Altimmune Inc.’s ability to start clinical trials for its coronavirus vaccine candidate now lies in the hands of regulators.

The Gaithersburg biotech has submitted its investigational new drug application for its intranasal Covid-19 vaccine, AdCovid, to the Food and Drug Administration, the company said Wednesday. An approval would allow the company to initiate a phase 1 study of the candidate.

Altimmune (NASDAQ: ALT) is on track to kick off that trial in 2020 and report data in the first quarter of 2021, said President and CEO Vipin Garg in a statement. Based on that data, the company “would plan to move swiftly” into a phase 2 clinical trial next year, he told us previously.

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