Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > 10 patients early 2021 for 25 for Breakthrough Designation

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Comment by ScienceFirston Mar 18, 2021 11:47pm

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Post# 32835664

RE:RE:RE:10 patients early 2021 for 25 for Breakthrough Designation

That's my reading too.

It's not to reach 25 patients. It's to have 3 months data, if not better (12 months), so you can discuss such data with the FDA.

That of course is the standard pattern. You have to have enough data on enough patients to see a trend. Not for this to be anecdotal because of couple of cases.

The fact that we under-treated our first 12 patients complicated TLT's job to have a stellar record to present.

The medical communitiy wants to see a large enough sample before trusting a new treatment, new procedure.

As of now, we don't know enough, though we all think numbers are gonna be fine. But the industry is not into guessing. It wants facts, numbers.

COVID-19 treatment could be fun if fully funded by the government but again, we'll have to go through all the phases that we've been through with NMIBC, that is Ph. 1 and 2 at least. It takes time. For the COVID-19 therepeutics, the FDA has so far approved only 1 treatment. 8 have been granted EUA. You just don't approve a drug because there are some investors that want their stock to go up. It's not like that that it works.

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Eoganacht - (3/11/2021 7:17:15 PM)
RE:RE:10 patients early 2021 for 25 for Breakthrough Designation

Of course, if we have 12 month results on the first 25 patients in August 2022, based on those results we should have a very good idea what our chances for approval are going to be and the stock price will reflect that.

Eoganacht wrote:If we get the 10 additional patients by May 1, after about 15 months, in August 2022 we can apply for Breakthrough Designation and Accelerated Approval. 6 months later, by February 2023, we should have the FDA decision on whether or not we can commercialize the treatment based on results from the first 25 patients.

floatinketucky wrote:Shawn Shirazi, PhD, Chief Executive Officer, Theralase®, stated, "Each CSS Theralase launches for Study II will aid in our objective of enrolling and treating 10 patients in early 2021 to achieve a total of 25 patients for potential Breakthrough Designation Approval and approximately 75 to 100 additional patients in 2021 / 2022."