This FDA decision is really irritating me.  We have a proven-safe drug for chronic human  use.  With an underpowered trial, and with no effect on stroke, it still narrrowly missed a super high bar of demonstrating statistically significant combined MACE reductions in all 3 of the broad and deadly conditions set as primary end-points.

Maybe were not being assertive enough with the FDA.  Maybe, after today's FDA decision on such scant evidence, Resverlogix should be getting in the FDA's face.  Urging them, given the additional study results and Cell reviews and given our increased understanding over the last 18 months, that the FDA should at a minimum give apabetalone  approval for certain CVD conditions (not stroke) conditional to BOM2 proceeding but as a Phase 4 trial. 

How could the FDA, today, look Resverlogix straight in the eyes and say we don't have reems more evidence of effectiveness than what has just been accepted and approved for Biogen? 

We need to spearhead an FDA campagin and quickly.  Strike the iron while its hot with these relaxed approval rules.   


JMHO