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drbio45

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drbio45

Re: pcrutch post# 117233

Tuesday, 03/29/2011 10:25:44 PM

Tuesday, March 29, 2011 10:25:44 PM

Post# of 252302
Still early data, but must have been good enough for the FDA/EMEA to grant a Ph2/Ph3 trial(not a pivotal trial or SPA though).

you are correct that it isn't an spa but you are incorrect that it is not a pivotal trial

call William Prather. If they meet the primary endpoint they can file, they do not need to run another phase 3.
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