$SNGX why is the NDA still not filed?? Notice in that whole long update they don’t say why it’s been so delayed? here is the reply I got from IR; No, we have not filed the HyBryte™ NDA. Due to disruptions caused by the global COVID-19 pandemic resulting in delays by the commercial active pharmaceutical ingredient contract manufacturer, Soligenix, Inc. is unable to provide the pre-requisite amount of accrued stability data required to file its HyBryte™ (SGX301) new drug application with the U.S. Food and Drug Administration by the first half of 2022. Therefore, the timeline for anticipated NDA filing with the FDA is being adjusted to the second half of 2022 with corresponding potential FDA approval adjusted to the second half of 2023.
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