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Sunday, May 10, 2015 8:49:42 PM
Here are the P values from 9-7-12:
placebo n/a
1mg = .0286
3mg = .0714
1 and 3mg pooled = .0154
The 3mg arm was not statistically significant.
In any event, none of these numbers have any value at all since these vials were mixed up and mislabeled -- so none of them show SS. Why the 1mg and pooled were SS but the 3mg was not is anyone's guess. The statistician at the time could explain it, but that matter is worthless to investigate at this point.
The only number that has any meaning is the subsequently published P value for the 3mg compared to the 1mg in combination with the placebo. Here we get a P of 0.217, which is not statistically significant by any measure.
So to be long this stock, you need to be comfortable believing the P is going to make the major jump from 0.217 to 0.05 or better based on the number of participants climbing beyond 600 and only placebo being in the placebo arm.
My advice to you would be to forget about the 9-7-12 numbers. You can't make wine out of manure.
Pharmaceutical companies commonly get SPAs for P3 trials. You can learn more here:
http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf
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