from the 10Q
Comments on Potential New MHRA Policies. In the UK, the MHRA issued a draft Guideline of important potential new policies under which clinical trials would be allowed to use external controls instead of within-study placebo arms, especially for severe or rare diseases, and the MHRA called for public comments during the second quarter. The Company worked together with physician collaborators, patient groups, statisticians, academics and political representatives to help mobilize public comments.
MAA Application. The Company and its teams of consultants continued to devote a large portion of their time to active engagement in the MAA process during the second quarter. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
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