Theralase Technologies Inc. V.TLT

RDW on youtube posted today

[DJDawg]

https://www.paidpromotionalmessages.com/companies/news/1034976/theralase-makes-positive-progress-on-phase-ii-study-on-bladder-cancer-targets-btd-with-fda-1034976.html

[DJDawg]

Just watched the interview on youtube. He goes through the whole pre-BTD, BTD thing again. Nothing new. He mentions other sources of funding that are being explored. Glad to hear him say it aloud (geographic licensing, royalty deals etc). Not sure if that is him being optimistic or hinting at a real effort or dialog that is happening now. The timeline for FDA full approval he mentions is slow

[riverrrow]

I don't follow RDW all the closely but I agree, I think he does his best to avoid being a promoter or pumper.

[Tapps21]

I hope most of you are still here in 2026 ;-)

[chry200030]

I think he made an error.. He said 2026 but he meant 2025.

[tdon1229]

I don't see an error. Treat the rest by the end of 2024 (hopefully). Add 450 days to the end of treatment to get to mid 2026 for data collection. Add six months to cycle through the FDA and receive approval (hopefully). Now reread the Forward Looking Statements disclaimer.

[99942Apophis]

Correct me if wrong, I was under the belief when a company was awarded BTD & AA for a segment of the patient population that was unresponsive then that company (Theralase) could immediately sell that treatment to that patient population which is 30 to 40 percent  of NMIBC in a given year.

[Oilminerdeluxe]

Maybe the BTD in itself won't bring much of a value boost, but a j/v after it is awarded might be what is needed. Or something like that.

[Rumpl3StiltSkin]

Yep that is exactly what AA is about. Commercialization. The official FDA approval will come in 2026 IMO. But the AA will come sometime in Mid 2024, IMO...

[Oilminerdeluxe]

Feels like the pre-BTD is harder than the actual BTD. Ahh, what to do. Buy of the century, or don't buy at all. It's never easy .-)

[Alamir1111]

Yep it's not easy.rdw was the only insider purchasing the .22 warrants  461.212 cost him 100000$ 

[Alamir1111]

Question to dj Dawgs.when research centres or hospitals doing these trial runs do they know the response rate of treatment or is it up to the principal investigator to inform them in timely matter if there is an issue with treatment protocol or succes??

[StevenBirch]

I agree with that Oil, the actual BTD seems like it is a rubber stamp after the hard work of the pre-BTD(s) is done. Also these guys pushing the 2026 timeline is them putting a negative spin once again. That may be when full FDA authorization is given but between BTD and AA there is much value to be added here hopefully soon. 

[Alamir1111]

Ok Steven no covid shutdown restriction ? 5 patients treated in 3 months at 15 research centers need 37 more.What would be the timeliness to Finnish the trial  ??

[Alamir1111]

Up to now we have an average of 1.8 patients treated per month Good cr nrs. Sorry the best 

[tdon1229]

FDA was catching flak because they were granting BTD & AA relatively freely during the past decade, but as many as 50% of those had to be recalled by the time final data for the trials was collected and processed in advance of a Final Approval.  As was reported in the open press, the FDA tightened up the approval process this past year as they attempted to ensure their success rate

[Alamir1111]

So in plain English when you grease the wheel you get results.When you run on so called shoestring  budget you get strict  regulations??

[Alamir1111]

Let's not forget the last fda approved treatment not much better than the previous keytruda treatment. Is it to give choice or variety reason?I guess tlt should qualify to 

[Alamir1111]

So fda is waiting for the final 100 patients results before giving btd or aa just in case mid term data is not satisfactory? ?but we have open communication ?didn't we ?  applie inI june for  pre btd and we  have clarification ??.6 months later still re applying for  pre btd.. about 6 weeks upon pre btd approval we get response for btd.It's such simple 

[Alamir1111]

So in my 10+ years in investing in tlt  ilearned eat lots of foods with high iron content the more the better .travel a lot specially places where there is a a lot of X ray exposure at border x ings.you shall be ok

[Alamir1111]

Tonight ufc is  honorimg Stuart scott fight against cancer

[Rumpl3StiltSkin]

I bet the FDA is very impressed with the trial CR data to date but they are in 'show me' attitude because of the high recall rate. I doubt TLT will have this issue, IMO...

