Dendreon (DNDN) Said to Artifically Inflate Provenge Data in 2010 Report - Reuters
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Dendreon (Nasdaq: DNDN) shares are active amid a Reuters report this afternoon that Provenge data is being analyzed differently than from what the pharma initially told U.S. regulators.
Reuters notes that data was not only off of the scientific norm, but it also artificially inflated the benefit when results were revealed to doctors and investors in a 2010 New England Journal of Medicine paper.
Both Dendreon and the U.S. FDA stand by initial viewpoints that the drug is safe and effective. Dendreon denied manipulation of the data today.
Initially running a trial in 2008 that Provenge provided a longer survival period versus a placebo in prostate cancer treatment, Dendreon said the cut-point age would be 65 years old. However, the IMPACT trial results published in 2010 used a 71 year old cut-point for the age-based analysis.
The deviation might indicated that Dendreon didn't like what they saw in the initial trial and were looking for something better.
Shares of Dendreon are down 1.2 percent on the session.
Reuters notes that data was not only off of the scientific norm, but it also artificially inflated the benefit when results were revealed to doctors and investors in a 2010 New England Journal of Medicine paper.
Both Dendreon and the U.S. FDA stand by initial viewpoints that the drug is safe and effective. Dendreon denied manipulation of the data today.
Initially running a trial in 2008 that Provenge provided a longer survival period versus a placebo in prostate cancer treatment, Dendreon said the cut-point age would be 65 years old. However, the IMPACT trial results published in 2010 used a 71 year old cut-point for the age-based analysis.
The deviation might indicated that Dendreon didn't like what they saw in the initial trial and were looking for something better.
Shares of Dendreon are down 1.2 percent on the session.
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