I remember Dr Lalezari’s passion well. This example wasn’t his only mention of asking the FDA for 4 doses. I clearly remember him saying he begged the FDA to allow up to 4 doses in the protocol prior to the trial. So he has said and talked about this dose issue more than once.

I hope this is the slippery slope the FDA slides on and bruises their ass and once the fall happens and we get great results from around the world. It will be satisfying to show them the results of trials that don’t have built in hurdles so high we can’t make it over them. Design is everything and guidance is suppose to help not hinder. Which angle did we get? Help or hinderance?