RE:2 weeks: It’s all it took for Merck to get AAScienceFirst wrote: 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
Nice find SF....Considering we are not a systemic drug (fewer reported side effects & less risk for serious adverse events), we are only a 2 dose treatment (vs 30+ doses for a full course of Keytruda; bladder instillation time of ~2 hrs vs IV infusion time of 15+ hrs), our current 12 month CR rate is trending significantly higher (28% vs 19%), & the total cost of our two-dose treatment should be well below that of Keytruda's (full course of Keytruda has been estimated to cost in excess of $300K US)...we have earned a seat at the front of the table, & any FDA response that takes longer than 0.5 to 1 month would be insulting. JMO.