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  • adeiflig adeiflig Feb 15, 2009 11:18 PM Flag

    FDA Comments....on DNDN DATA

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    • What kind of a nitwit are you, adeiflig? Did you just wake up?

      <FDA Comments....on DNDN DATA 2 minutes ago -adeiflig>

      Dated Oct 7 2008.

      Dendreon's latest test results won't speed FDA decision on prostate-cancer drug
      Dendreon said Monday that Provenge, its prostate-cancer drug, improved patient survival rates — but not quite enough for the interim results it unveiled to justify an accelerated bid for Food and Drug Administration approval.
      By Ángel González
      Seattle Times business reporter
      Dendreon said Monday that Provenge, its drug for advanced prostate cancer, improved patient-survival rates but not quite enough for the interim results it unveiled to justify an accelerated bid for Food and Drug Administration approval.
      The long-awaited clinical-trial results reported by Dendreon sent its shares soaring. However, the Seattle biotech firm will have to await the final analysis, scheduled for mid-2009, before it can ask regulators to approve the drug.
      The news is "not as good as it could have been, nor as bad as it could have been," said Paul Latta, an analyst with McAdams Wright Ragen.
      Dendreon shares closed at $6.93, up 33 percent, after jumping as high as $9 in early-morning trading, against the dismal backdrop painted by a global financial shakeout.
      The interim results "did not meet the pre-specified criteria" for Dendreon to modify the marketing approval it has pending at the FDA, said Chief Executive Mitch Gold in a conference call.
      The drug showed a 20 percent increase in survival rates among patients using Provenge, but to meet the study goals, the company needs to show a 22 percent drop in the risk of death based on 304 patients.
      Provenge, Dendreon's lead therapy, could be the first commercial immunotherapy to fight prostate cancer, if approved.
      But it has been a roller-coaster ride for many investors. In early 2007, the company stock rode as high as $19 on hopes that the FDA would approve the product that May.
      But the agency decided to withhold approval, asking for more data instead. That triggered a sharp fall in the stock price and an angry response from patients eager for a promising treatment.
      Hopes soared again when the FDA said it would look at the interim data presented Monday as sufficient to support an application for approval.
      But it seems investors must still wait for the final verdict.
      The final analysis of the data was originally due in 2010, but last March the company redesigned the clinical trial to fast-forward the results by a year.

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