tag:blogger.com,1999:blog-4287560491211025099.post968522735496275631..comments2023-09-22T08:24:01.913-04:00Comments on Antibiotics - The Perfect Storm: Suspending Disbelief - The FDA Reboot and Nosocomial PneumoniaDavid Shlaeshttp://www.blogger.com/profile/00228776693058791618noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-4287560491211025099.post-51708360602886703562012-12-03T08:44:13.676-05:002012-12-03T08:44:13.676-05:00Thank you both for your comments. I am less conce...Thank you both for your comments. I am less concerned about the specifics of the telavancin debate and more concerned that all the effort we have spent with the FDA since their announcement of a "reboot" has come up short. Although I still truly believe that the FDA will change - they certainly showed no evidence of that during the AIDAC meeting. Hence my red face since I have been telling everyone that the will, in fact, reboot. <br /><br />On the positive side, as I said, there was a recommendation for a limited use label for telavancin - consistent with what we are discussing in our meetings with FDA at Brookings. David Shlaeshttps://www.blogger.com/profile/00228776693058791618noreply@blogger.comtag:blogger.com,1999:blog-4287560491211025099.post-59284279838953810612012-12-01T13:43:33.670-05:002012-12-01T13:43:33.670-05:00From a news item I read,the implication that the v...From a news item I read,the implication that the vote against telavancin was toxicity- and not efficacy-based. Is this not true? (http://www.medpagetoday.com/InfectiousDisease/Pneumonia/36177) lynnhttps://www.blogger.com/profile/06624656162991974750noreply@blogger.comtag:blogger.com,1999:blog-4287560491211025099.post-5316849131516651172012-12-01T12:59:02.417-05:002012-12-01T12:59:02.417-05:00David- Well said. I do think we have is a knowled...David- Well said. I do think we have is a knowledge gap in AIDAC members; few of the members have been involved in "reboot" discussions or aware of them, and those that have will adhere to a rigid frequentist statistical worldview. Where are the Bayesians?<br /><br /> The public representative said it best: there was sufficient information in this package for a clinician and even a patient (as he described his own experience with VAP and blinking to communicate) to make decisions on the risk-benefit of a drug to treat life-threatening infections. MNDudleyhttps://www.blogger.com/profile/07567600101291127548noreply@blogger.com