[jeherr]

In regards to the panel being too restrictive or permissive, I think you have to look at the possible motivations for why. If you have a drug candidate that seems safe and effective, what possible motivation could the panel have for rejecting it? The pharma company gets their drug to market, patients get new and better drugs. The incentives are aligned so the issue with being too restrictive is a debate about how risky we should be approving new drugs.

On the other hand for a drug that’s safe but maybe not effective, there’s a lot of money to be made off of people willing to do anything to prolong their time with their loved ones who have been diagnosed with Alzheimer’s. Aside from that, the FDA can hurt it’s reputation by approving drugs that just don’t work too frequently and be accused of being in the pockets of the pharma companies. There’s a stronger possibility of corruption affecting the decision, and whether that corruption is real or perceived doesn’t matter much for public trust.