but they do make the unqualified assertion in the first sentence that they believe they have demonstrated to the FDA that they meet the 5 criteria outlined by the FDA.
I can almost hear them saying, we explained exactly why we thought we met the FDA criteria for approval. We told you exactly what we had done and that it meets the criteria. Apparently the FDA did not agree.
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)