In a worst case scenario, where Biel isn't granted approval, the stock price would probably decline as you point out. Hopefully the massive foreign sales we're anticipating would then send it back up. Actipatch is a global product. Would hate to see the US miss out. Go Biel$$$
I am not sure why it will not be approved when the company announced that they had a presubmission meeting with the FDA, and they were given the green light. In fact, the second meeting was cancelled because the company's questions were answered during the first meeting. I don't believe investors were given false feedback about the presubmission meeting. My only concern is if that meeting went so well, why wait this long for the approval?
I do understand the bureaucracy involved with the FDA. Good luck to all.