tag:blogger.com,1999:blog-62716487695149713.post3952206710649346134..comments2023-10-09T02:33:17.014-04:00Comments on ALS ADVOCACY: Which Out-of-Control Train Will He Board?ALSadvocacyhttp://www.blogger.com/profile/15638650524805735994noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-62716487695149713.post-21366262717426934652013-01-15T08:46:55.478-05:002013-01-15T08:46:55.478-05:00Because nothing has been done to address subpopula...Because nothing has been done to address subpopulations in #ALS c.t.s, it seems to me that we're two steps behind in what the FDA might be able and willing to do to expedite approvals for subpopulations. <br /><br />The spectrum of conditions that is ALS has been described by ALS scientists for over a decade, yet c.t. cohorts are filled based on when the ticket was stamped. <br /><br />Perhaps the FDA willingness to move based on strategic subpopulations will finally get our ALS organizations and scientists to smarter c.t. designs? I'm not a scientist, but I sure am familiar with the various out-of-control trains.ALSadvocacyhttps://www.blogger.com/profile/15638650524805735994noreply@blogger.comtag:blogger.com,1999:blog-62716487695149713.post-53332035708811993932013-01-15T08:27:34.138-05:002013-01-15T08:27:34.138-05:00Couldn't have said it better than this ... but...Couldn't have said it better than this ... but it seems to me that although this is so well known, nothing has been done to address it in over 100 years (at least no significant progress).<br /><br />Maybe this FEB 4-5 FDA Public Meeting will help progress in this area --> https://www.federalregister.gov/articles/2013/01/15/2013-00607/creating-an-alternative-approval-pathway-for-certain-drugs-intended-to-address-unmet-medical-need?utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov Thomas Murphyhttps://www.blogger.com/profile/16855460736487636102noreply@blogger.com