drbio et al re Paion:
The phase-3 results are so awful they simply can’t be whitewashed by claiming bad luck, imbalance between arms, or what have you. Not only was there no efficacy, the safety results were not great. From today’s PR:
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The rate of symptomatic intracranial bleeding within 72 hours after study drug administration was 0% in the placebo group, 3.5% in the 90 mcg/kg dose group and 4.5% in the 125 mcg/kg group.
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Although these numbers are better than the 6% bleeding risk on tPA, they have to be a big disappointment.
In spite of the half-hearted encouragement in the PR, I doubt that Desmoteplase has any future.
-when i first looked at the p/r I thought the same thing as you. The bleeding rate was actually less than I thought it would be.
9 people died from non neurological reasons more than 2 weeks after the stroke. They are treated as total failures on the stroke scale.
If you take them out, which I know you can't do for the fda I bet the response rate of the rest of the patients are in the 70 percent range.
I never considered the 90 ug dose more than a placebo and that is how it worked out in the trial. so you have 2 placebo arms with over 40 percent responses.
I think they changed something in the inclusion criteria.
stroke trials don't usually have more then 25 percent responses and that is with 3 hour windows, this went out 9 hours.
this was forest treating a pivotal trial like proof of princple
