Your question, "WHY? Why was this data not allowed in one or two of the clockstops to be introduced?"
Me: I think it probably was introduced to CHMP during those clock stops....because according the the question I asked AI just now, it seems we can't bring that data to the re-examination. It was "available" to CHMP and to Anavex before their opinion. If Anavex did not give it to CHMP before the opinion - like during the clock stops - they can't do it now. If they didn't give it to them earlier then they blew it.
My Q. to AI:
Can data acquired after initial submission but before the opinion be presented in the re-examination?
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"No, data acquired after the initial submission but before the initial CHMP opinion generally cannot be presented during the re-examination procedure if it was not part of the data package available when the Committee adopted the initial opinion.
The EMA guidelines explicitly state that the re-examination procedure "may be based only on the scientific data available when the Committee adopted the initial opinion". The purpose is to allow the applicant to address specific points of the original opinion using the existing scientific data, rather than introducing new data or information that the CHMP did not have the opportunity to assess during the initial review phase.
Data generated or acquired after the initial submission would typically need to be submitted as part of a new, separate procedure (e.g., a post-authorisation change or a new application), as it falls outside the strict scope of the re-examination process.
For further information on the re-examination process and documentation requirements, refer to the EMA Procedural advice for applicants on re-examination of CHMP opinions."
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