Ken-I have a slightly different take on the NP letter to Amarex demanding they file for approval from the FDA. It occurs to me that NP was not getting any answers to explain delays in the data collection. In order to flush the accurate info, a filing would result in a letter, and a denial, if for cause, they would state the cause and NP would learn what was going on. That's my take and I think it was a great idea.
It worked and now we know how bad they handled the account.