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Message: Breakthrough Therapy Question

Buckeyes, 

 

Not sure I agree with your timeline. FDA responds to BT requests within 60 days of receiving them. If RVX had filed in Nov, that would not jive with DM's 90-120 days estimate. If we go with 120 days from Nov 18 (when we first heard that timeline), and assume 60 days of that period is for the FDA, that would put the filing date somewhere in mid Jan. 

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