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 : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: keokalani'nui who wrote (205)9/4/2007 8:31:26 AM
From: kenhott  Read Replies (1) of 285
 
Well things are always less complicated when posting vs. real life. Amiodarone is, I believe, not labeled for this indication. Which in a way is good because it may be hard to match, giving CRME a good excuse to not pick amio. BUT marketing wise, amio is a great idea. Sotalol is a class 3 labeled drug. Interestingly sotalol is a drug that actually doesn't work that well for conversion but does work for maintenance due to maybe reverse use dependence. Amio appears to be a much better drug than sotalol for maintenance. So kind of the opposite reasons for picking amio. A smarter person than me would probably pick sotalol for the phase 3s which substantially lowers the phase 3 risks but increases the marketing risks.

The issue about placebo or comparator is one of clinical relevance. An extra 180 days of non-recurrence vs. placebo wouldn't do it for me. And I don't see CRME knocking that number out of the park so therefore my thoughts about the need for a comparator. Some people would argue that vs. placebo is not enough for approval regardless of the magnitude in something like time to recurrence. And they may be right depending on which side of the bed the FDA has fallen off of that morning.

Peter had started something about VPHM in another thread. My view is that the majority view that HCV-796 is dead is not substantially correct. There may be a surprise there.
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