I have to think they were trying to get more clarity from the FDA regarding the deficiencies (and were not able to do so). They make a point of saying in the PR that the FDA "did not provide additional detail". They 99% won't get approved in May now, but as long as a new trial is not required I would think this delays the approval no more than 12-18 months I think MYOV is now at very high risk for a take under as you like to say by the Sumi- whatever
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