Theralase Technologies Inc. V.TLT

Better assessment over the next 3Q of the famous 450-days CR

[ScienceFirst]

Each 3 months until late 2022 will allow us to confirm how we progress toward the 450-days CR % of at least 33 patients.  

So we won't be left in the dark until late 2022.  Within days, we'll have an update to see if we have improved our odds since Nov. 29.  Then, in 3 months (June), the picture will get even clearer.  Then, in Sept, we will get an even much accurate statistical significance of what we can aim for in Dec 2022 for a 450-days CR of 33 patients.   The higher we score, the more improbable it will be that the remaining 60 patients could reverse such trend.  So the moment for the FDA Breakthrough designation.

[Johnandrose22]

ScienceFirst....Thanks....Your timeline is clear and reasonable. Quick question for you or others on the board....Could Breakthrough Designation and Accelerated Approval be granted by the FDA simultaneously...or, are these clinical goals distinct?

[robertshaw]

If FDA is smart enough to grant BTD to our TLD1433 Asap, the great honor is on FDA 's side...

[Johnandrose22]

Thanks, Robertshaw....agree'd