RE:joking asideGoBBs wrote: The fda set the pdufa date ..the only official response is their response. PLI can pre-empt them but thats just their version of what wennt down. The only official response for the bla review is from the fda...so IMHO they should do their job. We'll see if they do.
OMG what do you want the FDA to say?? They told PL about the deficiencies and PLI did the news release... (I’m sure right when they found out about the problem - eyes rolling). Since PL and crew bragged MANY times about being in “constant contact with the FDA” how could this screw up have happened. Personally I wonder WTF went on that cause a YEAR DELAY when they were supposedly in “constant contact.” Someone screwed up BIGTIME. I have VOTED PL, needless to say not for you or your motions. Time to go. If YOU are in constant contact with the FDA and this is the result then you don’t have the capacity for this job.