It depends on what you mean by imminent. In the wo

It depends on what you mean by imminent. In the world of biopharma 1 1/2 months could be deemed imminent. It won't get any approval before all data is processed and a submittal for an EUA is done.

But the FDA is not going to tell a company to submit for an extension to a trial using only their drug unless they think the drug has efficacy.