Theralase Technologies Inc. V.TLT

Timeline

[Eoganacht]

We've treated 60 patients and it looks like we're only going to treat 40 more. If we continue treating 3 patients per month we will be finished the treatment phase by the end of July 2024. The 100th patient should receive their 450 day assessment by the end of October 2025. The data will be compiled and application to the FDA for approval to commercialize made in late 2025 or early 2026.

IMHO Roger was bang on with the timeline this time.

"In order to line this up and get all the clinical data in place and get this into a position for marketing approval which we hope to do in 2025, early 2026"

[skys1]

However, deals are often made before final approvals have been obtained. Especially when the treatment is in an area of substantial need like an effective NMIBC treatment with minor to no side effects, unlike the current treatments. .

[Eoganacht]

True. There could be a whole lot of very positive developments for shareholders before final approval, including the announcement of a jv, the granting of breakthrough designation, accelerated approval, priority review and the initiation of phase 1 trials for gbm and/or nsclc.

[ScienceFirst]

Roger has to go by book.   We can only have though pleasant surprises like: - adding more CSS, - being granted Breakthrough Therapy designation, - receiving a BUY order from additional brokage firms, - seeing institutional firms entering our capital, - uplisting on the NASDAQ, - being selected for Accelerated Approval, - receiving an official jv offer, - etc...  

[Rumpl3StiltSkin]

I got around to listening to the radio interview. RW does mention BTD AA Priority review at the end. So, I guess there is nothing new. We should get 'Formal' FDA approval in the '25-'26 timeframe. Yet we could still receive AA by end of this year, if BTD is applied for soon. Which it seems they are working on.

[StevenBirch]

Also, and my numbers may be a bit off, Roger mentioned it talking between 15 and 20 years to get to market and we are around 18 years TLT has been at this. And again commercialization is obviously the goal for the company but for the stock it should pop long before that. There are many catalysts before that point.

[riverrrow]

With that kind of timeline I think Roger is going to have a tough time raising money in the foreseeable future.  Remember how a bunch of posters a short while ago were predicting a pp.  Where is it?

[Longholder99]

Just because it's pontificated about on an anonymous bull board......doesn't mean that it will happen.  

[N0taP00p]

@riverrow: you won't have to wait long. It's either going to be a raise or a JV or some other capital infusion. I'm guessing one to two weeks for an answer. Max. 

[DJDawg]

My hunch is that the last thing they want is to spend the AGM hearing that people are unhappy about no money or no plan for money. As such, I predict - sometime in the next week, an announcement re so cash arrangement. JV would be nice but I suspect they just did another PP but to a bigger pool of investors such as ones that the new board member out of Boston may know. If they announce some

[Rumpl3StiltSkin]

Great question River,  Maybe we get some good/great and unexpected news soon...???

[StevenBirch]

Marketing approval in 2025 or early 2026 is Roger toeing the line and I think it has nothing to do with the stock price. The things that would have to happen before that can even happen would have the stock much higher than it is now. And whenever that does happen I think you are in buyout territory. 

[Rumpl3StiltSkin]

Yeah, I agree.

[2b7f6fab]

Considering the apparent success to date, enrollment could pickup and 100 patients treated by 1st quarter 2024.

[charlierock]

It's been a long haul to get to this point as many longs are aware. I feel TLT is in a real sweet spot as there are now so many catalysts near term that could take us to the promised land. Most importantly the data which looks extremely good and will continue to only get better as the results from the 12 under treated patients get farther in the rear view mirror. If the FDA see's it the

[Rumpl3StiltSkin]

Eoga, Didn't RW just say in the latest video interview? That we get ~100 treated by end of 2023/early 2024, then get it up for approval by FDA? IMO, this can only be done because TLT 'wants' to wait for 100 patients. Again, speculation, maybe the FDA said this to them? This would still require AA though right? To get this set up that early?  I guess this quote above is from the