Monday, January 13, 2025 6:34:00 PM
The first thing that comes to mind is that maybe it’s common for applications to be denied prior to the first CHM meeting, in which case they wouldn’t appear in any of the minutes. But who knows, there may be some other explanation.
I appreciate the DD and info here.
Just an fyi for you, this scenario isn’t necessarily possible.
The MHRA isn’t allowed to outright reject an application. If they recommend rejection, it must go through a CHM review first as a matter of procedure. The only way to skip CHM review is with an outright approval.
That being said, I don’t know how things work behind the curtain. Maybe if MHRA want to reject, rather than going through a CHM review, they can simply relay to the sponsor that they would recommend withdrawing/resubmitting. Who knows.
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