I find this hard to believe or incredibly stupid on her part. How could someone with that kind of position be out of the loop with whats is going on?
Dndn?
- Thread starter UnFoRGiVeN
- Start date
I find this hard to believe or incredibly stupid on her part. How could someone with that kind of position be out of the loop with whats is going on?
Update, looks good if the FDA follows normal protocol of the panel's urgings on a 13-4 vote:
DJ UPDATE:FDA Panel Backs Dendreon's Provenge Prostate Drug>DNDN
(UPDATES with additional details from panel meeting starting in 2nd paragraph and includes comments from Dendreon's CEO)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A Food and Drug Administration panel of outside medical experts Thursday backed an experimental prostate cancer treatment designed to stimulate a person's immune system to fight the cancer despite concerns it might not be that effective.
The panel unanimously said the first-of-a-kind treatment, Provenge, by Dendreon Corp. (DNDN), Seattle, was safe. It also said the FDA should consider approving Provenge despite two clinical studies showing it didn't meet it primary endpoints.
The Provenge studies showed the treatment failed to meet a study goal of reducing so-called time to progression, or the advancement of cancer. However, a subsequent analysis of one of the studies, which involved a total of 127 men, showed those receiving Provenge lived about 4.5 months longer than men not receiving the treatment.
Most panel members said that survival data suggests that the treatment might work, and voted 13 to 4 on a question about whether there was "substantial evidence" of the product's efficacy. The panel substituted that question in favor of voting on a question that asked whether the data presented established efficacy, or effectiveness.
About 15 people urged the panel to approve the treatment despite the failed studies. "What's the harm of approving a drug that has been shown to let men live longer...and is safe," said Steve Fleischmann, of Seattle, who was first diagnosed with prostate cancer in 2003 at age 47.
Some panel members said the FDA should require the company to complete a larger on-going study of Provenge to demonstrate whether the therapy really works while others suggested the product be allowed on the market on a limited basis until final data from that trial is released in 2010.
The FDA typically follows its panels' advice but is not required to do so. The agency is expected to make its decision about whether to approve Provenge by May 15.
Unlike existing cancer treatments, Provenge is considered a therapeutic vaccine that is made using a patient's own white blood cells, combining them with a protein which is then infused back into a person. The treatment is designed to stimulate the body's immune system to fight the cancer. Existing therapies are aimed at killing cancer cells or choking off blood supply and other proteins involved in cancer growth.
Dendreon is asking the FDA to approve Provenge to treat men with advanced prostate cancer who stopped responding to hormone therapy. The only other treatment for advanced prostate cancer that's been shown to improve overall survival is Taxotere, a chemotherapy drug from Sanofi-Aventis (SNY). Chemotherapy drugs often have significant side-effects including nausea, vomiting, anemia and infection that can make them hard for patients to tolerate.
The FDA agreed with Dendreon that Provenge was "generally well tolerated," with the most prominent side-effects being fever, chills and fatigue. However, the FDA said it was concerned about an increased number of strokes among patients treated with Provenge compared with patients who didn't get the drug.
While panel members said they were also concerned about the stroke risk, they felt it could be better characterized from the on-going Provenge study as well as post-market studies.
Shares of Dendreon were halted Thursday during the panel meeting.
Mitchell Gold, Dendreon's chief executive, said the company was "pleased" with the panel's outcome and would work with the FDA ahead of the May 15 action date on Provenge.
"We've always been convinced of the survival data," he said.
DJ UPDATE:FDA Panel Backs Dendreon's Provenge Prostate Drug>DNDN
(UPDATES with additional details from panel meeting starting in 2nd paragraph and includes comments from Dendreon's CEO)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A Food and Drug Administration panel of outside medical experts Thursday backed an experimental prostate cancer treatment designed to stimulate a person's immune system to fight the cancer despite concerns it might not be that effective.
The panel unanimously said the first-of-a-kind treatment, Provenge, by Dendreon Corp. (DNDN), Seattle, was safe. It also said the FDA should consider approving Provenge despite two clinical studies showing it didn't meet it primary endpoints.
The Provenge studies showed the treatment failed to meet a study goal of reducing so-called time to progression, or the advancement of cancer. However, a subsequent analysis of one of the studies, which involved a total of 127 men, showed those receiving Provenge lived about 4.5 months longer than men not receiving the treatment.
Most panel members said that survival data suggests that the treatment might work, and voted 13 to 4 on a question about whether there was "substantial evidence" of the product's efficacy. The panel substituted that question in favor of voting on a question that asked whether the data presented established efficacy, or effectiveness.
