"We believe that our prior written correspondence and interactions with the FDA under the SPA process constiute an SPA with the agency. The FDA may take a different view and could request additional safety and efficacy studies without having to identify a substantial scientific issue with our Phase 3 trial this is essential to determining the safety and efficacy of LEVADEX."
There's nothing to decide. As mgt noted during the cc discussing the CRL last week, the FDA is satisfied with Levadex efficacy and safety data and is not requiring further clinical studies. The section you are quoting from the 10k under "risk factors" has been unchanged since 2010, when the case of the so-called "missing SPA" raised by certain investors was satisfied by this specific mgt disclosure. The real question is: What ulterior motive and agenda do those (AF et al) have in rehashing subject matter that has long been put to bed and answered by mgt (and evidenced in the CRL) in a satisfactory manner?