Perhaps you need to review the previous results. The FDA phase 2 was not due to a previous FDA phase 1 test. The previous test was with the EU and the number of patients entolled was the factor which deemed it not sufficient in quantity. However the previous data indicated it worked. Either it did or it didn't? Either way there is an anomaly which I will investigate.
Ann: Results of Phase 2 Clinical Trial, page-125
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