Theralase Technologies Inc. V.TLT

One detail that I just noticed

[DJDawg]

In the recent MDA there is a section that reads:

In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group (“IBCG”) recommended that, “Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at 12 months, and 25% at 18 months is recommended.”2
The interim clinical data presented below meets or exceeds these IBCG guidelines.

When you look at the every one of the prior data releases, they have been close to the 50%, 30% and 25% target but not quite meeting all 3. This most recent data release is the first time they meet or exceed IBCG on all 3. I know some on this board were always set on the idea that reaching 25 patients was the trigger to apply to BTD. That never made sense to me as an absolute.

If they are using Kamat's reference points to buttress their BTD application then that may be one reason why they delayed the BTD a bit longer than they expected.

[ScienceFirst]

DJDawg ... TLT management never cut corners and have always priorises what needed to be done to achieve full results.  When Dr. Lilge, Dr. Rueck, Prof. Vaughn Betz, etc ... requested more time to further investigate or innovate, TLT gave them the time needed to do so, despite no guarantee of success.  TLT management took the heat for delays in order to let its top collaborators succeed.

[Longholder99]

Management can't win.  If they are meticulous and use consultation to ensure our chances at BTD and possibly AA....it's taking too long.  If they rushed and screwed up to please the children the masses would be running back to the OSC with another complaint. Watch and learn or sell your shares.   Jeeze

[Eoganacht]

Last year management announced that BTD would be applied for by the end of 2022. We're 5 months into 2023 and they are still working on the submission. I think it is very likely that second thoughts about the timing of the submission were based on communication with the FDA, the PI and the MSAB, along with the actual results that came in from the clinical trial sites. If, as Longholder99

[DJDawg]

I really hope that they are smart to use consulting firms to help on this. There are firms staffed by ex-FDA staff who used to be on the other side of the table reading the BTD applicaton. If TLT is using that kind of advice then that means they will/have submitted when they have been told it will most likey be successful. They also advise on wording and key data to highlight. Plus you get a free

[ScienceFirst]

Eoganacht/Longholder99 ... Well stated. Always interesting to hear from some that TLT management is incompetent when not a single big pharma was able to assemble a technology that could beat our treatment.  And it's TLT management that gave a chance to Prof. McFarland's molecule and allowed all its collaborators to go where no one went so far. Nonody here has an avg. cost above

[N0taP00p]

@eoganacht: I don't believe it is that complicated or intentionally vindictive. Don't you even want to know what the reason is for the delay as an investor?  There may be very good reasons, like you said.  Just tell your shareholders why there is such a delay.  We may not like it, but it ends the never ending speculation. I think they owe shareholders this basic info, no

[Eoganacht]

Of course I would like to know. All shareholders would like to know. Theralase used to be very open about what was going on. In the good old days we enjoyed Roger's frequent off-the-cuff interviews on the Korelin report. Emails and phone calls used to get us more than a standard "thanks for your support". And then the OSC came down on our heads like a ton of bricks. Shareholders

[BlueFranky]

Eoganacht - most excellent reply!

[StevenBirch]

Thanks Eog. Will you be going to the AGM?

[Eoganacht]

Hi Steven - no I'm on the other side of the country. Will you be going?

[StevenBirch]

I'm planning on it but I trust your expertise more than mine. I'm sure there will be enough people there asking the right questions. The last one I went to Roger was in the background, although he oozed confidence which I appreciated it will be nice to see him in a position to lay out exactly where we stand. 

[N0taP00p]

Appreciate the response, Eoganacht. I somewhat disagree with a few things you said because I've been in this ten plus years. Just a difference of opinion. End of the day, we all want the same thing. Have a great weekend. You bring a lot of constructive dialogue to this board. 

[Legit62]

Great post Eoganacht. Totally agree, no need to create any more missed timelines, when they get the Data and all the paperwork needed to sumit, they will, as much as us armchair quarterbacks like it or not, rather get the news when results are back from FDA , we are either going to be extremely happy or not. Buying penny stocks is a risk, so sit back and enjoy the show all you longs, our time is

[ScienceFirst]

DJDawg ... TLT management never cut corners and have always priorized what needed to be done to achieve full results.  When Dr. Lilge, Dr. Rueck, Prof. Vaughn Betz, etc ... requested more time to further investigate or innovate, TLT gave them the time needed to do so, despite no guarantee of success.  TLT management took the heat for delays in order to let its top collaborators succeed.

[ScienceFirst]

This is securung to see this, especially at this pivotal moment (applying for BDT): advisory fees (+36%) TLT management is not working in an isolated way. It has always teamed up with the best (UHN, etc ...) to get the best advices and the best results.  It went where no one ever went so far.  Despite all the time it took us, we're still alone in the PDT/PDC space, contrary