Theralase Technologies Inc. V.TLT

Pre-BTD(and BTD) Time-Line has been respected...

[wildbird1]

The last time TLT did mention Pre-BTD in a press release was March 27,2024.

TLT said about Pre-BTD '' TLT plans to resubmit the Pre-BTD submission to the FDA in 2Q2024 for FDA review of these clarifications. Once the Pre-BTD submission has been accepted by the FDA, TLT will compile a BTD submission for review by the FDA, in support of a BTD approval''.
2Q2024=April,May,June 2024.
We are in May 2024, TLT has until June 30,2024 to resubmit the Pre-BTD submission.
For those that pretend the BTD submission has been pushed forward, please provide proofs about your false insinuations. 

Note 1) The fact that TLT is hiring new people is a good proof that TLT going forward.

The data are reassuring...

Aug 29,2022    450 day CR%    = 21%
Nov 29,2022      ''           ''          = 28%
May10,2023       ''           ''          = 30%
Aug 29,2023      ''            ''          =33%
Oct 16,2023      ''             ''          =34%(optimized).
Nov 29,2023     ''             ''          =36%        ''
Jan15,2024       ''            ''          =39%        ''
March27,2024    ''           ''          =40%        ''

As we speak the best competitor to TLT-Ruvidar is Anktiva 36%CR at 12 months.
TLT-Ruvidar is 41% at 12 months....
Anktiva has so many exclusions criteria that we can not compare Anktiva to TLT-Ruvidar(Anktiva is treating patients that are in a better state of health,unlike TLT-Ruvidar who treat 100% of patients without restrictions no matter their state of health).
If TLT-Ruvidar had the same exclusion criteria as Anktiva,TLT-Ruvidar could easily have a CR% over 50-60%CR at 12 months.

There is definitively a lack of a good treatment for NMIB BCG resistant patients.
Conclusion, the FDA badly need TLT-Ruvidar.

Have a nice weekend.

[reconsider]

Here are 2 proofs of the ever-pushed BTD submission: August '23: https://theralase.com/theralase-releases-2q2023-interim-financial-statements/ The Company has submitted a pre-BTD submission to the FDA and based on the FDA’s feedback, the Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data

[Dumbeldorfwhite]

Don't worry bunkcro/sciencelast wont bother reading. Real question is is the AGM actually going to have the tough questions or will it just be another coombyeya fest. i miss the days of BOMBER and BionicJoe, I'm sure they're laughing their tails off right now.