As I understand it, "accelerated approval" means a

As I understand it, "accelerated approval" means a BLA or NDA that is judged more quickly. A BLA or NDA is a ton of work, taking something close to a year for a small biotech, based on finished Phase II (at least) trial results. Accelerated doesn't mean bypassing the usual system, just making the judgment process more swift. And I would be amazed if it were awarded based on trials totalling 43 patients. I think Breakthrough Designation is a more likely route to take -- the application is much shorter, the decision time quicker (60 days), and the burden of proof much less imposing. That said, Nader applied for BTD with the same trials, and was turned down -- though of course he didn't have the amazing survival results.