I am in the circle to know that a tremendous delay took place in the review process because of some difficulties at the inspection sites.
So do you know what the difficulties at the inspection sites were? Are you saying 6 weeks after the January CHM which concluded Jan 30? If so, I've read that the time after 2nd CHM varies widely, so what has you landing on 6 weeks? TIA
I can believe that. My fear, and thinking to myself prior to the inspections, was were they able to timely retrieve the archived data and the quality of the data be it GCP (clinical) or GMP (manufacturing) or Part 11 compliance (electronic). While the regulations existed, many companies dropped the ball when it came to Good Practices and when you're talking 10 or 15 yrs ago, I'm sure that was compounded.