As of the date of this report, the Company has sub
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Posted On: 10/23/2023 7:15:40 PM
Re: HouseofCards #138226
As of the date of this report, the Company has submitted the following to the FDA in connection with resolving the clinical hold: an aggregate analysis of cardiovascular events across all leronlimab clinical programs, a Safety Surveillance Plan, an aggregate safety data analysis, an updated Investigator’s Brochure, annual reports, a benefit-risk assessment, and a general investigational plan. The Company is currently finalizing a supplemental submission to address items discussed with the FDA during the informal meeting.
That seems to read that as of today (the date of this report), the supplemental submission hasn't been filed yet but maybe somebody else has a different take on the passage.
That seems to read that as of today (the date of this report), the supplemental submission hasn't been filed yet but maybe somebody else has a different take on the passage.
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