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Biotech / Medical : Indications -- Stroke
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To: nigel bates who wrote (61)5/13/2007 2:14:21 PM
From: idos   of 70
 
>The change in NIHSS, from day 0 to day 90 was found to be significantly higher in the DP-b99 treatment group with moderate to severe stroke at baseline (NIHSS 10-16). When all patients were analyzed together, the change of NIHSS was apparent but did not reach statistical significance.<

I wonder, how many of stroke patients will benefit from the drug if it shows efficacy only for those with baseline NIHSS 10-16.
Will this kind of efficacy make the FDA require a very large Phase III?
One more thing i am wondering about, it said they compared the drug to placebo. Would it not be better to compare to SOC?
T.I.A for your thoughts.

Ido
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