Theralase Technologies Inc. V.TLT

72% CR at any point in time.

[wildbird1]

First let's do a quick recap...
In the May 28,2021 Pressrelease TLT said " Study11 has a primary endpoint of Efficacy defined by " CR at any point in time".

In order to define the CR at any point in time, we have to use the Swimmer Plot numbers provided by TLT.
Nov,2022, Swimmer Plot & April,2023, Swimmer Plot.

In the Nov,2022 Swimmer Plot, the CR numbers at any point in time for the first 43 patients are as follow...
23 patients at   90 days.
  1        "     at 180 days.
  2        "     at  270 days.
Total 26/43 patients= 60% CR at any point in time.
Note: The above 60%CR was validated by TLT in the Nov 29,2022 Pressrelease.

Before we continue...Let's be clear on something, when TLT will apply for BTD,TLT will use only the latest updated Swimmer Plot numbers.
For now only the April,2023 Swimmer Plot numbers are permitted to be used to define the CR% at any point in time(efficacy).
In order to make a direct comparison with the Nov,2022 Swimmer Plot, I will use the first 43 patients in the April,2023 Swimmer PLot.
The CR% numbers at any point in time for the first 43 patients in the April,2023 Swimmer Plot are as follow...
27 Patients at   90 days.
  2     "         at 180 days.
  2     "         at 270 days.
Total 31/43 patients =72% CR at any point in time.
Note: All the above numbers are exactly as they are in the 2 Swimmer Plot provided by TLT.

The CR% at any point in time for the first 43 patients, went from 60%CR(Nov,2022), to 72%CR(April,2023), an increase of 20% in the last 5 months.
72% CR is also 10% higher than the 66% CR at any point in time of the phase1b trial.
Note: If you remember the FDA did like the 66%CR of the Phase1b trial (2Q2020 Newsletter).

With 100% safety and 72%CR at any point in time (and increasing) the FDA will have no choice but to seriously consider giving TLT BTD and or AA.

By waiting for the Q1,2023 strong efficacy data to apply for BTD, TLT is now in a position to force the hand of the FDA.

Note: Just in case somebody ask, the CR% at any point in time for the first 25 patients in the April,2023 Swimmer Plot is 76%CR.

Note: Although not in play for now, the 450 days durations %numbers looks very promising.

To conclude...
My precious TLT shares are staying with me.

[tundraroamer]

Been a long hold..revisiting my orig entry point and might buy a bit more.... Roamy 

[NotinKansas]

Not sure if that’s a fair comparison Wildbird. In the swimmer plots the well-responding patients tend to move up while the non-responding (and therefore no longer assessed) patients collect at the bottom. So, cutting off the April23 plot at 43 patients gives you a selection of patients that is more skewed to success than the 43 patients of Nov22. I’d say that the 62% efficacy at any point in time

[wildbird1]

NotinKansas, you start your post exactly the same way that greaterfoolfred does, by saying something that is misleading. You pretend that the NR patients collect at the bottom. How do you explain patient 22 , this patient is NR from 90 days up to 360 days, and he is not at the bottom of the Swimmer plot. And there is absolutely no mention anywhere in any Pressrelease that say that the NR patients

[enriquesuave]

It's obvious from chart and swimmers plot mirrors chart. 52 patients plus 4 non evaluable patients for a total of 56. Includes 12 undetreated at 90 days. Other time points the 12 under treated were removed. Now if in another trial patients were to be given 100 mg of a drug, but 12 patients were wrongly given 15-59 mg ( or 15-59% of intended dose), why in the hell should they be included in

[Eoganacht]

I hope they have eliminated the first 12 undertreated patents. But I don't think that alone can account for the 12 evaluable patients at 450 days. In the Nov. 29 MD&A there were 29 evaluable patients at 450 days. If we remove the 12 undertreated and the 3 from phase 1 we would have 14 patients. It has been 5 months since Nov 29 and 5 patients who were evaluated at 360 days should now also

[consultant99]

I hope you are wrong but that was my point as well. How do we only have 12 through 450 days when there were 13 fully treated as of the Nov 30th data. This seems like some kind of beauty contest where its the same data taken at different angles. Only Theralase can issue management notes that lead to more questions. Looking at the notes we had 12 sities for the trial and in January we were moving

[enriquesuave]

Hope we see more details from AUA presentation.  I see one missing patient plus no new data yet presented other than at 90 days in MD&A.  29 -12 - 3 - 1 = 13. 12 undertreated, 3 from PH1 and 1 who died.  Maybe one more who dropped out?

