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Tuesday, December 08, 2009 12:16:49 AM
sorry but i have to edit this post.
DYAX recieved approval for Kalbitor --- not a device
SOMX got rejected for Doxepin ----------not a device
actually NDA applications have a fixed date from the FDA , BIEL is demanding OTC cleareance for a device , the FDA does not have a date fixed for approving or disapproving such applications. Be patient folks or get out , because the way i see it is that we are in for a long long wait , and the pr guy only seems to be trying to buy some time.but that is just my 0.026 cents opinion
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