The speculation about it began with the discovery of "the planned publication of interim clinical trial data" having been added to the growing list of formal information requests that have been made by the SEC as it was written in the 10K.
It's purely speculation as to what it really means - what can be said is that while the list grows longer and longer as to what the SEC has requested information for - nothing seems to come from it. It's each shareholder's choice as to whether they are concerned about it. My choice is to not be.