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BENSALEM, Pa., July 28, 2021--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of CorMedix Inc. ("CorMedix" or the "Company") (NASDAQ: CRMD) investors concerning the Company’s possible violations of federal securities laws.
In July 2020, CorMedix filed its New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for DefenCath, an antibacterial and antifungal solution, as a catheter lock solution with an initial indication for use of preventing certain catheter-related bloodstream infections.
On March 1, 2021, CorMedix announced the NDA would not be approved "in its present form" due to "concerns at the third-party manufacturing facility." Moreover, the FDA "is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications."
On this news, CorMedix’s stock price fell $5.98 per share, or 39.87%, to close at $9.02 per share on March 1, 2021.
Then, on April 14, 2021, CorMedix announced it would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, including "[a]ddressing FDA’s concerns regarding the qualification of the filling operation [that] may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath."
On this news, CorMedix’s stock price fell $1.44 per share, or 15.37%, to close at $7.93 per share on April 14, 2021.
Then, on May 13, 2021, CorMedix announced that "[b]ased on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA." Among other things, the Company was required "to generate sufficient data to demonstrate that [the filling] process is a controlled process and is consistent with the agency’s requirements for good manufacturing practice."
On this news, CorMedix’s stock price fell $1.51 per share, or 19.97%, to close at $6.05 per share on May 14, 2021.
If you purchased CorMedix securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to email@example.com, or visit our website at www.howardsmithlaw.com.
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