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CUV, CLINUVEL PHARMACEUTICALS LIMITED
johnnytech
post Posted: Jul 17 2019, 03:19 AM
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If you have access to trading on the Brussels exchange, Acacia Pharma ACPH could be a very smart buy about right now. I put this on my calendar to research in July, but unfortunately there is no American ADR I found out. Their lead drug was FDA rejected not too long ago for the second time over manufacturing issues, and the stock went down. It's starting to show signs of recovery. After the first rejection, they resubmitted the 2nd time quickly, but didn't change manufacturer. They are changing partners now, so 3rd time is probably a good risk to reward investment.

https://endpts.com/fda-rejects-acacias-lead...acturing-issue/




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seeva222
post Posted: Jul 17 2019, 12:34 AM
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In Reply To: macgyver's post @ Jul 16 2019, 10:31 AM

Thanks, I'm interested to see what impact early payments have as both the coming quarters are the largest.

 
Hamster72
post Posted: Jul 16 2019, 03:22 PM
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In Reply To: Frogster's post @ Jul 16 2019, 02:22 PM

I'm at $11.5 for the quarter and $51.5m cash on hand. Look for $.05 dividend announcement as well.

Need new countries online for more....

What's up Doc? graduated.gif



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Dr Wally is not a doctor at all. He's a dentist.
 
Frogster
post Posted: Jul 16 2019, 02:22 PM
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In Reply To: seeva222's post @ Jul 16 2019, 08:57 AM

Guesses? GUESSES?!?

I'm at A$13.5m for the quarter, 30% growth YoY, and cash at quarter end of A$54.475m.




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Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

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macgyver
post Posted: Jul 16 2019, 10:31 AM
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In Reply To: seeva222's post @ Jul 16 2019, 08:57 AM

I think the average increase across the last four (possibly 3 quarters, it was a while ago I tried to do an average increase calc) was something like 63-65%. I’m expecting the same this time around, which will be very pleasing and point to increasing patient registrations.

Edit: That’s yoy, relative to its own quarter which was still in the average mentioned above.


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seeva222
post Posted: Jul 16 2019, 08:57 AM
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Any guesses on receipts with faster payments? We were up 66% this quarter last year. Are there new centres on line?

 

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Dr Wally
post Posted: Jul 15 2019, 02:32 PM
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It’s possible that once the FDA give in to the decades of positive data, EPP community pressure and straight up logic of the situation, multiple indications for Scenesse might see a green light in quick succession. Slight justice maybe for all the years wasted.

Once FDA approved for EPP, in depth information concerning Scenesse (the hype) that’s been kept to a minimum for over a decade, will freely flow and the reality of the drug (multiple health benefits and no safety concerns) will spread around the planet like a wild fire and communities will demand access to this utterly safe and effective photo protectant.

The FDA have accelerated the approval of all kinds of drugs and Viagra is proof that the drug doesn’t have to treat a serious or life threatening condition. With a safety profile second to none, why couldn’t/shouldn’t Scenesse be approved within a couple of years for multiple indications for the benefit of millions just like “Sildenafil” was in 1998?
—-

“”Sildenafil, the chemical name for Viagra, is an artificial compound that was originally synthesized and studied to treat hypertension (high blood pressure) and angina pectoris (a form of cardiovascular disease).

Chemists at the Pfizer pharmaceutical company found, however, that while the drug had little effect on angina, it could induce penile erections, typically within 30 to 60 minutes. Seeing the economic opportunity in such a biochemical effect, Pfizer decided to market the drug for impotence.

Sildenafil was patented in 1996, and a mere ****two years later–a stunningly short time compared to other drugs****–it was approved by the FDA for use in treating “erectile dysfunction,” the new clinical name for impotence.””
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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!
 
ignoramus
post Posted: Jul 15 2019, 10:38 AM
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Some on Sharecafe have a bogus fixation regarding the Scenesse manufacturing process of which they haven’t a clue ………not smart ……….very stupid………boring……… and of no value to anybody except the stock shorter. The shorter thanks you all.


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endymion96
post Posted: Jul 15 2019, 08:55 AM
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In Reply To: Johnny H's post @ Jul 14 2019, 04:50 AM

Bookmarked!


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Johnny H
post Posted: Jul 15 2019, 03:27 AM
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In Reply To: seeva222's post @ Jul 15 2019, 02:23 AM

There are 3 different parts to the manufacturing.

The API, the implant, and the packaging/labeling/batch release.

The API and the implant have always been manufactured in the United States. Clinuvel chose to use Catalent UK for packaging and batch release through their UK subsidiary for a number of reasons. After Brexit, they chose to move the UK subsidiary to Ireland and the packaging/batch release to Germany.

In theory, the API and packaging could be done in Europe. However, the implant will be manufactured at Evonik Birmingham for the foreseeable future. There is no comparable facility in Europe that can extrude the implants commercially.


GMP is a broad term that covers everything from medicines, devices, up to and including animal feed manufacturing. CMC has a GMP component, but it's much more involved. Evonik Birmingham does have a EudraGMP certificate, but that's essentially meaningless as far as FDA approval goes.

Post approval? Who knows. Maybe this agreement will be helpful, but for now, the FDA is going to do its own legwork.



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I heard about Clinuvel at Fyre Festival

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