Cover letter citigroup

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Acadia Pharmaceuticals Inc. The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form. Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed as a single group, the Division, in the CRL, cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval. The DRP pivotal HARMONY study met its prespecified primary and secondary endpoints with robust and persuasive clinical and statistical superiority of pimavanserin over placebo, which was a prospectively agreed prerequisite for the DRP indication. Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements. Over the entire course of the review, the Division did not raise any concerns regarding the agreed upon study design, including the issues raised in the CRL," said Steve Davis, Chief Executive Officer of Acadia.

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Bloomberg -- Revlon Inc. District Judge Jesse Furman froze the funds while the dispute played out. Citibank appealed his ruling. On Friday the bank will ask Furman to maintain the freeze pending the outcome of its appeal.

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Tim Scott Wednesday night. Progressive lawmakers and advocacy groups are hailing President Biden's sweeping multitrillion-dollar tax and spending plan as a major victory for the left-wing faction of the Democratic Party. The Supreme Court on Thursday ruled in favor of an illegal immigrant who was facing deportation, stating that they are entitled to discretionary relief because the government did not follow the rules. Senate lawmakers confirmed educator Gayle Manchin, the wife of Democratic Sen. Gavin Newsom in an upcoming recall election.
February 11, Pricing Supplement No. Filed Pursuant to Rule b 2. Registration Statement Nos.
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