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Re: DavidW2 post# 615372

Monday, 07/31/2023 9:26:06 AM

Monday, July 31, 2023 9:26:06 AM

Post# of 723941
A month or two back, I said couple of these excuses will gain traction as we approach fall.

1) The focus has shifted to FDA now? UK not number one priority anymore. So need more time to line up CRL and other million BLA pages?

2) Now applying strategically via Project Orbis. All RAs at once. Need extra months.

3) Flaskworks certification given off label demand considerations!

4) Tissue agnostic approvals is being worked on.

5) No MAA acceptance PR. Need to wait until final MHRA approval (in 2024?) for the big reveal.

6) Rolling review already in the works. Approvals can come anytime.
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