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.

TSXV:TLT - Post by User

Theralase Technologies Inc. > Is FDA submission material enough for an NR?

<< Previous

Bullboard Posts

Next >>

Comment by tdon1229on Dec 15, 2022 6:49pm

218 Views

Post# 35174616

RE:RE:RE:RE:RE:RE:Is FDA submission material enough for an NR?

tdon1229 wrote:
enriquesuave wrote:
Im thinking they had hired Vera to prepare this, and now it's just final stats needed to file? We shall see.

plantrader wrote:
N0taP00p wrote: Plantrader: Good point. I hope they have a way to do some parallel processing and complete the work in increments as data becomes available. I would think this is the case. But definitely could use some clarity from those that know this space.

Parallel work streams would be nice, but I don't expect it. In extrapolating the lack of info/communication from the company on the matter, I'm not going to expect FDA response until 2Q 2023. It'll be great if it happens sooner, or we get an update for clarity. But here's why I assume 2Q 2023 (I hope I'm being overly conservative)... 1) they hope the analysis is completed in 4Q 2022, but they aren't sure which is why they used the CSS availability disclaimer 2) after analysis, they have to author a clinical data report which I'm assuming will take a few weeks 3) then submit to FDA, and I believe I read the FDA has 60 days to respond? To either approve, deny or ask for more info? If more info is requested, that extends the timeline.

But to me it adds up to a hopeful 1Q 2023 FDA submission & a 2Q 2023 FDA response. If the analysis was already finished in 4Q 2022 & the clinical data report has already been created in 4Q 2022 then I assume they would have provided some sort of update. I haven't known too many small companies where silence means they're ahead of schedule.

Enrique,
did you read her book (it was posted online)? Very poorly written/edited. From what I read, she ran what was a low cost consultancy, employed interns to do the work. She never seemed a good fit for the position to me, but what do I know?

Looks like she went back to the consultancy:. I found this online today:
C.V. Dr. Vera Madzarevic | virtual-clinical (edupharma-virtual.com)

It appears English may be her third or fourth language.

<< Previous

Bullboard Posts

Next >>

Understanding tax loss season and the “Santa Claus rally”