Re: Breakthrough Therapy Question
in response to
by
posted on
Jan 06, 2020 07:10AM
grow, I think it is safe to assume that RVX was recommended by either the FDA or other regulatory agencies to apply for Breakthrough Status which is very good thing rather than RVX assuming they should try the Breakthrough status application. Is there a drug on the market right now that is 100% safe and reduces MACE by 50% with a .02 P value for severe CKD?? To me that might look like that is enough to award a breakthrough Status application from the FDA. As for the 90 to 120 days to hear back from the FDA I believe that is time from applying to getting a final answer from the FDA. Assuming the NOv 13 FDA meeting RVX should have a final answer by MId March. GLTA