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phil · 09-09-2012, 06:58 PM

This Adminisration has un-leashed some FDA bureaucrats, who are hell -bent on "dotting every ' bureaucratic ' i ", punishing co's for some not finishing trials after acc. appr was granted yrs ago. So they revoke avastin, reject acc apr for tdm-1, partial apr for pert. FDA Press releases on Friday nights to avoid publicity. Bureucrats who were angry that gen. appealed revocation of avastin. Bureucrats who dozed off during avastin super -repsonders testimony. Note that all are Genentech drugs. So the co. is under the gun with This FDA. Who knows when t dm-1 aaproval comes ? and whether there will be conditions. could be Nov., dec. ? march ? gen has done the trials, so exp access gets it to some pts, is agood pr move. remember thye pay for the drug in access. I havent called Gen., to ask how many exp. access sites are open ?

09-09-2012, 06:58 PM	#28
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: TMD1 is coming! This Adminisration has un-leashed some FDA bureaucrats, who are hell -bent on "dotting every ' bureaucratic ' i ", punishing co's for some not finishing trials after acc. appr was granted yrs ago. So they revoke avastin, reject acc apr for tdm-1, partial apr for pert. FDA Press releases on Friday nights to avoid publicity. Bureucrats who were angry that gen. appealed revocation of avastin. Bureucrats who dozed off during avastin super -repsonders testimony. Note that all are Genentech drugs. So the co. is under the gun with This FDA. Who knows when t dm-1 aaproval comes ? and whether there will be conditions. could be Nov., dec. ? march ? gen has done the trials, so exp access gets it to some pts, is agood pr move. remember thye pay for the drug in access. I havent called Gen., to ask how many exp. access sites are open ?