Theralase Technologies Inc. V.TLT

is it too much to ask for

[FGPstock]

BTD approval before a big event like this. The 60 days should b up if they filed like they said they were going to.

[ScienceFirst]

You don't seem to be on page on what they say and so far, they are respecting what they said: Dr. Mandel says that the company plans to apply for FDA breakthrough drug designation in the first quarter of 2023 on the basis of the Phase 2 clinical study data collected to date. So last time I checked, Q1 ends March 31.  Then add 60 days for the FDA. There maybe many reasons why they'

[FGPstock]

Ben, they keep kicking the can down the road. In the past, they said BTD to b "received" in Q4 2022 and revenues Jan 2023. You pushed this until they switch the dates. How can you respect what they say if it keeps changing. Why would you say revenunes Jan 2023 if you can't get close to that target. this is a pattern that has gone on forever, covid is no longer an excuse. You are a

[ScienceFirst]

Poor little armchair quaterback FGPstuck!  Did you take course from Bungee? Coming from the one that can't keep up the pace and is always off. We're on the verge of a FDA designation and you still whine, as usual!  Is this all you can do in life? We're on the verge of a FDA designation and it's certainly not because of you! We all know you hate TLT management. &

[ScienceFirst]

Lolll! Once again, our clown FGPStuck can't understand a basic concept! "they said revenues Jan 2023" No. They indicated that, starting Jan. 2023, we were entering a new phase:  "Commercialization Phase (projected)" To that end, the Jan. 3rd article gave us more insights (e.g. initiating talks with big pharmas in 2023-2024, applying for Breakthrough

[gojotv!]

To quote the 2021 Financials... "In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites (“CSS”)

[N0taP00p]

They probably pushed to Q1 because they couldn't finish all the work needed. Remember they had an asterisk about Q4 submission.  Let's hope there are good reasons if they push beyond Q1, like collecting additional data on patients that were almost due for a milestone check.  If the data projections hold, BTD should be a given. But then, anything could happen.  Given the BCG

[plantrader]

I see it similarly. All we can do is assume they will submit to the FDA in Q1 as promised. Do we know that they have submitted yet? No, not at all. It's possible they have, and it's possible they haven't. I'm not going to start getting concerned again until mid to late April. The #s can change easily for the better, or worse, due to a currently small sample size. Can't wait to