Anonymous
Guest
Anonymous
Guest
There a few instances where FDA went against adcom. 2 were for cancer and the other was for hypertension.
Does anyone know the language that the adcom voted on? Sounded like they voted on Vascepa with Statin to reduce CHD events. If that is the case, I understand the no vote and wait for Reduce it. Is it possible to still negotiate with the FDA for labeling for reduction of trigs 200-499 in mixed dyslipidemia?
We're you on the call last night? Amarin said they have NEVER went against the adcom. Put the kool aid down and wake up