Theralase Technologies Inc. V.TLT

Followed Stockhouse for a long time, but never made an acct

[BullCall2262]

 

Been in this stock since 2017. Their most recent Pre-BTD application was submitted in early October 2024. The FDA has 60 days to review and did, which left them with a recent response in early December 2024. Assuming the data they wanted to see was there and the only reason they didn't accept it, must have been some sort of formatting issue. That said, the Pre-BTD was then submitted just a few days later in December roughly between the 1st and the 8th (can't recall the exact date). The FDA has 60 days from that date which puts us right around Feb 8th timeframe to see if the data was presented correctly. In my opinion, the only reason to re-submit the Pre-BTD application only days later means they FDA was good with the data and just wanted to see it presented in a different format. What's next? The company would apply for formal "Break Through Designation" (BTD) and the FDA has 60 days to respond to that. It is a tedious process, but I believe if the Pre-BTD is accepted, you will start to see real money flow into this stock and it could get pushed into the low dollars quickly. The company stated that they are targeting 2027 for the approval of the drug, so it's still a few years away from that, but someone should partner up with them when the price is low to accelerate this process. It is a long process, but I would say we should see a significant stock movement within the next 3 months. This is my opinion, but good luck to all.

[Legit62]

Bullcall2262 your dates are right on, im assuming it didnt or wont take 6 weeks to review pre-BTD and its very possible our next update PR will be acceptance of BTD, since we have been through the pre process for well over a year

[enriquesuave]

Q1 we are also expecting preclinical animal data for bird flu vaccine from U of Manitoba I believe?

[Alamir1111]

Theralase® in conjunction with UM and PHAC have modified their focus to avian influenza (H5N1). These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase® H5N1 vaccine in the ability to  prevent animals from contracting H5N1, when exposed to the virus, which commenced in 2Q2024 and is expected to be completed by 2Q2025."