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Monkeypox: Siga Says FDA Hasn’t Indicated Emergency Use Authorization An Option for Tpoxx

 
• By Sarah Karlin-Smith

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

monkeypox public health emergency at FDA
FDA may soon find itself besieged by the monkeypox public health emergency. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Food and Drug Administration has thus far not given SIGA Technologies, Inc “any indication” that it is thinking about using the emergency use authorization pathway for the company’s Tpoxx (tecovirimant), an antiviral that may help treat monkeypox, the company’s Chief Scientific Officer Dennis Hruby told the Pink Sheet.

This could change, Hruby acknowledged in a 5 August interview, given the 4 August public health emergency declaration under Section...

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