Wednesday, May 28, 2008

GSK - clinical trials, ain't they a bitch?!

GlaxoSmithKline's Promacta, an experimental platelet-boosting drug, did not help control bleeding any better than a placebo, a U.S. Food and Drug Administration reviewer said in documents released on Wednesday.

"The data provided in this NDA (new drug application) do not demonstrate statistically significant, robust ... treatment effect in decreasing bleeding events," the reviewer wrote.

More at Reuters

Insider's view: So, why submit the NDA?

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