RE:RE:RE:RE:RE:RE:RE:RE:RE:NSCLC and GBM indications Hi Steven, I think we're going to get BTD in early December and maybe AA as well. Theralase has FTD and this should mean frequent communication with the FDA so they should have a pretty good idea what is about to happen. With all the insider buying and projections of commercialization in 1Q2023 things look good. Even if the FDA wants more results for AA - 2023 is still possible.
StevenBirch wrote: Eog, thanks as usual for your insight. We should have enough with the first 25 for BTD though? And it may sound crazy but they stopped Phase I early on stellar results. I know there is a big difference in going from Phase I to II and granting AA but at least the uncertainty may keep the sellers at bay and let this get some deserved momentum.
Eoganacht wrote: Great post Steven. I don't think it makes sense to talk about a "cure" for cancer. I will be more than happy if Theralase provides a safe, efficacious treatment for NMIBC, which is exactly what they are doing. From the results so far, I have little doubt that TLD1433 will receive FDA approval and even accelerated approval. The only question I have ( a point already raised by Enrique ), is whether or not the FDA will regard the results of 25 patients at 450 days as enough to base a decision of AA on, especially when almost half of these patients were undertreated. Another 18 patients were evaluated at 90 days as of Nov 30, and they should reach 450 days before Dec. 2023. If the first 25 patient results are not considered enough, maybe the 450 day results of these additional patients will be enough for the FDA to base their AA decision on. Anyway, in my opinion it's a question of when not if.
Approval of TLD1433 pdt as a mainstream treatment for BCG-unresponsive NMIBC will be a really awesome achievement. If Theralase can demonstrate that TLD1433 pdt is the best available treatment for NMIBC this should awaken a lot of interest in oncological pdt. Could pdt provide the best treatment for other forms of cancer as well? I'm guessing that this possibility will loosen a lot of purse strings as each big pharma strives to get a bigger piece of the cancer treatment pie.
This may be the moment Dr. McFarland has been waiting for - the beginning of the advancement of oncological pdt. :
"PDT is at a critical point on the Gartner hype cycle . If we do not bring PDT to the forefront for some clinical indication as mainline or adjuvant therapy soon, certainly it will become increasingly more difficult to find support for its development." StevenBirch wrote: Sun I think some of your questions are conspiratorial. As for management comings and goings none of that bothers me, I don't even think about it but I will allow that it's for others to think about it.
But when it comes to other forces keeping this technology from coming to market I have an issue with that - if I believed that I would have sold long ago.
My reasoning is that as great as we all think TLT is, and I do believe it is, it's not they have invented a pill that you just take and it kills all types of cancer forever or better yet prevents all cancers. It is just another among many treatments that we just happen to think is the best out there in terms of safety and efficacy as well as being the least invasive. And there are billions spent every day on what is currently the standard of care and we are just trying to supplant those treatments with a better option.
I don't see forces out there trying to prevent that because even though some people are so brutal that they care more about profits over the common good there is still plenty of room for both in this field. As for big money calling the shots I agree but not in suppressing it but rather to gobble it up as cheap as possible and I have no problem with that because it has allowed us to do the same and very soon with the right data the dam will break - there have been enough examples posted here to show that it always does.
I couldn't be invested here and think otherwise but differing opinions are what make a market.
Sunvalley wrote: Good morning Infinity. Interesting post .Just a little clarification if you will.Who , in your opinion is really in charge of the company? Who asked Shawn and Vera to leave.? Who set up RDW for banishment 5 years ago. ? Is there a "invisable hand " guiding the fortunes or misfortunes of TLT? Are they and have they been impeded from real progress by entities that benefit by keeping this technology from coming to market in a orderly manner? Is there a conspiracy working to keep a Cancer cure surpressed and thus keep the billion of dollars flowing to other sources as it always has? I posted some thoughts about 7years ago alluding to these possibilities because ,at that time, in my opinion it seemed that there was just too much money being made to allow a cure for cancer to take place.
Also the question of the treatment being mishandled initially has always been bugging me. I have always wondered who set RDW up for a fall and thusly slowed progress dramatically.
If we are given the green light soon on AA and BTD it will be clear that my inner thoughts have been misguided but in the unlikly event that the FDA delays approval in the face of such compelling evidence of a superior method of treatment , it will be clear that big money is calling the shots and not science.
I suppose that the numerous delays and setbacks are all part of the game when it comes to bringing something new to the market but sometimes I wonder about these things. Having said the above , TLT has indeed done a lot of things that have proved to be exactly correct and we have come a long way along the path to a cure with minimal finances however , and the future looks extremely promising in my view. So I will continue to remain a large stockholder and will continue to buy the dips.
Thanks to all for your past insights and thoughts.