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Thursday, July 26, 2007 3:14:28 PM
[OT SPPI] >…Pazdur opened up the ODAC panel meeting by saying that those endpoints were still under review. (Fine time to let the sponsor know!!! Whatever happened to the "Critical Path Initiative?"!!!!) In any case, everything went to hell in a handbasket after that. The vote was 12-0 to wait for the OS numbers to come in. (Those numbers should be available in about six months.)<
Sooner. That’s according to PHRM, and they ought to know because the final OS data are required by the EMEA as a formal update to PHRM’s pending MAA.
>All one of the analysts had to ask was "Did the FDA formally sign off on the amended protocols in the SPA?" No one asked. Maybe they just assumed. If Seizinger, CEO of GPCB, had said "yes," then he would have been lying.<
Seizinger has answered in the affirmative on various occasions. So the real question is what the definition of formally is
Sooner. That’s according to PHRM, and they ought to know because the final OS data are required by the EMEA as a formal update to PHRM’s pending MAA.
>All one of the analysts had to ask was "Did the FDA formally sign off on the amended protocols in the SPA?" No one asked. Maybe they just assumed. If Seizinger, CEO of GPCB, had said "yes," then he would have been lying.<
Seizinger has answered in the affirmative on various occasions. So the real question is what the definition of formally is
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