Joe Todisco, CorMedix CEO

CorMedix hit with sec­ond CRL for an­ti­fun­gal treat­ment, cit­ing man­u­fac­tur­ing and API is­sues

Fol­low­ing a C-suite shuf­fle, a shut­ter­ing of its Eu­ro­pean op­er­a­tions and a CRL for its treat­ment to pre­vent blood­stream in­fec­tions in pa­tients un­der­go­ing chron­ic he­modial­y­sis, CorMedix is still not im­press­ing the FDA.

The biotech has now been giv­en a sec­ond re­jec­tion let­ter, as the NDA sur­round­ing its an­ti­fun­gal so­lu­tion, De­fen­Cath, can­not be ap­proved un­til is­sues sur­round­ing its con­tract man­u­fac­tur­ing or­ga­ni­za­tion and the sup­pli­er of the API he­parin dur­ing in­spec­tions are re­solved, CorMedix said Mon­day af­ter­noon.

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