Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-59

What is your agenda? The independent report was on FACTUAL real world survival data. Your comments below suggest that the FDA would ignore this data?
Discussions of survival endpoints over multi trials is
and should be- irrelevant .
“survival endpoints will not be discussed “

You are inferring that the FDA - 5 years after that comment- would ignore real world data .

World sucks


Reg



In addition, as described in the 2018 FDA guidance document for clinical trial endpoints, time-to- event measures such as overall survival are difficult to interpret in single-1 arm trials, and Study 001 was not designed to detect differences in survival. And therefore, survival endpoints will not be discussed further by FDA.” PM transcript – page 65.

So the one thing that the FDA have said they are not interested in discussing further is what MSB are submitting as the key component to their resubmission.