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Re: Chuckles759 post# 114768

Sunday, 09/06/2020 5:27:48 PM

Sunday, September 06, 2020 5:27:48 PM

Post# of 233147
Great find, Chuckles. From reading the article it seems that MHRA now has the ability to make the approval for fast track use or for another trial. The good thing, is that until January 2021, MHRA will have its protocols mimic the EU protocols. Thus if we get U.K. approval for use, then EU approval should be much easier.
Also looking at the MHRA and reading the tea leaves, it seems to me that since we have already received UK approval for enrolling Brits in the S/C trial, a discussion of a submission to receive approval to enroll in a Phase 3 M/M trial would be perfunctory. So the discussion on Tuesday would probably be a very serious discussion about fast track approval of Leronlimab to use for M/M patients. The meeting would not produce an approval but frame the recommendation of the ethics committee and the research authority. So as I read the tea leaves, a positive outcome from that meeting would result in a quick consideration and fast track approval for use.
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