Replies to post #104041 on Biotech Values

[DewDiligence]

…MRK is trying to say that even though prior nulls were excluded from RESPOND-2 study, since 25% of patients in the trial had < 1 log reduction in viral load at week 4 while in the lead, they might be considered nulls.

Understood; however, this is a less stringent definition of null responder than the definition used by VRTX (#msg-54315761 bottom), which refers to a prior course of therapy.

[DewDiligence]

VRTX reports that 58% and 65% of patients in the Telaprevir ADVANCE and ILLUMINATE studies, respectively, stopped treatment at 24 weeks according to the response-guided protocol in these studies:

http://finance.yahoo.com/news/New-Data-From-Phase-3-Studies-bw-2646849491.html?x=0&.v=1

(Unlike the ADVANCE and ILLUMINATE studies in the first-line setting, VRTX's REALIZE study in the second-line setting treated all patients for 48 weeks regardless of the response.)

[DewDiligence]

MRK reports that 44% and 46% of patients in the Boceprevir SPRINT-2 and RESPOND-2 studies, respectively, stopped treatment early according to the response-guided protocol in these studies:

http://finance.yahoo.com/news/Mercks-Investigational-bw-1755524465.html?x=0&.v=1

Early response-guided stopping occurred after 28 weeks in the SPRINT-2 study in the first-line setting (which included a 4-week lead-in period on SoC only) and after 36 weeks in the RESPOND-2 study in the second-line (for non-null-responders in the first line).