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Friday, October 19, 2007 11:20:57 AM
i am "hoping" that EMEA does not reject it but gives an approval in any shape or form. you of all people on this board should know that just becos FDA rejects a drug does not mean emea will reject it. the writing was on the wall wrt the fda;s decision. no lowering the bar even though the bar is the same for all drugs for all conditions. with the emea, my limited experience tells me that they will view orbec more objectively and consider the risk/rewards. Is patient advocacy high on their agenda? If so they will approve the drug only if they are convinced 100% the drug works. It is safe and there are signs that it is effective. Hard to say what the decision will be considering they failed the primary endpoint. If there is a precedent then chances are good for approval, if there is no precedent i doubt emea will settle for anything less than an additional trial. We will soon know within the next month or two.
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