Theralase Technologies Inc. V.TLT

FDA

[Dumbeldorfwhite]

Why would the FDA grant breakthrough for 25 patients, of which, didn't even get the right dose? My guess is that is the hold up

[Eoganacht]

Because even with an inadequate dose the results were better than all competing treatments.

[Dumbeldorfwhite]

But they don't know if it's safe, because again they weren't given the treated dose, that simple and 1 patient died don't forget 

[Alamir1111]

Good bless his soul .It wasn't treatment related 

[Eoganacht]

They do know it's safe because the affected patients were underdosed. There is less likelihood of an underdose causing a serious adverse event than the regular dose. There have been 62 patients treated in the trial so far and there have been zero study drug or study device related serious adverse events.

[Dumbeldorfwhite]

Yup that makes total sense, hence why we have FDA approval already right?

[Alamir1111]

Y Eog the results are better .but they need consistence .

[Rumpl3StiltSkin]

They have decided to go with optimized patient data, that did cause a delay which is now in the rearview, IMO. No significant delay looking ahead, IMO. :-)

[Dumbeldorfwhite]

Heard that in 21', 22', 23', yet here they are still 48 patients away from the end goal and 5 million left and are all the clinical sites originally proposed up and running? I remember the days everyone saying "the trial is paid for" so we re good.

[Eoganacht]

They are 38 patients left to treat not 48.

[Dumbeldorfwhite]

Oops you re right so what's the proposed completion date again 2026? 

[Oden6570]

Scalliwag Alert !!!!

[Eoganacht]

Thanks Oden6570! My bad. Belated remedial action employed!

[Longholder99]

Had that one pegged in seconds

[Alamir1111]

Yes the completion of trial is scheduled for 2026. And rs capital has a .80 c forecast for sp

[chry200030]

.80 forecast is the 12-month forecast. so achievable in 2024. Should be a lot higher in 2026.

[Eoganacht]

Read the news releases. This is from 9 days ago: "Mr. Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase® stated, "To date, the Theralase® Study II clinical data has demonstrated best-in-class performance for a single agent, providing high efficacy, durable response and a high safety profile, with no serious adverse events directly

[Alamir1111]

Eog give  them 2 years of leeway 

[Alamir1111]

This post has been removed in accordance with Community Policy

[Alamir1111]

Sorry Dumb you right they claimed  phase 2 is covered

[Benedictus]

To date, the optimized patient cohort is up to 32 evaluated patients. It always amazes me the amount of people whod rather waste time posting uninformed opinions instead of actually spending that time reading the companys MD&A and financial filings to actually educate themselves on their investment.

[Dumbeldorfwhite]

Yay 32 evaluated patients!!!!  minus the 12 not treated correctly so 20!!!!!! Wonder why Vera stayed for like 3 months hahahahaha

[Rumpl3StiltSkin]

Ben, their investment is a TLT short position, explains everything.