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Re: DewDiligence post# 87820

Sunday, 12/20/2009 7:59:46 AM

Sunday, December 20, 2009 7:59:46 AM

Post# of 257257
BMY study

duly noted! ironic that it is BMY (and not roche) that is first out of the gate with a study looking at SVR without interferon
the design begs the question why BMY did not break up the active controls further into direct-acting combo + the individual components of SOC..this makes it that much harder for any non-interferon-containing arm to succeed imo (on top of the fact it is also in nulls - which i have to think was the only way to get this study past the FDA)

if they can get excellent SVR without SOC then not only would they be the first to show POC for a interferon/ribavirin-less regimen, but they would probably get this info in time to decide whether or not to fund a costly phase 3 lambda program
of course BMY also wins (and perhaps wins even bigger given their stake in lambda) if the quadruple therapy arm has good efficacy and is meaningfully better than the arm without SOC

one last factor making dropping soc altogether a bit less likely to succeed in this study is that both direct acting agents are high potency/low barrier to resistance drugs

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