Thanks for the reply. My understanding of the situation is actually very much the same as what you outlined. Here's my concern:
From the time the second cohort was added, a year has past. And the results of the year's work are that the company only now has revealed that they had to exclude samples from a significant number of participants. What is a significant proportion of 20? With 160 individuals screened in Phase 2, not having an adequate buffer to support the results is inexplicable.
And what exactly were the results? The PR says nothing about what the phase 2 study actually found.
With so much supposed expertise on board at BMOD, it's pretty ludicrous to fault the FDA. They just make the rules. Companies choose to play by them or not.
Bottom line: at no time did the company indicate procedural problems with the second cohort, and this borders on fraud IMO. To the contrary, they've as much as said all along that it was just a matter of routine analysis and collation of data from the study. And according to Cousins:
Video #1- CEO says “very good accuracy” go to the 2 minute mark on the video---
... Video#2—CEO says “very strong results” go to 8minute 20 second mark on the video--
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