These days, it's not uncommon to see campaigns calling for the withdrawal of a drug from the market because of safety concerns. That's why this campaign urging the approval of a drug is extraordinary. Proponents of Dendreon's Provenge took out this no-frills, half-page ad in the opinion section of Sunday's edition of "The Washington Post".
A patchwork group of about 150 investors, patients, activists, advocates, etc. came up with a total of 24-grand to buy the space. They claim to have found each other and to have raised the money over three months on the Dendreon message board at Investor Village. I heard from Dendreon this morning and they say they knew nothing about the ad.
The copy recaps the Provenge clinical trial results, the FDA Advisory Committee vote and subsequent FDA decision to delay a decision on the drug. At the bottom, in boldface, there's an appeal to "Please ask your Senators and Representatives to demand a reconsideration (by the FDA). The FDA wants to wait as much as 2-3 years for more data. Men dying of prostate cancer don't have that luxury. All citizens...should immediately contact Congressional representatives, urging them to ensure this travesty is reversed."
Arnie Mass, a Dendreon investor from Chicagoland who was the apparent ringleader of the group behind the ad, says, "This is democracy in action. It's a grassroots development. And we want the senators and congresspeople to hear this, so that they might take action. We are activists and this is how the story has to get out." Mass says he has owned DNDN shares for about four years and, so far, he claims to have broken even on the stock.
Dendreon says the FDA will possibly accept interim data from an ongoing, large clinical trial to consider approval of Provenge. That info won't be available until the middle or second half of next year. The company says the agency could also wait for the complete data to come in before making a decision and those results aren't expected for another two to three years. Last week, Dendreon revealed the SEC is conducting an informal inquiry into the Provenge saga.
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