Thursday, May 03, 2012 4:16:22 AM
Agree on jq's comments that Replagal's clinical data are problematic. I had thought that post approval data from 8 years of use in EU plus Replagal's treatment protocol approved by the FDA for compassionate use on top of GENZ's contamination issue/market shortage altogether, would have satisfied the FDA this time around.
And I wouldn't bet on that batting average
And I wouldn't bet on that batting average
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