The ONLY way this offering sees the light of day is if the company can justify the valuation. Meaning no investor is going to layout $10M in a private placement at 5xs the current price point. The only way the offering fly's is after the stock shows a support level well over a nickel IMO.
Personally, I don't believe they would be taking the time to make this offering if there wasn't a belief the ADA approval was going to happen. Meaning the testing is going well.