FDA pandemic delays strike again with Israeli microcap the latest to receive a CRL based on inspection setbacks
Israeli microcap Protalix Therapeutics and its partners at Italian pharma company Chiesi received bad news regarding their Fabry disease program.
The FDA issued the pair a complete response letter for the candidate, known as pegunigalsidase alfa, the companies said Wednesday. Regulators were unable to conduct an inspection of a manufacturing site in Israel due to Covid-19 travel restrictions, leading to the rejection, according to Protalix.
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