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Re: Biobillionair post# 220378

Tuesday, 10/22/2019 1:42:35 AM

Tuesday, October 22, 2019 1:42:35 AM

Post# of 426283
There is no spin.

What was said was true. Very very few drugs get accelerated assessment and the ones that do are usually for cancer or hereditary diseases. This has nothing to do with Adcom.

Only FOUR drugs received AA in 2018.

https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2018_en.pdf

Praluent, Repatha, Esperion’s bempedoic acid also did not get AA.

The difference between AA and standard review is only 60 days. This is really not that big of a deal.







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