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Re: None

Wednesday, 06/21/2023 8:40:40 PM

Wednesday, June 21, 2023 8:40:40 PM

Post# of 701147
Adding one more to the list of excuses we may hear from loyal supporters for no PR in Q3:

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.

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

6) We are in rolling review. So don’t expect any confirmation for months because they could be going back and forth with the regulators over some queries.
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