Theralase Technologies Inc. V.TLT

BTD timeline...

[wildbird1]

In the May 19,2020 Pressrelease, TLT received the FDA authorization to proceed with Phase 11 trial.
(Quote) Phase 11 has a secondary endpoint of duration of CR at approximately 360 days post-initial CR (End of Quote).

The above 360 days CR is for the phase 11 trial not for the BTD approval.

Question..For the BTD approval is it the 90 days CR% or the 180 days CR% data that will be used...????

The only timeline from the FDA site for a BTD approval is that the BTD request must be made before the end of the Phase 11 trial.
From the FDA site (Quote) For a BTD approval, a cancer treatment need to have an effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinacal benefit (End of quote).
It does seem that the timeline for a BTD approval is the prerogative of the FDA, but we must assume  that the minimum timeline is the 90 days CR% data.

90 days CR% Data...
From Eoganacht post April 18,2022..
Potential CR% = 82% at 90 days on 23 patients.
We know that the FDA is asking TLT for a CR% of approximately 66% on 20-25 patients for a BTD approval.
A potential of 82%CR at 90 days on 23 patients is huge.

If the 90 days potential 82%CR data on 23 patients is reasonably likely to predict a clinical benefit, as we speak the BTD approval request could have already been made a few week ago by TLT.

The FDA has 60 days to answer the BTD request, minus how many days ... ????

[enriquesuave]

I believe that 67% or better was for AA not for BTD.  But later they changed it to "significant efficacy " as potential for AA. BTD could be applied for at any time we have 60% CR on evaluable Optimized patients and 18% PR with a potential of up to 83% so far.  Numbers can go up or down 10-15% at this time point depending on outcome of next 25 patients.  IMO.  Of

[Eoganacht]

I believe that 67% number came out of a conversation between Theralase and the FDA from before the phase 2 trial started. It sets an unreasonably high bar for efficacy at one year. My guess is that the FDA was willing to commit to this number at that early stage because they thought the chance of Theralase achieving it was so minute. Merck received full approval from the FDA after achieving less

[Eoganacht]

My mistake. Dr. Jewett didn't mention the 67% in the 2018 BTV segment - he just said  "a significant portion of those patients". "Assuming that this phase 2 is positive and we eradicate this disease in a significant proportion of those patients then there is a pretty clear route to arriving at regulatory approval and we've recently had a guidance from the FDA which

[chry200030]

So what share price can we expect if we get commercialization in 2023? 

[LaserStock29]

What share price can we expect if we get BTD in Q2 2022?    What share price can we expect if we get Marketing Application approval (comm) in 2023 or late 2022?

[Rumpl3StiltSkin]

$2 ?  :-)

[Rumpl3StiltSkin]

Should be in the Dollars by then. If everything with NMIBC continues as expected.

[Pandora]

Sorry Eoganacht but I still get confused over quotes regarding numbers of patients. I never know if we are talking only about "optimized" treatment patients of Phase 2 or "all" patients and if the Phase 1b patients are ever included as part of "all" or not. Your quote: "The 25th patient received the 90 day assessment in December 2021. So before the end of 2022

[Eoganacht]

Hi Pandora, What I meant by the '25th patient" is the 25th patient treated in phase 2. Not including the 3 phase 1 patients and not differentiating between optimized or unoptimized - just the first 25 patients treated in phase 2. We know that the first 12 patients treated in phase 2 were undertreated so data for the first 25 patients will underestimate the true efficacy of the treatment.

[LaserStock29]

The question is has TLT been submitting the data to FDA on a ROLLING REVIEW taking advantage of it's Fast track status.. and receiving back communications from FDA on any critical questions they have so as the treatments go on and patients hit milestones.. the 'Case file' is open. Lets not make it seem like all the data is sitting on a usb drive at TLT headquarters waiting for the

[CancerSlayer]

Eoganacht wrote: Hi Pandora, What I meant by the '25th patient" is the 25th patient treated in phase 2. Not including the 3 phase 1 patients and not differentiating between optimized or unoptimized - just the first 25 patients treated in phase 2. We know that the first 12 patients treated in phase 2 were undertreated so data for the first 25 patients will underestimate the true

[Pandora]

Hi Eoganacht, Thank you for that breakdown - it is the clearest layout of who is who that we have been given. I appreciate your spelling it out in this manner. Hopefully the next report we get lays it out in a more understandable chart or charts.

[FGPstock]

Eog, Theralase has given us timelines before, but can you point to a recent statement from the company saying commercialazation in early 2023. Even if they received BTD tomorrow, that is still an agressive timeline, imo... Not sure why either the company and/or their analyst could lay the data a bit more clearly. Weren't they meantioned they were going to apply for BTD after 20-25 patients?

[Lesalpes29]

Who's the clown giving a thumb's up for a question!

[Rumpl3StiltSkin]

FGP, I believe the timeline of early 2023 was prior to Delta and Omicron, backing things up..?? Still, I expect they'll have AA by Middle of 2023.

[LaserStock29]

Again the question is if we get BTD asap  what is the PPS?  Has Theralase used the Fast Track to establish a Rolling Review submission and dialog with FDA so it doesn't have to act like a company that would just submit all the data as one package.. but can have back and forth this whole time as data comes in? When do we get to $1-2...... when the whole thing is over? 

