Just got off the phone with Investor Relations. I was told they have 75 days for HUD designation.
They are in ongoing talks with the FDA. Everything is on schedule, and they will release the news when it is available.
No matter what, they need to release a statement tomorrow or Friday. Frank said he expected to hear from the FDA in January. We can't go into next week without the situation officially clarified or the floor will drop out on the PPS. Let today be a warning to them.