Hi taylorstjames , just got a query on one of your earlier posts today you said that due to MSB not having received a CRL , this means they wont receive a CRL?. This meaning that its a 99.99 % chance of approval tomorrow. ?. Is this the way it usually works in that the FDA give a CRL before the due date?. Also like to thank you on some of your great posts . thanks
FDA does not over-rule positive ODAC decisions, page-28
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