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. > Opportunity to compare with ImmunityBio data

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Comment by CancerSlayeron Jun 28, 2022 11:50pm

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Post# 34789459

RE:RE:Opportunity to compare with ImmunityBio data

Quick summary of how the process works:

A drug manufacturer submits a New Drug Application (NDA) or supplemental New Drug Application (sNDA) along with the appropriate fee to the FDA. Supplemental applications are submitted when a drug manufacturer wants approval to market an already approved drug for a different use.

The FDA has 60 days to decide if the application is acceptable for review.

If accepted, the FDA then has 10 months to respond (or 6 months for a priority review) with an approval or non-approval or with a 'complete response'.

A complete response basically informs applicants of changes that must be made before an application can be approved.

enriquesuave wrote:

They submitted the BLA which after 60 days of accepted and all relevant information included properly, then the FDA will give them a PDUFA date 6 months later, so FDA answer will be in about 7 months. TLD-1433 will not need a BLA, but only an NDA much easier and less issues on which the FDA can poke at.

ScienceFirst wrote:

From that May 23 request:

May 23, 2022 - ImmunityBio Submits Biologics License Application for N-803 Plus BCG for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ

the FDA has 60 days to respond to ImmunityBio regarding the approval of their treatment against NMIBC. They should obtain the FDA approval by July 22 approx..

If we can synch an interesting news (like durable response data @270 days) couple of days after they obtain their FDA approval as the next SOC (Standard of Care), the market could compare our data with theirs. That could get us lots of interesting visibility.