The Botanix CRL is a prime example of what we're dealing with in the FDA world. BOT got CRL'd on a minor labelling request and whether the leaflet should be folded portrait instead of landscape. 6 months hold because of that AND another human study to see if they can unfold it correctly. SP takes a hit, BOT's bottom line takes a hit and armpits continue to sweat profusely while the FDA are playing Soup Nazi. You can't make this stuff up.
Ann: Mesoblast Type A Meeting with FDA, page-179
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$1.13 |
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