Theralase Technologies Inc. V.TLT

Applying for Breakthrough seems very close now

[ScienceFirst]

It's in the order of things that now that they met with MSAB (*1) after the AUA congress to have a final guidance and final review, that the work with a biostatistician and the regulatory organization is close to completion as in the April 23, 2023 MD&A, they were already working with them to compile a clinical report to apply for FDA Breakthrough.

So submitting the report to the FDA is probably very close, now that data has been revised.

*1:

In recent discussions with the Medical and Scientific Advisory Board ("MSAB") for Study II, the MSAB advised the Company to review the FDA Guidance to Industry1 on how to best classify Indeterminate Response ("IR") patients (patients assessed with negative cystoscopy and positive urine cytology), where the source of the positive urine cytology has not been determined.

[Rumpl3StiltSkin]

Agreed.

[N0taP00p]

SF: I read the latest NR as that they still have work to do on finishing the analysis of IR patients before they submit data. It all depends on how long the PI will take to finish all that for the dozen or so IRs. Then compile. Hoping there's a lot of parallel processing going on to reduce the time required. My take is we won't submit the data for another few months. So Q3 is my earliest

[Rumpl3StiltSkin]

According to the table 1 from the NR there are 5 IR patients left to evaluate 6 months from now. I don't think TLT will be waiting that long to apply for BTD just to determine where those 5 patients are.... My guess is they have recently applied for BTD. They have the numbers NOW for that and have for some time. IMO

[Lesalpes29]

We can really speculate that BTD before summer. Make lot of sense. GL

[enriquesuave]

They have 37 patients at 450 days, heck they can even apply for AA.  No need to wait to confirm those IR patients IMO

[Rumpl3StiltSkin]

Yep With FT, TLT is eligible to apply for AA NOW. BTD would just speed up the overall process, IMO. Should they also achieve BTD.

[StevenBirch]

I think today's news release is them saying those approvals are now on the clock, it's like they are working on the 'fine print'.

[Rumpl3StiltSkin]

I find it interesting that BTD isn't mentioned, at all, in todays NR...  Almost like it could be pending and they don't wan't to mess anything up??

[plantrader]

I had the same thought. As in, excellent update after such confusing unexplained data changes in the year-end report... but now they don't mention BTD? It was a perfect time to mention it along with the data clarification. So let's hope that omission was for a good reason.

[Rumpl3StiltSkin]

Or, maybe they are holding BTD for it's own seperate NR?

[BlueFranky]

Enrique.. something I've thought about for a while: ..maybe the delay was deliberate and they were waiting for the numbers to be right allowing them to bypass BTD and go straight to AA?

[enriquesuave]

Anything is possible, but at least BTD for now. 

[ScienceFirst]

It's the FDA that suggests/recommends to the sponsor to participate in the Accelerated Approval program (as it is a program, not a designation you apply on like the Breakthrough Therapy designation).

[CancerSlayer]

  I tend to agree Enrique...with a total of 37 patients already at 450 days & 3 of 4 additional promising patients rapidly approaching their 450 day assessments (before year end), it seems we are already nipping at the heels of an AA, especially when you consider our significantly superior CR%s compared to the approved competition.  Additionally, the KM curve predicts an even

[Rumpl3StiltSkin]

Exactly Gents, TLT has had FT designation for some time now. They now have the CR %s and number of patients treated to apply for AA. BTD would be another great NR for them, should speed things up considerably. But really they don't NEED it to move towards AA, Now... If they wanted to...

[enriquesuave]

I feel sorry for IBRX investors, but perhaps we may get to market before them and that would mean an even greater market potential for us.?  Time will tell 

[Eoganacht]

It might be difficult for them to capture market share when there is such a safe, convenient and efficacious SOC treatment already in place...

[gordo323]

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