Tuesday, March 03, 2020 3:59:56 PM
If the SAP is acceptable to all 4 regulators I believe we're in the process of unblinding, but if not, the delay will be until we have that agreement, or a determination is made to limit the regulators that initial approval would be made with. While the hang up, if there is one, is probably the U.S. FDA, which represents the biggest market, if in fact they're unwilling to make the necessary changes, it wouldn't be the first time great drugs were initially approved elsewhere, and the FDA finally went along.
I do believe that things are coming to a head, by the time of the Annual Meeting we'll know more, but what we'll know will be up to the company.
Gary
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