Theralase Technologies Inc. V.TLT

The new chart & the 450 days duration % numbers.

[wildbird1]

I like the new assesment chart, much easier to follow.

Ex: The 450 days 12 patients are simply the patients that have completed the 450 days evaluation.
Nothing is added to confuse the % numbers data. The same goes for 360,270 days...etc...
We have the %numbers in real time.
The Nov 29,2022 assesment chart were much more confusing.


The 450 days duration %numbers.
In a 3Q2019 conference call with the FDA, it was discussed that for BTD, safety&efficacy were the numbers that the FDA was looking for.The FDA did not include the 450 days duration %numbers(2Q2020 newsletter).

The reason the FDA did not include the 450 days duration numbers in the BTD process, is because the FDA know that after the BTD will be approved it will take many months before the treatment will be available to patients.
During that time the 25 patients will have completed their 450 days assesment. If the 450 days duration %numbers are not to the satisfaction of the FDA, the FDA can retract the BTD.
On the FDA site...The FDA said about BTD " FDA periodically assesses whether designated products continue to meet criteria for BTD. If the designation is no longer supported by subsequent data,FDA may rescind the BTD ".

The above is done to accelerate the BTD process, waiting for the 450 days duration numbers would slow down the BTD process.
BTD is for accelerating the process, not to slow it dow.

In short...
For now do not lose sleep on the 450 days duration numbers(although they are already promising, and the FDA know that).

[RoseHeaven]

Agreed 100% with you. The new data format is the right way to go. The old data format was misleading, confusing and has been skewing % CR or IR to the downside due to carry forward of NR patients to 450D, even though they did not reach to 450D assessment point. In old method, a NR patient at 90D or other assessment points carried forward spotaneously to 450D while a CR or IR patient would had to

[Eoganacht]

The new format is fine, but it doesn't provide the durable complete response for the entire evaluated population of the trial and this is the first thing I look for when results come out. Durable response is the secondary objective and it's an important way to compare our efficacy with already approved treatments. Keytruda finished with 19% and Adstiladrin with 24% On Nov 29 our 450 day

[Rumpl3StiltSkin]

Eoga, I believe the current 450 day CR % is 33 without the Phase 1 optimized and a bit higher with those 3 from Phase 1. Using the old format.

[CancerSlayer]

  Agree...a durable response means everything. If you just look at our current 270+ day data, 11 of 27 (41%) have demonstrated a CR & 13 of 27 (48%) have shown an overall response (11 CR + 2 IR)...those are good numbers & they provide valuable insight as to durability.   If you also consider that block of patients at 180 days, 7 of 10 were CR at that point in time & 6

[CancerSlayer]

Eoganacht...I just wanted to add that in addition to your contributions, I am also very thankful for Keytruda & Adstiladrin in having provided us a new "FDA-approved" durable response standard of 19% to 24%...a pretty low threshold to overcome, & imo, our chances for approval have gone up significantly thanks to them, especially when you consider there is still a dire need for an

[gorpwood]

Thank you. I am a long term holder but can honestly say this is the first time I have clearly understood the data presentation. Thanks too for providing context for the BTD application and criteria

[CancerSlayer]

  Nice post wildbird....You brought up an important point about the 450 day data.  Though it is helpful information, an FDA decision re: BTD approval is not predicated on 450 day data.  Having said that, any significant sample of such data can provide additional reassurance to the FDA & not only expedite the review process, but also reduce the chance of a rejection.  But

[plantrader]

CS, if BTD app doesn't require the 450 day data then what's your view on why they haven't applied yet? Especially after Dr Mandel said they planned to apply in 1Q. They had enough data but couldn't gather it fast enough or couldn't hire the necessary specialists in time? Maybe they had to wait their turn in line? I can't keep up with what we know vs what we're stuck

[CancerSlayer]

  I am in the medical field, but I don't consider myself an expert on this matter.  All I can say is that TLT would have applied yesterday if they could.  I believe the variable timelines given has simply been a product of availability of resources, FDA guidance & patient compliance/retention in the trial.  These variables are omnipresent in clinical trials & can

[plantrader]

Thanks CS. I'd have to be knowledgeable on the subject in order to disagree!  :)

[CancerSlayer]

  You're welcome.  Perhaps now you can help sharpen my betting skills when we convene in Vegas. Scientifically, the tech is a slam dunk....though I would settle for a reverse layup commercially : )

[thadeush]

Be careful in Vegas. Wear an N95 anywhere near people. On top of the ongoing COVID19, they have lethal, drug-resistant...fungus:  https://twitter.com/DrEricDing/status/1651964718179921921?t=wh9Wd6XcgLB7Z6KpP_BSKQ&s=19

[Rumpl3StiltSkin]

I'm not sure, just a lay person, I've always thought the 450 day time criteria is a split between the two treatments, being that they are 180 days apart, and simply adding that to the normal 360 day criteria..

[Oilminerdeluxe]

It would be nice to have a fresh batch of data before the next financing takes place. But the share price seems cemented here no matter what so perhaps it won't matter. Is it too early for a j/v partner to come in and pay for what is needed?  They must be running on fumes now. Thoughts? 

[Rumpl3StiltSkin]

Well, I have no idea how long they can hold out for? Another qtr and that would get them thru the next QTR update, and the AGM. By then we might have BTD and perhaps a JV partner? But then they'd need cash IF that doesn't happen. The way the stock is behaving says something happens sooner on cash piece though...

[greaterfoolFred]

My understanding of what data the FDA wanted for BTD application was one year after CR.  We first see a CR at 90 days.  90 days plus one year equals 450 days.  Thus they want 450 day data.   And they probably want the NRs included in the calculation of percentages. Have patience.  The Chemistry wil lead us to rhe promised land, despite a few bloopers along the way.