Dec. 6 at 4:32 PM
$ACHV I want throw this up here as I'm following this FDA pivot closely and am considering how it may impact
$ACHV outcomes
IMHO this is an important development: The FDA’s shift to a one-P3 standard materially benefits ACHV. Their dataset—two strong P3s plus extensive safety—now exceeds the required evidentiary bar, reducing regulatory risk ahead of the June 2026 PDUFA.
For vaping, a single P3 is now clearly enough, and with the Priority Voucher, approval could come faster.
Overall, the policy change de-risks ACHV, accelerates timelines, lowers development costs, and increases strategic and commercial value.
