Biotech Values

[upndown1313]

Gofishmarko, I really don't follow your logic that FDA should come out and say that adverse events found in combo studies post-approval would just as likely mean implicating the monotherapy if adverse events were found in the combo studies. To me this would hinder the development of combos, not encourage them, even post-approval.
IMHO we will likely see combos of oral HCV inhibitors planned this year. I suspect when both compounds are in PHIII, there is sufficient data to analyze the potential combo risk. Some of the potential candidates still have very good safety profiles. And given some of VRTX's recent results, I think they are now highly motivated to look at other non-approved drugs in a win-win-win (VRTX-partner-patient) type situation.