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


To: dr.praveen who wrote (59)8/31/2006 3:19:44 PM
From: keokalani'nui  Read Replies (1) | Respond to of 285
 
Whoa. Flat out "Not Approvable" for big pharma. Ouch. Were you following, was there an advisory committee meeting?

An investor does have to worry a little about patient size in x1235 IV P3's. Act 1 and 3 were planned years ago in a different era. Acute setting, one to two treatments max, two trials I guess makes it work out. Plus, Act 4 safety trial to come.



To: dr.praveen who wrote (59)8/31/2006 4:38:54 PM
From: kenhott  Read Replies (2) | Respond to of 285
 
I think SNY has known about this for awhile. CRME should be about 6 months behind now on the oral.

Edit: If the oral stays clean, CRME must partner this indication. The earlier the better and should focus on the big numbers and don't fight over $5-10m milestone. Get someone good and probably not Astella. Maybe they have gotten better.



To: dr.praveen who wrote (59)8/31/2006 11:13:21 PM
From: DewDiligence_on_SI  Respond to of 285
 
The SNY PR implies that the FDA is seeking hard outcomes data from the trial in progress:

“The primary objective of the study is to assess the efficacy of dronedarone in preventing cardiovascular hospitalizations or death from any cause…”

Something to think about if you’re investing in this arena.