Re: SA article - Omeros: Competition Is In Trouble
Sleepy:
Where you been?
"Technically (legally) the 12 mo clock begins when the last part of the submission goes in, and usually thats the clinical data, which takes the longest to review.
Rolling BLA does not do that much for the timeline."
Scratching my head here. Where does this 12 mo clock come in? Not sure what you are referring to? You sure about that? Its my undersatnding, but I'm not an expert, that a standard PDUFA date time line is 10mos. I need to double check that. And expedited review I believe cuts that to 6 mos. Again, that needs to be verified. But I'm pretty sure there is no 12 mo clock in this process.
And its my understanding, could be wrong, but the purpose companies covet the FDA agreeing to a Rolling BLA was in fact to expedite the process. Otherwise, what is the purpose of doing it at all?