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Wednesday, June 21, 2023 6:58:47 AM
Let’s circle back in mid to late August to see where we are. Given that my theories are BS, you should have had at least MAA acceptance PR by then, if not MHRA approvals.
Here are some things to ponder until then:
Why was PIP not filed in late 2020 soon after data lock or even 2021? PIP application submission takes over 18 months?
Why was CRL or some other CDMO not used for UK? They didn’t need to wait 30 months for Advent commercial certifications. It seems they are open to using it for US application. Why not do the same for UK instead of waiting 30 months? Advent could have been added at a later stage once approvals were granted.
These are all signs of a bigger plan to time the various pre requisites to line up with phase 2 combo study completion date. Or are we to assume they are just terribly inept with limited to no organization, planning, and multi tasking skills? Which one is it?
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