Dendreon Corp fka DNDNQ

[steveporsche]

I Guess We Know What AC Lead to This

Imagine if this was in place for the DNDN AC with the "established" question. From the FDA site:

When presenting a question for a vote, the Chair, DFO, or other senior agency officials should solicit and answer questions about its meaning before the vote begins. The objective is to reduce any potential confusion and maximize the meaning of the voting results by ensuring that the votes are based on a consistent and collective understanding of the question at issue.

Voting should be done simultaneously. The objective is to avoid any potential order bias associated with sequential voting and thereby enhance the integrity and meaning of the voting results. The committee Chair or DFO has discretion to decide the precise method of voting on a meeting-by-meeting basis. Examples include a simultaneous show of hands, a simultaneous show of “yes” or “no” cards, or a balloting method in which members simultaneously cast written votes. Whatever method of voting is employed, the names of the committee members and their respective votes should be read aloud or otherwise made part of the public record shortly after the vote is taken.

The question put to the vote should not be the subject of further discussion or clarification while the voting is underway (i.e., whereas a discussion and clarification of the question is encouraged before the vote, there should be no discussion of the meaning of the question while members actually cast their simultaneous votes). Once voting on a particular question has begun, that vote generally should not be terminated until the vote is complete. Following completion of the vote, consistent with the first bullet above, advisory committee members may explain their vote. Additional clarification of the question after a vote and a re-vote on a re-worded question may occur at the discretion of the DFO or committee chair.

In some instances, the Chair of an advisory committee may believe the committee should vote on a related or relevant question not posed by FDA. If the Chair wants to put another question to a vote on his/her own initiative, the Chair should first check with the DFO or other senior FDA officials present to be sure that the question is appropriate for the meeting, that it is consistent with the topic identified in the meeting notices, and that it will not affect the conflict-of-interest screening that had been completed prior to the meeting. If a determination is made that the question should be posed, the Chair should discuss the matter with the committee members before the voting begins to ensure that the committee members collectively understand the question and feel adequately prepared (either through the background materials or their own expertise) to render a meaningful/informed vote on the new question.

Briefing materials provided to advisory committee members as background materials before an advisory committee meeting should be thorough and, to the extent possible, include the questions that will be voted upon by the committee. The objective is to maximize the meaning and utility of the voting results by ensuring that the voters have had ample opportunity to study background materials before the day of the meeting.

http://www.fda.gov/oc/advisory/votingguidance.html