"before they had a chance to add them....." Really? you think it takes months to copy a data set that you already have, into the location the FDA specified? Do you really think that a mere 80 million dollars does not buy professionalism in things like having dates attached to 15 of the cases, or including what the FDA called the standard "graded" information that they require? They simply did a shoddy job and DID NOT FIX what the FDA specifically asked them to fix. How long should it really take to add some dates and generally clean up the shambles that they sent in?

Years and years of collecting payments, for what? An obviously sub-standard job that any competent CRO could do in a timely fashion?


"You need a diagnostic run on your car's engine? No problem. We'll have it for you in a year. Or maybe two. Or three. That will be 80 million dollars, please."