Rivulet Media Inc (fka RIVU)

[Inoviorulez]

yes they look at efficacy and safety like all other biotechs of course, but don't you think they would be more lenient since it is Aplastic Anemia. for example:

Sarepta Therapeutics works well, and the FDA is thinking about doing Accelerated approval for it because it is an unmet need. I'm just trying to show that biotechs that go after rare diseases have an easier time getting approval, than say those companies that go after cancer which already is crowded with drugs.

Look at DVAX going for Hepatitis B they showed good efficacy but safety was good too, but got rejected because more safety tests needed to be done. But the FDA is not worried because there are thousands of other treatments out there for hepatitis B.

Another example is Vivus and ARNA which both have horrendous side effects but got approved by the FDA why???? Because it has been 13 years for an obesity drug. Otherwise Vivus and ARNA would have probably been rejected if there were other drugs out there that were safer and had more efficacy.