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Yep, the big day is here. The stock should be halted all day tomorrow, and the "verdict" out around 3:30pm EST. The DNDN conference call is at 7:30pm EST. Good luck to all longs!
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FDA panel votes in favor of Dendreon cancer drug Marketwatch - March 29, 2007 5:05 PM ET
SAN FRANCISCO (MarketWatch) -- A Food and Drug Administration advisory committee on Thursday found Dendreon Corp.'s experimental prostate-cancer drug, Provenge, to be safe and effective.
Seattle-based Dendreon (DNDN) is asking the FDA to approve Provenge, which acts by stimulating the body's immune system, for the treatment of asymptomatic men with advanced prostate cancer who have stopped responding to hormone treatment.
Though the agency isn't bound by the recommendations of its advisory committees, it typically follows them.
The FDA granted the Provenge application priority-review status in mid-January, taking its review deadline to May 15. Priority review is intended for products that address unmet medical needs.
The advisory committee on Thursday voted 17-0 that Provenge was safe and 13-4 that it was effective.
There was concern that both of the late-stage studies submitted for consideration failed their endpoints, including the first study's primary endpoint of slowing the cancer's progression, noted Celia Witten, director of the FDA's Office of Cellular Tissue and Gene Therapies division. But that study, though small, "...did show a survival difference," she said in a telephone interview after the meeting.
In the study, which evaluated 127 patients, median survival of Provenge-treated patients was found to be 4.5 months longer than those who were given a placebo.
-------------------- ......in Psychiatry circles it's known as a "warning sign"
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What a gamble! Way to go guys. Wonder what it will open at?
I was sitting here watching Survivor, and my local news station station just came on and said "An amazing new vaccine for prostrate cancer, coming up at 11:00".
-------------------- "Great Day for Up!"....Dr. Seuss
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Fidelity won't even let me buy at premarket, says the price is too far away from the closing price. I wonder how many other brokers have this restriction. When the market opens, BOOM!
Jo
-------------------- "Great Day for Up!"....Dr. Seuss
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this one gapped up too high ... it has nowhere to go now but down for a massive "correction" ... think about taking your profits peeps... you can always buy back in later on... <shrugs> i could be wrong though... just don't get too greedy.. MM's will short it sooner or later...
-------------------- Let the world change you... And you can change the world.
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Zacks Bull of the Day for Apr 02, 2007 DNDN
Dendreon Corp. (DNDN) – Up Big on FDA News The company’s key product candidate, Provenge, received a positive opinion from the FDA expert panel. This will likely lead to the early approval of Provenge in May.