Theralase Technologies Inc. V.TLT

Chewing the fat. .5 .7 1. doses thoughts

[floatinketucky]

The Study will consist of patients who will undergo two (2) PDT treatments employing 0.70 mg/cm^2 of TLD-1433 at Day 0 and Day 180.
https://www.clinicaltrials.gov/ct2/show/record/NCT03945162?term=TLD-1433&draw=2&rank=1

ok we see who is listed to be included in the study.


In phase 1 study:
3 patients got .35 (half a dose)  100% CR AT 90 DAYS  pr-November 8, 2017
3 patients got .70 (full dose)        67% CR AT 18 MONTHS

This is what I find interesting at least one dirty dozen phase 2 patients got 30 percent under treated or a 70 percent dose. Almost smack dab in the middle of the half dose and full dose. 

Also the phase one study ended at 18 months so no further data was reported. Like the 24 month data...   

You can expect the bean counters to be salavating over the 30 percent under treated data.


So if a patient didn't get (2) PDT treatments employing 0.70 mg/cm^2 of TLD-1433 at Day 0 and Day 180 then they really didn't qualify for the study. 

[enriquesuave]

On average the 1st 12 patients of PH2 got undertreated by 75% and not 30% .  In PH1, of the 3 patients treated at the high dose, only 5 &6 got an optimized treatment, not patient 4.  We need a good 10-15 or more patients in a row treated with optimized procedure to be able to confirm approximate level of efficacy IMO.      

[enriquesuave]

However when we get next data if 2 out of 3 or more from patients 16,17 and 18 are CR , then we should fly IMo, that would be very impressive.

[O12009]

Does anyone know when patients 16,17 and 18 received there first dose ?

[Eoganacht]

Quite right. The results for 20-24 patients who have received the optimized treatment will reveal the genuine efficacy numbers for Theralase's NMIBC ACT. If the FDA uses those numbers to make their decision, accelerated approval is extremely likely.

[floatinketucky]

Summary: The total of these Study II variances (Study Drug Volume, Study Device Volume and Study Device Treatment Time) have led to all 12 patients being undertreated by the Study Treatment from between 30.9% and 154.3%.  PR-July 30, 2020 I never was a fan of the 75 percent average. Thats not in a pr anywhere. But PR-July 30, 2020  we see at least one patient recieved 100-30.9

[floatinketucky]

I'm solid on the science. It is moving into good production. Only slight scale problems with 1-12 and its all been resoved. I'm completly relaxed looking to pick me up another 100,000 shares. 

[fredgoodwinson]

Yes Float they seem to be back on track and with Rutherrin and the Vaccine as kickers they`re really not looking that expensive atm IMHO. DYOR.

[CancerSlayer]

Aaahhhhhh....thanks float.  What a nice respite from the madness.  Can always rely on you to relieve us of TLT tensions.   Too bad I'm tapped out like the others...but at least now I'm feeling relaxed about being poor ; ).  Good luck...CS.

[floatinketucky]

Thanks...   TLT   It's going to be good!!

[enriquesuave]

Correct Float , 1st 12 patients received between 69% and 13% of the treatment and they still managed to get a 25% CR and 14-15% PR..  From now on at least treatment is Optimized to not under treat.