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Re: boi568 post# 481196

Tuesday, 01/21/2025 12:27:57 PM

Tuesday, January 21, 2025 12:27:57 PM

Post# of 518957
It would be absurd and wrong to deprive patients of trying the drug for that long. Just to remind of the EMA conditional approval guidelines:

the benefit-risk balance of the medicine is positive;
it is likely that the applicant will be able to provide comprehensive data post-authorisation;
the medicine fulfils an unmet medical need;
the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation
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