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CUV, CLINUVEL PHARMACEUTICALS LIMITED
charch
post Posted: Jun 28 2007, 08:08 PM
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In reply to: traveler on Thursday 28/06/07 10:54am

Traveler,
I disagree that the big money is in the States. I reckon it is in Europe..they are gluttons when it comes to beauty. Vanity reigns supreme in Europe. In terms of population, Europe rivals that of the US and will eventually become the world's dominant economic force.

All the best anyway.
charch

 
traveler
post Posted: Jun 28 2007, 02:30 PM
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In reply to: polyphemus on Wednesday 27/06/07 11:05pm

Poly - it's late here in America and I don't have time to find the past announcements right now that stated this, but there was to be 3 Phase II trials in the 2nd half of 2007.

Now, apparently it's only 2. I do believe it is the AK Phase II that is missing.

Something isn't right with the AK indication. I was even told via email that AK Phase II would start later this year.

If earlier trial results for the missing indication disappointed, I'd prefer they just tell us.

 
polyphemus
post Posted: Jun 28 2007, 02:05 PM
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I take the following from the announcement - which I would have preferred released next week after the end of financial sell off we experience every year. Its not just BIO's, the market has retraced 5% the banks 10%

Funding is secure to complete the Program - No more raisings unless another indication is found.

Something is brewing in the pipeline for Orphan Status

They're working on the US IND application

The Investor update in April only mentioned two phase 3 for 2007 pg 11 and two ph 2, 1 filing of an IND in US. And realistically it mentioned the value of Transaplant recipients as being US240m for a total revenue stream of $500US

The AGM slides show that there were to be two phase 3 on 07, 1 for PLE and 1 for AK which I think is the missing one Trav refers to.

Without any further dilution earnings per share in 2010/11 of USD$ 0.80-1.60 per share should lead to a nice dividend greater than the 80c price today.





 
traveler
post Posted: Jun 28 2007, 01:42 PM
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In reply to: Klomp on Wednesday 27/06/07 10:07pm

David - I sent the company an email. They are hit and miss with their responses.

It may sound insignificant, but the bulk of this investment lies with the US market. For every 6 mos. to 1 year FDA approval is delayed, that can add up to an immeasureable opportunity cost.

And if they continue to claim credit for meeting deadlines, I'm going to call them on it when they don't meet them.



 
Klomp
post Posted: Jun 28 2007, 01:07 PM
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In reply to: traveler on Thursday 28/06/07 10:59am

Traveller - I would send Wolgen an email if you have concerns re the US application. He is generally very responsive

 
traveler
post Posted: Jun 28 2007, 10:59 AM
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QUOTE (traveler @ Wednesday 27/06/07 07:54pm)

Also, they had said many times this year that there will be 3 Phase II trials started in the 2nd half of 2007. Now they just mention two more in their remaining 2007 objectives.

We're missing another PHase II trial. Perhaps a Phase I trial did not go well.

And while we're at it, they are due (this month) for their quarterly newsletter. Guess that went in the dumper as well. Like the 2001 monthly Epitan newsletter that ended after 1 whole installment.

 

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traveler
post Posted: Jun 28 2007, 10:54 AM
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Wolgen did not mention the filing of the IND with the FDA as a value driver for the rest of the calendar year 2007.

They have said repeatedly it would be filed by the end of this year. So, if that objective is not reached, they are full of it. If they don't file the IND by the end of this year, they HAVE NOT reached an important self-imposed deadline.

This corporate file report was nothing more than an effort to strike back that the market's dumping of the stock for the past couple months.

The last page is nothing but PR crap - "see, look at all we've done."

Well, the big money is in the US. Until this drug is approved and available in the US, the stock price will not reach anywhere near its potential.

And if Wolgen does not get the IND filed by the end of this year, as was clearly the goal, he's dropped the ball. This would only greatly delay the time it will take for this drug to be approved in the US. Which will mean more delay, delay, delay.

They opened the US office 9 months ago. File the frickin' IND.

Originally, Epitan was going to file the IND in 2004. Enough is enough. Get the job done - otherwise, get ready for more share price woes.

People are staying away because of non-stop delays. And if the IND is not filed by the end of the 4th quarter 2007, it will be ANOTHER DELAY on this company's watch. If that is the case, I cannot blame anyone for bailing out on this stock and returning (or not) a few years later.

And this tooting your own horn PR crap is as transparent as glass.

 
panguna
post Posted: Jun 28 2007, 09:45 AM
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Clinuvel trial recruitment going well
09:19, Thursday, June 28, 2007

Sydney - Thursday - June 28: (RWE Australian Business News) -
Clinuvel Pharmaceuticals Ltd (ASX code: CUV) CEO Mr Philippe Wolgen told
Corporatefile in an open briefing lodged today that the company was
progressing well in recruitment for its Phase III polymorphous light
eruption (PLE) trials, and had started administration of CUV1647 in the
UK and Austria.
"We are awaiting three more countries joining the program this
summer season in the northern hemisphere.
"In Australia, we anticipate the start of the Phase III PLE
trial by the fourth quarter of calendar 2007," he said.
Mr Wolgen said Clinuvel had started Phase III Erythropoeitic
Protoporphyria (EPP) trials in Europe and would continue recruitment of
patients in the northern and southern hemisphere over the next few
months.
"The risks in the recruitment stage of the trials are there, but
limited. They lie mainly in the time it takes to enrol the required
number of patients.
"We are gradually seeing more and more patients themselves
approaching us to be part of our trials," he noted.

*****

The CEO said, "We currently hold approximately $61.5 million in
cash or equivalents - a tribute to the increased confidence investors
now have in Clinuvel.
"Over the past 18 months, we've successfully raised $67 million,
which will fund the continued development program for CUV1647.
"We have positioned the company well to achieve its aim of
commercialising CUV1647."
Mr Wolgen added, "our shareholders' register now includes a
number of well-known European and Australian institutions that hold a
long-term view on the company.
"We believe we have the market’s confidence. They support our
strategy to bring CUV1647 to market."
Shares in Clinuvel fell 1c to 89c yesterday.
ENDS

.



 
trisail
post Posted: Jun 27 2007, 03:35 PM
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In reply to: ezinameriadu on Wednesday 27/06/07 01:55pm

Ezi, some of the falls can be attributed to tax loss selling here in Australia as our financial year ends 30/06 and punters need to offset profits made during the year. So the price should begin to climb again come July (or at least hold).

Cheers

 
ezinameriadu
post Posted: Jun 27 2007, 01:55 PM
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The precipitous drop of CLVLY in the US from a high of $1.05 on April 13 to today's close of 70 cents(a loss of
exactly 1/3) is very disheartening. So far this week(Monday and Tuesday), CLVLY has lost 8.5 cents, 5.5 cents today). Since April 13, I have lost a tremendous amount of money. I'm still in for the long-run and am still optimistic, but I didn't expect such a steep decline. These are very trying times. I would like to buy more
shares, but like many of you, I'm all out of cash. This is my first experience with a penny stock and at my age, it will probably be my last. Bon courage, mes amis!

 
 


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