Inovio Pharmaceuticals Inc INO responded to the FDA's questions about INO-4800 and the Cellectra vaccine delivery device in October, the company confirmed to Benzinga.
Inovio Continues Phase 2/3 Trial Prep: The FDA imposed a partial clinical hold in September on the planned Phase 2/3 clinical study of INO-4800, its DNA vaccine candidate against the novel coronavirus.
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When announcing the partial hold in late September, Inovio said the regulatory action had nothing to do with the expanded, ongoing Phase 1 study.
The FDA is mandated to reply to the response submitted by the company within 30 days.
"We look forward to hearing back from the FDA in November and continue to prepare for a planned phase-II/III trial of INO-4800," Inovio said in a statement.
What's Next For Inovio: Inovio is scheduled to report its third-quarter results Monday after the close.
The company may shed some light on the potential resolution of the partial clinical hold and the vaccine timeline in the earnings report or in the call.
INO Price Action: In premarket trading Monday, Inovio's shares were up 0.7% at $10.09.
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