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jb_118

09/01/11 1:16 PM

#126039 RE: biomaven0 #126037

My take is it's either something major, or something unclear and they have lost confidence in their interpretation of FDA communications with them



It's been a while, but I recall Bill Marth saying on a cc that they basically asked the FDA to make an official response to them, the result of which was the CRL. Anybody else remember that?