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Re: davidal66 post# 1711

Thursday, 10/26/2006 6:20:33 PM

Thursday, October 26, 2006 6:20:33 PM

Post# of 57675
Stoll indicated that this does not reflect a 'class effect.' Cortex and Organon have met to compare notes, and Org24448 does not appear vulnerable, nor did CX516. They were not tested at the very high doses used this summer, but were almost certainly tested at the same dose level used with that first monkey. CX516 was used in what....600-700 people? Org24448 has probably approached that level in Organon's trials. Nothing has been seen that points to any class-wide side-effect.

Is CX717 toast? Given the high doses needed to generate this signal, it shouldn't be. With the FDA's high level of vigilance as it is at present? Possibly. Is this a class-wide effect that will affect all Ampa-modulators? I strongly believe that is not the case.

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