Dendreon/Provenge Saga: There Is News After All
Not long after I submitted my last post I got word that the House Energy and Commerce Committee sent a letter today to the four Congressmen who had requested a hearing into the Dendreon/Provenge saga. And the answer is "no." The stock, which had been rallying on heavy volume today, sank when we broke the news on "Closing Bell."
The Committee says it won't make a move until the Food and Drug Administration makes a final decision on Provenge. And that could be awhile. Chairman John Dingell (D-MI) writes, "An investigative hearing prior to an agency's final decision runs the risk of interfering with the normal regulatory process."
The four Congressmen wanted the Committee to look into alleged conflicts of interest and ethical violations by two of the FDA Advisory Committee members who voted against recommending approval of Provenge.
At the BIO CEO conference today DNDN CEO Dr. Mitchell Gold reiterated that an interim analysis of the big, ongoing Provenge clinical trial won't be available until the second half of this year. The company has said the FDA has indicated it might approve Provenge on that "sneak peek" data if the results are robust enough. Otherwise, it will wait for the final results to come in over the next year or two.
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