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BTH

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BTH

Re: glass_half_full post# 9397

Thursday, 06/16/2011 8:26:15 AM

Thursday, June 16, 2011 8:26:15 AM

Post# of 80490
Phase 1 trials are generally for safety and tolerability.

However, if the drug can show both safety (AND) efficacy on a broader scale and scope, it's considered a Phase 1/2 because a Phase 2 study is the one they consider the "efficacy AND tolerability" study, working upon what the P1 showed.

Essentially, they are taking the same road as they did for '534, which is to by-pass an entire and lengthy P2 because they feel they will have enough data to go straight to a Pivotal Study.



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