>>I would tend to trust Urdal who said something to the effect that the mention of the CMC issues in the CR letter was just a reminder to get it done.<<
1. Right. 483 issues are violations of FDA regs, typically involving cGMP issues. Experts report that cGMP inspections concentrate on issues such as recordkeeping, training, maintaining sterile conditions and the like rather than on merely observing operations during the course of the inspection since such "human factors" can easily get out of hand during a step up to large scale production, especially where it's obvious an applicant is intending on a substantial increase in people and equipment post any FDA approval. Follow-up surveillance inspections occur only every two years on the average.
2.Dave Urdal is an immunologist, not a production QA expert, and remedying such people issues might seem minor to him, even thogh the impact in schedule and tens of millions in added costs before first commercial revenues is hardly minor. In addition, Urdal did not sell shares before the 483 issues were disclosed.
2. OTOH, Bogdan Dryzinski (sp?), a selling Director is a retired Quality Assurance Director from Medimmune, a vaccine manufacturer in the same regional district of the FDA's Office of Regulatory Compliance (reputedly the toughest) as DNDN's NJ facility and an officer of a national regulatory affairs organization. Logically, I think that the actions of a quality assurance expert selling shares prior to disclosure of FDA Form 483 issues after a positive FDA AC meeting and less than 6 weeks prior to a PDUFA date says a lot more than the words of an immunologist after those same issues were repeated in an FDA CRL. Ultimately though, these issues will not be decided on a MB, but in a Federal District Court proceeding.
