There is rumor that the company has not been honest about the manufacturing process with the FDA. Manufacturing wanted to make a change in the production process to fix one of the many yield issues. The FDA is not aware of the changes that have already been made, so when they submitted the request in February, they had to admit to making changes in the production process without FDA approval. I think the size of the manifolds are the issue.
All of those involved in the submission were let go of resigned. QA, QC, Val teams were gutted. The FDA should come knocking at any time.
Hope this helps you connect the dots.