(For you, Tuck. Small contribution stacked up aginst all yours. BTW, I missed the presentation this is only from QnA.)
My words:
Haven’t been requested to prepare for a Panel. 11-week advance notice is a guideline not commandment. Had been preparing w/Astellas for panel, now preparing for label discussions. FDA could call one with 6 weeks to go or whenever. ‘Volume’ of interactions w/FDA is decreasing.
All anti-arrhythmics have had panel, why not V?
Others were oral/chronic or, in case of defidolide, had torsades. We’re iv, short ½ life, 1x maybe 2x admin in an ER setting. Much less risk potential. Can be sure oral will have one if it gets that far. (We are not asking for post-op label at this time.)
P2b oral on schedule. Int results still expected 4Q07, no I can’t give you an exact date, yes it could show significance if repeat dose (300mg?) follows P2a. Powered 2 sided test, p .05, EP is rate maintenance assuming 40% placebo and 55% drug. Any drug arm v plo could show SS. To date seems well tolerated.
EU registration strategy. Getting ready to plead at 10/07 EMEA meeting that comparator trial unnecessary. If lose argument, add 6 months for new study vs amiodarone. If not, file no later than 1Q08.
ROW IV partnering….Goal is complete ROW partnering by 2Q08, could split EU and Japan. Still wrapped up in oral (edit: clearly, results of P2b will be needed before anyone commits to iv only). We will not partner us/na oral rights under any circumstances.
Other programs: listen to call if you want |
