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after submission will take a year best guess. Fast track still might take that long.
One yr an overly pessimistic time frame,IMO. After decades longwait for new treatmentI doubt FDA would treatthis as routine.Then too, LSB is already a fast trackcandidate, and FDA hasalready been much involved in shaping ofP3 protocols.Finally, if the abovedoesn't work for you,the Agency always hasthe discretion to authorize humanitarian waivers pending approval.
Why not after market close tonight