Accelerated approvals are just that - accelerated and don't require the same standard of proof of efficacy. Just like Avastin for Breast Cancer - it got accelerated approval, turned out it didn't work, so approval was recinded.
The goal is to give patients access to potentially effective medications. They do this because people bitch when the FDA says "no".
The goal is to give patients access to potentially effective medications. They do this because people bitch when the FDA says "no".