This is incomphensible given that there are 30 million or more people with AMD SMD indications. What is the delay problem with the clinical trials process at ACTC? Anyone have any clues?
I have no clues.
But if anyone here thinks they can pull off a Phase 2 with 200 - 300 patients, is fooling themselves.
They don't have the human nor financial capital to pull it off.
The only reason Dr. Lanza has not re-upped is to stave off the possibility of Big Pharma pulling a
fast one, on the cheap, a la a poison pill.
Not correct! It is more likely that the FDA is providing guidance to ACTC as to Phase II scope requirements. Additionally, a good portion of the required funding will be provided by the sale of newly approved shares in combination with a JV partner contribution. They are too far along the path of success for this initiative to be halted in any way.
Even when this therapy is approved, and I do believe it will be, this is not a high throughput one-pill-a-day type of therapy. This requires a skilled ophthalmologist to perform, and the best case scenario is for the therapy to evolve in the way that LASIK has -- that specialized centers will open staff with docs to perform the injections and monitor the patients.
pootel_2004 • Mar 13, 2014 11:13 AM Flag
Peer reviewed science
Disclaimer: I am an amateur investor, but a professional scientist engaged in vision research
poot, I would have thought a "professional" would have been more familiar with the procedure : )
poot, I suggest reading about the procedure.
Ease of administration – very common surgery, ~90 seconds per eye
Trial being run by KOL’s but lack of special devices makes this therapy scale-able to the high volume clinicians
The FDA dictates who can be part of the clinical studies. My stepmom's boyfriend tried to enter a clinical study and the FDA would not allow him entry until he first had chemo and radiation for his condition. He did have the chemo and radiation which destroyed his immune system. He entered the clinical study but had no immune system to protect his body and he was riddled with infections. He died three weeks later.
The Cancer Cartel wins again...
CC/FDA - "Yes, that is a nasty cut on your arm, and there is currently a trial for a new treatment for just that kind of cut. You can participate in the trial, but only after you've undergone the established practices of being run-over by a steam roller and then dragged behind a train."
Victim - "But I really don't want to be run-over by a steam roller and then dragged behind a train, and I seriously doubt that that would help. I would prefer to just undergo the new treatment."
CC/FDA - "Sorry, but that choice is not yours to make."
The problem is well known. The inclusion/exclusion criteria for the trials is very selective. It is hard for people to qualify. Especially old sick people. The FDA wanted people who's eyes were essentially shot.
"What is the delay problem with the clinical trials process at ACTC? Anyone have any clues?"
Fact, I'd say ask ACT's management, but we all know that they are clueless, too.
Therefore the only reasons for owning this stock are Dr's Lanza and Langer, if they go the company is done.
I don't how Dr Lanza has put up with the incompetent management at ACT all these years. The only reason I can figure why he's still here is that knows he has the cure, and wants to see his lifes great work to it's final conclusion.
Also, given the snails-pace speed at which these trials are going and the amount of money being expended what does that equate out in costs for a single patient's injection(s)? Millions I would guess!