i'm with lia. there's one valid point in his letter (#2), and as for trials 09 and 02 and 17 as mentioned i'd need to look at their designs and results closer. i tried to look them up on clinicaltrials.gov, but didn't try very hard yet as i'm working nights and hating life right now. can someone direct me to them with a link?

i don't think the FDA put any credence in this guy's arguments. if anything he makes 1 good point then shows his hand by whining about a bunch of nothings for the next 8. he makes statements like, "using my sophisticated computer program" (or something similar, don't make me read it again please) or, "a former FDA bigwig told me this thing has problems" (again, paraphrased gossipy BS). these are reaching statements, hearsay stuff. i think we were all happy when the FDA didn't require any new studies in first CRL and i think they did have a slight change of heart (or was mngmt not listening....). i bet the FDA was feeling a little butthurt about exubera's failures and speculations. i don't blame them for wanting more trials though with the new inhaler. and i'm sure there is a degree of corruption, to what extent i have no idea.

it would be interesting to know if he ever writes letters in favor of drug approval, since his company is such an advocate of humanity. i don't even know if the FDA even read this, and they probably didn't make it all the way down to his disclosure. honestly i think it had nothing to do with the crl. i do think he knew the fda was close to an approval though, which is a leak for sure.

as for looking at ANOVAs and p values, i'm not you're doc. i should look into the previous trials more and will as it is good DD. but not now. sorry i can't give you much insight. i don't like him, though. i read that expose on him that somebody here posted.

chad