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Subsequent Events
9 Months Ended
Jun. 30, 2023
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

7. SUBSEQUENT EVENTS

 

On July 29, 2023 the Company received a Complete Response Letter, (“CRL”) from the FDA regarding the BLA seeking approval for Lymphir. The FDA has required Citius to incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review. Additionally, the FDA raised no concerns relating to the safety and efficacy clinical data package.

 

Remediation efforts related to the CRL are not expected to impact the Company’s 12-month cash runway.