There were posts about the target approval process and intervals from the start at submission. Then we all learned about validation and possible requests for information, and while expedited treatment was requested we don’t know if the application is being processed as expedited.
We do know that site inspections were in progress per nwbo during 3-4Q (I don't remember off hand when it was shared publicly) and the inspections could be thorough, taking a week or more per site, and we can assume some gaps and travel periods.
Although you can't rule out anything including another year of waiting, I very much doubt that will happen.
I believe we are much closer, as close as any day now, and within 2-3 more months at the outside. That's my guess and I think the odds are better than the odds of approval taking another year.
Time of course will tell!
And finally, "The sun will come up, tomorrow!"
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