Still Early But in next few months as we get a bit more data picture will be more clear. We are still affected by 1st set of 12 as we don't have enough 360 -450 day data on fully optimized ( 2 optimized treatments). . In the Optimized group, they added the 4 patients from 1st set of 12 who got an Optimized Treatment. Only one has remained CR for 450 days. I do believe we would have gotten perhaps 1 more CR at 450 days if they all had had a second optimized treatment. Also we are counting patient who passed away as a Nonresponder. These 5 patients are bringing our numbers significantly lower at 180 days and beyond. Until we treat another 10 or more patients these will still weigh down on 360-450 days data. However I'm sure that in their discussions with FDA for BTD, they will be explained in detail.
The market overreacted and did not fully understanding preliminary data. Vastly better than Keytruda or Vicinium so far. IMO. 60% CR on 20 evaluable patients of Optimized group (3 still pending). 12 out of 20 are CR and 4 out of 20 are PR ( have the possibility to be CR if UTUC is found). That would make 80% CR at 90 days ( double the CR rate Vicinium or Keytruda). From the 4 Nonresponders one was a patient who died of heart failure before 90 days but still counted as NR. One Single Treatment. The 180 days data and on include the 4 who received Optimized maintenance treatment only, hence CR drops to 40% on evaluable patients as they unfairly bring down the numbers. The next data readout will be very telling by looking at the 270 days data, as 16 patients are still pending ( 59%,). We are only seeing data from11 patients ( 7 primary optimized and Optimized maintenance treatments and 4 from 1st set of 12 and not to forget patient that passed.) We will see how many maintain CR and how many convert to CR status after a 2nd treatment. The FDA will be extra hard on competition when they see this data as they will have no choice but to favour a patient friendly treatment with better efficacy and less treatments. IMO of course. I would suggest that PR patients get screened for UTUC as early as possible in order to get reclassified hopefully to CR. As such property evaluate efficacy and not get fooled by potential reseeding of cancer in the bladder from upper tract . Just IMO