Theralase Technologies Inc. V.TLT

BTD is slow process.

[DJDawg]

In recent updates or intervies (I can't remember), RDW said that they met FDA in July and got the info that they needed to clarify some of the data. Most of you would agree that it seems to be taking forever to clarify whatever it is that needs clarity. It would be nice for RDW to enlighten the shareholder a bit more regarding what they are gathering. It all seems so vague.

The fact that the wording is "clarification" makes one think they want additional data on existing patients vs some other wording that would suggest more patient numbers needed.

In the past my speculation was that the FDA wanted 18 m data outcomes but I really don't know for sure. My guess was based on the update that they were seeking Health Canada approval to chase down outcomes on the CR patients from day 450.

"Post Study II Monitoring of Response - Patients, who achieved a Complete Response ("CR") or Indeterminate Response ("IR"), demonstrated a duration of that response at 450 days and remained in Study II will be monitored by the Company past 450 days, to help define the long-term duration of the Study II Treatment."

My thought was that why do then need to chase it down unless someone's asking for it. If they didn't build that in the protocol then it means they have to go to each location where the 17 CR's at 450 are from and request ethics ammendment to get any data past 450 days. Totally doable but slow if you know anything about research ethics.

I have noticed that several of the other big studies have emphasized that their CR's are confirmed by a central lab. So that would be the other thing. You would need to get the slides with the cells from cytology and then ship them to your one designated pathologist. Not hard to do but takes a bit of time. Thankfully it is probably only needing to be done on CR or IR at 450 day patients.

I've said this before, I'm just talking aloud in case anyone has any other idea what "clarity"
But they met with FDA in July. You would think that they could have done all this by now. So frustrating.

One day I would love for TLT to suprise us all in a really good way. Something happening sooner than expected or some JV money that is announced out of the blue or an uptick in recruitment. I would love for something that is a real "wow" moment from management. The science is so amazing but TLT so slow to progress it.

If management is reading these forums we would love more info on what is being clarified and why that takes so long.

[Eoganacht]

In order to get a BTD a company must demonstrate substantial improvement over available therapy. Adstiladrin was approved by the FDA in Dec. 2022. 18 month evaluation of patients was built into their trial. When Theralase spoke to the FDA about how to optimize their chances of getting BTD they may have been told that to demonstrate substantial improvement over Adstiladrin they needed to show a

[Oilminerdeluxe]

Is it possible to get a j/v deal or something similar before a BTD? I mean, they should have gotten it by now if that was a possibility, right? We need to sponsor our way through a few more months at least. Who knows, maybe they have something lined up. The update was solid. But 18 cents, jeez, that is ungodly frustrating. 

[wildbird1]

Eoganacht good post... About Adstiladrin... Adstiladrin is the best FDA approved treatment for BCG resistant patients. Adstiladrin has a 23% CR at at 15 months. Adstiladrin can't treat immunodificient patients. Adstiladrin has 274 major drugs interactions(that is huge). In spite of all the above Adstiladrin did get the FDA BTD approval. About TLT-Ruvidar... TLT-Ruvidar has a 39%CR(optimized,

[DJDawg]

Thanks Eog. It's good to talk it out. Your reasoning sounds good. I just wish that TLT would be more open about it as things are so vague and slow.

[Alamir1111]

The longer the approval drags out more pressure financially. .Credibility in business goes a long way..it's not rocket science

[Eoganacht]

By the way, if the FDA suggested Theralase submit the 18 month CR rate of Ruvidar PDT in order to demonstrate a superior durable response to available treatments then we are looking pretty good. At 18 months Adstiladrin's CR rate was down to 13% And Adstiladrin is the best available treatment with FDA approval.. As DJDawg often points out, once one of our patients has achieved a CR at every

[Alamir1111]

Nice since Ruvidar is so overwhelmingly  superior to other treatments btd aa should be no brainer.Did we Resubmit Pre  Btd Application Yet ??

[DeathXray33]

I'm @ > 1.25 million now.... Getting more next week also... # Cult-like-shareholder

[stocksnbonds458]

I believe they have met this criteria, have they not?

[patience69]

I think they have not yet received what they need from all of the sites. Pretty sure DJ has done an excellent job of explaining the current situation. And we wait!!!

[stocksnbonds458]

Agreed patience. From what I understand it's just a matter of retrieving information and data from the study sites that is already existing, they are not requesting new data to be extrapolated . The process of requesting this information is soooo textbook bureaucracy. First they must: 1. Submit a request to the Study Coordinator at each Site to receive approval from the patients to allow the

[Oilminerdeluxe]

The IR guy seems keen on replying to e-mails. A very welcome change. So if you have any questions, fire away and he will at least return your letter with an answer. We need someone to sponsor a GBM trial, any millionaires hanging around?

[Longholder99]

Perraton seems like a very genuine guy who probably wishes he could say more when he's talking to you.  I had a coversatukn with him and am happy with the discussion.  In a perfect world where people are honorable he would probably be able to say more.  But in this world of litigious and malicious whiney do gooders looking for an opportunity to be a victim of any sort

[DeathXray33]

They just keep pushing it down & down. I just keep picking up more & more.