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Re: manibiotech post# 673971

Thursday, 02/22/2024 3:30:40 PM

Thursday, February 22, 2024 3:30:40 PM

Post# of 701425
The FDA doesn't care what happens with the MHRA. DCVax wouldn't make it through an FDA Adcom if it is ever submitted.

If the goal was to get it approved worldwide, submitting to MHRA first makes no sense, regardless of them trying to get it approved via the "swift approval process".

If they thought the FDA would approve it based on the P3 the company would have submitted to the FDA first and then approval from MHRA would be near automatic:

From 2024, [the MHRA] will move to a different [regulatory] model, which will allow rapid, often near-automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe and Japan.



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