Remember FDA Commissioner's comments March 15, 2013
Read this and then tell me the FDA will delay this treatment to boys who desperately need it. Quote from Margaret A. Hamburg's speech to the Annual Meeting Massachusetts Biotechnology Council March 15. 2013.
"That’s why we’re striving for the appropriate consideration of patient perspectives in drug review, and soliciting input both on a range of issues associated with illness at different stages in drug development and on key issues at different stages of drug development.
Earlier this week I had a powerful meeting with patients and patient families to talk about what needs to be done to get innovative and life-saving medicines to them faster. I heard, from mothers of sons with Duchenne Muscular Dystrophy, poignant but honest and important accounts of how it feels when some of their children were enrolled in trials, and some don’t qualify for inclusion.
And all of them emphasized how willing they are to work with FDA and to work with industry to ensure their sons can get the groundbreaking treatments currently under development . . . while also helping to bring both new hope and meaningful answers -- through science and clinical research -- to the next generation of patients."