Covid-19 roundup: Inovio finally gets PhII rolling — but there's still a clinical hold; Low cost vaccine enters PhI/II in India
Inovio has managed to convince the FDA to sign off on a Phase II trial of its Covid-19 vaccine. But the Phase III portion remains clamped by a partial clinical hold more than a month after it was first imposed.
The little biotech said that regulators still have remaining questions about the device that will be used to deliver its candidate, INO-4800, directly into the skin. The plan is “to resolve the remaining device questions during the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of the trial,” according to a statement.
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