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frrol

05/08/16 12:55 PM

#146866 RE: To infinity and beyond! #146858

There was no mistake. Remember again what a Phase 2 is supposed to do. The Pririsol phase 2 has the typical # of participants for that. (In fact there are many Phase 2's that have fewer.) The FDA approved of the trial design, including the # of participants. And more participants does not equal better. More participants = more time, more money.

A phase 2 needs to have the adequate # of participants to achieve or reject its endpoints. This is why a Phase 3 is larger. Slightly different endpoints.