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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Linda Kaplan who wrote (5426)	9/2/1998 3:01:00 PM
From: biodoc	Read Replies (1) \| Respond to of 7041

Aviron received a refusal-to-file letter on Aug 31 for its BLA/ELA for flu-mist vaccine. The BLA was submitted on June 30. The reasons apparently had nothing to do with the efficacy trial, but related to the manufacturing process. In the Aviron case the Agency took the full allowable time to resond. I believe that if ZONA gets such a letter it will also be on the last day of the 60 day period (or even a few days later, as in the Aviron case).