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Re: DewDiligence post# 12611

Monday, 06/27/2005 6:19:26 PM

Monday, June 27, 2005 6:19:26 PM

Post# of 257272
Also on the upside: You'll presumably get better eyecare and monitoring than you might otherwise (part of why placebo groups can perform better than "historical controls") and photodynamic therapy (Visudyne) can be given if the doctors think it is necessary.

However, I find it odd that they don't mention the visual acuity standards or the statistical significance that the FDA is looking for when they agreed to the SPA.

From the PR:
"Photodynamic therapy (PDT) will be allowed for all patients if deemed necessary by the study physician. The total number of patients enrolled into each Phase III study will be based upon analyses of data from the Company's existing and ongoing Phase II clinical trials, as agreed upon with the FDA."

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