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exwannabe

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exwannabe

Re: hoffmann6383 post# 423436

Thursday, 12/02/2021 3:15:51 PM

Thursday, December 02, 2021 3:15:51 PM

Post# of 699712

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.
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