Cyclopharm Limited (ASX: CYC) announcesthat the US Food and Drug Administration (USFDA) has provided a Complete Response Letter (CRL) for the New Drug Application (NDA) for TechnegasTM. The USFDA has determined it is unable to approve the NDA for TechnegasTM in its present form and has provided a definitive list of items and recommendations for outstanding elements to be addressed within a 12-month period. Cyclopharm expects to resolve all these elements with a view to securing approval for commercial sales of TechnegasTM in the US market in 2022.
CYC’s Managing Director and CEO, James McBrayer commented; “While the elements in the USFDA’s CLR letter are attainable within the required timeframe, we are disappointed with this news of the additional technical information requests. Effectively the CLR has extended the expected approval timeframe by around nine months.”
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