RE:Getting patients for the studiesHankerchief wrote: Interesting that there is competition for patients to enter the phase 2 trial when outcomes have such potential. It makes me wonder if there shouldnt be some sort of back up plan to do studies in places where medical tourism is so popular....eg The Caymans. Theralase has the cash. Imagine starting a phase 1 for GBM (or others) in a more regulatory friendly environment. Could move faster and cheaper and effective management will draw attention no matter where it is done imo. It's just taking so long while folks with no hope with current treatments are dying. Could still proceed with the 7 patients in Canada for bladder ca. Get a few success stories with GBM and it will draw some eyes IMO. I wonder how Mcfarland (and others) feels knowing she has developed such a great compound yet it is taking so long to get throught the system? 17 million dollars should leave enough to start some IV studies on animals. Then a phase 1b in the Caymans. Then notariety. Etc. How hard is it to inject a pig with IV tld 1433 and check some blood work? Shouldn't cost millions. Would also start some healthy competition IMO.
I think you have demonstrated exactly why Clinical Trials are left to be coordinated and supervised by people that know what they are doing. People that understand the balance between getting a product to market in a safe and scientifically proven manner and not turning over the apple cart of ethical issues that come up when treating actual patients (nevermind pigs).
Sure there are a lot of clinical trials on bladder cancer but there are none that compare to TLT's treatment. Out of all of the badder cancer patients there are only a handful of people that meet the exclusion criteria for our trial. It will take to time to complete the study, but in the end the data will be extremely valuable and worth the wait.
And after completing a successful phase 2 with quality data any additional phase 1-2 trials will be earning a little more respect than we have had to deal with in this trial.
Macer