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NanoViricides (NYSE-A: NNVC) CEO Dr. Anil Diwan said the company’s recent FDA application for rare pediatric disease designation for its antiviral candidate NV-387 carries both scientific and commercial implications. In an interview with Proactive, Diwan highlighted that the reinstated FDA program could provide a pathway to a Priority Review Voucher (PRV) if NV-387 is approved, potentially accelerating development timelines or creating an additional monetization opportunity.
Diwan explained that the rare pediatric disease designation is intended to support faster regulatory progress. He noted that securing a PRV upon approval could significantly shorten timelines or be monetized. He also said that these regulatory designations can increase FDA engagement, including more frequent meetings and faster development timelines.
The interview also focused on NV-387’s development strategy, which is centered on measles. Diwan said the company is pursuing regulatory pathways to speed progress, building on prior steps including an orphan drug designation submission.
He emphasized that there are currently no approved antiviral treatments for measles, underscoring the unmet need the company is targeting. Diwan said the company has been preparing for FDA filings after successful animal studies in humanized mouse models for measles, describing the drug’s performance as “extremely well.”
Diwan pointed to growing measles concerns in the United States, particularly among vulnerable populations. He cited several factors contributing to the need for therapeutic options, including:
According to Diwan, the combination of regulatory designations and increased FDA engagement could help the company move more quickly through development. He said the company is pursuing these designations to support accelerated timelines, particularly given the lack of approved antiviral treatments for measles.
“When someone gets the disease, they need treatment,” Diwan said, linking the company’s regulatory efforts to the clinical urgency created by measles resurgence and vaccine limitations.
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