I believe approval is assured, but when is the question. It's likely to gain approval elsewhere, most likely Europe, as if they need to, they can inspect the production facilities.
Trump prevented others from coming here in the beginning of the pandemic, it's rather fitting that by itself, that wasn't sufficient, and he did little else. Now we're prevented from going elsewhere.
If the FDA would be willing to work with other regulators, they could inspect the production facilities for them, they could even Zoom conference from the plant, it's a shame that we believe we must do everything ourselves. Imagine where we might be if we purchased tests and testing equipment from the South Koreans, or the Chinese back in January or February.
Gary