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Wednesday, October 25, 2006 1:19:33 PM
Something I've been curious about is why do the acute studies in rats and primates, and the longer 3 month studies in rats and dogs? There are several possible explanantions I can come up with -
1) Primates are expensive, so having done one study with them already, Cortex switched to the cheaper dog model for the 3 month studies.
2) Switching to dogs results in total tox data in 3 species rather than only 2, which might be seen as a plus.
3) Another scenario has some sinister overtones (just speculating here) - that having noticed a histo "finding" in the original acute primate data (Cortex noticed it but apprently the FDA didn't, since they allowed the Phase 2a trials to proceed based on that very same acute animal data), Cortex decided to switch from primates to dogs for the 3 month studies (thus eliminating the chance for a repeat of the primate "finding"). Not saying this was their rationale, but I suppose it's a possibility.
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