Seres therapeutics announces u.s. fda correspondence following positive ser-109 phase 3 study results

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.
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