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toomorrow

10/02/16 1:38 PM

#32661 RE: tjguy #32659

This isn't the same as a drug approval which is assigned a PDUFA date. This type of approval has a 365 days timeline from the date it is submitted and can be approved at any time during that 365 day time frame. XXII submitted Jan. 1, 2016 (as I remember), so they should have an approval by Dec. 31, 2016, or any time between now and then.

FDA is on board for this product.