Theralase Technologies Inc. V.TLT

pre-BTD and BTD

[DJDawg]

For those of you who were wondering what is the missing data for BTD application.

My hunch is that the main detail that makes BTD on hold at the moment is that FDA is wanting 18 m data vs current 15 m data.

Interesting fact (from my area of work) is that if you are doing a research trial and want to find out how patient is doing you are not allowed to just look up the chart or email the investigator or physician. If the protocol covered up to 15 m then you have to apply for approval to go and get more detail about how patients are doing.

The prevailing pattern of immune drugs is that they work (to a degree) while you are taking them and then once you stop, the cancer comes back for many, given a bit of time. From other companies I follow I get the sense that the FDA wants longer follow ups to make sure the CR is being held.

So, if TLT was told by FDA that the BTD needs 18 m data then they cannot submit BTD till they get the protocol modification approved and then they can call the research sites and get the 18m data.

[skier59]

  Theralase® expects to apply for pre-Breakthrough Therapy Designation (“BTD”) before year end.   This is what they stated in today's NR via emails. So hopefully they are referring to 2023.

[Oilminerdeluxe]

Ha ha yes, 

[FGPstock]

I am not sure how this is good news... what it signals to me is they are having trouble raising money, again, which is not surprising as not too many big investors want to pay .22 for a stock trading at .18-.19. Also, last year they announced they were applying BTD befoire year end, now, a year later, they are supposedly applyhing for pre-BTD, which I thought they are currently now. Regardless, I

[DJDawg]

One hopes that they met the minimum requirement and are just pushing for the most they can get given that you are only allowed one LIFE per year. One hopes.....

[FGPstock]

DJD, greats news would be that they are oversubcribed, not that they are desparate for money. The last time when they only raised $450,000+/- the pumpers said that that is all they needed to get us to the promise land. Does anyone else see a big disconnect here between great CR numbers and the lack of interested investors/partners...

[DJDawg]

I totally agree with the disconnect between the CR numbers and the money raising success/lack of it. It is one reason I am so grateful that the science clinical data is gathered by scientist who don't actually work for TLT. They gathered the data that is so promising and it gives me more confidence in the science compared to data that only comes from the company lab. I really wish I could

[FGPstock]

In the 2019 raise they had Maxim in NYC raise for US investors. One would think if big pharma really knew about how this could b the next SOC for ballder cancer, or any investor fthat matter, money wold never b an issue..

[Alamir1111]

Sure big pharma knows about tlt.our principal investigator doing  work for them. Our Research centers deal with big pharma.

[Benedictus]

In my opinion, everything you listed in that post, and likely far more behind the scenes that we're not privy to, is exactly why they have had such difficulty raising funds, forcing investors to endure this begging bowl go it alone dilutive path.   To see such an enormous divergence between the incredible science along with the impressive CR data this far advanced in a pivotal trial vs

[N0taP00p]

The Market Herald "article" clearly says pre-BTD submission in the next 6 months.  And you're saying the email says by the end of the year.  Probably 2023. One of them is right. Maybe they need to correct the article then? 

[BudFoxx2020]

It is not the market herald article saying the next 6 months.  It is RDW.  They just quoted what he said in the interview. Watch the interview.  Cheers. https://themarketherald.ca/theralase-is-raising-up-to-5-3m-to-complete-bladder-cancer-study-2023-11-06/amp/  

[riverrrow]

The FDA needs to release the 15m and 18m data and CR for Keytruda and Adstiladrin (both approved and in use) before demanding this data for Ruvidar.  

[Paradise818]

That's a good one!  That will happens when pigs fly.

[Longholder99]

18 month info requirement is speculative.  Not sure what the point of making people think there will be more delays would be.......?

[DJDawg]

It is definitely a bit of a guess but based on the fact that in the area I work we tend to put emphasis on having a total of 1 yr follow up from the last "treatment". Maint at 6m means that following to 18m is what would be ideal. The recent trial modification approval was interesting in that they asked Health Canada for approval to follow up a bit further on the CR patients and use a

[Alamir1111]

Under the featured news link check out another article  Empower  the fight against bladder cancer.

