My understanding of the term non-compliance is that DMX was not compliant in supplying information to HC.
That is, HC's complaint does not lie in the data,or the drug, but in the alleged failure of DMX to supply some component of information deemed necessary by HC.
To my eyes, the following comment,
"The directorate has raised issues, which the company believes should have been resolved by clarifying the information already submitted."
This response would be stated something like this, in "other circles":
"It's right there in front of your eyes, you buncha dummies! In 15 days, we'll draft an answer that will read the data for you, seeing as you can't read it for yourselves!"
It was a pretty testy response. I liked it, a lot.
Regards,
Jim |
