3Q07: Complete enrollment
4Q07: Report clinical results
Early 2008: Submit BLA
Late 2008/early 2009: FDA decision on BLA
As to the timing, I appreciate you are being so meticulous and transparant. I heard it, but couldn't give it a place. You are just doing that.
To give some positive swing to the CC. For the first time Cox was selling the technology as the priority in the overall portfolio and indicating that it has the potential to become a cash cow (a.o. in the area of FOB). He also clearly indicated that they need partnerhips for Atryn/HD in the US, as such giving an indication that they cannot burn more shares to develop things at their own expense (though there was some remark on FVIIa which I would like to listen to again).
GTCB is talking with many parties. Would it be odd to expect such a partner for the US popping up before they finish Phase III in the US and issue the BLA? After all, the EMEA put the data upside down and finally could not find a "lasting" reason to stop it from being approved. It might be interesting for a partner to fix the deal as early as possible, making the positive outcome part of the deal.
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