As Jim said, you don't know until you know. Which he knows all to well. To say they don't currently have any outstanding questions from the FDA is disingenuous at best. They didn't have any outstanding questions from the FDA last year until the date proscribed by statute which caused the delay.
I finally got a chance to watch the webinar, been traveling the past two weeks. I may take the time to break down my issues with many of the things stated and left unstated later. For now all I can say is if there's a pony in there it will take a very big shovel to find.
As Jim said, you don't know until you know. Which he knows all...
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