Theralase Technologies Inc. V.TLT

The real efficacy numbers

[Eoganacht]

We all know that the first 12 patients were severely undertreated. The first 8 patients had very little chance of a CR as they did not receive an optimized treatment. The next 4 patients all received one optimized treatment so they at least stood a chance of achieving a CR even though they did not receive the 2 optimized treatments that all subsequent patients received. If we want to know what the efficacy would look like without the initial undertreatment we should, at the very least, remove the first 8 patients from the results. If we include the 4 patients who received only one optimized treatment I think we can be confident that the efficacy results would be at least this good without the intiial dosing mistake.

Here are the most recent results we have for 90 and 450 days from the Nov 29 MD&A.

	90 Days			450 Days
Assessment	%	#		%	#
CR	53%	26		28%	8
IR	14%	7		10%	3
TR	67%	33		38%	11
NR	33%	10		62%	18
Evaluable	43			29

And here is what our efficacy results should look like with the 8 completely undertreated patients removed from the results.

	90 Days			450 Days
Assessment	%	#		%	#
CR	69%	24		38%	8
IR	20%	7		14%	3
TR	89%	31		52%	11
NR	6%	2		45%	10
Evaluable	35			21

We should be looking at a durable CR rate of at least 38% and an overall durable response rate of 52%

Has anybody seen any other BCG-unresponsive NMIBC treatment with a total response rate of 89% ?

 

[Eoganacht]

Sorry, I made a mistake in the second chart. Our actual total response rate at 90 days was not 89%. It was 94%!   90 Days   350 Days Assessment % #   % # CR 69% 26   38% 8 IR 20% 7

[Infinity]

Eoga,  Those are impressive numbers by removing the 8 + 4 under treated patients or partially under treated.  Just curious,  would it not be better to simply isolate those 12 patients as a separate group and offer them the correct dosages.   If I were one of the 12 patients who got treated with a lower dosage,  I would happily accept the optimum dosage and hope for

[enriquesuave]

Very impressive numbers indeed and they also contain 1 patient from PH1 which was probably not eligible to be included( patient #4) as had also not received an optimized treatment. Plus the patient who died of HF and was counted as NR even though he had a negative cytology report at day 30 ( 95% predictive of CR status at day 30).  So 2 extra patients who are negatively affecting our results

[Eoganacht]

If we also removed those 2 NRs we would have a total response at 90 days of 100% !

[StevenBirch]

This is why these presentations and face to face meetings with the FDA are what matters, they can add colour to the data that they don't need to in their updates. Some people want that colour from the company to put their mind at ease but we have good people here for that and many thanks to them while we wait. The wait will be worth it.

[N0taP00p]

Eoga: Shouldn't the second set add up to 100%?  I always appreciate your posts. Not criticism just trying to understand. Apologies if I missed anything obvious. 

[Eoganacht]

Sorry - I messed up the 90 day chart with the 8 undertreated removed. It should be:   90 Days   % # CR 74% 26 IR  20% 7 TR 94% 33 NR 6% 2 Evaluable 35

[fredgoodwinson]

Thanks once again Eoganacht. You have consistently provided most valuable common-sense assurance - crucially in an understandable format.

[Rumpl3StiltSkin]

Bravo! Eoga. :-)