"I will take IPIX's 'early September' comment literally. It did not say first half of September, but rather it said early September (to me meaning sooner than later, but i can always be happy with it meaning before Sept 15th as well)."
Here's the language from the PR: "Interactions with the Food and Drug Administration, through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September"
Interactions? Not sure what that means. It sounds like the process would begin with the submission of an inquiry by IPIX, the assignment of a review team, a review of the submission and a response to it. Kind of like a SPA submission.