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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (205)	9/2/2007 10:46:38 PM
From: Biomaven	Respond to of 285

Issue with amiodarone is that it works very well, but comes with a whole lot of safety and tolerability baggage and so is something of a last resort. So they may not be able to show non-inferiority (because of Amio's good efficacy), and arguably they shouldn't have to if the drug is as safe as they claim. They may instead be able to get away with a placebo comparator. I do agree design of an oral trial will be very tricky. But there's a big unmet need, so the incentive is certainly there. Peter (No position now or ever, but watching with much interest).

To: keokalani'nui who wrote (205)	9/4/2007 8:31:26 AM
From: kenhott	Read Replies (1) \| Respond to 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.