Theralase Technologies Inc. V.TLT

November 2022 Upcoming Report

[RoseHeaven]

August 29, 2022 Report - # of Patients waiting for evaluation at each reporting stage 

1) 90 days - 7 patients 
2) 180 days - 4 patients
3) 270 days - 2 patients 
4) 360 days - 6 patients 
5) 450 days - 2 patients 

These are the patients likely to get evaluated and to be reported in November 2022 report. It is very likely that only 2 patients would be evaluated at 450 days by November 2022 report making the total number of evaluable patients 26, only 1 patient more than 25 patients TLT was aiming for BTD. 

If these 2 patients were evalauted as CR at 450 days (best case scenario), total CR pateints at 450 days to be 7 out of 26 evaluable patients brining CR to 27%.

I am expecting a big boots in CR at 360 days as 6 more patients would likely to have evaluated by November 2022 report.

Do you think 27% CR at 450 days is good enough for BTD?
Or TLT should wait for more patients to be evaluated at 450 days for BTD? 

Thanks

RH

[ScienceFirst]

Riseheaven ... Merck's Keytruda had 41% @90 days and 19% @365 days.  And they required many more treatments than us  had more SAE and only suits approx. 20-25% of the eligible patients.  So our treatment has everything the FDA wants in a treatment: - high efficacy - little to no SAE - low # of treatments - no patient discrimination - stand alone treatment - high CR

[RoseHeaven]

Thanks SF, agreed! Feeling confident about investment in TLT as derisking continued. Cheers, RH 

[Eoganacht]

The criteria mentioned by the FDA when announcing the granting of accelerated approval to cancer drugs is ORR and DOR. The Astrazeneca website explains these criteria: Clinical Trial Endpoints in Cancer Research: Four Terms You Should Know Overall Response Rate (ORR)   Overall response rate, or ORR, is the proportion of patients in a trial whose tumor is destroyed or significantly

[DJDawg]

Great series of post last eve. I think that it is very helpful that a company can request an advice meeting regarding BTD with the FDA. As per the FDA website "Can a sponsor get preliminary breakthrough therapy designation (BTD) advice from the review division prior to the submission of a formal BTD request? A sponsor can contact the regulatory project manager (RPM) in the division to

[enriquesuave]

2 extra CR at 450 days would make it to 28% CR.  As well, PR patients will eventually be reclassified as CR or NR,  could be up to another 13% for a maximum of 41% CR at 450 days.  That would be on 26 patients where 12 were severely undertreated ( 5 of these were dropped without ever getting a 2nd treatment) and 1 patient who sadly died of heart failure ( counted as NR)although this

[CancerSlayer]

  I think you're right about the FDA knowing more details than we think...and considering our ACT is a non-systemic, highly efficient (two-dose) & stand-alone option, I think the minimum %CR needed for approval may be lower than some anticipate.   In addition to consideration of drug delivery (I.e. systemic vs non-systemic), the CR threshold for approval could potentially be

[Yoly900]

Ok guys let me help you Whst about FIRST APPROVAL IN CANADA NO FDA THERE NOBODY MENTIONS 

[CancerSlayer]

  Quick answer....Yes.   Merck set a relatively low bar at 19%, and in order for a patient to reach that low bar, he must undergo "systemic" treatment (with its associated side effects) every 3 weeks...for up to 24 months as long as there is no disease progression.  Such a treatment-intensive systemic treatment demands there be more patient-friendly & effective