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relocatedmetsfan

08/09/19 7:26 PM

#207485 RE: Larrybirdlegend #207476

LBL - What I don't get is the following...

The decision to go to AC should be made as soon as possible, perhaps even before receipt of the application, especially for priority reviews.




Something came up at the last minute.

People have been talking about mineral oil for years now, and the FDA would have honed in on this at the first sniff of an sNDA if this was the reason.
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oneragman

08/09/19 7:37 PM

#207490 RE: Larrybirdlegend #207476

Larry, IMO it's all about MO. AMRN needs to leave no doubts that V's benefit had little to no effect from it.