Av­enue touts progress with FDA on em­bat­tled pain can­di­date af­ter two CRLs, failed ad­comm

Av­enue Ther­a­peu­tics says it is most­ly in agree­ment with FDA on tri­al pro­to­cols for a po­ten­tial Phase III safe­ty study, which could lead to the biotech’s first ap­proval if the tri­al and read­out go in Av­enue’s fa­vor.

The Fortress Biotech sub­sidiary is­sued a state­ment Mon­day af­ter­noon de­tail­ing re­sults of a March 2023 type C meet­ing — and now has min­utes in hand that Av­enue says show some agree­ment be­tween the com­pa­ny and fed­er­al reg­u­la­tors.

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