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Tuesday, July 19, 2016 12:22:26 PM
IMO, this is where Pfiffer earns his keep. Not just an attorney, but was 10 years as an FDA appeals official. He dealt with the CRL's and responses. IMO, if anybody knows the workings about how to respond effectively and has credibility with the FDA it's him. Personally, I would have liked him on the CC yesterday too, but what they can say may be limited.
"Beware of missing chances; otherwise it may be altogether too late some day" -- Franz Liszt
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