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Re: exwannabe post# 806607

Saturday, 01/03/2026 1:27:32 PM

Saturday, January 03, 2026 1:27:32 PM

Post# of 818702
Yes, as you point out, a second meeting does seem to be to delve further into major issues, but these second meetings also address COMPLEX issues - be they objections, as you point out, OR as of yet, UNRESOLVED issues including many other topics including new scientific evidence, new indications, changes in classification, further consideration of orphan designation, etc., which cannot be resolved through written responses alone. Specialists and patient representatives may also be invited to present their views or findings at these meetings.

So a second CHM meeting seems to be a regular and planned part of the MAA process to ensure a proper and thorough response to a complex medicines application, which I think EVERYONE here and everywhere, would agree DCVax-L represents.
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