A major reason was that FDA could not determine the individual contributions of BOT and BAL. This same concern with contribution of components almost led to a third CRL of Replimune's RP1 plus nivolumab in advanced melanoma. In Replimune's case, the melanoma expert community got behind RP1 and the adcom voted in favor of accelerated approval.Quote:why didn't the FDA grant Agenus accelerated approval for their 19%/23% ORR?
Dr. J might possibly be very aware of Agenus' situation and thus his reluctance to introduce an ICI...