I agree with your sentiment about it taking longer

I agree with your sentiment about it taking longer than 30 days. I said this on Ipoop about 3-4 months back. FDA process isn't a strict black-and-white timeline kind of thing. Especially when dealing with human lives. There's probably a specific case manager for this application who is having an ongoing dialogue with Koos in addition to the official responses and questions.

Regardless, numbers are facts and over 75% of initial applications get approved. There are credible members of the medical community on board and all of Koos' deadlines have been met so far with amazing amounts of transparency.

The only real downside to continuing back-and-forth with FDA is that it increases the costs of operating before positive results, which MAY (but not necessarily) increase the amount of dilution needed.