[FGPstock]

Laser, I think we all wish we knew the answer to that question and most of us thought it would b over by now... Years ago ppl were talking $50-100...

[Lesalpes29]

Where are the thumbs up? Coffee brake in the Boiler room!

[Lesalpes29]

Last post about Laurel and Hardy... you have to remember that those two very good posters! are with us since april 4th and 5th. Enough said... GL longs.

[Rumpl3StiltSkin]

Some posts, by some posters deserve a different finger. Stockhouse doesn't offer that one...

[lesflics]

No one here knows the answers to these questions. Contact the company. That way you can have your questions ignored by the appropriate people.

[LaserStock29]

Ill just hope that these next patients to be checked in april/may/june will oscillate the price back to .50c then.. https://stockhouse.com/companies/bullboard/v.tlt/theralase-technologies-inc?postid=34545532 Patient #16 hits 1 year this Friday March 25th Patients # 17 & 18 hit 1 year April 27 Patient # 19 on May 28th for 1 year June 11th is patient # 20's 1 year. Patient #16 hits 1

[Rumpl3StiltSkin]

Laser, Now that Vera, Dr. Rad! is on board that is her job. I have no reason to doubt her ability. I think BTD is what gets SP to turn the corner, stop any shorter nonsense, etc... The data didn't appear to quite be there in the last PR, I'd be very surprised if the next PR doesn't verify BTD, or at least let us know where it is??

[socksnblonds642]

PPS is super speculative at best. Do they sell the technology or arrange a licensing agreemen? So may factors in these agreements. Impossible to come up with a PPS. Anyone that can come up with a PPS is FOS. I liken these biotechs to our mining exploration companies. They find the gold but the big money is with the company that pulls it out of the hill and gets it to market. Still oodles of money

[Rumpl3StiltSkin]

Well, yeah. How do we do this today? No way really. But I will go out on a limb and state that TLT is on sale $$. Based on where it should be already. There is a major market PPS disconnect here.

[ScienceFirst]

Pandora ... The FDA doesn't mix Ph. 1b data with Ph. 2b data un their decision. 

[ScienceFirst]

 - Only data of Ph. 2b - On the first 25 patients (not only the optimized as the FDA doesn't allow sub-groups) - Data @450-days for the 25 patients  That would allow the FDA to take a sound decision.  ________________   ScienceFirst - (4/25/2022 10:29:03 AM) RE:RE:RE:RE:RE:BTD timeline... Pandora ... The FDA doesn't mix Ph. 1b data with Ph

[ScienceFirst]

TLT could, on its side, delay this, if it wanted to put all the chances on its side and add 12 more patients to the negative impact of the first 12 undosed, so they could present data on the first 37 patients.  That's an option they could give to themselves to ensure that the % of efficacy are to its advantage.  But Eoganacht showed that even with the first 25, our chances are

[LaserStock29]

Again, the question to your subposition is has Theralase established open communication with FDA with it's Fast Track and got a Rolling Review.. so that the scenario you just outlined below is avoided. Your subposition reads like TLT is sitting pouring coffee with a usb key waiting on a 'package of data' rather than having a Rolling review. The data should already be presented to FDA

[Rumpl3StiltSkin]

Laser, do you have her number/e-mail? I'm guessing she is on top of this process, icluding the FT piece that is already there...

[LaserStock29]

https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-trackA A drug that receives Fast Track designation is eligible for some or all of the following: More frequent meetings with FDA to discuss the drug's

[ScienceFirst]

In line with what I always posted; 25 patients @450-days 1. Break Through Designation Update. In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to

[wildbird1]

Eoganacht...your first statement of 67% could have been correct. Below is the exact wording of the 2Q2020 Newsletter about BTD preconditions. 2Q2020 page 3... " It was further discussed (with the FDA) that Theralase would potentially be eligible for Breakthrough Therapy Designation("BTD") and/or Accelerated Approval ("AA"), if Theralase could demonstrate clinically

[Pandora]

"A potential of 82%CR at 90 days on 23 patients is huge." At what point in time i.e. what specific date do we expect to hit this "potential" of 82% of 23 patients at CR. There must be a target date of getting there -- and then the bureaucratic followup of verification of data, etc. could take how many days thereafter?

[wildbird1]

Thank's Pandora & Enriquesuave for the clarifications... It is not always easy to interpret the BTD FDA process. In my post the big word is "predict"  "Reasonably likely to predict a clinical benefit" Predict = The prediction of future behavior. My point is that it is the FDA that has the last word. Because of TLT cancer treatment " immune response" the

[LaserStock29]

BTD leads to the Marketing Application where said drug/therapy would be commercialized with the caveat that the reasonably predicted efficacy maintains.. then the 'good will' of if you like 'temporary commercial permit' can continue.  We should have that for patients 40-125 (roughly).. imo.. with a nice healthy $1-2 pps and then roll that into the other indications. via small

[Oilminerdeluxe]

A sea of treated patients would be lovely to have. Instead of this slooooooow grind. But that is how things work I guess. Maybe we will get another update in a few weeks' time. You never know.