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Re: flipper44 post# 605501

Thursday, 06/29/2023 9:11:14 AM

Thursday, June 29, 2023 9:11:14 AM

Post# of 701209
Agreed. Q3 will come and go and excuses will keep piling up.

I wrote about these excuses a few weeks back. Some of this will likely trend as we move into late 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. They want to trap shorts!

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