DNDN.. I just listened to the CC..
Apparently 3 year survival was prespecified to be done in the initial design..but not a pre-specified endpoint..TTP and time to pain were..TTP did not reach statistical significance.
The CEO in his initial remarks basically stated what the PR indicated..All 127 patients regardless of gleason score showed a statistically significant and greater survival advantage than any other P3 heretofore published late stage prostate cancer trial.
Although asked by several analysts..they would not release #'s.."we'll be presenting/publishing the data at upcoming conferences"..would not state definitively if they'll be presenting at upcoming ASCO prostate cancer meeting in February...
Based on this data, they are having active discussions with FDA for: broader label since the current trial is for gleason less than 7, accelerated approval and using current study as post marketing are part of discussions, manufacturing: "not a problem..we have an east coast facility and west coast and are working on maximizing our ability to launch Provenge"
Analysts asked repeatedly about more numbers, which published studies is he comparing his results to: "I'm not going to do the comparative analysis for you."
Another asked specifically about the taxotere study which had 2.5 month median survival advantage..the CEO went back to his response that "these survival #'s are better than any published P3 prostate late stage prostate cancer."
Re: partnering..we are in a position to launch Provenge ourselves in the US and are looking for ex-US partnering, if a partner wants to be a part of the US launch, it has to bring value to DNDN."..in another statemtent(answer)by the end, he said, "if they want a piece of the US share, they have to convince us they deserve it."
IMHO..this was a tickler PR for the 'partners' out there who've been rebuffing them, the analysts who have downgraded them of late..although encouraging, not enough meat for the clinician/scientist..I reviewed my notes from previous PR's and found that in their Sept 03 they stated that 90% of the 127 patients had received Provenge between 2000 and October 2001(last randomized patient enrolled)
because it allowed salvage cross-over..so I don't know how they are coming up with the placebo data..any thoughts anyone?
[edit: .these patients received 3 Provenge infusions within one month and that's it.]
I hope this helps a bit!
Zeta |
