Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-256

"“In addition, as described in the 2018 FDA guidance document for clinical trial endpoints, time-to-event measures such as overall survival aredifficult to interpret in single-arm trials, and Study 001 was not designed to detect differences in survival. And therefore, survival endpoints will not be discussed further by FDA.”"

If you don't see my interpretation of this statement as having pretty much exactly that meaning then I don't know what more to say. The FDA says the study wasn't designed to detect differences in survival so there is no point is discussing it (therefore long term survival data is irrelevant). How do you think my interpreation of this statement is wrong?