RE:RE:RE:RE:RE:URGNGo off shore and offer to treat 5-10 patients for free (or more). Then when they get better, look out. IMO.
AND continue to go through the current usually regulatory process.....over the next 10 years.
Hankerchief wrote: fredgoodwinson wrote: Not so sure that Urogen will not be a problem for us.They got 86% CRs in low-grade NMIBC with UGN-102 and seem very confident that they will do well against high-grade with UGN-201 Vesimmune.
https://seekingalpha.com/article/4199096-urogen-pharma-urgn-ceo-ron-bentsur-q2-2018-results-earnings-call-transcript?page=4
Don`t forget that Ciclomed is being trialled at the same time while we sit - yet again - waiting for someone at HC to take over 3 months` to decide whether something that has likely already saved 2 bladders in practice is OK to use.
TLT can go against tumours that neither of these 2 can treat and increasing the dwell time of existing therapies is a large element of this competition but the inertia of the Canadian Health Bureaucracy combined with our limited access to finance may have cut us off at the knees for NMIBC.
Starting to think like Hankerchief that the Caymans look pretty nice from here.
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.”