I have not said that a CU program is in fact coming; rather, I’ve said that DNDN longs have been intellectually dishonest in the way they have dismissed the possibility.
Is there some precedent for this? Do you have an example of a drug that was given an approvable and immediately instituted a CU program. I asked someone else espousing this view and he gave an example of Revlimid - but Revlimid was actually fully approved. They opened a CU program for a completely different indication.
Dew - Do you have an examples at your fingertips of drugs given a thumbs up by the AC and then given only an approvable by the FDA. In my ODAC database from 12/03 through 2005 there are none - 5 thumbs up and 5 approvals. It would be interesting to see a counter example.