I think the myth peddled about "Real world evidence RWE" has been twisted slightly by the Zelira zealots.
RWE is about using large bulk data (from trawling medical records and EMR's) and using data analytics to prove safety.
It doesn't mean doing low sample size trials and measuring low amounts of observational data, as I think some people on here appear to have misconstrued.
I'm very familiar with FDA rules, RWE and pathways to New Drug Approval.
ZLD are not planning on taking any drug to NDA
Their monetisation plan is to sell non-FDA approved (but cleverly branded drugs) in jurisdictions where the regulations allow.
ZLD Price at posting:
4.5¢ Sentiment: None Disclosure: Held
