And of course, if he rejects Provenge or delays its approval, and his cancer comes back. Provenge eventually proves work, he will be the laugh stock of medical community of all time.
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DNDN after FDA decision on May 15
- Thread starter codedeep007
- Start date
Do you know the p value?
If you have 20 patients, 100% live on treatment arm, 100% die on the control arm.
The treatment will be approved, period.
I suggest you go back to school.
If you have 20 patients, 100% live on treatment arm, 100% die on the control arm.
The treatment will be approved, period.
I suggest you go back to school.
Quote from codedeep007:
Do you know the p value?
If you have 20 patients, 100% live on treatment arm, 100% die on the control arm.
The treatment will be approved, period.
I suggest you go back to school.
Keep talking your book... Why such a ridiculous trial? Every legit compound had hundreds if not thousands of patients. Taxol had what, 1200+?
My biz partner is an biotech analyst, so I'll rely on his and his colleagues opinions over some dildo talking up his gamble. They're approx 70/30 against approval.
http://psa-rising.com/med/immun/provenge--fda-lui.html
Overall survival is the most reliable cancer endpoint, usually the preferred endpoint, and studies can be conducted to adequately assess it. An improvement in survival is a clinical benefit. The endpoint is precise and easy to measure, document by the date of death. Bias is not a factor in endpoint measurement. Demonstration of a statistical significant improvement in overall survival has supported new drug approvals.
Now, let's look at overall survival difference in D9901. This 4.5-month median survival difference is clinically meaningful, but it has the following limitations, as Dr. Bo-Guang Zhen will discuss in detail in his presentation. First, post hoc analysis. All survival analysis were done post hoc, because survival was not the pre-specified endpoint, the primary method for survival analysis, and its comparison was not pre-specified. Second, it's one study with a small sample size, so the difference could be due to chance alone. Therefore, uncertainties exist regarding the persuasiveness of the survival results in the support of sipuleucel-T BLA efficacy claim, and that's the reason why we're all here to discuss these issues today, and FDA would like to seek advice from the advisory committee.
Dr. Liu.
Now, let's look at overall survival difference in D9901. This 4.5-month median survival difference is clinically meaningful, but it has the following limitations, as Dr. Bo-Guang Zhen will discuss in detail in his presentation. First, post hoc analysis. All survival analysis were done post hoc, because survival was not the pre-specified endpoint, the primary method for survival analysis, and its comparison was not pre-specified. Second, it's one study with a small sample size, so the difference could be due to chance alone. Therefore, uncertainties exist regarding the persuasiveness of the survival results in the support of sipuleucel-T BLA efficacy claim, and that's the reason why we're all here to discuss these issues today, and FDA would like to seek advice from the advisory committee.
Dr. Liu.
We all talking about risk and reward when we put our money on the table.
This time the FDA director is betting his own life, so where is risk, flu like symptom?
This time the FDA director is betting his own life, so where is risk, flu like symptom?
If running a red light can save Dr. von Eschenbach his own life, would you think he likes to do so?
Quote from codedeep007:
We all talking about risk and reward when we put our money on the table.
This time the FDA director is betting his own life, so where is risk, flu like symptom?
Earlier you were parroting p-value... now it's a matter of treatment risks? You yahoo stock board experts never fail to amuse me. How about the poor-sap who chooses Provenge and croaks after 3 months of progression? I've seen many remissions with Taxol.
Moron: The risk is a treatment with nothing but placebic-value becoming standard of phucking care!
I have no position in DNDN, nor do I care to gamble on the outcome. I have no interest in entering into a debate with an amoeba. Welcome to my killfile.
The two trials show that Provenge reduce progression 1-1.5 month for the first year. Not good enough. But amazingly it does it every year not just for the first year like other cancer drugs.
Do you get vaccined every year? No!!!!
Think, Think Think! 1.5 * 3 = 4.5 month. WOW!
Medium survival length is not good enough, after half patients die, nothing is going to change. The survival rate count.
Again, Do you get vaccined every year? No!!!!
Do you get vaccined every year? No!!!!
Think, Think Think! 1.5 * 3 = 4.5 month. WOW!
Medium survival length is not good enough, after half patients die, nothing is going to change. The survival rate count.
Again, Do you get vaccined every year? No!!!!