This from the FDA update 4 April. "A determination of the submission is scheduled to occur during the standard 90 day review period....Having already been approved in Australia, Canada and Europe, it is a relatively straightforward process by which the FDA will compare the syringe against a pre-approved predicate device...we are confident in the status of our submission."
Given that we're 60 days into a maximum 90 day period, it could come at any time. I also recall Alan Shortall saying in an update that FDA approval would coincide with conclusion of the negotiations and full commercial roll-out, or words to that effect. Haven't looked up the precise wording, but my feeling is that it's all coming to a head as planned.
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