Early approval and Orphan Drug designation are 2 separate things. I have quoted the appropriate paragraph from the FDA website. And I think it would have to be a pretty significant global health ailment for the FDA to grant early approval (think Covid). Risk v Reward. MSA is not a significant global health ailment, so the risk of an early approval and getting it wrong will have the FDA being sued from here to infinity and back. The reward of an early approval is enormous for those who have MSA, but insignificant compared to the risk.
What to hopefully look forward too, page-22
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