What if Breakthrough Therapy was based on 20 patients???One last thing to consider versus what we see in the June corporate presentation milestones ...
Considering this:
MD&A of August 30, 2022:
on approximately 20 to 25 patients enrolled
Lets assume this scenario where the cut-off was p#20 (instead of p#25):
P#20 had been treated by June 11, 2021. So plus 450-days = Sept. 4, 2022. Lets add 1 month for processing results and sending them to TLT and we end up Oct. 4, 2022 for a submission. Then 60 days (2 months) for FDA to reply =
Dec. 4, 2022.
Knowing that p#1-12 had been undertreated, and that it weakened our overall numbers, it would have required impressive results from p#13-20 to convince the FDA. Assuming that these 8 patients all achieved convincing TR (CR+PR), and considering Ph. 1b p#5-6, it could have been enough data for the FDA.
That's probably why TLT then came up with a distinction between the overall pool of patients versus the optimized group (p#13+) in the Nov. 29, 2021 news release. Like if they had already done this exercice for the benefit of an earlier meeting with the FDA.
https://theralase.com/theralase-releases-3q21-financial-statements-and-newsletter/ An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:
- 7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days
- In the total population of 33 patients (@ 90 days):
- 42.4% achieved Complete Response (“CR”)
- 12.1% achieved Partial Response (“PR”)
- 21.2% are Pending
- 24.2% achieved No Response (“NR”)
Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.
Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.
- In the total population of 18 patients (@ 90 days), who received the optimized treatment:
- 44.4% achieved CR
- 11.1% achieved PR
- 38.9% are Pending
- 5.6% achieved NR
Hence, the potential for CR is up to 94.4%***
Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis.
In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR
So maybe a sample of 20 patients (with convcing results from p#13-20) was convincing enough after all. Instead of 25.