Biotech Values

[DewDiligence]

VRTX – The fact that the interim PROVE-3 numbers for patients who had relapses in the first line are immensely better than the numbers for patients who had non-responses or breakthroughs has the effect of fragmenting the second-line setting and making it harder to handicap what the FDA will request from VRTX.

My numbers in #msg-26290780 were based on the presumption that the different subgroups of second-line patients would not see huge differences from one another. If these subgroups do in fact show huge differences from one another in the final PROVE-3 results, as now seems likely, the FDA may be inclined to hold off an NDA review until phase-3 is completed, hoping that the phase-3 data help to sort out the inter-subgroup differences.

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