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CUV, CLINUVEL PHARMACEUTICALS LIMITED
stripeyrascal
post Posted: Today, 02:05 PM
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In Reply To: scipio79's post @ Today, 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: Today, 02:00 PM
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In Reply To: scipio79's post @ Today, 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: Today, 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: Today, 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  
 
seeva222
post Posted: Today, 12:20 AM
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In Reply To: Johnny H's post @ Yesterday, 10:58 AM

My only concern on efficacy is that the EMA used patient voice. I agree it doesn’t look like a hurdle right now.

 
Johnny H
post Posted: Yesterday, 10:58 AM
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In Reply To: seeva222's post @ Yesterday, 06:50 AM

We're bulletproof on efficacy. It was my biggest fear a few years ago, but the least of my worries now.

Compared to some of the drugs that have been approved by the FDA recently, Clinuvel is light years ahead on efficacy, and..... it's for an ultra-orphan indication.



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Clinuvel until my bowels release for the last time.

Said 'Thanks' for this post: royco  
 


endymion96
post Posted: Yesterday, 10:21 AM
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In Reply To: MinusSinus's post @ Yesterday, 07:06 AM

I agree with that conclusion. This study bolsters the case even more that Scenesse will be approved. Firstly, because efficacy is not in doubt, secondly because EMA already approved it, and thirdly, because the FDA has had 4 years of additional data to review.

Tom Petty once wrote a song ...

The waiting is the hardest part
Every day you see one more card
You take it on faith, you take it to the heart
The waiting is the hardest part

 
Clinhope
post Posted: Yesterday, 10:17 AM
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QUOTE
Final concordant and discordant regulatory outcomes

Further to the above resubmissions and reexaminations of applications, we compared final regulatory outcomes. If an application was not resubmitted/reexamined by an agency, the initial outcome was also considered to be the final outcome. By this accounting, the proportions of applications finally approved by the EMA and the FDA were similar (93% and 92%, respectively). Resubmission/reexamination of initially nonapproved applications increased the concordance between the agencies to 98% (105/107) of applications


Very nice. Interesting that the FDA has a slightly higher non-approval vs the EMA. I'd like to see if there is a difference (probably not statistically significant) of approval ratio for those who get EMA approval 1st and vice versa.



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Member of the “ALL-IN” club 2018.
 
MinusSinus
post Posted: Yesterday, 07:06 AM
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In Reply To: sharelooker's post @ Yesterday, 06:39 AM

Nice study - of all drugs that have EMA approval, 91% also got FDA approval.

Would be nice to see the raw data to see the sequence of decisions to see how many drugs had EMA approval before being submitted to FDA. But technically, the success rate should be even higher in that case.





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Comments on Clinuvel on my value investing blog (English):
https://www.minussinus.de/2017/11/14/for-english-readers-of-minussinus/
 
seeva222
post Posted: Yesterday, 06:50 AM
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In Reply To: sharelooker's post @ Yesterday, 06:39 AM

Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies’ conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application.

 
 


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