Only good thing about such a significant barrier to market entry...

Only good thing about such a significant barrier to market entry is that once through that gate it should be just as difficult for any competitors to get through the FDA......unless there is skullduggery at play!!!! I understand the need to ensure efficacy and potency as the FDA don't want trust undermined in the drugs that are made available but really this shows it works for kids with no other chance of survival....... I suppose if the families paid good money for Disallowed that would be an additional kick in the gut. It just seems MSB is having to go that extra mile to get approval for something there is no competition for....very odd.