The hold – which is applicable to the Phase 2 and 3 trials but not Phase 1 – is due to concerns the FDA has with the “Cellectra” device that has to be used to deliver the vaccine.
Inovio will address the FDA questions in October.
The news has had a negative impact on the company’s stock, which dropped by 39 percent after the announcement of the FDA’s hold. The development comes as Inovio seeks additional funds to proceed with the development and planned production of its vaccine.
“Inovio and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA’s partial clinical hold and subject to the receipt of external funding to conduct the trial,” said Inovio.
Inovio first drew international attention when it announced it was working on a DNA-based COVID-19 vaccine in early March. The company also said at the time it was planning to have a million doses ready for distribution by the end of the year.
Read more about Inovio at the Yahoo!News by clicking here.
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