RE:RE:RE:RE:CONFUSEDGoBBs wrote: There are two timelines, one is just to accept the BLA , is it acceptable to the FDA or not ...does it meet their filing requirements or not ..thats what was supposed to be a 60 day response from the FDA. The second timeline depends upon we are granted a standard 10mos or priority review 8mos. They make sure the filing meets the requirements and then when it does they do the review. Anyway we're way past the 60day mark obviously but you will have to ask PLI management why....if they tell you , let us all know :-)
WEll absent any other information, and I've ask asked the company but they can't provide anything, I'd have to guess based on what you wrote GoBB that the PLI submission was NOT adequate... otherwise we'd have aurely heard what kind of review we are progressing with. That, or the entire process is just that far delayed... which I personally don't feel is as likely.