CorMedix Inc (CRMD)

[namah sivaya]

Looks likely no meeting, only a couple month delay. CRMD now technically has a gap to fill. Worst over here.


The actions CorMedix ( CRMD ) needs to take to address deficiencies flagged by the FDA in its recent rejection of the company's application for its DefenCath catheter-lock solution are manageable and will likely result in a quick resolution, Truist reckons. CorMedix ( CRMD ) is targeting a May refiling with the FDA, and Truist says it believes a "Class 1" resubmission is likely, given that the FDA concerns weren't linked to the safety and efficacy of the product but rather issues at the contract manufacturer. A Class 1 response would mean a two-month review, with an FDA decision by July, the firm says.