| http://www.w3.org/ns/prov#value | - Such risks and uncertainties include, among other things, (i) the possibility that, due to regulatory, market or other factors, a New Drug Application will not be filed in the U.S. within the anticipated time period or at all; that regulatory approvals in the U.S., EU and other jurisdictions in which applications have been or will be filed will not be approved within the anticipated time period or
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