The group wants the FDA to immediately approve Provenge or at least reconvene an advisory panel, without Scher, to review the medication; declare the FDA can't interfere with Provenge marketing, sale and use, absent additional findings or tests results that indicate any further safety concerns; and that the defendants improperly denied available aid to dying patients and are liable for any injuries caused to them, among other things.
The lawsuit, which you can read here, recounts the laundry list of complaints that prostate-cancer patients and investors have voiced - particularly on the Internet - in recent months because Dendreon's Provenge vaccine was endorsed by an FDA panel in March, but then delayed in June.
That happened after Scher and one other panel member wrote the agency, urging further review of Provenge data, an action that some patients and investors believe was part of a conspiracy. Since then, allegations of conflicts of interest have surfaced on the Internet concerning Scher and the other panel member, Maha Hussain. The SEC, meanwhile, is investigating Provenge clinical trials.