RE:Great News before Christmas ?Eoganacht wrote: As of August 20, 2021 Theralase had treated 24 patients in the phase 2 trial and planned to treat one more patient before the end of September for a total of 25 patients. If this was accomplished, 3 month data for the 25th patient should be available before the end of the year.
By the end of this year then, we should know what percent of the first 25 patients achieved a CR at 90 days. Whatever that percent is, it is not likely to change very much in the succeeding 360 days, as this treatment has demonstrated a high rate of durable response after an initial CR. So - sticking my neck out here - before 8 weeks is up, we may be able to guestimate the 360 day CR rate for the 1st 25 and have a good idea whether or not accelerated approval is likely to be granted. In my opinion this could be a very potent catalyst.
The first 25 include 12 patients who were initially undertreated and Theralase will continue to treat patients throughout 2022. When the application to the FDA goes in at the end of 2022, included will be the 360 day CR rate of the first 25, plus whatever other CR data has been collected throughout the year for patients who have recieved only optimized treatments.
In my humble opinion an sp below 30 cents in 2022 is very unlikely.
Over a larger sample of treated patients, those first 12 who were under-treated shouldn't significantly impact the ultimate durable response rate imo. However, in the short term, as more patients receive a primary "optimized" treatment, I'm anticipating we will see a corresponding increase in the CR rates. Any proportional increase we can achieve in the CR rate in the near term with optimization should help accelerate the BTD/approval process imo. I'm betting the FDA will take a more favorable look at optimized vs non-optimized patients.
I also can't ignore the number of patients in the Keytruda trial who ultimately underwent subsequent bladder removal. Of the 79 patients (80+%) who had persistent or recurrent disease after Pembrolizumab treatment, 36 (46%) ultimately had their bladders removed. Certainly need more patient-friendly, bladder-sparing options for these unfortunate people...it's only a matter of time in my optimistic opinion : ). Good luck...