Friday, November 19, 2004

I arranged a meeting among Medimmune (Flumist), the FDA, and Stewart Simonson to try to pursue ways to get broader approval and utilization of Flumist for next year to make up for the anticipated shortages since Chiron will almost certainly not be able to re-fill the gap by next year. Present at the meeting were Medimmune CEO David Mott, President Jim Young, VP of Reg Affairs Peter Patriarca, CMO Edward Connor, Sr. Director Scientific Affairs Kathleen Coelingh. From FDA were Les Crawford (Acting Comm) and Jesse Goodman (head of CBER). Also, Stewart Simonson, Bruce Gellin, Pamela McInnes, Ralph Tate. I am trying to be the facilitator to have FDA look at Medimmune data on 50 to 64 year old people sooner rather than later so that Medimmune can produce an extra 10 million doses for next year. They need approval for this age group or else then cannot take the risk of making 10 million more doses and not be able to sell them.