Theralase Technologies Inc. V.TLT

Above the unachievable???

[ScienceFirst]

Quite possible that the "by end of Q1" "delay" to apply for Breakthrough Therapy might be to make sure we're above the "30% may not be realistically achievable".

We had patients #27-31 that were due couple of weeks after the Nov. 30 financials.  Delaying a bit the FDA application to have them in our pool of data for the FDA would make a lot of sense to put all the chances on our side and be above what seemed realistically unachievable by the IBCN led by no one else than our MSAB Dr. Kamat!  All this with 12 undertreated patients!

 

The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in 53% of patients evaluated at 90 days and 28% of patients evaluated at 450 days.
 

Even before Keytruda turned in disappointing response rates, the International Bladder Cancer Group had deemed the FDA's 30% durable response at 18 to 24 months criterion as "likely too high and may not be realistically achievable."

[N0taP00p]

There's only so many ways we can describe a zebra. See back posts from others on this topic with very detailed calcs.   Wait for the data. It's later than we thought but hopefully better than we thought. Let's hope AA comes attached. Let's hope TLT is the first candidate for the Frontrunner program.  Do some research on this if you have time to kill. 

[Rumpl3StiltSkin]

If this process drags on... And TLT isn't awarded AA until early next year. When that does come I think CR+IR %s could be up there pretty high... 60s 70s... :-) the 1yr CRs + IRs would be even higher. And that is the number Stock analysts might focus on?

[Rumpl3StiltSkin]

Personally, I think we can still achieve AA sometime in '23.

[ScienceFirst]

From this file:   2023-GU-ASCO-Poster-Presentation-02-01-2023.pdf (theralase.com)   we have evaluable 29 patients.   The breakdown is:   - 8 CR @450-days.  They appear on the top of the chart, all in black.  8 / 29 = 27.6% - 3 IR @450-days.  They appear in green, with an arrow, immediately below the 8 CR.  3 / 29 = 10.3% - 11 TR @450-days

[Oilminerdeluxe]

I seem to recall Dr. Kulkarni saying in a video that 3 out of 10 CR would be phenomenal.

[DJDawg]

The poster is nice for showing patient data but I did it slightly differently so that can see which NR's are DONE vs still being evaluated. I also did a conservative estimation of what to expect with next data release. Similar to what you found SF except I went with more cautious estimation on the IR at 360 to 450. For your interest https://postimg.cc/ZCZc2MkR

[ScienceFirst]

And this upcoming 30.3% CR @450-days includes 10 undertreated patients out of 33 evaluable patients!  Imagine the efficacy % without them.  That would give something like: - CR of 43% (10 / 23 = 43% CR @450-days)! - IR of 22% (5 / 23 = 22% IR @450-days) - TR of 65% (15 / 23 = 65% TR @450-days) - NR of 35% (8 / 23 = 35% NR @450-days) All this  with 2 doses that deliver