[Legit62]

This might be because of the talks with FDA that we might be getting AA along with BTD and that FDA wants info to be as clear as possible when and not if they approve it.  I honestly believe we get both and we start making money. The other part of the equation is no one touches us until we have at least BTD, considering we are on small canadian exhange with very little cash runway 

[StevenBirch]

AA along with BTD would be nice, I definitely agree that nobody would do a deal before at least BTD. But maybe Roger knows there's definitely a deal to be made once they get BTD hence the mutiple small PP's just to keep things going.

[Legit62]

Thats very plausible because our treatment for cancer is probably safest,best, least side affects and least number of treatments to come along in more than a decade. The scare factor right now with this PDT treatment is past PDT treatments didnt work, so some are scared off, once we get BTD and AA we roll. Now its just patience

[Eoganacht]

I'm hoping that Drs. Kamat and Kulkarni will help to spread the word among  urologists that this new PDT treatment for NMIBC is a completely different animal from the old one that used photofrin as a PS. Photofrin was also efficacious for NMIBC but it was just not cancer cell selective enough to be practical. At the level of light exposure that killed the cancer cells too much

[Alamir1111]

Eogonacht when a company applies for pre btd it is rewiuved by  a panel of experts in that field urologist.These experts as our 2 dr K are advising working for more than 1 company.So they have to tread lightly  cause you don't want to bite the hand which feeds them If the majority of experts agree on that preticular treatment is worth submitting to Fda.In tlt case these experts might

[Alamir1111]

It is kind of like jury duty when they call you up  Fun part is majority of experts can be associated with competition or not.Will see I agree Btd for tlt would be huge

[Alamir1111]

On last video r  poked his finger in wasp nest

[Alamir1111]

I'm learning new tech chat gp or al artificial tech so my posts are not  exactly represent my personal  views. I suggest to talk to a qualified investor advisor before making a decision..Give you an example I asked al to ask Shakespeare  about btd.His answer was to be or not be. Wise guy eh  ? 

[Alamir1111]

Asked al about chinese chicken .Response was fried balls with sweet and sour or honey garlic..where I grown up chickens didn't  have balls 

[Benedictus]

I actually wonder if the current "concern factor" is more about the perceived "learning curve" for ruvidar treatment mentioned by Kulkarni and whether there is a question as to commercial viability of a left of center protocol, especially when you read how excited these doctors are about the ease of integrating adstiladrin into their treatment protocol.  There appears to

[wildbird1]

Benedictus said " Doctors are excited to integrate Adstiladrin into their treatment protocol". After reading this link, I have big doubts about Adstiladrin being a serious competitor to TLT-Ruvidar. https://drugs.com/drug-interactions/nadofaragene-firadenovec,adstiladrin.html It is said " There are 274 drugs know to interact with Adstiladrin, along with one disease

[Benedictus]

Thanks for pointing this out wildbird1. 274 drug interactions is significant. How curious that particular issue was not even discussed between Drs. Daneshmand and Bibalacqua. 

[Mikee3003]

No that was not a mistake, he said 2026 and he meant it!

[99942Apophis]

Once again correct if wrong, thank you. When Roger said 2026 was that to treat the patient population over & above the 30 to 40 percent of unresponsive NMIBC?  Ok what I'm saying here is if they get AA & BTD then can they not immediately treat the unresponsive population and after PH2 is completed and have reached 15 or 18 months on all patients, Theralase should be able to

[Benedictus]

Roger says "the company is also going to be investigating non-dilutive forms of financing into 2024". He did not say discussions are ongoing or they are in advanced negotiations. In the context of what the CoB said 6  months ago ("the company is commencing to actively explore international partnering, licensing and distribution opportunities"), I'd say Roger's