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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Gulo who wrote (14330)11/23/2004 10:47:00 PM
From: charlyt  Read Replies (2) | Respond to of 52153
 
"Never"? That is why I wanted some feedback on what the statement meant.

The comparison may not constitute proof that the treatment triples survival, but isn't a difference that big (70 v 26 weeks) kinda hard to attribute to open-label bias or placebo effect? Or am I just completely wrong (it wouldn't be the first time) and the comparison is meaningless because of some factor I don't understand?


It has happened several times where an apparent survival benefit in an uncontrolled early study compared to historical controls was NOT confirmed when a phase 3 controlled study was performed.

Two examples off the top of my head are Biomira with Theratope in breast cancer and Isis Pharmaceuticals with Affinitak in NSCLC. Both appeared to have large survival benefits (many months) coming out of phase 2. Both showed nothing in phase 3.