I think Avion submits a plan of procedure and then it's up to the FDA. Discussions, what is the hart of a SPA, will then eventually lead to an accepted protocol. Or not if they don't come to an agreement.
From a traders view it would be good to go a bit higher before the news comes in. Then mid twenties must be possible imo. Of course if it is damned good news.
I don't think the FDA put forward programs, they only have their guidelines on which they decide. In the case of Lupuzor, Avion has come up with a new way of defining endpoints and that will be certainly food for discussion.