RE:Accelerated Approval and Priority Review
floatinketucky wrote: 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.
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 the medical community at large. But expect continued sp resistance despite more promising data...such is the game of a promising penny stock. Found this posted on another board...simple concept, but no less applicable here than it is with most other pennies...
"The weekend was a childish gong show. I think there are people with deep pockets out there that know we have the goods....and until they have accumulated enough shares they will keep this churning at these levels or lower. I have learnt long ago the stock market is a game and all us small players ( and yes we are small unless you have an 8 figure bank account ) can do is sit back and enjoy the ride. The big players will decide when they will open the barn door and let the horses run !!!"