- Jan 23, 2002
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Originally posted by: Slew Foot
Some interesting things I learned while doing Pubmed searches.
It looks like physicians are highly in favor of Sipuleucel-T(Provenge), as it appears to be effective some of the time for resistant tumors. The FDA was aiming for a 22% reduction and the drug hit 20% late last year, though the company insists that due its late acting course, it should rise to 22% by now. Considering its a two year study with 500 people, youd need to help an additional 10 people in 3-4 months. Its possible though I cant find any literature or documentation about how exactly they are implementing the IMPACT study. The latest publications for the drug were late last year in journals I never heard of, most seem to agree that the FDA did wrong not to pass the drug the first time around, and makes notes of some conflicts of interest at the FDA.
Edit:
The conference call is at 9 am tomorrow premarket, which is a good sign. I signed up to listen in on their webpage.
The bid hoopla back then was one of the FDA people making the no decision was backing a similiar type of drug from another company. DNDN's Provenge has tremendous support from prostrate cancer patients and people in the medical field, and has been proven. It's been hindered by politics and special interests. The 22% needed was a compromise between the company and the FTC to get this ball rolling.