F2G Ltd encountered a significant setback as the US Food and Drug Administration gave the firm a complete response letter (CRL) for olorofim in invasive fungal infections. F2G said it is confident it can chart a path forward for the drug that will not require a new clinical trial.
Manchester, UK-based F2G announced the CRL on 19 June, saying that the FDA had requested additional data and analyses and that the additional information would require time and resources that extend beyond the current review period. The company had filed for approval based on data from the first 100 patients in the 203-patient Phase IIb Study 32
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