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Theralase Technologies Inc. V.TLT

Alternate Symbol(s):  V.TLT.WT | TLTFF

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.


TSXV:TLT - Post by User

Bullboard Posts
Post by fredgoodwinsonon May 08, 2020 10:39am
302 Views
Post# 31002880

IND Timeline

IND Timeline

The limit of the timescale for the FDA to come back to the Company on the Clinical Hold Response is very clear (see below) - this is presumably why they have confidence in mid-May:

'The IND application sponsor is expected to address the cited deficiencies in writing and submit a complete response to the issue(s) identified in the clinical hold letter in a separate submission. Once the complete response to all of the clinical hold deficiencies has been received, FDA will review the submission within 30 calendar days and determine whether the applicant’s response to clinical hold satisfactorily addresses the issues. The investigation may resume after FDA (usually the Division Director or their designee) has notified the applicant that the investigation may proceed.'

 
Bullboard Posts