That is a very good accurate concise description o
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Posted On: 06/17/2019 1:01:30 PM
Re: ClosetInvestor #4057
That is a very good accurate concise description of what happened... " In regards to the BLA, we are victim of our own success ."
People complaining about other indications suggesting their eyes is not on the prize of drug approval with combo. While we wait on the safety data for 700mg and FDA's decision on to use 525mg, they are not sitting around twitting their thumbs, they are working other avenues. I guess it appears with these prs they forgot about the BLA, but that is their #1 priority. Nothing can be done to speed it up, we must wait for the data from 700mg or the decision from the FDA to allow 525mg.
People complaining about other indications suggesting their eyes is not on the prize of drug approval with combo. While we wait on the safety data for 700mg and FDA's decision on to use 525mg, they are not sitting around twitting their thumbs, they are working other avenues. I guess it appears with these prs they forgot about the BLA, but that is their #1 priority. Nothing can be done to speed it up, we must wait for the data from 700mg or the decision from the FDA to allow 525mg.
Quote:
"In regards to the BLA, we are victim of our own success. When the Monotherapy success of more than 90% was announced, the FDA made us switch the approval of combination therapy for the higher dose, therefore the timelines changed since more data was requested (rightfully so).
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