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Re: bladerunner1717 post# 10700

Tuesday, 05/03/2005 10:26:23 PM

Tuesday, May 03, 2005 10:26:23 PM

Post# of 257275
>>Obviously, the Phase II 209 study and the two phase III's will be running concurrently. (Is this unusual?)<<

It’s somewhat unusual but not unheard of. For instance, MYGN is doing it in its AD trials (#msg-6207570).

More common than separate and overlapping phase-2 and phase-3 trials is a joint phase-2/3 trial that keeps the same patients (or some of the same patients) in the two trial phases. EYET and QLTI have each done this.

The risk of overlapping trials –as you pointed out earlier today— is not getting the phase-3 design completely right.

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