Iterum Therapeutics (ITRM)

[swanlinbar]

We are pleased to have concluded discussions with the FDA and reached agreement on key elements of the trial design to support the potential resubmission of the NDA for oral sulopenem for uUTI under the SPA process," said Corey Fishman, Chief Executive Officer. "The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to ******starting recruitment for this trial as soon as possible.*******