“Botanix will also bring forward the annual safety update to FDA including the pharmacovigilance report from Japanand anynew safety findings reported in the scientificliterature(which would otherwise usually be filed in March each year).”
I guess they need to have it all prepared when they resubmit? Not sure why FDA wouldn’t just take it when it’s ready in March if they aren’t intending to grant approval until July, you’d think safety data would need to be update and complete…
“Botanix will also bring forward the annual safety update to FDA...
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