Theralase Technologies Inc. V.TLT

How long to BTD and then AA

[BlueFranky]

Let's hear it everyone

[Rumpl3StiltSkin]

I think, since this NR stated they have completed the milestones, they'll be using the older CR data to submit BTD, ASAP. We may have BTD before AGM. There I said it. Now TLT is cursed. ;-)

[BudFoxx2020]

As long as there are suckers out there.  It will go on and on and on.  I mean in 2014 they promised commercialization and cure in 2016.  Lolololololololol.  As long as ScienceFirst and his crew can milk this.  It will keep going.  Like the saying goes there is a sucker born everyday.  Anyways PP is coming this is a given and so obvious.  Unless you been

[consultant99]

So the FDA appears to have moved the goal posts such that the trial now includes only those patients that have received the Study Treatment as defined in the management notes.  In the BTD update the company notes the criteria: Primary objective is CR at any time Secondary is duration of CR at 12 months after initial CR. Tertiary objective is safety. BTD is available if certain criteria are

[Rumpl3StiltSkin]

99, That is how I originally looked at it too. I'm not so sure now after reading the NR a few times. I think they are putting together the BTD right now. Not using the 'New Math' but the Old CR data, which includes the 12 unoptimized. They have met the Phase 2 milestones. Seems to me we have two ways of looking at the data now. The old way has served to get them where they can apply

[CancerSlayer]

  I agree....as per the NR, the BTD app is currently being compiled & will be based on "real math" or valid biostatistics.  The only unknown/delay is how they plan to handle the unoptimized group.   I don't believe there should be any "fair" or "market-friendly" way to present hard data, & I certainly don't believe any regulatory

[Oilminerdeluxe]

Is it two new patients at 450 days in the next 3- month update? Let's get the financing over and done with. Then perhaps things will run a bit smoothly again

[enriquesuave]

If they are 21 evaluable patients at day 360, then there will be 21 in 3 months at day 450.  IMO

[Oilminerdeluxe]

Yes, that was what I thought too, but someone wrote two, so I had to ask. A bit of a difference. But then, that BTD could not be in doubt as they have that pool of patients once mentioned, 20-25. Good. Finally, the waiting gets easier. Thanks.

[enriquesuave]

I believe they have more than enough patients for BTD.  They can and will have to show All data, both with and without 16 non eligible patients. (12 undertreated, 1 who died and 3 from PH1). The FDA will be able to evaluate the effect of these undertreated and non eligible patients on the overall data.  I expect guidance on AA after data submitted.  Just IMHO 

[Oilminerdeluxe]

That would a nice thing. Would no doubt bring fresh eyes. I can't believe it didn't move up yesterday, but perhaps it is as easy as needing the BTD and then later AA. The conference should be good exposure.

[gordo323]

Alot of interest at opening today . Level II   Theralase Technologies Inc. (CA:TLT) Size Bid Ask Size 26500 0.235 0.255 24000 27000 0.230 0.280 2500 2000 0.225 0.300

[gordo323]

All of the .255 asks are gone now. Level II   Theralase Technologies Inc. (CA:TLT) Size Bid Ask Size 4500 0.245 0.275 7000 10000 0.240 0.280 2500 22000 0.235 0.295

[consultant99]

Based on FDA guidance, Mr. Uddin expects Theralase to apply for breakthrough designation for Ruvidar when it achieves a complete dataset of 20-to-25 patients during a follow-up period of 450 days. To date, Theralase has reported that it has 12 evaluable patients which showed a CR of 67% at day 450. Looks like Research Capital is assuming that we need at least another 8 evaluable patients before

[enriquesuave]

No according to swimmers plot in 3 months there will be 21 patients reaching 450 days looks like it will be between 43% CR and 53% at 450 days on 21 patients ( 53% if both IR patients are confirmed CR). IMHO 

[consultant99]

Am I not reading the plot properly? There are nine patients currently at 360 days but only two have arrows which according to the legend are pending visits treatments or analysis. The remaining 7 are listed as HG NMIBC which I took to mean they are no longer in the study. 

[enriquesuave]

Perhaps only patients which are CR or IR at 360 days have pending visits for potential CR/IR status.  Those NR at 360 May perhaps not need and will be counted as NR?  No reason why they won't be counted.  Overall it looks like we should be seeing about 18-25 CR patients out of 37 ( 52-15 12undertreated plus 3 from PH1 removed from Swimmers plot.  That would be 48-68% CR at

[enriquesuave]

Correction 18-25 out of 40. PH1 patients lready removed but not 12 under treated. 45-60%CR. Imo

[Rumpl3StiltSkin]

Ok Enrique, I agree and that sounds great. Yet I think we get to see this next 3 months data at end of May... Right?

[enriquesuave]

I actually agree. It will be 6 months since November data. So it will show 21 patients or more at 450 days perhaps 

[StevenBirch]

Enrique, doesn't the statement below jibe with what you are saying and we are NOT months away from applying? And of course we should learn more on Sun/Mon after AUA? It seems like there is always a 3-step process to any news release. First reaction is usually positive followed by a more negative tone and then the "we are on the right track" opinion. I guess that is partly due to the

[Rumpl3StiltSkin]

Don't want to step on an Enrique response, Cuz I'd like to hear it too... If they wanted to do some application today, towards BTD, they have the numbers w/o using any Phase 1 data. 8 CRs out of 24(including the 12 undertreated) is 33%

[Donein25]

So if I understand you correctly; if we get an update at the end of May, it should include 9 new patients evaluated at 450 days? Thats how i read it.

[Rumpl3StiltSkin]

But won't we see that CR data in 1 month? :-)

[Rumpl3StiltSkin]

Slayer, I'm  just talking about the FDAs, or someones, idea that the 12 unoptimized shouldn't be included and also the 3 from Phase 1. And any that have decided to drop out? Whatever the new CR data compiling is moving forward. Seems more fair. Will definetly give TLT better CR numbers.