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Wednesday, October 10, 2007 8:54:39 PM
"HOWEVER, Dor provided additional data to the FDA. Is the final package (two studies plus new data) enough for approval? Perhaps, but McDonald was implying that the two studies was enough ... the FDA disagrees."
I think the new data DOR provided is from the two completed trials, that was probably not provided before, for whatever reason. Were you implying that DOR got the data from some other unnamed trial? IF the data proves to be satisfactory then obviously the two studies are enough.
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