xoma is still in the pre-meeting or at the meeting?
then BLA application,
then 2 months for BLA application acceptance,
Fast track is usually announced at the application acceptance time (my opinion: Fastrack is assured if BLA accepted),
then 6 months for Advisory panel review (outside panel is a sure thing),
then couple of weeks (or months) for FDA approbabble letter
(or non approbable letter),
then final labeling (could be months to years, but xoma is prepared for long time, so it should not be more than 2 months for final market readiness),
In the meantime, at some point later than sooner, a publication of the DATA,
And the rest of the nuances in between (hu211, ing1, genimune, and rest of garbage). |
