Theralase Technologies Inc. V.TLT

Accelerated Approval and Priority Review

[floatinketucky]

Theralase Granted FDA Fast Track Designation for NMIBC Phase II Clinical Study
Monday, November 23, 2020 7:00 AM

TORONTO, ON / ACCESSWIRE / November 23, 2020 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that the U.S. Food and Drug Administration ("FDA") has granted Theralase® Fast Track Designation ("FTD") for its Phase II Bacillus Calmete Gurin ("BCG")-Unresponsive Non Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In Situ ("CIS") clinical study ("Study II").

As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase's development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system ("TLC-3200"), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.

[charlierock]

Thanks for posting for potential new investors Float!

[floatinketucky]

Your welcome, So much stong science here. 

[ScienceFirst]

So that's at the minimum 6 months (not to mention most logically 12 months past the 3-month CR date as per the recent FDA guidelines) after the 20th or 25th patient. Fast Track designation (FTD) can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and

[CancerSlayer]

  Thanks Float...for keeping this Gong Show on track.  In the meantime, just waiting for enough data (or an approval) in one or more indications that can trigger a handsome buyout.  Ultimately, having Big Pharma's stamp of approval, finances & buckle down marketing push, should propel our "perceived outlier" technology to broader & more rapid acceptance by

[Johnandrose22]

I might be overthinking (or underthinking) this but I find the somewhat ambiguous description the company uses to express their FDA guidance as intriguing: 20-25 patients enrolled and “treated”: Does that mean patients receiving the initial dose of TLD1433 are considered “treated” or only after receiving the second dose after six months? Who demonstrate “significant” safety and efficacy: For the

[Longholder99]

I agree with you John. Ambiguity without overpromising is a nice skillset of wording that may come from Shirazi and his background. Rome wasnt built in a day. I continue either foolishly or as a great investor.....to accumulate regularly. Damn the torpedoes.

[floatinketucky]

Consider the significant difference between the phase 1 study and the Phase 2 first 12 patients who were grossly undertreated. Expect CR percentages to significantly improve during the phase 2 study. If the CR percentages approach Phase 1 study levels the FDA may also consider appropriate action. A related and noteworthy point: Phase 1 study was terminated early due to very excellent results. The

[CancerSlayer]

  I appreciate your level-headed response John...much like Covid, this board has mutated into an ugly contagion.  I fully agree with your comments.  TLT has correctly allowed for some flexible interpretation in regards to "significant" safety/efficacy.  As for "treated", I believe any accelerated FDA approval will primarily hinge on a sliding scale of

[CancerSlayer]

Though 12 months post initial CR appears to be the new 12 months post treatment CR based on the updated guidance.

[Rumpl3StiltSkin]

The first CR is at 90 days? As long as we've waited what is another 3 months?

[floatinketucky]

Theralase Technology Demonstrates High Kill Rate of Coronavirus (BSL-2) TORONTO, ON / ACCESSWIRE / November 13, 2020 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated