3 ms·
Okay, but Biogen has 9 years to do the confirmatory study and they've indicated that they'll take their sweet, sweet, time with it. Also, it's not like we have
by wyxuan 5y ago
Okay, but Biogen has 9 years to do the confirmatory study and they've indicated that they'll take their sweet, sweet, time with it. Also, it's not like we have 0 evidence: we have two, 4-5 year long studies that show how well it works: and the benefit in one was marginally positive and the effect of aduhelm was negative in the other.
Sarepta's Eteplirsen was in a similar situation: little data to back it up and a very controversial decision. They also had to do confirmatory studies, but it took them 3 years after the approval was done for the study to begin.