Above the unachievable??? Quite possible that the "by end of Q1" "delay" to apply for Breakthrough Therapy might be to make sure we're above the "30% may not be realistically achievable".
We had patients #27-31 that were due couple of weeks after the Nov. 30 financials. Delaying a bit the FDA application to have them in our pool of data for the FDA would make a lot of sense to put all the chances on our side and be above what seemed realistically unachievable by the IBCN led by no one else than our MSAB Dr. Kamat! All this with 12 undertreated patients!
The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in 53% of patients evaluated at 90 days and 28% of patients evaluated at 450 days.
Even before Keytruda turned in disappointing response rates, the International Bladder Cancer Group had deemed the FDA's 30% durable response at 18 to 24 months criterion as "likely too high and may not be realistically achievable."