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post Posted: Today, 09:01 AM
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In Reply To: polyphemus's post @ Today, 08:22 AM

Correct. As I remember PW indicative price per implant quoted at an earlier AGM was $7000 AUD per implant. After all the negotiations and pharmacovigilance requirements, he negotiated a higher price.

post Posted: Today, 08:22 AM
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In Reply To: Johnny H's post @ Today, 06:56 AM

The graphic displays EPP when the annual cost was unknown - it was expected to be between 15k-20k Euro per annum, although at the time Italy was indicating 32K Euro.

As we now know that PW was able to organise a 70k Euro per annum uniform price. This is expected to be carried over into the US.

So double or quadruple the graphics estimate of $ market size for EPP.

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post Posted: Today, 07:38 AM
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Johnny H
post Posted: Today, 06:56 AM
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In Reply To: seeva222's post @ Today, 03:05 AM

Receipts from customers for FY 2019 was $32.2 million, and that's with EU market penetration on the lower end.

If I had to guess, those numbers are for EU only and projected based on intermediate market penetration. I would expect a complete EU rollout to be somewhat higher.

Clinuvel until my bowels release for the last time.
post Posted: Today, 03:05 AM
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In Reply To: investek's post @ Today, 01:12 AM

That graphic looks wrong. 40mm for EPP?

post Posted: Today, 02:01 AM
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In Reply To: FarmaZutical's post @ Yesterday, 07:34 PM

23 October 2014
EMA/CHMP/709396/2014 Rev.1
Committee for Medicinal Products for Human Use (CHMP)
Assessment report
International non-proprietary name: afamelanotide Procedure No. EMEA/H/C/002548/0000

Not sure if the FDA docs had any more recent info on trial CUV011...
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Share Cafe Sentifi Top themes and market attention on:

post Posted: Today, 01:12 AM
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In Reply To: FarmaZutical's post @ Yesterday, 07:34 PM

I’ve also been patiently waiting for the results of this trial (CUV011) and it is my personal belief that Wolgen is being very strategic with the duration of the trial/release of the full results.

I had a quick look back through a few of the past AGM presentations, see graphic below, I think it’s worth re-reading what Wolgen said years ago.

I think there are some other trials that never released full results, I haven’t completed an exhaustive review however I don’t recall ever seeing final results for CUV015 - Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE).

Clinical and regulatory progress:
- European and Australian Phase III trial (CUV015) preliminary results reported December 2009; see the announcement here
- Additional European Phase III trial (CUV032) commenced in Northern Hemisphere in spring of 2010
- Safety and efficacy shown in Phase II trials
- Program deferred
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Said 'Thanks' for this post: FarmaZutical  San Diego  the near future  Verharven  Farleap11  
post Posted: Today, 12:59 AM
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If this does show progress for DNA repair what are the market implications?

Does this go to a broad-based market? Or will this just be used in high-risk situations?


post Posted: Yesterday, 09:19 PM
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In Reply To: FarmaZutical's post @ Yesterday, 07:34 PM

This leads directly into the description of the recently granted patent where it states the compounds in particular benefit immunocompromised patients (in addition to the general public).

This was a Phase II trial. Would not be surprised therefore that at some stage, hopefully soon, results will be released. There are surely other trials where information was never released - this has been going on for 13 years. Dr Dennis Wtight key person in CUV1647 study.
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post Posted: Yesterday, 07:34 PM
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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.

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.

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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Said 'Thanks' for this post: PortugueseMan  IntiRaymi  waz  PunkassDerm  Alaaf  Texas T  endymion96  

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