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Wednesday, August 23, 2023 4:24:45 PM
They can speak about 1.7 million pages and 27 modules but not about what that actually means in terms of where exactly they are applying, when, and what indication? No one buys the crap anymore.
You are again back to one of these excuses I laid out a few months ago.
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) Rolling review already in the works. Approvals can come anytime.
Sounds like excuse number 3 and 4 is what you are going for! Will you be disappointed if only a UK application for GBM indication is submitted in the end?
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