CRMD - CorMedix shares crash on FDA's DefenCath complete response letter

CorMedix (CRMD) shares plummet 50% premarket after announcing that the U.S. FDA has declined to approve its DefenCath catheter lock solution, citing concerns at its third-party manufacturing facility.FDA, in its complete response letter, did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when the health regulator informs the facility of the specific concerns, the company.Additionally, FDA is requiring a manual extraction study to show that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.CorMedix also said that it will request a meeting with the health regulator to obtain agreement on its proposed plan for resolution of the issues at the manufacturing facility, which the company expects to happen by mid-April.FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on the efficacy

For further details see:

CorMedix shares crash on FDA's DefenCath complete response letter