I think BTD will come first and would've have positive
I think BTD will come first and would've have positive impact for FDA approval
I am sure IPIX had medical trial statistician on stuff to assess the power of the trial before trial was open for accrual , so 30 patients could be sufficient number to analyze the statistically significant end-points.
FDA could ask or not for more powered trial for confirmation
As OM is such debilitating and potentially fatal condition with no SOC , I think pressure will be on FDA to grand the approval.
Results of PII B-OM trial are very compelling to me as an investor and MD.... no doubt about it !!!!
I do hope "wisdom" of decision makers ( FDA) will prevail.
This IMO
cheers to all faithful longs
6
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