Seres Therapeutics Inc

NASDAQ:MCRB   3:59:59 PM EDT
22.34
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Seres Therapeutics Announces U.S. FDA Correspondence Following Positive Ser-109 Phase 3 Study Results

Published: 09/11/2020 11:17 GMT
Seres Therapeutics Inc (MCRB) - Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive Ser-109 Phase 3 Study Results.
Seres Therapeutics Inc - FDA Reaffirmed Its Prior Guidance Regarding Efficacy Requirements to Support a Ser-109 Bla Submission.
Seres Therapeutics Inc - FDA Reaffirmed Its Prior Guidance That at Least 300 Patients Will Be Required for Safety Database.
Seres Therapeutics Inc - FDA Indicated There Was Not a Reason for a Meeting at This Time.
Seres Therapeutics Inc - Seres Had Requested a Breakthrough Therapy Designation Meeting With FDA.
Seres Therapeutics Inc - Expect to Expand Ser-109 Safety Database So Co Can File a Bla As Soon As Possible.
Seres Therapeutics Inc - Plan to Seek Continued FDA Dialogue to Discuss a Rapid Path to Product Approval.