Jul. 24 at 5:35 PM
$APVO Regulations (42 CFR Part 11)
Under the Final Rule, results information submission could be delayed for up to 2 additional years from the date of submission of a certification that either (1) an unapproved, unlicensed, or uncleared product studied in the trial is still under development by the manufacturer or (2) that approval will be sought within 1 year after the primary completion date of the trial for a new use of an approved, licensed, or cleared product that is being studied in the trial (81 FR 64983).
The estimated study completion date for APVO436 in its current phase of trials was 6/15/23. If you consider a two year delay reading the reg. above, we are in the window of phase completion. Yes, it could be months with no additional news....or it could be tomorrow. My guess is sooner than later and if its sooner, oh what a day that will be!
