The orphan app is quite a nice piece. If the status is granted, it will certainly generate interest.
Regarding 2, yes it makes a difference. However, seeing that he is probably the most leading authority on FDA orphan drug initatives and a champion of them, having him agree to do the app is a big plus. Big plus.
I certainly hope they get it, it would be a game changer. If the PRV would come, that is a wammy game changer. Instant returns.
As we approach 60 days. I will twitch a little.
Was the 50% survival rate in the lethal mouse model expressed previously well? That is truly impressive.
HS