FDA Could Request Additional Confirmatory Trial For Dendreon's (DNDN) Provenge

April 15, 2009 9:29 AM EDT

According to reports from FT.com's MergerMarket, the FDA may request additional confirmatory trial from Dendreon (Nasdaq: DNDN) before Provenge approval due to first-in-class status. The article comes from Pharmawire.com.

According to the article, Dr CK Wang, an oncologist at the Cancer Institute of Dallas, said Provenge will receive scrutiny from the FDA, based on the failure rate of previous cancer vaccines. This is the first vaccine immunotherapy up for FDA approval When asked whether the company would be asked to conduct a confirmatory trial, Wang said that is always ideal.

Shares of Dendreon ramped 132% yesterday on the positive Provenge news.

Link to FT.com Article


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