Theralase Technologies Inc. V.TLT

TLT Conclusion - On a good track...

[mkailis]

Conclusion:

Study II has delivered significant clinical results to date for the primary, secondary and tertiary objectives.

Dr. Vera Madzarevic, Ph.D., Director of Clinical Development and Quality Assurance at Theralase^® stated, “From the 38 patients treated to date in Study II, those evaluable patients, have achieved 50.0% CR at 90 days and 25.0% have maintained this CR for at least 450 days, since primary study treatment. Additionally, total responders (CR +PR) at 90 days is 60.5% and 18.4% at 450 days; however, there is significant data still pending. This provides clinical support for achieving the primary and secondary objectives of Study II. The tertiary objective clinical data is promising, as only 7 SAEs were reported to date. Theralase^® believes these 7 SAEs are unrelated to the Study Drug or Study Device. In conclusion, it is encouraging to see, from the preliminary clinical data that the Company has accumulated to date, that if the trends continue, then Theralase^® is on track to achieving the primary, secondary and tertiary Study II objectives.”

[enriquesuave]

Maybe we get BTD this week and surprise market .  Initial sell off from those who unrealistically expected 100% CR?  Results are amazing, best single agent by far so far  IMo

[socksnblonds642]

These numbers point to BTD for sure IMO. I don't know that a public company can just magically announce that they received BTD without first supplying information like this to the market. If it was full trial results they wanted to present then they would obviously have waited. 

[Legit62]

Does anyone know when Phase 2 trial is done with all the data?

[FGPstock]

@legit, it has been a while since i look at the trial design, but I believe the PHII is set up for 125+/- patients. Then TLT mentioned they would be looking to apply for BTD and AA after 20-25 patients, which we have surpassed. My numbers may not b exact, but close enough, I am sure someone w a highlighter and no other life will correct me.

[Legit62]

Sounds good, so we have a ways to go before full data is actually analysed and we can get concrete CR rates. Was hoping that we have good enough results now to get BTD, which IMO we do compared to other treatments available at this time. We may get that news shortly because they didnt want to post they already applied for BTD before they actually receive it. IMO

[ScienceFirst]

Legit62 ... The info you're looking for appears on TLT's website. But your question is not the one that matters.  The one that matters is to identify the pivotal moment we'll reach a statistically significant data that will trigger a Breakthrough designation that will then attract a big Pharma for a jv. ______________   Legit62 - (4/5/2022 9:55:46 AM

[Legit62]

Loooking at these results today, that time looks like it has come compared to other treatments available, also to consider our low dosing and safety

[LaserStock29]

Can anyone confirm that the BTD would lead to a Marketing Application status for the ability to sell TLD-1433 in the marketplace while the confirmatory trial (our Phase 2) continues to the 125 patients. That was the whole point right...  Someone dig up that DD from 2019-2020. Cheers

[Rumpl3StiltSkin]

I have a quick reply Laser, I am 90% sure that TLT will get AA on ~ 35%, or probably better, 1 yr CR results. Yes BTD would happen at some point before that on those same numbers. It would be highly unusual for a BTD candidate to not go commercial off of numbers that are perceived as 'great'. Especially cosidering 1433s safety profile. I'll try digging for the real info later today.

[jicoop]

well, market not liking the results : I'm still dogesting and having coffee.  0.38 CAD -0.08 (-17.39%)

[Mongoose1975]

yeah wtf is up with that

[riverrrow]

As usual the data appears muddled.  Personally I can't make heads or tails of it.  GLTA.

[Longholder99]

Lots of numbers. Not east to decipher unless you have spent a lot of time on this one company...whichmanybjave not. No mention of BTD or vaccine which is where the real money comes from. I wonder if they caved and releases released incomplete info because the phone wouldnt stop ringing. Market is spooked a bit.

[Pandora]

And I believe that is the main reason for the market reaction. First off there are those that had visions of sugar plums dancing in their heads and the news today does not confirm the sugar plums. The data is not presented in an easy way for novices to understand and I have to believe the shareholder base includes a large number of novices. From my own perspective a couple of points I find

[jicoop]

Ok, so my take on the numbers portion , which hopefully adds to the info presented so far today by Pandora and couple others. Note, I am not a scientist, just a number cruncher , and I will summarize as quickly as possible . Firstly, The optimized table seems to present worse results than the first non optimised table, not sure why that is, Company would have to answer. I will concentrate on the