Some whine on TLT management, depict them as poor managers. That's probably coming from those that lack vision, when TLT is working for their own investments! We had similar reaction from Bungee and some others when we had no news for 6 months between Ph. 1b p#4 and p#5, while TLT was working on an optimized procedure!
In the Jan. 3rd Biotuesday, there was this interesting info below that went unnoticed to many and that might potentially explain why the submission of the FDA Breakthrough Therapy in Q1. (so potentially up to March 31).
If you look closely, there is a pool of 5 more optimized patients within 3 months (p#30-34), between 360 and 450 days. And we also know that p#26 was in the Nov. 30 data and reached its 450-days around mid-November. So lets assume for a moment that TLT could add 5 more by mid-March. That would mean they could exclude the first 50% (6) of the 12 undertreated patients and submit data on p#7 to p#31, for a total of 25 patients, 20 of them being optimized patients. That would di-facto increase their efficacy %s both @90-days and 450-days. Such improved efficacy %s would then appear in the FDA press release, which is what matters the most. We could then be above 60% @90-days (instead of at 53%) closer to 35%+ @450-days (instead of at 28%). Attendance at ASCO-GU and AUA would then see an additional progress since what they saw on the posters.
In November 2022, Theralase reported encouraging interim clinical data from the pivotal clinical study, with 53% (43 evaluable patients) achieving a complete response at 90 days; 29% (34 evaluable patients) at 360 days; and 28% (29 evaluable patients) at 450 days.