About 15 people urged the panel to approve the treatment despite the failed studies. "What's the harm of approving a drug that has been shown to let men live longer...and is safe," said Steve Fleischmann, of Seattle, who was first diagnosed with prostate cancer in 2003 at age 47.
Some panel members said the FDA should require the company to complete a larger on-going study of Provenge to demonstrate whether the therapy really works while others suggested the product be allowed on the market on a limited basis until final data from that trial is released in 2010.
The FDA typically follows its panels' advice but is not required to do so. The agency is expected to make its decision about whether to approve Provenge by May 15.
Unlike existing cancer treatments, Provenge is considered a therapeutic vaccine that is made using a patient's own white blood cells, combining them with a protein which is then infused back into a person. The treatment is designed to stimulate the body's immune system to fight the cancer. Existing therapies are aimed at killing cancer cells or choking off blood supply and other proteins involved in cancer growth.
Dendreon is asking the FDA to approve Provenge to treat men with advanced prostate cancer who stopped responding to hormone therapy. The only other treatment for advanced prostate cancer that's been shown to improve overall survival is Taxotere, a chemotherapy drug from Sanofi-Aventis (SNY). Chemotherapy drugs often have significant side-effects including nausea, vomiting, anemia and infection that can make them hard for patients to tolerate.
The FDA agreed with Dendreon that Provenge was "generally well tolerated," with the most prominent side-effects being fever, chills and fatigue. However, the FDA said it was concerned about an increased number of strokes among patients treated with Provenge compared with patients who didn't get the drug.
While panel members said they were also concerned about the stroke risk, they felt it could be better characterized from the on-going Provenge study as well as post-market studies.
Shares of Dendreon were halted Thursday during the panel meeting.
Mitchell Gold, Dendreon's chief executive, said the company was "pleased" with the panel's outcome and would work with the FDA ahead of the May 15 action date on Provenge.
"We've always been convinced of the survival data," he said.
Exactly.
See my earlier newswire post.
People are misinterpreting the true results of this panel's statement, and CNBC's Mike Huckman did A TERRIBLE DISSERVICE to investors by botching the FDA commentary HORRIBLY.
This was commentary on safety, and not efficacy.
See my earlier newswire post.
People are misinterpreting the true results of this panel's statement, and CNBC's Mike Huckman did A TERRIBLE DISSERVICE to investors by botching the FDA commentary HORRIBLY.
This was commentary on safety, and not efficacy.
that's true - i didn't even multiple 78k * 5 to get a number much larger than 100k*2.
wow, what a great april fool's joke! originality for posting on the wrong day - but none for the post itself, as i'm sure no one has EVER posted on a yahoo msg board saying they had a position they didn't have.
*cough*
wow, what a great april fool's joke! originality for posting on the wrong day - but none for the post itself, as i'm sure no one has EVER posted on a yahoo msg board saying they had a position they didn't have.
*cough*
Trading 16-17.
My interest in it is not my own. Trying to get my neighbor's wife to get him out of bed - he's long a good bit at mid 6s and could use a big day.
My interest in it is not my own. Trying to get my neighbor's wife to get him out of bed - he's long a good bit at mid 6s and could use a big day.
short 78000 shares of DNDN @ $5 ????????
Currently DNDN @ 16.65
!!!!!!!!!!!!!!!!damn, now DNDN @ 19 !!!Quote from shelupinin:
short 78000 shares of DNDN @ $5 ????????
Currently DNDN @ 16.65
gonna short it after market open
again, it is a naked shorted stock. See reg SHO. All these offshores are now underwater, and the Prime Brokers, under tremendous scruitny, are going to have to call in the debits.
In Pennies, they will come in and defend. When the buying is done, or even ebbs, they will sit on the offers and try to cover. I'm watching one of those now that's doubled in two days. But in one like DNDN, they will not be able to kill it.
There are many others with good cancer results they don't let move, like DCTH, and CVM. I own neither, just pointing out what heartless bastards they are.
DNDN is a nightmare on the street now. Since the SEC or DTCC will not release the number of fails, it could run into the hundreds of millions of shares. Where's that take you?
In Pennies, they will come in and defend. When the buying is done, or even ebbs, they will sit on the offers and try to cover. I'm watching one of those now that's doubled in two days. But in one like DNDN, they will not be able to kill it.
There are many others with good cancer results they don't let move, like DCTH, and CVM. I own neither, just pointing out what heartless bastards they are.
DNDN is a nightmare on the street now. Since the SEC or DTCC will not release the number of fails, it could run into the hundreds of millions of shares. Where's that take you?