[Eoganacht]

Yes, we need clarification. It seems a very odd procedure to update the 90 day column and not do so for the other time periods in the very same table without even commenting about it. Was the deceased patient ever included in the data? He/she died before their 90 day assessment. I suppose 2 patients could have dropped out.

[wildbird1]

In the Nov,2022 Assesment chart there is 29 evaluable patients at 450 days. In the Nov,2022 Swimmer Plot there is 11 patients at 450 days. In the April 2023 Assesment chart there is 12 evaluable patients at 450 days. In the April 2023 Swimmer Plot there is 12 patients at 450 days. The only difference seem to be that the 2023 Assesment chart and the  Swimmer Plot are synchronised. That make

[greaterfoolFred]

For the love of God Wildbird,  look at the plot,  look at the table,  USE YOUR MATH SKILLS.

[NotinKansas]

I agree that the 12 undertreated should be removed from the analysis, but they are not removed from the current data presentation at all. Not at 90 days and not at any of the other time points. From those 12, two made it CR all the way through to 450 days and one ended IR at 450 days (see MD&A of 28 April 2022). They are in the swimmers’ plot. The others will be there as well, up until the

[NotinKansas]

Hi Wildbird, no offense, I appreciate your attempts to help us arrive at a better understanding of the numbers, but I don’t pretend or mislead. To further explain my comment: the ordering principle in these swimmer plots is the number of assessments patients have received: those who received 5 assessments appear on top, those who received only one, appear at the bottom. In our case we have 10

[Rumpl3StiltSkin]

I get these numbers, and I agree. Though I think the 12 undertreated do represent an unfair, slightly, representation of 1433 for NMIBC in this Phase 2.  I don't think all of the undertreated would have been CR if treated properly, but 63% or so might have been. Certainly at 90 days. So I would add them back in at that % to come up with new percentages for 90 days at least...

[CancerSlayer]

  Like your arithmetic...due to the fact that this type of ACT can potentially produce a delayed CR (i.e. an NR followed by CR, which could be attributed to our ACT's immunogenic properties), I generally like to look at data that reflects that potential, even though the ultimate durable CR% may not change.  Of the 52 patients, 32 (62%) had obtained a CR at any point in time.  

[NotinKansas]

CS, I agree that removing the 12 undertreated would provide a clearer picture, and the overall results would indeed improve. But if you recalculate efficacy and duration without those 12, you also have to deduct the CRs and IRs they have yielded (and which now are included in the data presentation), otherwise you end up with too rosy numbers.

[CancerSlayer]

  If my numbers are correct (will blame my age if they're not), dismissing the first 12 would yield a 23% improvement in our durable response.  I can live with that...

[NotinKansas]

Sorry, I read you wrong, nothing too rosy in your numbers indeed. I'm also looking at a mid-thirties CR rate at 450 days ex. Phase Ib and ex. first 12 Phase II. And in addition to that, a 63% likelihood of someone remaining CR until 450 days if they achieved CR at 90 days (this based on all Phase II data so far). This percentage would probably also be higher if you remove the first 12, but

[wildbird1]

NotinKansas, thank's for responding to my post. I like it when peoples take the the time to respond. I read your last 5 posts. Let's see.... 1) You pretend that the "non-responding patients collect at the bottom"(your exact word) of the Swimmer Plot. 2) In the Nov,2022 Swimmer Plot there was 10 NR(red dot) patients at the bottom of the Swimmer Plot. 3) In the April,2023 Swimmer

[greaterfoolFred]

...or possibility #3,  some time went by, and some of the 90 day red dots were reassessed at 180 days and their dots are now shown in the 180 day column.  And some of the 180 day dots were reassessed at 270 days and their dots are now shown in the 270 day column.  And some of the 270 day dots were reassessed .....  Do you see a pattern?

[NotinKansas]

Wildbird, once again, I’m neither pretending nor misleading. All the numbers I quote are taken directly from the respective MD&As. In Nov22 we had 40 evaluable patients, 21 CRs and 6 IRs at 90 days (Phase II alone), now we have 52 evaluable patients, 28 CRs and 6 IRs at 90 days (Phase II alone). This means we added 7 CRs, 0 IRs and, by consequence, 5 NRs at 90 days. Now you’re right, not all

[Alamir1111]

Did anyone of you check out  Patients FollowUp For Safety And Efficacy? Outlined in Tlt website.might explain some of confusion or not