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Biotech / Medical : Biotech Valuation
CRSP 56.68-2.4%Dec 12 9:30 AM EST

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To: Gary Mohilner who wrote (9298)10/13/2003 4:32:22 PM
From: Biomaven  Read Replies (2) of 52153
 
Perhaps we need to make allowances for the site being Chinese - things get distorted in translation.

You are right that efficacy isn't well defined, and depends partly on what the alternative treatments are. Thus if a drug achieved six months survival in late-stage pancreatic cancer we'd say that it showed efficacy. But the same result in a more treatable early-stage cancer wouldn't mean anything.

Ultimately the FDA looks at survival, but in the past few years they have conceded that it is reasonable to look at surrogate measures (like numbers of CR's and PR's) in Phase II trials as well.

IMGN remains a puzzle to me. Their concept certainly makes sense - it just hasn't seemed to have worked well in humans to date. Perhaps they just don't get good antibody penetration within large hypoxic tumors. Maybe it would work much better in early-stage patients, but it's hard to try it on them given they might have good alternative (and approved) therapies.(The same issue of course faces many anti-angiogenesis drugs).

Peter
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