2 weeks: It’s all it took for Merck to get AA 2 weeks!
It's all it took for the FDA to grant Accelerated Approval to Merck in 2020 for the same condition as ours.
That would explain our "Commercial revenues (projected)" milestone so close to the p#25 450-days.
Having superior data than Keytruda, it's legitimate to think that we could see similar response from the FDA.
First time I see this. For BCG-Unresponsive, Merck obtained the Accelerated Approval.
In 0.5 month!
BLA 125514 Supplement 79 4
KEYTRUDA
PEMBROLIZUMAB
MERCK SHARP & DOHME
4/14/2020
4/28/2020
0.5
PROVIDES FOR AN ALTERNATE DOSE/SCHEDULE OF 400MG EVERY 6 WEEKS FOR ADULT PATIENTS WITH BCG-UNRESPONSIVE, HIGH RISK, NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) WITH CARCINOMA IN-SITU (CIS) WITH OR WITHOUT PAPILLARY TUMORS WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY