News Focus
News Focus
icon url

Hosai

01/21/25 12:27 PM

#481197 RE: boi568 #481196

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
icon url

williamssc

01/21/25 12:53 PM

#481204 RE: boi568 #481196

Having Blarcamesine off the market only helps shorts and big pharma. Blarcamesine is a proven safe and effective oral delivery. Our great need is what got the less safe intravenous mabs approved.