News Focus
News Focus
icon url

iwfal

10/15/11 2:50 PM

#128528 RE: exwannabe #128526

DCTH -

The issue most talked about is that the safety records were incomplete, the FDA wanted the patients' hospital records.

The third issue, which is almost never talked about, was that the FDA wanted a statistics issue "clarified".



Tx. I was only reading the PRs - I haven't spent the time to listen to the cc's (which is where I presume things like this were mentioned consistent with small bio's desire to hide the damaging data).