SWEET! Again you’re welcome! Hehehe
$Iterum Therapeutics(ITRM.US$ • Ireland-based pharma said it would resubmit its new drug application (NDA) for its oral anti-infective compound, sulopenem, with the FDA in the first half of Q2 2024 sooner than its initial plans.
• The company said that the filing would address the concerns the regulator raised in July 2021 when it declined to approve the product. At the time, the company targeted sulopenem for patients with urinary tract infections caused by quinolone non-susceptible pathogens.
• Iterum (ITRM) expects the FDA to review the resubmitted NDA and arrive at its decision in the first half of Q4 2024.
• Additionally, the company noted that its year-end cash and cash equivalents and short-term investments, with funds from an equity offering launched in February, would support its operations into 2025.![]()
• The company said that the filing would address the concerns the regulator raised in July 2021 when it declined to approve the product. At the time, the company targeted sulopenem for patients with urinary tract infections caused by quinolone non-susceptible pathogens.
• Iterum (ITRM) expects the FDA to review the resubmitted NDA and arrive at its decision in the first half of Q4 2024.
• Additionally, the company noted that its year-end cash and cash equivalents and short-term investments, with funds from an equity offering launched in February, would support its operations into 2025.
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