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biosectinvestor

12/02/21 3:05 PM

#423438 RE: hoffmann6383 #423436

Yes, it was a while ago. A few weeks or months ago I was looking for the language and had to go back further than I thought. And since most of the time such info is reiterated in subsequent filings, I presumed they had made the application and no longer were able to discuss it.

I took it silently as a bullish indicator though it can be taken any number of ways. Just all IMHO.
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exwannabe

12/02/21 3:15 PM

#423444 RE: hoffmann6383 #423436

On one of your points, the 12-31-20 10k form was the last mention of a fast track approval process. Since that point they have been silent on this subject.


It has been in every 10-K for years and never in any other filings.

BTW, Fast Track is a program that is normally applied for in mid stage development (before a P3 is even started). It is similar to Breakthrough and RMAT. It is to grease the wheels leading up to the BLA submission. None of the change the approval timeline.

EDIT: Might be in an S3 also. But last of those was a few years ago.