Cyclopharm Limited’s (ASX: CYC) provides the following update of the US Food & Drug Administration’s (USFDA) timetable in respect of approval of the Company’s New Drug Application (NDA) for Technegastm.
As previously advised, the USFDA is scheduled to commence its pre-approval audit of Cyclopharm’s manufacturing facility during the week commencing 29 March 2021. The Company has been actively assisting the USFDA in preparation for this audit, and has provided them with further information to assist with their NDA assessment process. Cyclopharm notes such audits outside of the United States are presently rare given the current difficulties associated with international travel. Furthermore, the Company believes the USFDA’s continued and active commitment to complete the audit, as scheduled, demonstrates the importance of Technegas™ for the US market.
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