|From: burp (Rep: 73)||Date: 01/04/2019 07:44|
|Forum: Nabriva Therapeutics AG - Msg #108||Thread #674055506 (Rec: 0) |
|When receiving a PDUFA this is the best wording you want to see in the acceptance letter...|
In the NDA acceptance letter, the FDA stated that no filing or potential review issues were identified. In addition, the Agency stated that it has not referred CONTEPO to an advisory committee meeting at this time.
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