Hi Jim,
"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!"
Great point. She has been clear in the recent past that HC was like reading tea leaves given they do not interact with the drug applicant during the review process. Her comments in the NR today do seem to indicate that if there was dialogue, she would have answered their question/issue inside of the timeline of the review period, rather than initiating a formal LONC and response process.
You are right, it seems the issue is not insufficient data, but rather some questions about the data or product. The last time we had and HC issue (Aug 2000), the issue was the need for more sufficient data. She has not said anything about the need to supplement the application this time.
The process at HC is a joke, and I am convinced that we are getting screwed by them due to our size and the fact that FDA has not replied yet.
joe |
