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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Frogster
post Posted: Yesterday, 09:43 PM
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In Reply To: Clinhope's post @ Yesterday, 09:29 PM

I don't disagree that Fda approval would be of seismic magnitude, but I do think that if there are ambitions to be a broad based company, simultaneous progress on parallel fronts is not an unreasonable thing to expect. I just hope they been doing something in this vein and not (yet) telling us about it.



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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: odi01  Clinhope  NewToCli  PunkassDerm  CUV88  
 
Clinhope
post Posted: Yesterday, 09:29 PM
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Because it is an event horizon. Our future relies so heavily on the outcome of the FDA decision that thinking beyond that point is as much speculation as trying to answer what will the world be like once General Artificial Intelligence is created? We can guess and we can prepare for likely scenarios. But ultimately, the answer to what action we take or the outcome of our future will only be unveiled when we reach the event horizon.



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Member of the “ALL-IN” club 2018.

Said 'Thanks' for this post: NewToCli  Farleap11  
 
Frogster
post Posted: Yesterday, 09:05 PM
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In Reply To: NewToCli's post @ Yesterday, 08:55 PM

Agreed. There is So MUCH stuff that has gone dark since the Fda application delays/extensions that we might hope for a whole raft of newsflow after any approval.

Regarding VP, that was due to start European spring, with 6 or 8 month follow up (can't remember the precise detail) so that should be ongoing.

There should have been another indication announced early this year. What's going on with paediatric scenesse? Where are the oft referred acquisitions....... Etc etc.

I get that some stuff strategically relies upon fda approval. I'm not sure I get why everything seems to be waiting for it.



--------------------
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: NewToCli  
 
NewToCli
post Posted: Yesterday, 08:55 PM
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Maybe we need to think a step further as fda approval. Approval is very likely and we shouldn’t doubt it anymore. The market partly also priced in approval with a high probability (prices above 32 aud). To continue the stock price rally the questions are further then just approval
- what will happen after that? How long does it take to materialize profits? What’s now with the other indications? How is Cuv going to scale the Scenesse platform? What happened with VP trial? any progress in topical? Etc etc ... I think the path forward even with approval is not very clear to the market... and keeping everything secret and slow doesn’t help anyone in the end. Why do they register trademarks and then not use them for years? Etc etc


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macgyver
post Posted: Yesterday, 08:08 PM
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In Reply To: Farleap11's post @ Yesterday, 05:52 PM

I asked Johnny H recently the same question. He can tell you, it’s a possibility afaik.


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Farleap11
post Posted: Yesterday, 05:52 PM
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Back on March 22nd LevelHeaded2000 (“LH2”) posted an interesting article commenting on some of the content of the CUV Newsletter of 10 January announcing release of the original PDUFA date. Also included in the post were observations based upon a selection of extracts from FDA approval procedures. The essence of the post was that, “….. Clinuvel already has Priority Review however I believe they also have Expedited Review within the Priority review designation. “ LH2 went on to point out that the goal of an ‘expedited review’ is to approve the drug at least 1 month before PDUFA goal date, “provided that no significant application deficiencies prevent an early action.”

We now have reason to believe [ thanks to the excellent research carried out by JohnnyH] that the PDUFA date was subsequently deferred until 6 October 2019 due to work still to be completed by EVONIK in relation to FDA production process queries.

The purpose of this posting is to seek clarification or an opinion from LH2 [or other person(s) who might care to respond], as to whether it is still possible CUV could be granted approval at least 1 month before the revised PDUFA date notwithstanding the delay caused to the originally proposed date due to there being a, “significant application deficiencies [to] prevent an early action.

If this is still the case, then perhaps we could be in for a double whammy in or around 6 September (3 weeks away) when the post-marketing authorisation commitments are due!



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stripeyrascal
post Posted: Yesterday, 02:05 PM
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In Reply To: scipio79's post @ Yesterday, 07:30 AM

anatara life sciences (ANR). they have a proven treatment for scour in pigs and are just commencing human trials, hoping for improvements in IBS and IBD patients. but i think i have been lucky rather than savvy when i put a bundle on CUV 8 years ago. i have had plenty of bum steers too.

 
waz
post Posted: Yesterday, 02:00 PM
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In Reply To: scipio79's post @ Yesterday, 07:30 AM

Companies worth investigating are: IMC, BOT, PO3, MDC, ANR, NAN

Also, a very interesting article (but might need to evade paywall):

https://www.afr.com/companies/healthcare-an...20180503-h0zku0

 
Fortescue Bullro...
post Posted: Yesterday, 10:17 AM
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At a guess, any company with a line of attack on Clostridium difficile should be worth a look.

 
scipio79
post Posted: Yesterday, 07:30 AM
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A little off subject, but have any of you invested in a company focusing on the microbiome, essentially gut health? I'm looking at a few companies and would like to get input from this savvy group of investors. Thanks.


Said 'Thanks' for this post: waz  
 
 


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