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Replies to #88047 on Biotech Values

wallstarb

12/23/09 9:06 AM

#88052 RE: DewDiligence #88047

So the drug doesn't work and it essentially gives you glaucoma!?!

Where do I sign up for that!

"Over the 24 month period 5.1% of patients receiving the high dose and 2.1% of the patients receiving the low dose had received a trabeculectomy (filter surgery) to reduce their eye pressure."

Trabeculectomy is a surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork

turtlepower

12/23/09 4:57 PM

#88106 RE: DewDiligence #88047

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?