RE: RE: RE: RE: RE: Australia NewsArte, I think other than the case of being a refractory drug can let Urocidin fetch a higher dosage price, there is another reason for Endo to cancel the original test program. The fact that there is no good candidate for the refractory patients, the FDA will approve it more readily with less stringent requirements if Urocidin can demonstrate its efficacy in this population. Hence, a faster route to the market.
As for medical ethics, neither Endo nor BNC has the license to practice medicine. It is merely providing a drug. It is a business. Its ethic lies in 1. doing what it takes to bring the drug to the market as fast as possible, 2. bring reward to its share holders.
It is the MD that decides what drug to use and when to use it. If Urocidin proves its efficacy in the refractory population, no one is stopping the MD or the patients to use it in the the early phase. They might be stopped by the insurance companies or the government in Canada's case due to cost factors. But, even if Endo went through the tests and met all the requirement to prove its efficacy as a first line drug, there is no guaranty that the insurance would not still insist on using existing BCG as a first line due to its cheaper cost and reserve Urocidin for the refractory cases.
So, why not take the faster and less complicated route. Get it approved as soon as possible and fetch a higher price. Eventually, if there are enough successful cases, the MD and patients will pressure the insurance company to cover it as a first line.
Just my opinion as a doctor who have been embroiled in fights with the insurances on behalf of his patients his whole career.