the fear of every other long investor here with their bullshit telling why everything is so bad and marketing is so bad and management is so bad and why Tanabe will totally break down CUV in x years...

i cant read this shit anymore...
for sure, everyone thought after FDA approval the SP will rise and stay at 40-50 AUD but on the other hand CUV is actually under the top 10 of shorted stocks at ASX and this will not last forever...

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post Posted: Feb 10 2020, 10:16 AM
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In Reply To: Johnny H's post @ Feb 10 2020, 09:59 AM

It's interesting that management incentives called for an increase in market cap from $1.5B to $7.5B in 4 years (late 2023). That would be a tremendous rise in shareholder value. But as Johnny outlines, and I agree, there is virtually no way vitiligo will be approved before 2023. And as we all know approval does not immediately translate to revenue.

So what does management believe will drive such a dramatic increase? There should be good penetration in the US and many other countries at that point for EPP but will that be enough on its own? More likely the company will have vitiligo approved, one or more other indications close to approval and potentially a pipeline to treat several other indications in trials. At that point the company agrees to be acquired for $7.5B and management rides off into the sunset. I'm perfectly good with that scenario.

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paul jackson
post Posted: Feb 10 2020, 10:15 AM
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So fast forward to the November 2020 AGM, the Company's bragging points for the year of accomplishments will be:

- AU approval for EPP
- Started a Phase IIb USA vitiligo trial
- USA rollout of EPP

As someone mentioned before last month, 2020 will all be pretty underwhelming.

This is once again a multi-year hold. Now you know why folks aren't storming the gates to get in CUV right now.

Wolgen is damn lucky that after all these years, there hasn't emerged a serious group of competitors. He
is saved by the ineptitude of the other research projects that never reach human testing. And they go
back to the early 1990s...such as Bab Gilchrest's work on pTpT

3...2....1...before the Tanabe rebuttal posts start....

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Johnny H
post Posted: Feb 10 2020, 09:59 AM
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In re: the type C meeting, it's absolutely the right thing to do. Once the FDA and Clinuvel agree on trial design and endpoints, it's binding on the FDA. If the data shows that Scenesse is effective for treating vitiligo, the FDA has to accept the data.

This is something Clinuvel should have done for EPP, but for whatever reason, didn't.

The good news: sNDAs are much faster. Clinuvel can reuse 4 of the 5 modules that they used in the NDA for EPP. No risk of a CRL for CMC issues or safety issues.

The bad news (or not so good news, if you prefer): The vitiligo trials, if similar to previous ones, are quite lengthy. 180 days of active patient participation at a bare minimum. If Clinuvel is setting up for a phase IIb trial, it means they later have to do a phase III, which will be just as lengthy if not longer. Best case scenario is Scenesse approval for vitiligo in 2023. I would be shocked and very pleased if Clinuvel is able to deliver on the best case scenario.

Vitiligo approval is the catalyst for making the company "orders of magnitude larger", so I'm glad we have some concrete evidence that they are now taking steps to achieve this.

"In today’s world some shareholders enjoy complaining to Board and management but then they do not sell their stock, they hold on and sometimes buy even more."

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