There are'nt really any ramping comments above, but clear presentation of the stats relating specifically to ODAC decisions. Care to elaborate on your stats? Its too simply a stat. 22% of 364 rejected. Not ODAC cases. Of the 22% rejected what were the percentage rejected by the Committees or approved? If 40% of the cases were rejected by the Committtee and only 22% by the FDA yours is actually a postive figure when clarified. Certainly in the study I gave you the only time FDA rules against ODAC were where they overturned a negative ODAC decision. That's comfort to many investors on here ahead of a likely restless night...
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- FDA does not over-rule positive ODAC decisions
FDA does not over-rule positive ODAC decisions, page-10
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