The FDA approval process doesn’t require or depend on peer reviewed papers, if there is one they will read it too.
Instead the FDA team will want to review the NDA presented data and analysis, do their own assessments of it and review and do their own statistical analysis etc. like Kun Jin and team would do.
All the experts are available either in-house or externally to call on for their opinions.
Investors however would like to see a peer reviewed publication on the P2b/3 trial data and results, especially before any FDA decision.
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