Replies to post #164640 on Biotech Values

[oc631]

Per Seeking Alpha transcript of today's VRTX CC, it appears VRTX management said during Q&A that the results in the 200mg PK studies of VX-135 compared favorably with the results seen for sofosbuvir at 400mg. Is that not a fair statement?

I'm not sure what was discussed on the call today. A hold has been placed on the VX-135 200mg dose by the FDA. The 200mg dose may relate to European studies.

[DewDiligence]

VRTX management said during Q&A that the results in the 200mg PK studies of VX-135 compared favorably with the results seen for sofosbuvir at 400mg. Is that not a fair statement?

It might be fair, but it’s essentially meaningless. PK studies are not demonstrations of efficacy.

[genisi]

VRTX management said during Q&A that the results in the 200mg PK studies of VX-135 compared favorably with the results seen for sofosbuvir at 400mg.

But if you look at RVR data of the two drugs then for VX-135 in combination with ribavirin "All patients achieved undetectable HCV RNA during the 12-week dosing period, and 70 percent and 80 percent of patients in the 100 mg and 200 mg dosing arms, respectively, had undetectable HCV RNA within four weeks of initiating treatment", while sofosbuvir in a similar combo has produced 100% RVR in all GT1 (null and naive) patients in ELECTRON study.