how good was TST's preparation and AdCom Strategy???..so concensus seems to be that AdCom execution failed miserably, just check the vote, but i gotta wonder was the failed execution built on failed preparation and strategy...
..i wonder this for many reasons but based on this one alone primarily, i forecast the vote would have been 16 yes and 6 No (i didn't expect the full 25 panel to vote) and i broke it down as such: i had 7 bladder cancer folks who i thought would all vote yes, i had stats and chemo (fojo???) voting no and then i had 9 "soft" yes votes (like folks in brain cancer, etc. but somewhat unsure given their affliations with MD Anderson, etc.)
..we had also read that in fact TST did "faux" AdCom's with various experts but i wonder if their practice sessions really focused on the likely negative commentary that may occur (which is a broad measure but basically is all the non-301 related stuff) and i ask this as they seemed unable to communicate well on some difficult items and i will use one example in particular:
- one member who i've posted on before stated that he believed only 3 responses in 93 patients could be directly attributable to MCNA...that was a stunning statement (it was backed up with appropriate commentary IMO) for which TST had no really good response and IMO was a signficant contributor to the no vote..
maybe it seems that TST hadn't prepared well enough for a difficult session and if i could easily estimate resistance TST should have banked on it and prepared for it.