Biotech Values

[DewDiligence]

VX-950 CC post-mortem:

PROVE-1 and PROVE-2, which can logically be viewed as one study in two pieces, constitute one of the most complex trial designs I’ve ever seen in a phase-2 study in any indication. The analysts on the CC had to ask numerous questions about the rationale for the trial design, which was not always apparent even after the carefully worded explanations

Clearly, the company’s hope is that the treatment outcomes will be sufficiently phenomenal to enable an NDA to be submitted in 2007 based on phase-2 data. Whether this can in fact be done is unclear, but you can’t fault VRTX in planning for it.