[RoseHeaven]

Hi DDawg: Thanks for all your inputs which are always amazing. One thing I do not understand why TLT has been waiting to discover the need for 18 months CR data when they have FTD. My understanding was that TLT would have the previlage to have frequent communication with FDA due to FTD. What went wrong? Are all high school students sitting at TLT? Looks like mistakes are the chronic issues for

[Yajne]

RH...or is it just some crafty goal post shifts by the regulator, acting in the interests of big pharma? Just speculative questions on my part....

[DJDawg]

I'm not really sure. My area of work doesn't work with FDA but we do recruit for thyroid cancer trials. My personal gut feeling is that frequent communication with the FDA seems a bit fluffy. The FDA is a beauracracy so when I read that I don't know if I imagine a dedicated phone line back and forth. My hunch is that the BTD review committee is its own silo and they can just look at

[Eoganacht]

From the start the protocol of the trial was 2 treatments - one at 3 months and one at 6 months. The primary outcome of the trial is efficacy evaluated by CR at any time, The secondary outcome of the trial is duration of CR at 12 months post initial CR. There is every reason to think that these are the efficacy criteria the FDA will use to judge whether or not our treatment has demonstrated

[Longholder99]

Facts is what we like.   Not supposition that makes for a negative sentiment. Good thing the FDA doesn't read this site and instead uses facts and results to make their decisions. Kinda like investors should.  Thanks for your clarity Eoganacht.  

[FGPstock]

facts is something that seems to be ellusive with TLT...

[Legit62]

Has anyone heard anything on latest financing, we are into second week??? was hoping this closed with some cash in the coffer???

[Lesalpes29]

Somebody said it could close next week. They are trying hard to reach the maximum $$$. Hope they will succeed and put the money discussion out of here for a year or more! GL

[StevenBirch]

We saw a lot of selling that was related to the financing but it has slowed down, maybe when it looks like the small investors are finished stepping up someone will buy the rest. Maybe even insiders? It would be nice just to get this out of the way but for sure it will be before our update at the end of the month. I don't see anyone buying much at these ridiculously low prices until it closes

[Legit62]

I tried buying shares later in day yesterday at different bids but no luck, orders wouldnt go through???

[DJDawg]

Great points all around Eog. I'm just guessing based on what I have seen in my area of work. I thought that the 6m treatment was a tweak but I couldn't find my reference so I must have misremembered. Thanks for catching that. Overall, all I've been saying is that in areas that I'm familiar with, outcomes that are considered as most informative are ones where you have 12m follow

[Benedictus]

Dawg, I'm curious if you have any thoughts about the amended optimization treatment and whether this would impact AA timeline (assuming all goes well and the company receives BTD approval)? My concern is whether the FDA would want to see a measurable number of this new cohort advance toward 450 days before approving AA.  

[DJDawg]

I think that if the amended protocol just leads to some patients getting treatments at 0,3,6 m vs now 0 and 6m, they will still look really good if that CR holds from 12 m after the last treatment. If a few get a 2nd treatment at 9 or 12 m then those won't be interpreted quite the same way. I believe that the modification is partly about getting patient's to stay in the trial for the full

[greaterfoolFred]

I thought the news release was pretty clear on this; the 15 month data is all they want, but the cytology results from all of the study centre labs have to be confirmed in a central lab.  This means selecting an accredited lab, having samples sent there from the study labs, getting the work done, and then paying for it. Not to mention proving that the samples were stored properly the whole

[DJDawg]

I suspect they need 18 m data for the patients which exists but just need approval to ask for it. The central lab part should only be for the 14 CR patients so don't need to chase pathology samples on the others. But again, would need approval to have it sent to a central lab. All in all, it could be one of those things that could happen by end of year....or note. We just don't know