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

To: Ian@SI who wrote (5377)	1/9/2002 9:18:57 PM
From: hm	Respond to of 52153

Re: combo therapies. Logically, FDA regs say that the pivotal trials have to demonstrate that the combo is statistically superior to each individual component. So to get a combo approved, the trial is probably going to be at least 4 arms (combo, 2 components, placebo). That of course just gets approval for one dose of the combo. I would imagine that designing a trial with 2 investigational components making up the combo would follow the same pattern. One of the challenges will come in knowing how to power the study as there will be uncertainty about the efficacy rates of the individual components. There are endless potential other clin dev complications. Nonetheless, I think this may be the way forward in some disease areas (e.g., stroke) where a good pre-clin rationale can be put together. RE: trials with 2 investigational drugs. Apparently Sanofi is running a schizophrenia trial in Europe comparing 2 separate investigational agents vs. placebo (and presumably against each other). HM