DEWDILIGENCE >The slowness of the BLA submission—16 months from the time that the final 9902a were reported until the last BLA module was filed—suggests to me that DNDN was in no hurry to get the BLA done because they themselves do not expect approval on the first review cycle. <
So are you suggesting that DNDN filed this BLA for the veneer of it and for eye candy for the shareholders even though in their words the FDA encouraged them to do so?? I have a hard time believing they would waste millions of dollars and significant time and effort in something they didn't believe they had a decent shot at. Additionally, weren't you the one on the yahoo message boards that said DNDN would never submit a BLA based upon these two studies - that basically it was a bluff? LOL