HER2 Support Group Forums - View Single Post - Access to T DM-1

schoonder · 01-12-2012, 02:00 PM

Phil,
You did a fantastic job in showing how firmly the FDA is choked up with obsolete regulations that deal with approval process of lifesaving, state-of-the-art drugs and the consequences. Of course it goes much deeper than that, first with FDA Oversight Subcommittee failing to take any action to overturn this abominal ruling and secondly, a media more interested in reporting on an assassinated nuclear scientist, or a body found on grounds belonging to the queen of England, or Gingrich calling Romney a liar and the like.
The clock is ticking, HER2+ MBC patients are dying and nothing is being done to "expedite" approval of T-DM1.

01-12-2012, 02:00 PM	#56
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: Access to T DM-1 Phil, You did a fantastic job in showing how firmly the FDA is choked up with obsolete regulations that deal with approval process of lifesaving, state-of-the-art drugs and the consequences. Of course it goes much deeper than that, first with FDA Oversight Subcommittee failing to take any action to overturn this abominal ruling and secondly, a media more interested in reporting on an assassinated nuclear scientist, or a body found on grounds belonging to the queen of England, or Gingrich calling Romney a liar and the like. The clock is ticking, HER2+ MBC patients are dying and nothing is being done to "expedite" approval of T-DM1.