Theralase Technologies Inc. V.TLT

New Press Release - Theralase(R) Releases 1Q2023 Interim Financial Statements

TORONTO, ON / ACCESSWIRE / May 30 2023 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug...read article.

[ScienceFirst]

On our way to FDA Breakthrough Therapy designation.  No doubt. Primary endpoint (90-days) (n=53 patients) CR % = 66% IR % = 8% TR % = 74% In line with the potential trajectory I posted 3 months ago.   The Swimmer's Plot illustrates: 13 Evaluable Patients that achieved CR at each assessment date and thus achieved the primary and secondary objectives of Study II

[Legit62]

SF, sounds like our numbers to date are in line with FDA BTD and AA, any ideas on submission to get this rolling?? Thought we have all criteria they were looking for. These numbers must pop out at Big Pharma also

[Pandora]

Simple question, simple format, re the swimmers chart. On the right hand side (450 days) - if the chart was made up as patient numbers progressed to 450 days then the first patient would be line 1, second person = line 2, etc. starting at the top and going down to 39. But that would also suggest the "first" 13 patients went through as CR, ie. the green ones. But --- 12 of the first 13

[NotinKansas]

Pandora, there is indeed some chronology in the plot as obviously the patients listed as having had their 450 days assessment have been longer in the trial than those that are still awaiting certain assessments. But within the cohorts, patients are not sorted chronologically, but based on the quality of their response: the better responses on top, the poor responses at the bottom. The first 12

[StevenBirch]

These scheduled updates continue to be confirmatory and that is great news but the two things we are looking for, financing and BTD/AA, could come at any time in a news release. I would expect financing news before the the AGM and if not BTD/AA before then it should at least provide the opportunity to hear a little more than we get in these bland data updates, especially with Roger back in place.

[Dreimer200]

You are correct. But that peculiar approach to the data is entirely misleading, and – I would argue -- perverse and subversive.   The string of greens – followed by a string of reds – can give rise to the following immediate and speculative responses:   1. Holy cow! It looks as though everything was hunky-dory. Then they ran into a problem!   2. What happened? I thought

[NotinKansas]

I agree with your sentiment, but perverse and subversive I wouldn’t call it. The plots are a more comprehensive and transparent way of sharing data than the summary tables they also provide. From the last plot, for example, you can derive that someone who achieved an initial CR at 90 days, has a 62% chance of remaining CR all the way through 450 days, which is something rather relevant in light of

[stocksnbonds458]

Perverse and Subversive? What an absolutely assinine comment to make just because you have trouble reading the data as presented. I agree it can be difficult for us to fully understand, but this data is set up now in "FDA speak" in the format that the FDA wants to see, not in Dreimer format. 

[Pandora]

Thanks NotinKansas. My problem is my brain does not work in that fashion. The chart on the left side represents to me that there are 58 patients being tracked. I would like to think that they are Patients #1 to Patient #58 by order of enrolment -- to me that is straight forward - and the bottom of the chart kind of suggests that, by the arrows depicting the time frames. ie. Patients #54 - #58 have

[NotinKansas]

I don’t believe there are formal rules prescribing how data in a swimmers plot should be ordered. Sometimes you see them ordered purely chronologically, sometimes differently (as TLT does). A possible reason for TLT to do it the way it does, may relate to privacy concerns: it is more difficult to link results to real patients (e.g. for those with some involvement in the trial) in a non

[Eoganacht]

Makes sense NotinKansas. IMHO the swimmers's plot is arranged in a perfectly logical manner. Our major concern, when looking at each time frame, is how many patients were CR, how many were IR and how many were NR at that assessment point. With the results arranged from the top - by CR - IR - NR you can tell at a glance how the trial is going. For example if you look at the 450 day time frame

[ScienceFirst]

Eoganacht... That's exactly that. "The trial is going to be judged by the results achieved, not by the order the patients were treated. "

[TriumphSpitSix]

Still on the "To Do" list. Bottom of MDA Page 5: "The Company is currently working with both a biostatistics and regulatory organization to compile a clinical data report for submission to the FDA in support of the grant of a BTD approval."

[Yajne]

That statement is unchanged from the last update a month ago. I'm hoping they're saving progress on the BTD application for a separate NR, to give it more visibility/impact....and soon I hope

[TriumphSpitSix]

These numbers seem sloppy and rushed. They were concerned about being late with the report and this should have been proof-read a few more times. This is just ONE of the typos.

[TriumphSpitSix]

Stockhouse didn't accept my screenshot. This should be 66%: The interim clinical data demonstrates that 60% of Evaluable Patients (Patients evaluated by a Principal Investigator (“PI”)) achieved a CR at 90 days post primary Study Treatment and 33% achieved a CR at 450 days.

[ScienceFirst]

Triumph ... I think you're right.  May 10, that CR was 60%.  It is now 66%.    

[TriumphSpitSix]

Nevermind I guess. The chart in the news release is different than the chart in the MDA with the 60% vs 66% figure being different based on whether the patient was "evaluated by a PI" or not. They still haven't found a simple and cogent way to present all this information...

[Eoganacht]

The 66% CR represents CR at any time which is the primary objective. The 60% CR is the CR at 90 days. On the swimmer's plot there are 3 patients who were NR at 90 days but went on to achieve a CR at a later time period.

[TriumphSpitSix]

Yes, thanks. I figured it out after comparing both charts (NR vs MDA).