AI
| Followers | 72 |
| Posts | 3426 |
| Boards Moderated | 1 |
| Alias Born | 04/28/2004 |
Tuesday, January 11, 2005 6:14:31 PM
yeah, i'll need to listen to that before i clutter up the board any more.
From that transcript, it sounds like Gold is on drugs. First he says that, unlike 9901, 9902A did not show a statistical benefit for gleason less than 7. But in the next sentence he claimes that what they're seeing is encouraging?!
Presumably his spin is that since 9902A is trending similarly to 9901, and since the latter was positive, it bodes well for the former.
>How reasonable is it to conclude that Provenge confers a survival advantage regardless of Gleason score, and the retrospective analysis picked up a chance grouping in TTP?<
I don't think it would be unreasonable to consider that a specific subgroup in a trial, provided it was large enough, could be the main driver for an overall survival benefit. So a specific subgroup with a lengthened TTP consequently stretches out median survival in the trial and allows it to reach significance.
(sorry, i had to edit this: Since you refered specifically to Provenge, I have to say that it doesn't look very reasonable to assume that a broad survival advantage is offered by Provenge. I initially read your questions more as asking "is it reasonable to think that an ITT survival advantage could be observed with only a subgroup showing an improvement in TTP?" Clearly I got it all wrong.)
I think this ambiguous situation with DNDN and its 9901 and 9902A trial results are the exact reason why the FDA likes randomized trials with prospectively defined endpoints
From that transcript, it sounds like Gold is on drugs. First he says that, unlike 9901, 9902A did not show a statistical benefit for gleason less than 7. But in the next sentence he claimes that what they're seeing is encouraging?!
Presumably his spin is that since 9902A is trending similarly to 9901, and since the latter was positive, it bodes well for the former.
>How reasonable is it to conclude that Provenge confers a survival advantage regardless of Gleason score, and the retrospective analysis picked up a chance grouping in TTP?<
I don't think it would be unreasonable to consider that a specific subgroup in a trial, provided it was large enough, could be the main driver for an overall survival benefit. So a specific subgroup with a lengthened TTP consequently stretches out median survival in the trial and allows it to reach significance.
(sorry, i had to edit this: Since you refered specifically to Provenge, I have to say that it doesn't look very reasonable to assume that a broad survival advantage is offered by Provenge. I initially read your questions more as asking "is it reasonable to think that an ITT survival advantage could be observed with only a subgroup showing an improvement in TTP?" Clearly I got it all wrong.)
I think this ambiguous situation with DNDN and its 9901 and 9902A trial results are the exact reason why the FDA likes randomized trials with prospectively defined endpoints
Join the InvestorsHub Community
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
