Theralase Technologies Inc. V.TLT

Additions to Study Design

[Eoganacht]

• Surgeon has the option to deliver up to 2 more re-induction Study Procedures, if the patient recurs

• Patient followed up quarterly for 2 years and then semi-annually for 3 years

[Oilminerdeluxe]

Ungodly frustrating. But what can you do? Hope we get a nice update whenever it arrives.

[Eoganacht]

I think this is good. The trial still ends at 450 days past initial response, but Theralase will continue to compile durable response data. I don't think any prospective treatment we've heard about so far will be able to compete with Ruvidar PDT's durable response and Theralase will have the data to prove it.

[Oilminerdeluxe]

Hope you are right. We deserve a boost or two upwards. Hopefully, Roger's well of funds will not dry out going forward when the next need arises.. 

[Eoganacht]

I'm hoping that Theralase has already made a deal but that it's dependent on getting BTD. As of 4 days ago (March 18 Corporate Presentation) Theralase was still projecting BTD in the first half of 2024.

[Oilminerdeluxe]

Good. I didn't even know a new presentation was out, lol. That sounds within our grasp. Fingers crossed.  

[DJDawg]

any changes on the March 18 slide deck vs the previous one?

[Alamir1111]

Oct 23 presentation shows Resarch capital as analyst March  18 no mention of them 

[Alamir1111]

Premarket. Study device .projected mid 2023 end 2025 https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device#:~:text=Medical%20devices%20range%20from%20simple,kits%2C%20and%20blood%20glucose%20meters.

[Mikee3003]

Eoganacht - I very much doubt a deal is in place dependent on getting BTD. If this was the case TLT would be handcufed with a LOI and I would certainly expect that a if there was a signed LOI it would be considered material information and a news release would need to be issued. 

[Eoganacht]

Mikee3003 - as a secret agent for Theralase management, don't you think I'd know better than you? But maybe I'm just another poor schnook long who can't resist speculating about his Hail Mary pass retirement funding  longshot. Eh?

[Oilminerdeluxe]

Ha ha, good one!

[DeathXray33]

"I'm just another poor schnook long who can't resist speculating about his Hail Mary pass retirement funding longshot." Lol... I'm right next to you. We'll be able to go camping, hiking & fishing a lot more. Roger & Sherri are awesome!!!

[menoalittle]

>> But maybe I'm just another poor schnook long who can't resist speculating about his Hail Mary pass retirement funding  longshot. Hey, I'm right there with you, eoganacht ! (for 5 years or so now... and it's getting mighty long in the tooth.) but, what do I know...    

[Eoganacht]

Once Ruvidar PDT is approved Theralase will be able to point to it's superior efficacy immediately and it's superior durable response will emerge more and more over time as Ruvidar maintains it's CR rate while Adstliladrin (for example) declines. With safety and only one or two treatments required Ruvidar will become the obvious choice.

[Johnandrose22]

It is stunning to me that our primary source of understanding, guidance and perspective comes from Eoganacht and not the company. Thank God for this good and generous man to share his insights with us.  I can't imagine trying to sustain motivation and enthusiasm for our investment without him. How do people who are not on this board understand anything the company has done? Maybe

[Mikee3003]

JohnandRose22 - Perhaps our friend Eoganacht is the "unofficial" communications person for Theralase??? Call me paranoid, suspicious.........are there any communications with Theralase's executive members or any employees?........hmmmmmmmmm   

[Johnandrose22]

Ah, Mikee3003, thank you....After over 10 years investing in this company and attending  this forum there is little that can surprise me. My dilemma is this.....At this point, I trust the integrity, honesty, guidance of Eoganacht and others on this board more than I do the company's CEO and his administration. I don't think I'm alone with this. That's a problem.

[judgesmails]

Interesting perspective and I agree to some extent. I think the company is continually trying to succeed, but without a doubt they have dropped the ball at times.  Mostly a victim of 'the system' (& all the covid bullsh--), but some of the blame is on Theralase leadership also. Pre BDT is supposed to be in the rear view mirror.  But not a peep about that.  Should be at

[Eoganacht]

Theralase is now following up with patients for 60 months - exactly the same time period as Ferring is using with Adstiladrin treatments. This will facilitate a durable reponse comparison of the two treatments.

[Donein25]

These lengthy additional surveillance times were never part of the original or even the optimized trial. It is important to remember that accelerated approval is now only granted with a plan in place for additional confirmatory surveillance in single arm trials. 60 months sure fits the bill for an additional surveillance plan under AA. I'm not saying that AA is just around the corner, but this

[riverrrow]

I'm sure everybody here would agree that AA would be huge.  The sooner the better.  Thanks for your post.

[Longholder99]

Does it make sense that if AA is in the crosshairs.  Enrollment has stalled because after AA is acheived they can start charging money for treatments.  Saving the bank account   Would explain trial parameter changes as well.   Just a thought.  

[StevenBirch]

Would also explain why Roger is doing the small PPs every couple of months, I doubt they can keep going back to the same people if there was going to be a major delay. They must have some idea they are close and we just have to suffer these little price corrections until it all happens. 

[riverrrow]

While the number of patients that have reached 450 days is much smaller than the goal of 100 patients  and therefore the confidence level  in the CR% is smaller than desired, surely the lack of side effects and especially lack of serious side effects is a huge plus that should warrant huge consideration at this stage of the trial.  BTD an AA here we come.

[Galaxym31]

Powers that be should stop torturing cancer victims with multiple treaments and severe side effects eh .