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Couch

06/08/16 1:04 PM

#203761 RE: WeeZuhl #203760

Exactly the article I had in mind. It's why I think Elite may not need an AdCom meeting particularly since Eli 200 is an IR product and not subject to REMS.

Hike

06/08/16 1:13 PM

#203765 RE: WeeZuhl #203760

Yup, that is all I could find as well.
Next Adcom is scheduled in September. Nothing in between.
If Elite were to be part of that the PDUFA would need to be extended and I would think we would know that by now.