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Wednesday, August 09, 2023 8:59:20 AM
As I highlighted couple of months ago, one of these excuses will start trending as we approach end of summer.
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 or ILAP. All RAs at once. Need extra months.
3) Flaskworks certification given off label demand considerations!
4) Going after 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.
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