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CUV, CLINUVEL PHARMACEUTICALS LIMITED
macgyver
post Posted: Today, 04:05 PM
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In Reply To: macgyver's post @ Today, 03:59 PM

Nope.

 
macgyver
post Posted: Today, 03:59 PM
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I wonder if we will see large amounts of shares in the auction after 4pm....

 
odi01
post Posted: Today, 03:02 PM
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https://walletinvestor.com/stock-forecast/c...tock-prediction

 
Dr Wally
post Posted: Today, 02:55 PM
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In Reply To: Frogster's post @ Today, 02:37 PM

There have been many times when I’ve deluded myself for sure but not with this baby. Safety is always a legitimate concern until proven otherwise. In the case of Scenesse its been well and truely proven scientifically and anecdotally via 15 years of grey market use and possible abuse. How long is long enough to have safety concerns stifle a *brilliant* drugs progress?

Seeva has put sh1t on my posts many times before so that’s why I was a little harsh. I didn’t expect anyone else to take offence, especially concerning Scenesse safety.😬



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50+ on or before PDUFA... GLTA that have seen the future and kept the faith. 😎
 
LevelHeaded2000
post Posted: Today, 02:40 PM
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In Reply To: Dr Wally's post @ Today, 02:04 PM

A lot of investors assume that since the FDA rejected it before, then there is a high chance it will be rejected today. What they are ignoring is that the FDA that rejected Clinuvel does not exist anymore. It is a completely different agency operating with different decision makers and different legal guidance. As a result, the probabilities are completely independent outcomes and the previous rejection has very little to do with the current FDA.

If it was any other drug with any other history that had a 15+ year safety profile, demonstration of high consumer demand, and already approved in Europe for years then investors would not even question it. But, due to the fallacy that the FDA of 10+ years ago is the same as the FDA today people judge it's FDA chances as low probability.


Said 'Thanks' for this post: Dr Wally  bretto32  
 
Frogster
post Posted: Today, 02:37 PM
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In Reply To: Dr Wally's post @ Today, 02:04 PM

Safety is always a concern - indeed the primary concern - for any and every pharmaceutical product no matter how benign it may appear and no matter how long it's been used. There are many cases of drugs with a far longer history and wider use profile than Scenesse suddenly being found to have major issues.

Happily, the criticality of this is not lost on Dr W, not will it ever be by the FDA, EMA or any other agency.

I have no reason to think that Scenesse is anything other than a very safe drug, but if you truly believe that safety is a non issue and not even worthy of consideration, then I think you're deluding yourself.



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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.

Said 'Thanks' for this post: Dr Wally  macgyver  
 


Dr Wally
post Posted: Today, 02:04 PM
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In Reply To: seeva222's post @ Today, 01:14 PM

“As long as the safety profile holds up”

Haha are you serious? Safety hasn’t been an issue for a long, long, long time. Scenesse is better than safe it’s actually therapeutic so there’s no sane reason to cause concern or even question safety in 2019.

On the other hand FDA rejection for a second time would devastate this company BUT theres no logicall reason at all for that to happen: is there?😬. It would be an injustice based purely on stupidity and complete ignorance if it were to happen. Not happening!

In 2019 the FDA explicitly understand the incredible health benefits of this drug even though it will open the door to mass Afamelanotide usage down the road but what would be the problem with mass use of a super safe drug to prevent devastating diseases anyway? Were not in 2005 anymore Toto!

Expect plenty of SP games till FDAs fortifying, validating, uncertainty destroying approval is announced.

The lower the price goes the stronger the buy. These opportunities will be long gone soon so if the market is stupid enough to let the bottom fall out of Clinuvels SP before FDA approval then that’s a great thing.

Oh sh1t, now I see. That’s what your doing questioning the safety. Haha nice one. 😉





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50+ on or before PDUFA... GLTA that have seen the future and kept the faith. 😎
 
seeva222
post Posted: Today, 01:14 PM
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In Reply To: LevelHeaded2000's post @ Today, 12:35 PM

It’s low on EPP Europe alone. As long as the safety profile holds up, quarterly numbers will drive it higher regardless of the US outcome.

 
LevelHeaded2000
post Posted: Today, 12:35 PM
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My guess is the silence after the FDA meeting has made some investors nervous. The PE of Clinuvel is only 65. Assuming it gets approved for the US and it only sells as much as in the EU (they are similar market sizes) the PE will be cut in half to 32. Keep in mind the drug is not being sold in a large portion of the EU because it is so fragmented from a regulatory standpoint. The US will not have that problem. From day one it will be sold everywhere. So, assuming the US will only double rev/income is very conservative.

Then add on Japan,Australia,Canada which would follow shortly after an FDA approval and I think a PE ratio of <= 25 is realistic. All this without counting for any product sales growth in the EU as it rolls out more or additional indications.

The price is way too low considering this. Biotechs are not known for value-investing, but the current share price is nearly at value-investing levels. It is basically trading as if it was rejected by the FDA. If there is even a > 0% chance it gets approved by the FDA the share price is incredibly oversold.



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badass79
post Posted: Today, 12:22 PM
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always unsettling to see...I don't know how absurd a thought this is but perhaps investors selling shares to pay for taxes owed. I did. US tax day 4/15



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Surely you can't be serious?

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