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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST
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To: dr.praveen who wrote (7)7/12/2006 12:33:01 PM
From: keokalani'nui   of 285
 
>>I feel their RTF letter might be just due to the recent FDA's electronic version formatting problems.<<

Not quite. True, the conclusion/presentation data was not properly footnoted to the detailed data sections. That is, the way the data was linked to the assertions was inadequate. But further, the fda apparently ran a quick audit on one of the charts and it didn't foot. At that point the fda had spent probably 30 minutes with it and said we don't trust anything in here.

Also, Astellas chose to file a "Common Technical Document" instead of the more common NDA. This likely also added to the fda's discomfort level.

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