While we wait on manufacturing validation after the 17 missing SOC/placebo patients down payment on approval 7 years ago, not much left except high fives once MIA gets approved. Rolling submissions are kind of expected to have been done over such a lengthy delay to get manufacturing up to SOC production level and expected pricing. MA is designed to be able to catch up to MIA approval so surprise, surprise, the exceptions rule to adequate and well controlled trials gets the last laugh at your doubts and those of your post hoc brothers. Best wishes.
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