research reports and media, page-3200

"Perhaps others can tell me if I am reading this (below) correctly, but it appears that if accelerated approval is granted on the "reasonably likely" basis that changes in the biomarkers are producing the result of clinically beneficial outcomes (i.e. disease modification) then "this approval pathway requires post-marketing studies to confirm clinical benefit."

Yes that's exactly how you should read it. AA would likely mean (1) DMOAD on label and (2) FDA requesting post marketing follow-up trials (Phase 4). This is not that uncommon, however, I also note FDA is starting to crack-down on the timeframes biopharma's are taking to execute the post marketing trials given the lack of financial incentive to complete.......what a problem to have given this will be the least of our concerns.

It shows exactly why OA-008 is such an important near term catalyst.