tag:blogger.com,1999:blog-3500936220214961312.post2718144893646763319..comments2023-10-02T04:06:53.185-04:00Comments on Brass and Ivory: Life with MS and RA: FDA Issues Refuse to File Letter on Fampridine-SRLisa Emrichhttp://www.blogger.com/profile/10862232056342347990noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-3500936220214961312.post-69864736692247643882009-04-01T19:01:00.000-04:002009-04-01T19:01:00.000-04:00Yes. No new studies. Include additional supporti...Yes. No new studies. Include additional supporting information and reformat the data. <BR/><BR/>Honestly, they should have gotten it correct in the first place. This is why they hire the expensive specialists AND the FDA helped to set-up how the final studies were to be conducted.<BR/><BR/>This will likely delay approval for an unknown amount of time. Whatever the outcome, I still won't be able to afford the drug, but I hope that it works for many others.Lisa Emrichhttps://www.blogger.com/profile/10862232056342347990noreply@blogger.comtag:blogger.com,1999:blog-3500936220214961312.post-45446548154874805032009-04-01T12:01:00.000-04:002009-04-01T12:01:00.000-04:00Interesting... curious to hear more about it as th...Interesting... curious to hear more about it as things move forward.Miss Chrishttps://www.blogger.com/profile/11731458343222525114noreply@blogger.comtag:blogger.com,1999:blog-3500936220214961312.post-75832580626419014232009-04-01T10:14:00.000-04:002009-04-01T10:14:00.000-04:00It is not (as I understand it) a refusal of ACOR t...It is not (as I understand it) a refusal of ACOR to file, but the FDA to file. Just paperwork, all will pass shortly. The Diane has spoken.Diane J Standifordhttps://www.blogger.com/profile/11862850657925658079noreply@blogger.comtag:blogger.com,1999:blog-3500936220214961312.post-13317747610808066062009-03-31T23:32:00.000-04:002009-03-31T23:32:00.000-04:00Do I read this right, no more work or testing, jus...Do I read this right, no more work or testing, just rewrite the proposals? Sounds like what my senior english teacher did with my term paper.awbhttps://www.blogger.com/profile/05029157758859447422noreply@blogger.com