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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.

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.

Clinuvel until my bowels release for the last time.

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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

post Posted: Yesterday, 10:17 AM
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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.

Member of the “ALL-IN” club 2018.
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.

Comments on Clinuvel on my value investing blog (English):

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.

post Posted: Yesterday, 06:39 AM
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A nice read for the weekend!

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post Posted: Yesterday, 06:05 AM
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In Reply To: Billy Boots's post @ Aug 16 2019, 07:29 PM

Hang in there Billy; we are 7 weeks away from FDA approval. In times like these just take a look at the 5 year graph of sp. We are about to pull up from this nose dive.

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Billy Boots
post Posted: Aug 16 2019, 07:29 PM
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In Reply To: badass79's post @ Aug 16 2019, 03:48 PM

I agree 100% there's so much bullshit going on with CUV, I sometimes wonder if it has been worth the stress over my 20 bloody years with these shares. The only good thing if we get dumped is knowing PW won't get his Soccer team. thumbdown.gif


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