What makes me especially excited, after reading this Mozz, is…. How smart it was to have a throw at the stumps with our 5052b pathway. The FDA have already been through our submission and the feedback (whilst isn’t necessarily exhaustive) is an impressive foundation off which to work towards our next NDA application or accelerated approval application etcetc.
What I’m saying is, now we know where our competitors are at, AND what the FDA think about our dossier already, we are as de-risked as we can be right now.
Hats off to you for going to OARSI and hats off to Rennie and co for their measure twice, cut once approach.
MOZZ OARSI 2023 - NOTES, page-79
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