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Msg  14456 of 14491  at  7/29/2022 7:07:15 PM  by

schmiggins

The following message was updated on 7/29/2022 7:10:28 PM.

 In response to msg 14455 by  redplate
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Re: FDA filing

Not sure how anyone can be surprised, though. Once we saw final confirmation of all positive new data a few weeks ago the calendar took over and made an AA submission a no-brainer. And I see Mr. BiotechObserver on twitter saw (or now sees) that too. I quote:

BiotechObserver:

"Accelerated Approval filing is a no-risk proposition for FDA.
Phase 3 topline readout will be available by the PDUFA.
FDA's decision will be made for them by the trial results.
To bet on AA, you are actually betting on positive Ph3 trial outcome.
For $SRPT, it means that In the event of a positive phase 3 trial, they will not need to then begin the process of filing a BLA, submit it, and then get a PDUFA for 8 months later in order to commercialize.
It creates a mechanism by which, IF trial is positive, they get to market nearly immediately."

I don't know why our clever analysts are so dense, but possibly they are just afraid to "go out on a limb" that is really as thick as the trunk itself.

Meanwhile, "the fall" seems very slowish for submission, since Doug had just told us it was essentially ready to go three weeks ago. Possibly it's the calendar again. In other words, he wants data from say 40 or 50 phase 3 trial boys to have to show the FDA ... let's say a month before the PDFUA date. We probably will have that much data by March 2023, we give it to FDA by April, and they can grant approval in May.

I think PDFUA's are maximum a 9 month wait after submission but I understand that with great data they need not wait until the last moment. I would ask Doug on Tuesday how many boys we had dosed by March 2022, and if it's 40 or so. then I'd give Sarepta a month to compile it and a month for the FDA to look at it.

That will give you your approval date pretty much .... if you DARE to get real about it.



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Replies
Msg # Subject Author Recs Date Posted
14457 Re: FDA filing schmiggins 0 7/29/2022 7:14:10 PM
14458 Re: FDA filing redplate 0 7/29/2022 7:59:22 PM




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