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Re: DewDiligence post# 88047

Wednesday, 12/23/2009 4:57:54 PM

Wednesday, December 23, 2009 4:57:54 PM

Post# of 257262
PSDV -

By the Modified ART method, in Trial A 22.6% of patients in the low dose and 24.1% of patients in the high dose gained 15 or more letters compared with 12.6% of control patients (p = 0.057 and 0.026, respectively). Trial A was not statistically significant for either dose



Is this is a mistake or am I interpreting the number incorrectly? The high dose p value is .026 and this is stat sig.

PSDV’s two phase-3 trials in DME failed to hit its primary
endpoint, and the other trial may also have failed, depending on
the FDA’s interpretation.



According to the release for the ART analysis both trials were stat sig and for the modified analysis trial B was stat sig. Why do you write the other trial may have failed?

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