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rgdphd

03/17/14 6:06 PM

#97899 RE: toofun #97897

You can trust that elite and their CRO know what sample size is needed. This is not a guessing game as to what works for the FDA.
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lasers

03/17/14 7:04 PM

#97908 RE: toofun #97897

A Pivotal Phase2B is generally 80 t0 90 persons as it was for Phase2B ELI200.

Waiting to hear on Pivotal Phase2B ELI201 which should be underway now.

As for Pivotal Phase2B ELI216, I am expecting at least 80 to 90 persons and perhaps higher. A Phase3 ELI216 was going to be 300 persons back in 2008 with respect to ELI216 at that time.