Theralase Technologies Inc. V.TLT

BTD application

[Eoganacht]

29 patients have now been evaluated at 450 days. 3 of these were from phase 1 so 26 phase 2 patients have now been evaluated. Submission of the BTD application to the FDA could happen at any time and the FDA will then have 60 days to respond.

[Legit62]

Eoganacht, whats your feeling on these results? BTD?? 

[Eoganacht]

I think they're great. If the 3 partial responders at 450 days are reclassified CR that will be a 450 day CR rate of 38% - double that of Keytruda which received FDA approval.

[enriquesuave]

The FDA will look at all data and take into account increasing CR as the initial 12 patients have less of an effect on numbers the more we treat.  Awesome numbers IMHO 

[enriquesuave]

7 out of 7 newly treated patients seem to be CR at 90 days. In August 19 out of 38 evaluable patients were CR.  Today 26 out of 43 evaluable patients are CR.  Awesome improvements.IMO  Aug  38 evaluable patients:         19 CR  patients = 50% CR.          6 PR patients = 16 % CR  Total =66% responders Nov. 43 evaluable

[Legit62]

Great explanation of the numbers sounds like we could have very bright couple months in front of us

[enriquesuave]

Also a nice 9 patients have been treated since last MD&A in August.  Pace of treatments seems to be picking up.  August was 42 patients plus 3 from PH1 for total of 45  Now it's 51 plus 3 for total of 54.  The 7 pending from August all seem to be CR as numbers went from 19 CR to 26 CR patients.  Can't get any better. IMHO   

[Eoganacht]

7 out of 7 pending patients all CR! That really is awesome! This trial really seems to be hitting it's stride!

[DJDawg]

Hold on everyone. I'm pretty sure that there are only 4 new CR's at 90 days. Not 7. Read the way they changed the terminology.

[enriquesuave]

  5 new patients were evaluable and we got 7 new CR at 90 days, so perhaps 5 out of 5 new evaluable patients are CR ( 2 of the 7 are still pending) and 2 patients became CR from previous 38 and are no counted CR also at 90 days.  Still numbers are improving extremely well IMO   Even at 450 days, we are now at 28% CR plus 10% PR potential CR for a total of 38% total responders Vs in

[CancerSlayer]

  Very exciting news!... My take Enriquesuave:  We got 4 new CRs at 90 days (went up from 19 in August to 23 now) & a total of 7 new CRs at any point in time when including the 1 pt. at 180d & 2 pts. at 270d.   Regardless, the CR numbers continue to climb, indicating that an optimized treatment protocol works....And more than likely, the offering of an additional

[enriquesuave]

Correct  you and Dawg got that right  I just read that note at bottom of chart.  Yes so 4 out 5 newly treated patients are CR, and there is a new PR patient, so probably 1 out of the new 5, still amazing.  

[enriquesuave]

This high efficacy shows that probably more treatments for those not Cr or PR would lead to increased efficacy.  So far this looks like heading to an efficacy of over 80% total responders.  IMO  Also, the fact that Cystoscope exams are still clear at 450 days highly points to the probability that all or most PR patients at 450 days have a high chance of being CR, and that suspicious

[CancerSlayer]

Yes, I agree there is a strong likelihood that a not insignificant % of IRs will be re-categorized to a CR.  Ultimately, I could also see a % of patients showing an improved response to a protocol that involved more frequent &/or a higher number of treatments.   And from what I can gather, the cystoscopy results can be heavily dependent on the type of cystoscopy used (white vs blue

[CancerSlayer]

Amazing indeed...of the 5 newly evaluable patients, 80% had a CR at 90d, & possibly 100% depending on further eval of the IR patient.  What represent huge buy signals for me is...1). Our 450d CR rate has increased by 33% (21% to 28%), lending additional credence to the fact that the timely protocol modification became a welcomed blessing in disguise & 2). The current 28% CR at 450

[Infinity]

Enriquesuvae and Eogonacht,  Thank you for bringing clarity to this board..   Much appreciated.

[Mikee3003]

Just a matter of time before the market recognizes that TLT is on big pharmas acquisition shortlist.  Warren Buffet: "The stock market is a device for transferring money from the impatient to the patient" TLT shareholders all know the definition of patience! BTW - Whether you like the management or not we all want the same.....MASSIVE RETURNS! GLTA

[Legit62]

Totally agree, BTD and AA sets us in cross hairs

[StevenBirch]

Thanks Enriquesuave, a pretty good increase in the pace of newly treated may be the nicest surprise in this update. That is a validation far more important than an uptick in the stock price.

[99942Apophis]

Wow  wow  wow, now we do know as predicted by many here it keeps getting better. 

[blackjack0]

Could the people doing the procedure be learning from previous experiences and now they seem to have it down pat. Thoughts?