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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST
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To: keokalani'nui who wrote (202)8/31/2007 3:21:20 PM
From: kenhott  Read Replies (2) of 285
 
My thoughts are that I see phase 2b oral as the low hurdle in this entire set piece. And people will get excited about the oral potential when (best guess) they push out "positive" data. After which we will have the committee meeting on IV. So opportunities in my mind for both ups and downs.

Why the meeting? IV exposure is short. Suppose to be quick so either it works or it doesn't work. Why a meeting? Clinical relevance? Maybe. Safety/interactions/related? Likely. Clinical relevance would only put the knock on IV if negative. Safety would put the knock on oral also. CRME has been saying no safety issues, no safety issues. The fact is that this drug is a lot about being safer. So if that bomb is coming, it will catch the market completely by surprise.

The oral opportunity is large but complicated because I don't expect CRME to have the most efficacious drug. They will have to be smart in framing the right set of phase 3s not just to get by the FDA but also for marketing. It won't be easy because I believe they will likely have to run vs. a comparator drug and that showing equivalence in time to recurrence (for instance) is far from a given. Likely they will get an advisory committee for the oral. It will take skill to walk that line. I could always be wrong about requiring a comparator. But I won't believe "vs. placebo only" is a winning strategy from the company or anyone else until the FDA shows up with an approval letter.
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