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Friday, May 10, 2024 10:31:02 PM
Nonetheless, the biggest part of any such inspection(s) is to inspect the readiness of the underlining manufacturing process which has already passed although at the time the MIA was issued the MAA had not been submitted yet. But essentially they are the same. I don't think is necessary to inspect it again/
So if other inspections are still required, they would be minor in comparison with manufacturing inspection part.
Then, there are two scenarios:
A. If MHRA deems those minor inspections are unnecessary or if it has already inspected before during compassion use approval process, etc., then the approval may come any day in the near future; and
B. If MHRA's inspections occur shortly after 10Q, ie today, then it won't unreasonable to expect the approval may occur before ASM by the end of June.
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