SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Apricus Biosciences
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: eico20 who wrote (1273)6/4/2015 12:24:16 PM
From: eico20  Read Replies (1) of 2026
 
I've been listening to the adcom, very interesting, I'm seeing alot more of the FDA concerns over side effects and drug and alcohol interactions which are more than Sprout or anyone has revealed before, but there are ways to mitigate those risks as shown in the presnetations on both sides, THE FDA does acknowlegde HSDD as a disorder with unmet need so opinion to the contrary doesn't matter at this point, the key is for Sprout to show they can manage the risks and get the FDA to lighten up on the diary vs the FSFI on efficacy and lighten up on the SSE as a primary endpoint, if Sprout can do that, and so far doing well, they should get a positive vote, still not sure which way it will go strong placebo effect is still an issue, alot of exclusion on the trials of patients on other drugs
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News