CC recap
I have management information and comments to questions asked under the appropriate indication. Some answers, which have been discussed often, on this and other boards, I have left out.
CABG
results due end of Nov, possibly early Dec.
Something said about looking at 20 tables.
TBI
results due end of Dec., possibly early Jan.
NDA end of 05, timetable depends on results
Marketing/partnerships will depend on results. All scenarios being considered.
Addiction study was not required.
The trial protocol was accepted by the FDA, not instigated. The trial protocol was designed by experts in the field from Europe and the US.
There is no further subdivision between GCS 4-6 and 7-8.
It is not appropriate to compare this TBI trial with others due to difference in protocols. After unblinding that would be possible.
PRS 211,375
PHI 1H2005, probably 10 healthy patients, single dose for safety. Possibly go into two separate areas - cancer pain and/or postsurgery pain
- different mechanism than Vioxx.
As far as results goes, nobody knows anything.
Questions from the following
David Bouchy, RBC
Harris Nesbitt
Fdzllc
Gregg
Steve Zabo?
Israel |
