i think our challenge remains the same. the unknown / little guy, has a much higher burden of proof than the established company.

if either (i) we had crushed our primary endpoints, or (ii) were a well known company that had gotten an approval already, we'd be off to the races.

my take is that while this should be approved, we didn't exactly lay it out on a platter for the FDA.

if we had hit our PE, i'd be screaming, yelling and clamoring right now - but we left it in the gray area. Hopefully the next trial will leave no gray.....