CRMD ALERT

Investors With Substantial Losses Have Opportunity to Lead the CorMedix Inc. Class Action Lawsuit - Seite 2

Then, on April 14, 2021, CorMedix announced that it would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, including “[a]ddressing [the] 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 more than 15%.

Finally, 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 [the] FDA.” After an analyst pressed for clearer information on DefenCath’s manufacturing deficiencies on a conference call held that same day, CorMedix’s Executive Vice President and General Counsel, defendant Phoebe Mounts, disclosed among other things that “there are times when there may be unexpected results obtained”; that the FDA “expect[s] us 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”; that “sterility is a very important part of that process,” as well as “the accuracy in making sure the right volume of DefenCath is loaded into the vials”; that “we’re talking about thousands of vials during the manufacturing run”; that CorMedix must “generat[e] a lot of data to make sure that . . . all the equipment has been qualified for the intended use and every step in the manufacturing process has been qualified”; that “th[e] process needs to be very robust, [and] needs to be reproducible”; and that “the burden is on the manufacturer to demonstrate that the facility can do that process reducibly and generate the required product for commercial distribution.” On this news, CorMedix’s stock price fell an additional 20%, further damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased CorMedix securities during the Class Period to seek appointment as lead plaintiff in the CorMedix class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the CorMedix class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the CorMedix class action lawsuit. An investor’s ability to share in any potential future recovery of the CorMedix class action lawsuit is not dependent upon serving as lead plaintiff.