tag:blogger.com,1999:blog-4241416962008169508.post3325307779562101534..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: A 37-Patients-Treated With Sugammadex "Seeding" Study: Will FDA Be Swayed?Unknownnoreply@blogger.comBlogger4125tag:blogger.com,1999:blog-4241416962008169508.post-71732831171908001192008-10-28T18:53:00.000-04:002008-10-28T18:53:00.000-04:00You were right definitely a PR campaign.The AP is ...You were right definitely a PR campaign.<BR/><BR/>The AP is running with it.<BR/><BR/>See<BR/><BR/>http://ap.google.com/article/ALeqM5iJuaNKBTrSw6zZy1KJ1Jm00A2tnwD943OG680<BR/><BR/>SalmonAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-86719392653820199142008-10-28T17:35:00.000-04:002008-10-28T17:35:00.000-04:00Thanks Anon.I should have looked things up myself....Thanks Anon.<BR/><BR/>I should have looked things up myself. I mainly follow other therapeutic areas.<BR/><BR/>This simply looks like the publication of part of the data (rocuronium only) from study 302 that is presented on slide 102 in the document you referred to. So the study has already been reviewed by FDA as part of the original submission.<BR/><BR/>It looks like this is just a publication will help SP to hand it out to physicians eventually (the 2.7 minutes and 49 minutes in this study are about double what are seen in other studies so it makes the difference look a lot more impressive), and so the scientists can add a publication to their CV (for promotions and for job hunting). (See we did the extra work and wrote it up and published it so now can use it for marketing etc.)<BR/><BR/>This is pretty standard fair for industry to publish a phase III study like this. I'm just surprised that they did a press release. Plus the timing is interesting. Maybe it's for investors so they might say, wow 2.7 min vs. 49 min that's impressive SP does have something with this drug after all.<BR/><BR/>SalmonAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-12044842320652080502008-10-28T17:00:00.000-04:002008-10-28T17:00:00.000-04:002.7 minutes vs 49 really is the magnitude of the d...2.7 minutes vs 49 really is the magnitude of the difference, just check the other trial data.<BR/>It's all posted on the FDA website, even with the trials aims so you do not need to guess at those ;-)<BR/><BR/>http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4346s1-01-Schering-Plough-corebackup.pdfAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-72091917518746431122008-10-28T14:28:00.000-04:002008-10-28T14:28:00.000-04:00I don't think that this would alienate FDA at all ...I don't think that this would alienate FDA at all especially not senior staff.<BR/><BR/>As I recall SP tried to make the argument at the time that it should be approved for a select subpopulation who would need more rapid reversal in an emergency situation. However I don't think the studies were appropriate to justify approval on this basis.<BR/><BR/>This study could be used to justify the risk and an approval for this limited indication as they're claiming a 2.7 minute offset with sugammadex vs. 49 minutes. (Could that be a typo and they really mean 4.9 minutes?) <BR/><BR/>The market for this indication is likely so tiny that most sales are likely to be for off-label usage. Not that SP would ever promote such a thing or would physicians try to save either 45 or 3 minutes so they can hurry up to the next surgery (but assuming a $1000/hr it does at up).<BR/><BR/>SalmonAnonymousnoreply@blogger.com