CorMedix presents on LPAD at FDA public meeting
CorMedix announced that Phoebe Mounts, EVP and general counsel, presented at a public meeting on July 12, 2019 hosted by FDA discussing the Limited Population Pathway for Antibacterial and Antifungal Drugs. In her presentation, Dr. Mounts recommended several ways in which the LPAD draft guidance for industry issued by FDA could be strengthened, and emphasized the public health importance of the LPAD pathway for novel antimicrobial products such as Neutrolin. The LPAD pathway was established by the 21st Century Cures Act and is intended to encourage the development of certain antibacterial and antifungal drugs to help address the critical public health and patient care concern that has resulted from the current decline in antibacterial drug research and development as serious antibacterial and antifungal drug-resistant infections increase. In February 2019, the Company reported that the FDA agreed the Company can request consideration of Neutrolin for approval under LPAD at the time of the filing of the NDA.