Theralase Technologies Inc. V.TLT

how can an NR become not an NR?

[DJDawg]

I'm happy with the most recent data but I have a dumb question. How does a NR patient get revised to a PR or NR. If you look at the 270 day data (copied from Eoganatch post), 14 NR's became 12 NR's. I thought that an NR implied malignancy in the urine cytology AND visible disease on cystoscopy. I can see that a PR could be revised if the cells found in the urine cytology are found to come from a location in urethra or ureter (outside the field of treatment of TLT + light). I just don't get how you revise a NR when it implies that they visualized some tumour in the bladder.

Thoughts?
- maybe a site investigator give a patient an NR designation because they saw something with the scope and then revised it later based on second opinion from a top investigator?

Any other explanations?

May 30, 2022 - Number of Patients
	90 Days	180 Days	270 Days	360 Days	450 Days
CR	17	16	10	5	5
PR	8	7	2	4	2
NR	12	9	14	14	15
Total Evaluable	37	32	26	23	22
August 29, 2022 - Number of Patients
	90 Days	180 Days	270 Days	360 Days	450 Days
CR	19	16	13	9	5
PR	6	9	7	3	3
NR	13	9	12	14	16
Total Evaluable	38	34	32	26	24

[Rumpl3StiltSkin]

Dog, there are 2 treatments in this Phase 2. So at some point after the second treatment, some of these patients went from NR to PR/CR....  :-)

[DJDawg]

What I mean is that in the previous release from 3 months ago, there were 14 NR at 270 days. That means that 14 patients were assessed and given that designation. I get that they could respond and become a PR or CR at the next timepoint or 360. But this is them going back and revising the 270 day designation on two patients so that there are only 12 NR in the newest report (vs 14 NR at 270). It

[Rumpl3StiltSkin]

Hmm, I understand your point. Why did this happen? Anyone have any idea?

[Yoly900]

So breakthrough status will happen in Dec this latest report is good for fda to grant btd 

[Rumpl3StiltSkin]

I think it is important to keep in mind, at this point in this Phase 2 trial, it is the clinicians that are determining these numbers...

[Yoly900]

You just discovered AMERICA your smart. 

[Pandora]

I should probably just leave it alone but I won't because my "fuzzy" logic can't balance the numbers. What tends to confuse me is what I consider the "missing" category - I have probably said this before. I assume "Total Evaluable" is not actually "Total Patients in the Trial". The title says "Number of Patients" but then they use the term

[Pandora]

Not sure if it is answering my own question but in going back a bunch of pages, I found a Gebremeskel post of August 23rd that discusses/shows another category called "Pending" as posted in the MD&A -- this 'pending' number being separate from PR. I then went to the August 30 MD&A in Sedar and found the company did not produce a chart in a similar format to the May 30

[wildbird1]

Pandora... Here is the link for the Theralase Quaterly Newsletters. https://theralase.com/quaterly-newsletters/ I am not sure the NewsLetters number are going to help, as the Newsletters numbers are sometime confusing, but always interesting to read.

[wildbird1]

Sorry the link doesn't work. Go on TLT website... in the menu... click on "Investors resources" click on "Quaterly Newsletters".

[Pandora]

wildbird1 - (9/6/2022 7:05:56 AM) RE:RE:RE:RE:how can an NR become not an NR? Sorry the link doesn't work. Go on TLT website... in the menu... click on "Investors resources" click on "Quaterly Newsletters". Thanks wildbird1, I found it on the website last night and they ask for your email address. You give your email address and get a note saying they have sent an

[Pandora]

Found the Quarterly Newsletters this morning but the last issue is November 2021 https://theralase.com/quarterly-newsletters/