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CUV, CLINUVEL PHARMACEUTICALS LIMITED
LJS
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.

 
polyphemus
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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sharelooker
post Posted: Today, 07:38 AM
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https://www.asx.com.au/asxpdf/20191210/pdf/...fnb0p8lw6vb.pdf


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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.
 
seeva222
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?

 
investek
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
SCENESSE
International non-proprietary name: afamelanotide Procedure No. EMEA/H/C/002548/0000

https://www.ema.europa.eu/en/documents/asse...t-report_en.pdf
p46

Not sure if the FDA docs had any more recent info on trial CUV011...
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sentifi.com

Share Cafe Sentifi Top themes and market attention on:


investek
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.
https://www.asx.com.au/asxpdf/20101110/pdf/...sm5bzb6dtjw.pdf

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

https://www.clinuvel.com/polymorphous-light-eruption-ple/

https://clinicaltrials.gov/ct2/show/NCT00472901
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seeva222
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?

Tx

 
waz
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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Attached File  Amended_description_with_annotations.pdf ( 46.12K ) Number of downloads: 14

 



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FarmaZutical
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.

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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