Let's play the other side of the equation for a moment:
Suppose Stoll clarifies the exact nature of the initial histological issue that bothered the FDA. He could characterize it in a few sentences. Then he could detail why Cortex was not concerned: because they hadn't seen it again. Then he could detail how this event did not occur in the hyperacute testing in primates. Then he might characterize why Cortex and consultants came up with just one more three month study to fully satisfy the most hardy of FDA skeptics and how nothing untoward has been seen to date.
Such a scenario does not mandate success. The FDA could still delay things, but it would fully alleviate any concerns and clear up any confusion. Witness the immediate 'post-hold' price spike to 3.8 and 'post hold' price drop to 2.8 for more about investor confusion, anxiety and doubt.