"The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by the study's design (p-value less than 0.043), and PROVENGE reduced the risk of death by 22.5% compared to placebo (HR=0.775);...."
The Phase III protocol pre-specified stat significance defined p value as 0.043 and the results announced is 0.032.....this announced results are still unaudited!!!! When the BLA is submitted to the FDA, the audited results (i.e. after trial sites inspection by the FDA inspectors, corrections on the CRFs-case report forms etc etc...) the p value may be close to border line or worse, may even be greater than 0.043!!!!
Plus, did you see the vaccine administration procedure??? It is very cumbersome!! One needs to take out patients cancer cells, modify it with provenge and then re-inject back to the patients............this is too cumbersome for a 4 months survival extension.......the cost probably not worth it!!!
Also, look at the language "successfully exceeding the pre-specified level of statistical significance...:
As opposed to saying that the extension of survival is statistically significant...what about clinical significance??? Too many issues...not a clear cut advantage!!
Oh get the fuck outa here. You have no idea what you're talking about, this is all OLD, KNOWN news as far as administering the drug...you're a bloody moron, and you're about to lose your ass. There is an investigation kicking off as we speak about that last minute trading. It had NOTHING to do with news, it was a bear run and 100% illegal. Someone's gonna fry.
1. 4 months survival is too short with lack of clinical significance
2. These results are unaudited so the p value significance may not exist
3. Transporting blood from a patient to a center and process steps involved for the treatment is too cumbersome to charge significant money...also may introduce safety risks to the patient
4. there are alternate treatment options (that are not officially approved by the FDA) called available therapy which gives the same or even better survival extension than Provenge with less side effects and less cumbersome administration procedure
I guess it is not significant too cumbersome and too expensive if you don't have prostate cancer. I suspect that a 4+ month extension of life may be viewed differently by those with prostate cancer. By the way, if I knew the results in advance I would have bought a lot more shares of DNDN.
You don't know what you are talking about. People donate blood every day...no problem. Blood in these cases is shipped to processing center, processed, then returned to MD for injecting into patient. Very easy!!!
Let me see. Urologists and doctors say it is a game changer and said the head of the Amercian Cancer Society said he would vote for approval
Who should I believe, some loser on a message board or people in the know.
Yes, you are the loser, so I don't believe you.
What about the reports of high blood pressure and clots?
From March 2007:
And although Provenge was found to be "relatively well-tolerated" overall, with chills, fatigue and back pain as the most common side effects, the FDA expressed concern that patients treated with the drug showed a higher rate of cerebral vascular accidents, or strokes -- 3.9% vs. 2.6% in patients given a placebo.
Strokes and other brain-related problems were no more common with Provenge -- a worry raised by earlier studies. However, four men given Provenge suffered lung clots, though none were fatal. High blood pressure was twice as common with Provenge. Overall, the rate of serious side effects was the same in each group.