The FDA has 60 days to review the final submission, and after this, if the application is acceptable for review, a PDUFA goal date will be set. It should be noted that the drug was granted Breakthrough Therapy Designation in 2019, reducing the review time from 10 months to 6 months.
"We see scope for Provention to meet its prior guidance of a potential U.S. approval of teplizumab for the delay or prevention of T1D in at-risk individuals in mid-2021... Teplizumab is a potential breakthrough asset, with highly significant results in subjects 'at-risk' for end-stage T1D," Amusa commented.
Looking at the Phase 2 "at-risk" study, even though it's smaller in size, the data represents the "first demonstration of therapeutic modulation of disease progression in T1D, strongly supporting Provention's approach to treating autoimmune disease in the early stages," in Amusa's opinion. In addition, the therapy was praised in an editorial published in theWhat's more, Amusa estimates the at-risk population is a blockbuster opportunity just in the U.S.
Taking the #99 spot on TipRanks' ranking, Amusa is currently tracking a 31.8% average return per rating.
Please😀🛫........
humana and other medical ins are gonna rake in the money, when medicare for all is implimented, people and or government will pay for supplimental ins. this insurance is cheap, because medicare pay most of care, win, win for private ins.
Funny how the Wall Street casino always uses gambling metaphors to describe investing in the stock market.
thanks
Joe Biden didn't win! TAKE THEM ALL TO COURT MR. PRESIDENT! They can't get away with cheating in Swing States, or USA will never have a Republican President again. The media doesn't pick our President's. Censoring of Republicans must stop. The fact checkers are ran by partisan's
thanks
About to social credit our every step?
Biden didn't win! TAKE THEM ALL TO COURT President Trump. They can't get away with cheating in Swing States, or USA will never have a Republican President again. The media doesn't pick our President. Censoring of Republicans must stop. The fact checkers are ran by partisan's!
Time to short them then
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Source: BusinessInsider - 🏆 729. / 51 Read more »