Has the FDA ever approved a drug based on trials from India or other foreign countries? Can they go from phase II in India to phase III or II in the US?
Care to enumerate these alternatives along with their probability of approval?
The .05% confidence limit is not generally considered good enough, but a barometer, and an easily duplicable number, and duplication is the name of the science game.
I think you got things backwards there. Confidence intervals most often start at 95% or 99%.
The only citation I could find for a value of 0.05 related to an oncology trial was:
Statistical Significance "The results of a trial are usually considered statistically significant when data comparison results in a p-value of 0.05 or smaller. If the p-value is 0.01 or even 0.001, the results are considered even more significant because there is less likelihood that the results are due to chance." http://www.cancer.gov/clinicaltrials/resources/in-depth-program/page4
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