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Re: meirluc post# 773145

Friday, 06/27/2025 1:33:12 PM

Friday, June 27, 2025 1:33:12 PM

Post# of 822566

Since we have not received such a PR, it is my guess that
the MAA was not referred to the CHM because it has been encumbered
by major objections.



Perhaps, it was referred to the CHM to consider all solid tumors...That is what I believe and I will certainly get ridiculed for it.

That is why I believe, the request for RWE was requested...Submissions end Monday so it's interesting the timing coincides with the new regulation on patient specific manufacturing....All those special patients and positive results will be considered in the approval process. To ignore those results is tantamount to malpractice IMO.
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