Af­ter CRL, CorMedix says new fil­ing has been ac­cept­ed by FDA; Spine Bio­Phar­ma nets a mod­est Se­ries B

Af­ter a man­u­fac­tur­ing slip-up led to a CRL last year, a small biotech says its new ap­proach is ready for the FDA.

NJ-based CorMedix re­filed its ap­pli­ca­tion for its an­tibac­te­r­i­al and an­ti­fun­gal treat­ment to pre­vent blood­stream in­fec­tions in pa­tients un­der­go­ing chron­ic he­modial­y­sis, the com­pa­ny an­nounced Mon­day. The FDA has ac­cept­ed the fil­ing, con­sid­ers it a “Class 2 re­sponse” and will look at it as part of a six-month re­view, CorMedix added.

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