Biotech Values

[DewDiligence]

> VRTX CC – A couple of the questions were aimed at getting the VRTX folks to admit they were angling for approval based on P2 results, but they didn't get too far except for an acknowledgement that it was a possibility. Assuming the product stability data is done by early '08, they could file at that time based on P2, or wait for P3 data and file in late '08.<

VRTX is smartly playing this both ways: the official guidance is that they do not expect to submit the NDA based on phase-2, but (wink, wink) the guidance for the timing of the NDA submission—mid 2008—is such that it would be impossible for the submission to be based on phase-3.