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no2koolaid

11/26/14 1:52 PM

#136521 RE: dr_lowenstein #136511

One responds to the FDA as one needs to. The FDA gets to decide when a meeting occurs and one might expect that is only subsequent to their questions being answered. So, any delays are an FDA choice not subject to review or revision by anyone other than the FDA.

Couch

11/26/14 2:29 PM

#136532 RE: dr_lowenstein #136511

The CEO stated he had a phone consultation with the FDA in October and then met face to face in November. I see no problem with this. Please tell me what the explicit problem is with this?