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BooDog

04/05/19 12:31 PM

#259757 RE: PlentyParanoid #259752

I'll chime in. The EOP2 minutes don't need to be released, and imo, for the most part may be more confusing to anyone not familiar with the science. Like me, an engineer type, not a scientist. But we may still be able to decipher most of it.

But we don't need it.

The protocols, when announced, will be a result of not just the EOP2 minutes but possibly even more to ensure the integrity and potential elements that make the trial complete.

The whole back and forth about many subjects is just hot air. This included.

I suspect that the protocols will be announced concurrently with a license, AND funding. I think some patience can go a long way.

Have a GREAT Friday!!

$IPIX

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I am saying that making the transcript public may not simple matter. It may need FDA's permission due to confidentiality and might end up being redacted (what would say then?). I can be wrong about this - would not be the first time. I am fairly confident that Loanranger is willing to educate me.

On related note: have you seen any company making public EOP2 meeting transcript? Highlights as in: "FDA gave go ahead for P3 with these endpoints (plus possibly some safety related requirements)", but whole transcript? BTW: we already happen to know what endpoints for brilacidin in SOM are going to be, don't we.



And no, they don't release FDA meeting transcripts that I've seen. It comes out in the protocol.

Jeez people!!
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frrol

04/05/19 1:24 PM

#259762 RE: PlentyParanoid #259752

We know the FDA OK'd a phase 3 and told us how it would need to be (protocols, endpoints, etc) to be deemed successful. And the little we were told made sense. It would be shared with any potential partner. The pharmas would consider that and all of B's anti-inflammatory data to date (the B-OM and B-IBD phase 2's) to make a decision.