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Re: Doc logic post# 623689

Wednesday, 08/23/2023 4:24:45 PM

Wednesday, August 23, 2023 4:24:45 PM

Post# of 703809
BS. You apply for a single indication in one jurisdiction as quickly as you can when you are struggling to keep the lights on. You don’t waste time and continue to finance at depressed valuation when you have had an opportunity to submit UK application for GBM soon after MIA in April. They are hiding some things and it will become obvious to folks when we approach the end of the year with no news.

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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