Theralase Technologies Inc. V.TLT

When push comes to shove...

[Eoganacht]

... there's very little doubt Theralase will be able to demonstrate significant safety and efficacy clinical outcomes for 20 to 25 patients after their 450 day assessment in 4Q2022 (FDA approved Keytruda only achieved 18.4% CR at 360 days and the Theralase treatment is far safer and more tolerable.) IMHO this means accelerated approval in 2023 with a corresponding increase in value.

From the MD&A:

"FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD as a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.

 

In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments. "

[Sunvalley]

Good to hear Eoganacht. Always value your opinion and insight.

[ScienceFirst]

Eoganacht ... Everything matches with the updated corporate presentation of Feb. 7 where they expect to receive a Breakthrough designation around November/December. The 25th patient has been treated in September 2021 as the August 30, 2021 financials make mention of 24 patients treated in the Ph. 2.  So let's assume that patient #25 has been treated mid-September 2021.  450 days of

[ScienceFirst]

What are the timelines for FDA to respond to a breakthrough therapy designation request?  FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.  Source: https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies

[ScienceFirst]

Interesting ... 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 which the active IND is assigned and request the “Preliminary Breakthrough Therapy Designation (BTD) Advice Request” template. This template should

[Eoganacht]

Makes sense ScienceFirst. And as far as the chances of getting FDA approval, there's this: "Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least