the benefit-risk balance of the medicine is positi
Post# of 147672
(Total Views: 612)
Posted On: 09/15/2024 2:25:31 PM
Quote:
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.
Leronlimab in Alzheimer's, MASH, Long Covid, ME/CFS for starters. If by unmet medical need they mean a drug that could outperform anything else on the market without SAEs that list could be greatly expanded.
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