Biotech Values

[gofishmarko]

>> If the FDA saw a serious—perhaps life-threatening—problem in a combination trial, they could place a clinical hold on all VX-950 development until they sorted it out. Is this a risk VRTX will be willing to take? <<

Given the longstanding unmet need for an effective treatment for nonresponders , I would expect the FDA to be relatively accomodating in this situation. I can imagine a conversation where the FDA agrees that any new , unexpected SAEs in the combo trial will be assumed to be due to the combo and not to VX950 , assuming a good monotherapy database , of course , and subject to change based on postmarketing safety data. Absent this sort of up-front understanding , however , I agree that VRTX would be wise to wait on the combo trials.

BTW , Alam's CC answer to Werber's ITT question sounded like the ramblings of a madman. I bet Alam's eyes were spinning in circles. No wonder he wanted to take it offline.

The VRTX halo is showing some corrosion.