Yes, but on a different note if the the FDA is considering passing this drug through Phase II (efficacy), they'd view 'sameness' favorably if the drug had proven safer in Phase I. Add to this efficacy of the tested drug in racially diverse populations, and you have a potential blockbuster. So whereas in the context of your example the data indicates that the drug may not be better at treating the underlying problem, it might be irrelevant to the larger premise of drug approval. Adit.
On 9/29/07, Shyam Visweswaran <[EMAIL PROTECTED]> wrote: > > > This is the question you (or the > study investigator) are presumably interested in > answering – this is not the p-value. If you take > this to be the p-value then you are confusing the > two probabilities depicted in the previous > paragraph. > > In a nutshell, the p-value gives the correct > answer to the wrong question. > > - Shyam > > >
