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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