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Re: meirluc post# 690932

Monday, 05/13/2024 10:21:10 AM

Monday, May 13, 2024 10:21:10 AM

Post# of 730856

1. The 150 fast track started with the MAA submission on 12/20/23


Your assumption. NWBO did not say this (even though they know when the clock started). There statement does not preclude that they were issued a Request for Clarification that they complied with and was certified in March. If so the clock start would probably be on March 4.

Even before 2024, MHRA decisions were not rendered more than a year from submission.


In 2023 (through Nov) the MHRA approved 9 new products that were not rubber stamping EMA approvals. Of those 9, 5 took over 400 days.

But I do like the general world -view that approval is prior to the ASM. Only 1-1/2 months until we here biosecinvestor explaining how it should never have been expected by then and it was just shorts projecting false timelimes.

And will repeat come Sep when the more reasonable timeframes come to pass.
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