RE:RE:RE:From 6 months down to 5 months approval time...bio,
i like loe's analysis found him wimpy on price targets (binary event outcomes should have two target prices, one assuming positive outcome a second assuming negative outcome)...AdCom's are IMO a "confidence" game no more and no less..i assume panel members are honest but very risk adverse and all FDA BD's i've seen are "negative" (ie pointing to the risks and consequently asking for advice) which is perfectly as it should be...propenents then need to convince the panel either via its submission or in-meeting commentary...IMO whilst MCNA data package was what it was the leadership of TST failed miserably in the "confidence" game..my hope is that as Adcom was not a complete blow out negative that the FDA goes with the entire view and gives approval.
eg. example of failed execution, when one chemo bomber asked about pricing, TST response was pathetically inadequate but i don't blame the TST responder i blame TST leadership as CEO or COO should've been there and responded (as TST responder didn't have the org authority over pricing)...and response shoulda been simple "this is not the venue to discuss pricing" (which BTW it isn't) TST was playing checkers in a chess match and sucks for shareholders.
regards.