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CUV, CLINUVEL PHARMACEUTICALS LIMITED
juxtaposer
post Posted: Yesterday, 10:10 PM
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In Reply To: LJS's post @ Yesterday, 07:25 PM

If it’s the same review of dendrimers I read my take away was a possible CUV/SPL collaboration to be had in transdermal usage.

 
LJS
post Posted: Yesterday, 07:25 PM
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I believe the recent pullback may have something to do with a rapid move up in anticipation of reaching asx 200 but not getting there. Another investment I have was a bit of a surprise inclusion and has risen around 15% despite going ex dividend and no other news. Funds might be re-allocating out of at least some of their purchases. I also think the short % has been rather high lately. Given I think it's a greater than 75%?chance for approval, anywhere $18-20 would be a great entry and very dangerous for shorters leading into June. We'll see. The data collected through pharmacovigilence is fantastic for the company. No doubt the side benefits from increased sun exposure will be documented, along with any pre-existing ailments that may have had an impact through scenesse usage. As an aside(for those who follow SPL), there is a recent publication which includes a commentary on the use of dendrimers for drug delivery. It would be interesting to see CUV and SPL could combine to produce an oral tablet/capsule of scenesse. Two Aussie companies technology to create something like a scenesse capsule would be great if ever approved for the wider community and those not keen on an implant. Not sure about a 10 bagged from here soon but no doubt in time if the potential is reached it's very possible IMO. GLTA. Quarterly should be next week and I expect a similar or slightly higher figure for this one and a significant increase the next two , especially if distribution in the US happens.


Said 'Thanks' for this post: royco  
 
LevelHeaded2000
post Posted: Yesterday, 07:34 AM
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I never calculated much off-label use either way. The price is too high for it. Patient registry or not is just a blip. All that matters is FDA approval. A post marketing surveillance plan would help force a higher price of the drug and keep competitors out, IMO.


Said 'Thanks' for this post: macgyver  scipio79  royco  odi01  
 
macgyver
post Posted: Yesterday, 07:32 AM
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In Reply To: seeva222's post @ Yesterday, 05:44 AM

It’s a conversation we’re having. And yours is a theory. The FDA doesn’t reject a drug based on speculation. That would undermine the whole process and invite accusations of corruption and incompetence. I’m ok with the discussion, and I see no threat to my investment from it. Not even 5%.

 
rabbitrun
post Posted: Yesterday, 07:06 AM
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In Reply To: seeva222's post @ Yesterday, 05:44 AM

If there's going to be a patient registry like in Europe, there will be no off-label.

 
seeva222
post Posted: Yesterday, 05:44 AM
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In Reply To: macgyver's post @ Yesterday, 04:17 AM

I didn’t determine that it was the FDA reading here, it was cause-and-effect. I believe they responded to something written here. I don’t think the chances are of great that it would happen but it doesn’t serve us in anyway to have an off label conversation. Clinuvel seems very careful about it’s wording around strict adherence to protocol.Even if the chance was .5%... why would you do it? I would follow their lead.

 


macgyver
post Posted: Yesterday, 04:17 AM
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In Reply To: seeva222's post @ Apr 24 2019, 11:39 PM

Another conspiracy theorist. Proof? Or you heard from someone else? If you think the FDA will deny approval because off label is mentioned on ShareCafe then the whole approval system is detrimentally flawed, and the hard work, trials and treasure spent to get to this point will have been for nothing. That doesn’t make sense. I think it beneath you if you demean the people at Clinuvel and their hard work by insinuating that just the mere mention of off- label can destroy their efforts. I know your investment is precious to you but don’t let money cloud your sense of reality.


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royco
post Posted: Yesterday, 02:57 AM
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In Reply To: scipio79's post @ Yesterday, 01:12 AM

The Ema pass data is crucial for cuv to understand its own product better.
It is probably better and more detailed then the actual trial data.
And it is an extra insurance for a safe development.
Some limitations with roll out and continued gathering of real life data will also make sense in the USA.



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Ἀρτεμίσιον
 
scipio79
post Posted: Yesterday, 01:12 AM
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In Reply To: seeva222's post @ Apr 24 2019, 11:39 PM

I am not saying Clinuvel can't control it's own product, merely the FDA can't limit a doctor's professional judgment. I expect Clinuvel to limit itself, at least in the short term.


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rabbitrun
post Posted: Yesterday, 12:05 AM
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Annoying top-of-the-page ad you need to scroll past, but interesting read:

https://www.fiercebiotech.com/biotech/biote...s-behind-report


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