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Re: MinnieM post# 238767

Wednesday, 08/29/2018 10:20:45 AM

Wednesday, August 29, 2018 10:20:45 AM

Post# of 403131
Indeed. I'm certain we would submit the BTD app 'as soon as possible' and there is every reason to believe that that was greater than 60 days ago, and no reason to not announce a positive BTD decision, so it is likely we were declined. Our results are encouraging but had some serious hair on them, specifically the subpop where placebo showed 'efficacy' and B showed 'none'. That is tough to explain scientifically and the FDA might view this as justification to continue with thorough, un-expedited testing.

We'll eventually find out what actually is happening with B-OM. We do know we intended to apply, that we are in "negotiations" with a pharma, and that we have a deadline of Sep 30 if we expect to get more capital from Aspire.
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