a) What percent of 483s are addressable quickly (e.g. without waiting for a full reinspection (in a month or two))?
b) Are you involved in NDAs or on-going ops? I would assume that there is a difference in company panic factor depending on whether it is already in production?
If they received a 483 for manufacturing issues, that is material IMHO. If an investigator working on the DNDN trial received a483, that would be immaterial.