I have sold 2/3 of my position. Even if they get a CRL, I will be ahead! The shares I hold now, are are paid for! Still a risky bet! 50/50 After reading the FDA TRACKER ARTICLE, I do not think the CEO has been completely truthful in the past. Although the FDA has handled this in a incompetent manor! They should have said from the beginning, the only chance for approval is to run another trial. I do think they will get the approval but it is to close to call! Worst case I make a few hundred dollars, best case a few thousand!
The FDA is the reason that prescription medication is expensive. They need to be proactive. They have a bad habit of taking a back seat approach to drug development. Typical government nonsense!