Application, page-13

Cheers @Potstock88 for the detailed response and overall you make some excellent points. BTW I have previously listened to the webcast twice and liked what I heard. It was very informative.

I guess the overall thing I’m highlighting is that the FDA have a long and proud history of making unexpected decisions. As you previously pointed out with the Biogen example, the Advisory Committee voted 10 to 1 against, but the FDA approved.

In a reverse example last year, Mesoblast got shafted when the Advisory Committee voted 9 to 1 in favour, but the FDA subsequently ruled against. After the initial ODAC vote the Mesoblast CMO Dr Fred Grossman said: “Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.”

As you said, the Acadia/Neuron NDA may appear as close to a slam dunk as possible. You may be right. I hope you’re right but nothing is assured when vested interests, skull-duggery, big pharma influence and lobbyists are involved with FDA processes. Just saying…

GLTAH