If the completed BLA were submitted I believe we'd be assigned a PDUFA date. Here's a link to the FDA Calendar and best I can tell, we're not yet on it.
I believe that they may very well be doing a rolling BLA, I'm uncertain if it can be done with all 4 regulators, or if some don't permit it. Who knows, the completion and inspection of Sawston may be the last thing that's needed for the submission of the complete document.
I believe that most PDUFA dates are set 6 months after the complete submission, however, in the case of the rolling BLA I'm uncertain if they would put it on the schedule with under 6 months, or more likely they could make a decision well before the PDUFA date.
Perhaps someone here knows if when the FDA agrees to a rolling BLA will they return a submitted part of it requesting a modification prior to the submission of the entire document. I would hope that an advantage of a rolling BLA would be the FDA recommending changes up front, before the submission is considered fixed and changes will result in approval delays.
I believe that submissions to the FDA are rather like what Astronauts face knowing they're sitting on something with millions of parts that all were bought from the cheapest supplier. I'm told that BLA's have millions of pages, that may be an exaggeration, but the idea that something on just one of them could result in a delay, or denial. There should be an easier way of getting drugs approved.
Agree with the Ken Lay assertion. Enron was the ultimate old boys club. LP certainly seems to have a pair (hopefully full house or better), but not likely party to the club not in this space/endeavor…..Otherwise Lay’s position on the list would be at risk.
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