Theralase Technologies Inc. V.TLT

"CR at any point in time'

[wildbird1]

While we're waiting, here is an interesting thought.

1) In the May 28,2021 pressrelease TLT said" Study11 has a Primary Endpoint of efficacy, defined by Complete Response" (CR) at any point in time".

2) In the 2Q2020 newsletter TLT said" In a 3Q2019 conference call with the FDA, it was discussed that TLT would be potentially be eligible for BTD and or AA, if TLT could demonstrate clinically significant results, similar to the safety(100%) and efficacy(66%CR) results observed in the Phase1b NMIBC clinical study at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated".
Note 1) The 66%CR being the final results, consequently it does become "66%CR at any point in time" for the Study1b trial.

In the Nov 29,2022 pressrelease the "CR at any point in time" is 26/43 patients = "60% CR at any point in time" up till now for the phase11 trial.
As more and more optimized patients are treated the CR "at any point in time" will increase.
As we speak the CR at any point in time could be easily be over 65-70%CR.
Given time it could easily surpass N803+BCG(71%CR at any time(Eoganacht posting)).

Note 2)The 450 days 28%CR is for the secondary endpoint of duration (the fact that it is steadily increasing is a very good omen for TLT).

Note 3) In the Nov29,2022 pressrelease, the terciary endpoint is safety(100%). Peoples on this board have no idea how big 100% safe is for the FDA. It does mean that no patients will die using TLT treatment, and the FDA will not be endangering patients lives by approving TLT treatment.

In short...As we speak TLT has...
-A treatment that could already have a CR at any point in time over 65-70%CR in the phase11 trial(with only half of patients treated in the phase11 trial, it is extremely good).
-A treatment that could already surpass the 66%CR at any point in time of the Phase1b trial(2Q2020).
-A treatment that could already surpass the CR at any point in time of N803+BCG.
-A stand alone-treatment(doesn't need BCG)
-A treatment that is 100% safe.
-A treatment that cost less than competition.
-etc...

Note 4) Every time the SP is stuck at a new level, somebody start to talk about a PP.
Who care about a pp, a pp will not change the fact that TLT has the best, most affordable and safest treatment that the FDA coulfd offer to patients that were 100% guaranteed to lose their bladder.

Question?
Could a treatment that is 100% safe and as we speak could have a 65-70%CR at any point in time(and increasing) be good enough for BTD&AA?

Tough question, for the FDA.

[StevenBirch]

Wildbird I think you knocked it out of the park and I don't think you took liberties with the data just to put a positive spin on things. We also have positivity from management in both words and action so we should expect good news, the only question is when?

[Alamir1111]

Thanks wildbird  The last phrase you wrote is importantant to note. Is it good enough for fda.?one example advisory board voted   10 to 2 in favour of approving a drug  thats huge confidence guess what fda response was   The issue they had was labeling..now they need to reaply. Remember we have Fast track designation they comunicate  between each  other have

[Eoganacht]

Nice post wildbird1. We should have our trial update and BTD/AA application status in the next few days. On Nov 29 there were 11 patients treated but not yet evaluated at 90 days. Those patents, and any others treated in Jan or Feb, should up our CR at any time.

[skys1]

Great posts wildbird & eogan. It brings up a subject I have been thinking about for some time. We know they are in frequent contact with the FDA, which has told them that TLT could potentially be elligable for both BTD & AA if they demonstrate results similar to safety100% which I don't think is a concern, and efficacy in the area of 66% CR. Couid the current hold up be due to

[Johnandrose22]

Thank you, Skys1, for your typically insightful post.  I, too, have intuited a strategy to bind BTD/AA together. I don't know if there is historical precedent for this, but the increasingly immense clinical results, to date, cannot negate this option. Thanks, again, for your contributions and many others. John

[skys1]

Johnandrose, The dual approval has happened before. I believe it was the FDA's resonse to an immediare need. IMO  with the supply problems with BCG and severe side effects of Keytruda, the current NMIBC treatment situation problems would probably qualify for it.

[Johnandrose22]

You've just put into words what I have been sensing for some time...hoping that this dual approval will be realized....Thanks, again.

[Rumpl3StiltSkin]

Interesting Question, Personally, this is my opinion, I think the clock could be running on both, since TLT only needed FT and the CR data to apply for AA. Yet I think getting BTD first should speed up the process. 

[Lesalpes29]

Who cares about an other PP! How to put people on something less important then overall results and the outcome from it! Good post Wildbird for sure. GLTAL 

[O12009]

The one part of this that I'm interested in is the successfully treated part the first 12 in phase 2 was not successfully treated. Does that remove them from the numbers?

[Oilminerdeluxe]

Thanks, Wildbird. Very encouraging read.

[BlueFranky]

Wildbird- AWESOME POST