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Re: None

Friday, 10/02/2020 5:32:02 PM

Friday, October 02, 2020 5:32:02 PM

Post# of 698578
It seems there are two prevailing theories for the delay, both of which stem from calls with DI but are quite different:

A. They haven't PRed a delay since the update/TLD is just a few days away, and no sense in doing PRs a few days apart.
(post 313618)

B. Delays per interactions with the gov/FDA--perhaps discussing the SAP or BLA and response time is longer per COVID.
(posts 313304, 313310, 313410)


Option A implies TLD (or at least DL) early next week, B could mean weeks or months if they're trying to get full buy-in from the FDA on SAP before unblinding...?
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