Theralase Technologies Inc. V.TLT

Phase11 450 days CR% data for BTD approval in Dec 2022...

[wildbird1]

Let's talk about the 25 patients 450 days data needed for the FDA BTD(Break Through Designation) approval request in Dec 2022.

In the last Press Release(Aug 29,2022), the results are for the period ended June 30,2022(180 days to go in 2022).
In this Press Release the most important numbers are the 270 days culumn numbers.
                                                                                            270 Days
Complete Response(CR)......................................................41%
Partial Response     (PR).......................................................22%
Total Response        (CR+PR)...............................................63%
Evaluable patients................................................................32 Patients at 270 days.
(270 days+180 Days to go in 2022=450 days in Dec 2022).
These 32 patients (including the undertreated) will have completed the 450 days data required for the BTD approval, in Dec 2022.

In the same Press Release TLT said " The Company will compile a clinical data report for submission to the FDA in support of a grant of a BTD(Break Through Designation) approval after completion of the 450 days assessment for 25 patients".

1) From the 3Q2021 NewsLetter(Nov 29, 2021) We know that out of the first 32 patients treated(these patients will get their 450 days data in Dec 2022), 18 patients are optimized patients.
2) From the 2Q2020 NewsLetter(Oct 26,2020) We know that out of the 12 undertreated patients 3 patients(25%) are CR patients(These 3 CR patients will get their 450 days data in Dec 2022).
3) In the 1Q2021 NewsLetter (April 2021), TLT said " To date, the Phase11 NMIBC clinical study has enroled and provided the primary study treatments for 18 patients (including three patients from Phase1b study treated at the therapeutic dose) for a total of 21 patients.

Important Note: The above mean that the 2 CR patients from the Phase 1b study will be included in the Phase11 study data.

CR(Complete Response) + Optimized Patients.
  3 CR patients from the 12 undertreated patients (450 Days OK).
+2 CR patients from the Phase 1b study (450 Days OK).
+18 Optimized patients (450 Days OK).
Grand total 23 450 days patients data (OK).

These 23 patients could be included in the 25 450 Days patients data that TLT will submit to the FDA for BTD approval in Dec 2022.
Question...What will the 25 450 day patients CR% look like in Dec 2022 if they are included ??????

Some people are focusing on the Share Price instead of the Data,with a little more patience the DATA could reward you beyond your wildest dreams.

And TLT has the Covid-19 Wild Card, news could be imminent(maybe a grant $$$).

Hold on to your precious TLT shares.




If these

[skys1]

Great post wildbird. No question the numbers are starting to look very good, especially when compared to our competion. On the vaccine front, the animal trials must also be going well, as you don't spend the money and time acquiring patents unless you have something successful to protect with a patent.

[Legit62]

Wildbird, everyone keeps bringing up phase 1 results, the FDA will sure know how to look past non optimized patients when they review results, our results are very very solid at this point and should be even better next media release, share price wlll follow up, to what degree, i have no idea

[CancerSlayer]

  Agree Legit....I have a very hard time believing the FDA would accept any invalid (or at least less valid) data from ANY trial that could ultimately compromise its final decision re: the grant of an AA, or even a BTD for that matter.  Although data from the underdosed 12 may not impact our ability to get a BTD numbers wise, the final analysis & publication of trial results should

[skier59]

You are absolutely correct CancerSlayer, but unfortuntately it seems Shareholders have no rights to express their opinion in Canada, no matter how upset they might be in the direction, even though we own part of the company ! What a strange situation. I thought being a Shareholder gave one certain rights to discuss their approval or disapproval of a companies direction !

[Eoganacht]

It has probably crossed the minds of most posters, at some point, that instead of submitting complete data for patients 1- 25 to the FDA it might be better to submit the data of patients 13-37 and ask the FDA to remove the results of the first 12 patients as outside trial parameters. This would likely delay our preliminary data submission by a year, but at least the data would reflect the true

[Johnandrose22]

"the results..of the first 12 have already done their damage...." indeed, Eoganacht....thank you for your candor. I remain convinced that this technology is remarkable....but, boy...the road has been replete with cliff hanging turns. I remain hopeful and steadfast.

[Yoly900]

Failure is close its already bankrupt 0.20 worthless paper. It'll be more worthless this week nothing works here the share price is real and pathetic so I own this pos for years I just hope it goes bust fast so I can lick my wounds and learn a really big life lesson. FOLKS THIS IS REAL 0.20 going lower this is just a dream please go bust so our pain will subside forever and ever. 

[Yoly900]

This post has been removed in accordance with Community Policy

[Rumpl3StiltSkin]

IF they wait 90 days to do it, I was thinking they could do 1-37.

[stocksnbonds458]

I agree that they should wait and submit data from patients 13-37 instead of going with the present results. As per your post Sept 1, results presented Aug 29 2022 indicate a 69% NR at 450 days. The nearly 70% "No Response" 450 days after treatment is due to the undertreated patients being included in the total.

[CancerSlayer]

Yes...as per TLT reporting, the first 25 patient data will be submitted for review.  Unfortunately, there's no way around this FDA guidance...unusual as it is.  Seems like an FDA slap on the wrist for the prior clinical oversight....JMO.  It will be interesting to see how the final results are published & what the outcome of peer review is.   It's certainly odd

[Johnandrose22]

Thank you for your typically honest and insightful relections...I am comforted by your experience and understanding.

[CancerSlayer]

Always honest : )...Just my thoughts:  The experimental nature of science is like the art of molding soft clay...its shape can be embellished under the direction of one's hand.  However, once hardened, it takes on the singular form of concrete wherein lies a singular interpretation.  Good luck...

[stocksnbonds458]

A rather somber mood here these past few days.

[CancerSlayer]

Nah...people just killing time until we reach that ultimate milestone.  Back to real life for me until the next milestone.  See you all near the finish line.

[DJDawg]

I'm not sure why anything needs to be somber. The CR is moving up nicely. While some are discouraged that the 12 undertreated are weighing down the CR%, it strikes me that BTD doesn't have the same standard as a full APPROVAL. The FDA can look at the data and give BTD without risking accidentally approving something too early. Hopefully the full story of what has happened with the

[Lesalpes29]

Think the same... scratching my head why on heart we have to wait for one more patient. Results are good enough for many People who are waiting for a more friendly! Treatment. An other 3 months here... an other 6 months there... when you have this cancer it's an eternity.

[Johnandrose22]

I love that image/metaphor...Will hold on to it...best to you.

[ScienceFirst]

Eoganacht ... I agree that TLT will go on and submit data @450-days on the first 25 patients because that's what the rules were, right at the beginning.  The FDA will recognize the potential of of treatment with the Ph. 1b p#5-6 patients and with those of Ph. 2 p#13-25, for many reasons: - it is a novel standalone drug  - it's has much better efficacy than BCG - it only requires

[ScienceFirst]

On Feb. 7, 2022, Roger probably received hints from the FDA that they would still be serious candidates to Breaktrough designation and Accelerated Approval program given the fact that Ph. 1b p#5-6 had been, as of August 2021, cancer-free for 2y with a single dose, so the update to its corporate presentation to include a Breakthrough designation milestone around Dec. 2022 and commercial revenues

[wildbird1]

I agree with Legit62 & CancerSlayer, the FDA will not take into account the undertreated patients in the final Phase11 study data, one reason is that the FDA has agree that the new accepted treatment protocol is the optimized treatment protocol. In the Nov 23,2020 PressRelease TLT was granted FTD(Fast Track Designation). TLT said " As a Fast Track designee, TLT will have access to early