RE:RE:Nasdaq-Orphanhey bearskin, if you want to get back in my good book, here is a challenge for you (which BTW will help all owners)...WTF is up with the non-FDA thingy, it is very quizzical...here are my thoughts:
a) is BoM diabetes or cholesterol??? and what difference does that make in FDA world???
b) is BoM chronic care or life threatening unmet need??? that makes a big difference IMO
c) ????
and i say this as best i can tell the trial design seems pretty SOP by FDA standards..event based, adaptive, long duration, etc.
ps still like to see 208 as mono but hey there you go