From today’s PR, meeting on schedule and they gonna pursue NO to get approval like BLPH did...
In light of the developing COVID-19 pandemic and as of March 23, 2020 , Novan has not received notification from the U.S. Food and Drug Administration (“FDA”) regarding a delay or cancellation of the Type C meeting scheduled on April 1, 2020 . The meeting was originally scheduled and is set to be conducted as a teleconference. The purpose of the teleconference is to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (“NDA”).
As a further update, Novan intends to explore the use of its proprietary Nitricil technology to progress a potential topical oral or nasal treatment option for COVID-19, targeting the reduction of viral shedding and transmission. Nitric oxide (NO) has demonstrated the ability to inhibit viral replication of viruses within the Coronaviridae family2 and Novan has an extensive body of in vitro and in vivo anti-viral data demonstrating the efficacy of our proprietary technology. Novan has initiated a work order to complete in vitro assessment of our Nitricil technology, berdazimer sodium (NVN1000), against species within the Coronaviridae family, including SARS-CoV-2, the virus that causes COVID-19. The Company is also exploring the potential for federal grants to support these efforts.
Novan’s operations have continued amidst the COVID-19 pandemic, with the majority of employees working remotely, and the Company continues to monitor recommendations from the Centers for Disease Control and Prevention ( CDC ) and other federal, state and local public health and administration officials for further actions and adjustments.
1. Intent-to-Treat Population (“ITT”): consists of all subjects who are randomized. 2. Akerstrom S et. al., Nitric oxide inhibits the Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus. J Virol 2005; 79(3):1966-9.
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