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imho

10/23/25 12:08 AM

#504048 RE: Steady_T #504046

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.

This paragraph is in a section titled "Types of applications and applicants", talking about the literal application, not the 180 day review itself. This assessment event came and went in the first month of the process. If they meant the review process itself it would have read exactly that or similar (ie "data" not "application"). Furthermore, changing mid-review opens "disclosure" issues and other problems which CHMP and the applicant want to avoid.

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