Dsuvia Resubmission Might Come by End of Q1
FDA minutes of January Type A meeting expected by end of February. On the maximum dose issue, they have data which supports the safety of more than the recommended dosage over a 24 hour period, but I think it's more likely that they will go the conservative route and lower the maximum dose over 24 hours. Only trial needed is a one month max human factors study. Zalviso resubmission is ready but being held until Dsuvia is sufficiently advanced. European opinion expected H1, Dsuvio (in Europe) approval possible H2. In general, sounded very positive. Preparing for possible AdCom where of course there is the risk of bias against anything to do with opioids.