Theralase Technologies Inc. V.TLT

Data to date going to the FDA

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If Theralase has toppling data current/material news. The may take that data to date to the FDA. Sometime Theralase cannot report due to regulatory restrictions.

Competitors will know this and report during the assessment period trying to inspire impatience.

Here is why I am considering this scenario...

They normally report
Cancer research updates and Cutting edge covid research updates in the quarterly.

However this time around they have PR the covid research
Theralase® Demonstrates Proof-of-Concept for Canadian-Made COVID-19 Vaccine
Toronto, Ontario – February 7, 2022

Ok then look to the insider buying...


The Corporate presentation is of no interest to the FDA.
The Company newsletter is of no interest to the FDA.

The FDA is interested in the data to date.

May 19, 2020Shawn Shirazi went on to say, "In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company,
post receipt of the FDA IND authorization, based on the clinical study data collected to date.

It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation ("BTD") and/or Accelerated Approval (AA)

if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated."

This is the link to the quarterly newsletters... Currently the public only has information on this study up to NOV 28 2021.

Link to TLTFF NEWSLETTERS



TLTFF long.