1. Not as far as I know. At the followup CC after the CRL, DNDN reported that the CRL letter listed the Form 483 as a reason for not approving. Gold said that they had been working on the issues raised in it since the FDA pre-approval inspection during the week of February 12. I didn't realize until after the CC, that a Form 483, a Notice of Inspectional Observations, is given to a plant manager at the conclusion of an inspection before leaving. It does not list recommendations or guidance but violations of FDA regulations. FDA regulations incorporate tough cGMP standards, and according to Quintiles Consulting, nearly 20% of biotech companies fail their preapproval inspections. There are thousands of references in Google to FDA Form 483's.
2. FDA regs state that if a reinspection is required, the PDUFA clock is reset by one review cycle, six months in the case of a priority review, after the FDA accepts a corrective action plan that is implemented by an applicant.Since cGMP problems tend to be recordkeeping, training errors and the like where promises just won't work, an unannounced reinspection requirement is likely. The DNDN non-disclosure problem is compounded by the fact that in the 10K issued in March and signed by every Director escept Susan Bayh, they not only fail to list the preapproval inspection and its outcome in the Section describing Ongoing Regulatory Activity, but describe the requirement for the inspection as something that hadn't occurred yet. Both the CEO and the CFO certified the 10K per Sarbanes Oxley as being materially accurate.
3. Actually, I assume that there were no leaks of the Form 483 problems, but it is likely that many of the employees in New Jersey and possibly some family and friends knew of them and what they meant while working to correct the problem areas. I just assume that these folks didn't follow the example that the BOD members set, but given the huge trading volumes in DNDN shares, the chances of detection if improper trading had occurred would be minimal.
4. A question for you. Do you think that a few FDA docs who knew about the poor preapproval inspection outcome also noted that DNDN's CEO sold $2.7 million of DNDN shares without telling his shareholders about that problem?
