RE:RE:RE:Everyone should just take a step back and calm down.dam, here is what i believe/know:
a) companies receiving CRL's rarely if ever give a full account of the failings (FDA did a study confirming this as they are concerned about "truth")
b) FDA had a range of options available if uncertain (like asking for more data) but i suspect had determined it had enough data
c) re. 2nd trial, that is pretty much FDA SoP and as MCNA failed in PIII to confirm PII it IMO tells FDA that TST doesn't really have a handle on MCNA (which is likely true)
d) those people are SOL (but are they??? as FDA seems to believe that MCNA doesn't offfer them benefit either)
e) safety was fine but all PIII's will prove safety and efficacy and if stats is an issue redo all...
..again IMO AdCom was a strategic failure and likely was signficant in FDA's decision, I had TST as a split win going in, but they suffered a split loss, failure was TST didn't present to gain confidence to convince...shame on CEO and COO for not leading the team, never seen it before