Thursday, October 23, 2025 12:08:27 AM
We have seen the relevant regulation quoted on the board.
Which quoted regulation? This one?
A conditional marketing authorisation may be requested by the applicant together with the marketing authorisation application, or proposed by the CHMP (after having consulted with the applicant) during the assessment of the application.
Of course, the CHMP need not go strictly by the guidelines and conditions may be part of the assumed approval, but it would still be a full approval. IMHO.
For these reasons, I interpret the guidelines differently than most. I could be wrong.
IMHO
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