Theralase Technologies Inc. V.TLT

Another look at the data

[Eoganacht]

There's nothing really new here. I'm just obsessing over the numbers while we wait. The table below is from the MD&A from the end of August. I have added the number of patients beside the percentages and included the "No Response" patients. This table includes the 3 full dose patients from phase 1 (2 CRs and 1 NR) Out of 24 patients evaluated at 450 days there were 21% CR and 13% PR for a Total Response rate of 33%

Assessment Days	90 Days		180 Days		270 Days		360 Days		450 Days
	%	# of patients	%	# of patients	%	# of patients	%	# of patients	%	# of patients
Complete Response	50%	19	47%	16	41%	13	35%	9	21%	5
Partial Response	16%	6	26%	9	22%	7	12%	3	13%	3
Total Response	66%	25	74%	25	63%	20	46%	12	33%	8
No Response	34%	13	26%	9	37%	12	54%	14	67%	16
Evaluable Patients	38		34		32		26		24

If we remove the 3 phase 1 patients from the table (2 CRs and 1 NR) we have the results for 21 patients evaluated at 450 days. Of these there were 14% CR and 14% PR and a Total Response rate of 29%

Assessment Days	90 Days		180 Days		270 Days		360 Days		450 Days
	%	# of patients	%	# of patients	%	# of patients	%	# of patients	%	# of patients
Complete Response	49%	17	45%	14	38%	11	30%	7	14%	3
Partial Response	17%	6	29%	9	24%	7	13%	3	14%	3
Total Response	66%	23	74%	23	62%	18	43%	10	29%	6
No Response	34%	12	26%	8	38%	11	57%	13	71%	15
Evaluable Patients	35		31		29		23		21

The data submission to the FDA of 450 day results for the first 25 phase 2 patients will incude the results of 4 more patients. The best case scenario would be if all 4 were CR. This would be a 450 day CR rate of 28% and a total response rate of 40%.

Assessment Days	450 Days
	%	# of patients
Complete Response	28%	7
Partial Response	12%	3
Total Response	40%	10
No Response	60%	15
Evaluable Patients	25

But there's really no reason not to include the 3 full dose patients from the phase 1 trial. Theralase will be submitting complete 450 day data on 28 evaluated patients. The best case scenario for the 28 is a 450 day CR rate of 32% and a total response rate of 43%. It should also be kept in mind that this submission represents 450 day results for only 25% of the patients who will be treated in this trial, and half of that 25% was undertreated. The results of the (at least) 75 patients yet to reach 450 days should significantly improve the numbers. There is also the possibility that the 3 NR patients will be reclassified CR which would mean a possible 450 day CR rate of 40% for the 25 patients and 43% for the 28 patients.

Assessment Days	450 Days
	%	# of patients
Complete Response	32%	9
Partial Response	11%	3
Total Response	43%	12
No Response	57%	16
Evaluable Patients	28

[DJDawg]

Thanks for posting!

[99942Apophis]

Nice job Eoganacht,  you probably recall mentioned 5 patients were removed from the study because of "no" response which someone said back then that doing so would also reduce the NR total for the study on the American side. That being said has not been reflected in the released  numbers by the company here in Canada. If this is true & accurate ( which is unknown to me

[DJDawg]

I know everyone is hopeful that that 25 is the magic number for BTD submission but I would argue that it is not so simple. The FDA info says that as you get closer you can request a meeting to discuss whether the data is enough to get BTD. Kind of a way of checking in and getting a preliminary thumbs up vs being told that should aim for another x number of patients and a total CR of x %. As such,

[Pandora]

I would like to see them take those 12 "undertreated" patients out of the data base completely and write them off as what they are - a mistake! That is very unlikely to happen but their numbers muck up all numbers for evermore, whether it be 12 out of 25 or 12 out of 100 they distort the true result. Question then is - do the reviewers work around them? imho.

[wildbird1]

The optimized patients effects... I would not worries to much about the 12 undertreated patients, as more optimized patients are treated, the TR(CR+PR) increase. TR= number of patients that still have their bladder after TLT cancer treatment. Exemple, PressRelease AUG 29,2022.                                   &

[Legit62]

So so close we will see this SP adjust accordingly,already believe FDA has taken into account those 12 under optimized patients. And are just waiting for the next patient results to grant us BTD then AA, then off to the races

[Yoly900]

Than your sayin 1.00 by march another waist of time stop insiders 0.02 on way eventually yes 0.45 we go down Roger and company gotta collect 2.6-3mil next year we'll take it up shoot once more oh wait you guys not me  

[Rumpl3StiltSkin]

Dog, I think 20 is the minimum number to submit for BTD. TLT waiting until they can submit 25 bodes well, I think. I think when the decision is being made 60 days later that the numbers, crunched nicely by Eoga, will be even better. Perhaps closer to 60% TR. And they might be slightly better still, into the 60%s, once the AA is being considered. So I think this is a slam-dunk. Wish I had some

[Eoganacht]

Here is what Theralse reported about BTD in the most recent MD&A: Break Through Designation Update   In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical

[DJDawg]

Thanks. I just have trouble seeing this as a set in stone thing when the FDA website talks about companies arranging a meeting when they are getting close to BTD application.

[Eoganacht]

Yes, we don't really know what communication is going on behind the scenes between Theralase and the FDA. Hopefully the company will fill us in before the end of the year.

[stocksnbonds458]

Dawg, from what I understand after talking with someone close to the situation is that the FDA have had a number of conversations with TLT managent regarding BTD and the progress of their therapy. I was also told that the FDA has the discretion to "read between the lines" with regards to results, with the possibility that they could disregard much of the botched "first 12" from

[Yoly900]

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[StevenBirch]

Thanks S&B, I always thought that if we could see how the 12 under treated skewed the results obviously the FDA would see it and take it into consideration. It's eerie how that and the covid delays could mean that this all comes together as Roger's suspension is due to end. Maybe it is that and not some toxic work environment that some have suggested for the rotating executives, Vera

[Oilminerdeluxe]

Thank you, S&b. Needed to read something positive. Music to my ears :-)

[Yoly900]

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[Yoly900]

This post has been removed in accordance with Community Policy

[Yoly900]

Any one out there 12:00 noon here Russia. Roger is a crook arkadymanscammmmm 

[Pandora]

I keep trying to rationalize the NR (No Response) number. Maybe I was spoiled by the Phase 1b study. How do you rationalize a No Response of 16 patients? 12 give a response yet 16 give "no" response? Or is there more to it than that?