We’ve discussed this at length previously and I
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Posted On: 10/06/2020 1:14:50 PM
Re: LaundryMoney #59989
We’ve discussed this at length previously and I think the final decision was we don’t exactly know but if it does occur, aspects of a BLA such as manufacturing and safety will be estbalished.
I’m terms of NASH, or any other indication, leronlimab will still have to demonstrate efficacy in an FDA approved trial and have the data to prove it. Trials to prove efficacy typically are the longest part of the drug approval process. The previous safety and manufacturing data will reduce processing of the BLA, but I’m not sure how significant of a reduction it will be.
I’m terms of NASH, or any other indication, leronlimab will still have to demonstrate efficacy in an FDA approved trial and have the data to prove it. Trials to prove efficacy typically are the longest part of the drug approval process. The previous safety and manufacturing data will reduce processing of the BLA, but I’m not sure how significant of a reduction it will be.
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