Theralase Technologies Inc. V.TLT

INVESTORS ARENT BUYING IT YET

[Tarbaby]

Its obvious the news that Metformin combined with Rutherrin kills cancer cells in a petrie dish just doesnt do it for investors.
They need an independent lab to repeat that on tumours implanted in live mice.

[Tarbaby]

But I personally bought more shares on that news..plus all the other amazing features the company recently reported such as how Rutherrin potentiates so many other treatments like chemotherapy and immunotherapy and virus destruction etc.. Im a believer..

[Infinity]

I would rather if TLT would concentrate on NMIBC which is so close to BTD or even apply for FDA approval once 85 patients are treated and results presented.  Investors are wary about TLT approach of multi directional/multi application approach without any meaningful solution to raising capital.  We have all seen them struggling with PP and PP with the same results.  Existing

[Kayz88]

This ^  All the happenings are great, exciting and hopeful. But for now I'd feel better if management took a paycut, extend the runway, get through NMBIC, raise the stock price, secure funding at a higher rate and THEN going back to paying themselves $400k/year

[Lesalpes29]

Dreaming of a good JV with a big BP behind. Helping us not Stealing us! 'Avoir les moyens de ses ambitions' for a change. GL

[StevenBirch]

What makes you think they aren't concentrating on NMIBC? I mean really, what can they do in between screening, enrolling, treating and waiting for data? Besides that Roger has said their main goal is completing Phase II, unless you have some other evidence?

[Infinity]

Do you really need more evidence?.  Other than shifting BTD Deadlines, not knowing the correct data format expected by FDA, FDA not accepting data as presented and requiring more verification, Hiring and Firing of Specialised clinical study experts like Vera for example.  Lack of Continuity in Sr Management causes delays.  Do you really need me to go into every delays and shifting

[DJDawg]

Agree that TLT at a management level has been a bit amateur. I think they tried to do something big with no background in doing it. Other pharmas would hire staff very experienced in this area and it would be an efficient machine. They are a small time laser outfit that stumbled on some amazing science. Points for early recognition but demerits for everything after that. All we can hope is that

[Legit62]

Great point DJDawg,have to agree with you on this one, the party bus has slowed but will pick up steam shortly,lets hope we bring in the 10 million people have been talking about,we need the funds now

[Gooseybear]

TLT is having to jump through additional regulatory hoops due to the checkered past of the CEO with the regulators. I've worked with regulators in the US so I've seen that trust with them means more than data.

[Longholder99]

The FDA granting approval or not based in trust vs data on an oncology drug.  Hokding back now because of some half baked whiney complaint of many years ago for cold laser therapy claims....probably generated by a competitor looking to delay the inevitable success of Theralase.  Is insane to consider.  Would it then be your supposition that were RDW a trusted CEO and just a better

[DJDawg]

I think that the FDA is more likely to be biased against easy BTD for newer technologies. I also think that they are more likely to approve if the application comes in with the consultative support of the most expensive consultants who are all ex-FDA and well connected. A tiny venture company in Canada with a new technology.....

[Infinity]

Agree with you on this.  FDA is not used to seeing this technology coming from an unknown Canadian Micro-cap company.  We do not have High Profile lobbyists woeking for TLT.  Perhaps the singlw biggesr reason for delays.  

[Gooseybear]

If you think that the FDA regulators don't talk to their international counterparts you are sorely mistaken.  As a longtime holder of TLTFF, I want them to succeed but don't be blinded by your holdings.

[CancerSlayer]

There has been an unfortunate evolution of agencies like HUD, the CDC & FDA.  They have evolved from being community-supportive advisory agencies to agencies of power & influence..imo.  One doesn't have to look far to see the revolving doors between many Federal agencies & the private sector.  In the case of HUD, one can open the door (after a 1 yr cooling period) to

[riverrrow]

Sometimes one lone wolf bureaucrat can wreak havoc with a company's future.

[CancerSlayer]

Per FDA guidance (August 2024, Revision I), the primary efficacy endpoint for bcg-unresponsive NMIBC with CIS should be CR rate.  Sponsors should consider CR rate in the context of the duration of CR. Keytruda CR rate = 41% (39/96) Keytruda 12 month CR rate = 19% (18/96) Ruvidar CR rate = 63% (41/65) Ruvidar 12 month CR rate = 28% (18/65) The goalposts set by Keytruda lie a short distance

[Bigkahuna57]

@CS, please correct me if I don't recall these details as has been stated.  1) The Keytruda/BCG compound requires many more installations/visits. 2) Keytruda has possible debilitatiing side effects.  Do patients get followup after treatment to see if they are reactive to these side effects? Is that a treatment data point ever recorded so those reactions are tracked?  Or would

[Gooseybear]

I can only respond as to my personal experience with NIMBC since 2017 currently in remission. Thank God. I'm not familiar with a Keytruda BCG compound. I've only been through 20 BCG treatments as Keytruda has significant side effects according to my Urologist as BCG is currently his standard of care. It's my understanding that Keytruda is only used for advanced stages of bladder cancer

[CancerSlayer]

It is/should be routine to have follow-up after treatments to monitor/document/report both treatment response & side effects, whether it be in a clinical trial or in practice. Keytruda & other combo therapies are indicated for the treatment of high-risk bcg-unresponsive NMIBC (CIS), which is a more advanced stage of NMIBC.  However, this advanced stage of NMIBC would be considered an

[Eoganacht]

Hi CancerSlayer - I completely agree that the way DOR is reported gives a false picture of a treatment's efficacy and "a high percentage of a low percentage is still a low percentage." However this is the way all of the competition reports their data and the FDA is used to receiving data  this way and they rule on treatment approvals citing this sort of DOR presentation as one

[CancerSlayer]

Agree with your total patient number, which gives a more accurate account of the "available" 12 month data at this point in time...my 12 month CR would be worse case scenario, which is still very promising.  I will have to remind my old brain next time....thanks again for your reminder/input.  My intentions were good : )

[Infinity]

I get it that the Duration or response preferred by FDA does not statistically validate the efficacy of a treatment accurately.  It kind of ignores pretty much all the No Response or Partial response Category of patients.  The Point is FDA make the rules and we play by their rules.   Cancer Slayer has tabulated it as Keytruda CR rate = 41% (39/96) Keytruda 12 month CR rate = 19

[Eoganacht]

And thanks very much for the brand spanking new FDA Guidance - August 2024. Here is a link to that document. document is being distributed for comment purposes only

[DJDawg]

Hi Eog, Great find. Did the new guidelines change the %'s sought for CR and DOR? Did they make any comment on the issue of some drugs being a perpetual treatment? How that alters the interpretation? DJ

[Eoganacht]

Hi DJDawg - I didn't see any information like that - check it out - it's only 11 pages of text https://stockhouse.com/companies/bullboard?symbol=v.tlt&postid=36195359

[CancerSlayer]

Dawg must have me on ignore ; )...

[DJDawg]

Sorry dude. You are never on ignore. I was just reading the most recent few posts and didn't go further down the thread for today. Thanks for answering the question. I value your knowledge and contribution!

[DeathXray33]

That's true. Evil forces around us. Expose evil no matter who they are. We are going to win.

[Gooseybear]

As to your last statement, it would be nice. Based on the political environment in the US, I think prayers will help.

[frebeach1]

Completing the NMIBC study first is exactly what Roger stated at the last AGM. BareoaksDave