Theralase Technologies Inc (TLTFF)

[Hank Kerchief]

Maybe it's time to start treating GBM off shore. Perseus is doing it with immunotherapeutics.



https://scbiznews.com/news/government/44688/


Regulatory approval
Dr. Robert M. Sade, director of the Institute of Human Values in Health Care and professor of surgery at the Medical University of South Carolina, said “there are ethics questions involved.” Those questions, he said, should be directed as much to the FDA as to any medical company taking the medical care offshore.

“The FDA has produced a system that retards the introduction of effective new treatments,” Sade said. “It takes a billion dollars and 10 years to put a new product on the market because of the demands of the FDA for multiple studies, for all kinds of information that I believe is largely unnecessary.”

He said physicians who are involved in providing such offshore medical treatments are “ethically bound not to use treatments that have no basis in science. There are people who take treatments offshore because they are quacks.”

Sade said “if there is scientific evidence the treatment is effective but still hasn’t been approved by the FDA, it would not be unethical to take it offshore.”