That’s what I was hoping wasn’t the case, even though all indications pointed that way.I don’t have much insight into the internal workings of FDA but my suspicion given recent experience with previous submissions is that this is directly related to staffing. Typically when we submit the data package and related documents, FDA will conduct a preliminary review and then give us general timelines of when we can expect to receive questions from them, and then a deadline by which they need to approve or reject the changes. They normally start sending questions about a month in advance. With all the changes and chaos, we’ve been getting questions from them as late as just a week prior to the deadline, often very late in the evenings or over the weekends.
Great info, thanks.