“Why are (your typo) this percentage (of approval after 2 CRLs) so high?Because, if your product doesn't have a good chance of approval, you would give up on that product and move on rather than resubmit the BLA for the FDA to go through the approval process again.”
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Precisely, @ddwn.. a lot of companies would have given up and they did give up, including at least some that I know of and have invested in that are from Australia.. Of course, this is an inference, but I would say it’s an inference that is well informed and grounded in evidence of similar cases.. My opinion therefore is the same as yours and quite a few others’
Pick Today's Price Range Low-High... Just for Fun, page-1156
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