Comments on: Doing the FDA Petition Limbo http://caretolive.com/2008-01-20/doing-the-fda-petition-limbo/ CareToLive | Help Men With Late Stage Prostate Cancer | Provenge Now! Tue, 06 Jan 2009 09:07:16 +0000 http://wordpress.org/?v=2.3.1 By: Bob Range http://caretolive.com/2008-01-20/doing-the-fda-petition-limbo/#comment-154 Bob Range Wed, 23 Jan 2008 17:16:27 +0000 http://caretolive.com/2008-01-20/doing-the-fda-petition-limbo/#comment-154 To disregard the overwhelming vote of confidence in the safety and substantial demonstration of efficacy of Provenge by your Advisory Committee strains credulity. You claim to be focused on science. Do you not understand that science will be vastly advanced with the issuance of at least a conditional approval for the licensure of Provenge? Instead of being a protector and benefactor to the health and well being of the American people you serve, you have become, in my opinion, a bureaucratic impediment to the advancement of life saving treatments to terminal patients with no options left to forestall their death. If this indictment were not serious enough, it truly saddens me to say that there are also very disturbing signs pointing to corruption within certain elements of your agency. This is not meant to be a sweeping indictment or criticism. That would be grossly unfair to your thousands of dedicated, hard-working employees. But something has gone horribly awry. Get your act together! To disregard the overwhelming vote of confidence in the safety and substantial demonstration of efficacy of Provenge by your Advisory Committee strains credulity. You claim to be focused on science. Do you not understand that science will be vastly advanced with the issuance of at least a conditional approval for the licensure of Provenge?

Instead of being a protector and benefactor to the health and well being of the American people you serve, you have become, in my opinion, a bureaucratic impediment to the advancement of life saving treatments to terminal patients with no options left to forestall their death. If this indictment were not serious enough, it truly saddens me to say that there are also very disturbing signs pointing to corruption within certain elements of your agency. This is not meant to be a sweeping indictment or criticism. That would be grossly unfair to your thousands of dedicated, hard-working employees. But something has gone horribly awry. Get your act together!

]]> By: Leonard Bonn http://caretolive.com/2008-01-20/doing-the-fda-petition-limbo/#comment-152 Leonard Bonn Wed, 23 Jan 2008 12:57:07 +0000 http://caretolive.com/2008-01-20/doing-the-fda-petition-limbo/#comment-152 Please--Please approve Provenge NOW! every day you delay another 80 men die a painfull death--without hope, Not only do the men die but their entire families suffer along with them There is ample convincing evidence that Provenge works! Your own Advisory Committee says so. Your own team said that the data was convincing enough to submit a BLA. Your own Statistician said that the data was convincing. It is long past time to grant approval, Dont let another man die unnecessarily Please–Please approve Provenge NOW! every day you delay another 80 men die a painfull death–without hope, Not only do the men die but their entire families suffer along with them

There is ample convincing evidence that Provenge works! Your own Advisory Committee says so. Your own team said that the data was convincing enough to submit a BLA. Your own Statistician said that the data was convincing.

It is long past time to grant approval, Dont let another man die unnecessarily

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