Theralase Technologies Inc. V.TLT

Today marks 2 weeks (or longer)

[TommyNickels]

... since pre-BTD was filed. We dont know the exact date but worst case scenario has us at 2 weeks.

"Reply in 2 to 3 weeks" 

A meeting could be set up for next week. Or already Happened.

Final touches on formal BTD could be underway.

In mid-Aug, Roger sure seemed confident he could get formal BTD application sent off.

What has changed to make that no longer the case?

[Kayz88]

There was a reply in 2 to 3 weeks? I don't remember any mentions of that. Do you have sauce? 

[TommyNickels]

Back in December 2023, Roger stated jn a video that he expected a response to his would-be pre-BTD in "2 to 3 weeks". We now know that it got delayed from Q1 to Q2 to Q3 and likely got filed first week of Q4. I messaged IR and asked for specifics but they would only say "filed as of 7am, Oct 7". They would make no comment about whether or not Roger would make public the

[O12009]

BJ no matter how hard you try, your still the number one basher of this stock. Which big pharmaceutical are you working for?

[Eoganacht]

Hi TommyNickels - I doubt that the delay was caused by the need for an outside safety auditor. According to the 29 Nov. 2023 MD&A with respect to the 11 SAE's reported at that time: "Theralase® believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device, as reviewed and confirmed by the independent Data Safety Monitoring Board (“DSMB”)."

[TommyNickels]

You are corrext. Thanks for the clarification.  "Additional clinical data is required, prior to a pre-BTD submission to the FDA" -- May 30. How did Roger not.know this back in December 2023? Il

[Eoganacht]

In July 2023 Theralase had their first pre-BTD meeting with the FDA. At that time the FDA advised them to collect longer term patient data and to verify all data at a central pathology lab before submitting an actual BTD application. Since July 2023 Theralase has known exactly what data the FDA wanted and they have tried to get it in order to submit another pre-BTD.Theralase has been overly

[BlueFranky]

Thank you for such a solid explanation, Eog!

[Yajne]

Agreed, great explanation Eogan. At the time it felt like a bit of 'moving the goal posts' ....and it still kinda feels like some outside influences finding clever ways to cause delays. JMHO though

[Oilminerdeluxe]

Thank you, Eoganacht. That made a lot of sense. Good. That should be the last hurdle.  Would not mind them letting us know when they send in the actuall BTD application, but I guess they will do what they find best. 2025 could be massive.

[TommyNickels]

Thank you, Eog. So Roger finally has the data they want.  Presumably all patient specimens have been re-examimed / validated by this "central" lab. And we now have sufficient data at the 2 year and 3 year mark. Time to fire off an official.application !

[2b7f6fab]

For all we know pre BTD may have already been accepted and BTD could already been sent off.  I don't think we'll know anything until a decision has been made. glta

[DeathXray33]

"After Failed Confirmatory Trial, Gilead Withdraws US Accelerated Approval Of Trodelvy As Bladder Cancer treatment" ------------------------------------------------------------" Gilead Sciences plans to voluntarily withdraw U.S. accelerated approval for Trodelvy in metastatic urothelial cancer. The decision followed results from the TROPiCS-04 study, which failed to meet its primary

[CancerSlayer]

After two cancer trial flops (as a 2nd-line NSCLC treatment & now with advanced bladder cancer), Gilead may be having second thoughts about having acquired Immunomedics/Trodelvy for $21B back in 2020?  In Trodelvy's favor, it was approved in April 2021 for triple-negative breast cancer (TNBC...an aggressive form of breast cancer that lacks many hormone/IT receptor targets, which

[TommyNickels]

Gilead could snap-buy Theralase from its petty cash.

[Paradise818]

With all the recent failures in cancer treatments, Theralase's Rudivar is looking better and better as a safer and more effective treatment for many types of cancers.  All we need is a catalyst which would be BTD and AA and it's off the races.  Maybe we get bought out for 21 Billion.  I'll take 5 Billion.  LOL.

[TommyNickels]

BTD approval and Theralase is a different company. Will be interesting to see how the stock gets re-priced? 45 cents? 75 cents? A buck ?

[managementfirst]

BTD approval means 5-10 billion worth company, stock price will be around 20-30

[Feedman2980]

I sure hope you are right. $2 to start would be great but it is certainly got a lot more potential  Need to get off small market

[TommyNickels]

Pre-BTD filed in Q3 and Roger said it would be?

[managementfirst]

They anounced the pre-BTD have been filed on October 7, 2024. https://stockhouse.com/news/press-releases/2024/10/07/theralase-r-provides-update-on-bladder-cancer-clinical-study

[TommyNickels]

No, that's not what they announced. We don't know when it was filed. Could have been the Friday before. Or Thursday.  Or Wednesday.  Possibility it was filed in Q3 as some suggest.

[2b7f6fab]

You'll know BTD has been apporve when you see the stock price move up before the FDA announces it. :)

[StevenBirch]

It's funny, I never thought there were leaks with TLT except for when they were doing PPs but that was probably naive to think that. It just turns out that every good news release they came out with was never going to move the stock, they were all good for de-reisking and future value but the only one(s) that would move the stock would come from the FDA. So I agree we should expect some

[2b7f6fab]

There's your sign.