I have been looking into how a publicly traded company handles material information when it involves the FDA and a drug trial. It sounds like the legal problem is that if the company puts out info about a trial, and the FDA looks at the data differently, the investors could have a lawsuit opportunity. If we look at the completeness if the CD12 trial, it gets really complicated if the full report is not complete and only initial or topline data is released. It does not look like it is an issue with the FDA wanting to control information, more of a legal problem. Companies are typically advised to release as little info as possible to avoid mis-leading investors with incomplete data reads.
I have a feeling that giving the FDA the raw data in a way avoids the problem of what Cytodyn has to publicly disclose. the trial data not being formatted means it is not for public consumption yet. This could be a good thing as the FDA reaction to it will likely be what we hear first.
link to informative article:
https://www.orrick.com/en/Insights/2020/05/Ma...-Companies