As I have said before, it will be approved as the political fall out of it not being approved is too great for those that run the show at the FDA. They are all about politics.
1) Long term survival rate should be end point for all cancer trials automatically. All needed is a few investors pick up phone talk to their congressional representatives, that will put a lot of pressure on FDA. 2) "According to Ex-FDA director, the Provenge won't be approved." If you were FDA director, what are you going to do? I would say you are much likely to approve it now, because you want to show you are a man! Have the courage! And you can make a difference showing that FDA works for people of United States not for hedge funds like those Ex did.
i dont think its that simple. I work in the drug industry and let me tell you how stringent the FDA has become towards smaller bio tech firms in the past 5-6 years. Drugs like vioxx threaten more than benefit the lives of those who take it. FDA has to be extra careful not to approve drugs that cannot accomplish their primary goal. If DNDN was a big company like genentech, they are more likely to approve drugs based on results. For example, one of genentechs drug almost skipped phas e2 because the phase 1 results were so good and so many supporters of the company pressured to speed up the process of drug approval. For small, non track record companies its a different story. Being a man, I sure hope provenge is approved, but its not surprise if more data is needed.
Vioxx problem? Use short term data to predict long term effect. All cancer drug trials use short term data to predict long term effect. When facing life threat danger, do something, for cancer patients if a government does not give them the last choice, why should we pay tax?????
There won't be a clear approval, or rejection, here is two possible decisions on May 15. 1) Provenge will be approved, but DNDN must complete the IMPACT, and subject to revoke based on that result. ($30+) 2) Provenge will be approvable upon IMPACT interm results but must complete the trial ($12)
Heh. Cramer talked it down last night, and it went down more than a dollar (to $16.80) before recovering.
FDA director will be remembered for his action on Provenge: 1) Approved, verified later with IMPACT. He is the man, brave, has courage, saved thousands of lives. He made the difference and on his way to White House. 2) Wait until full IMPACT data, Provenge is effective, approve: thousands patients died from the cancer because of no alternative treatment, he is asked to step down, 3) Approved, but 3 years later IMPACT data comes in shows no difference, the approval is withdrawed. He testified on congress showing no-side effect, panel approval, public suport, phone records showing list of senators, congress men asked for approval. He is credited with courage and remain on the post. 4) Wait until IMPACT full data which shows no difference, the Ex-director hosts a show on CNBC, I told you...
FDA director Andrew C. von Eschenbach, M.D two-time cancer survivor? three-time cancer survivor? might choose to save his own life. If cervical cancer vaccine works, the cancer is caused by some transmitted unknown viruses through re-production process, it's highly likely DNDN is on the right track. Can he wait for anothor three years? http://www.fda.gov/oc/voneschenbach/bio.html
http://www.laf.org/site/c.beIKLOOrGpF/b.507293/k.6E55/Andrew_C_von_Eschenbach_MD.htm In 1976, Dr. von Eschenbach obtained a fellowship in urological oncology at MD Anderson Cancer Center in Houston, Texas, where he was the founding director of the Prostate Research Program... He got his cancer from doing research on Prostate cancer, in his heart, he just knew some of the samples he had worked on might contain some unknown viruses that caused his own cancer, if that is true, the best way to fight a virus is vaccine. His cancer is not caused by gene mutation... but by viruses that can triger Prostate cancer. Think, think, think, ...., the man is not just trying to save thousands of lives, he is saving his own.