Further to this, the research projects for Formulations and for Companion Diagnostics are due to report in November. One with UoW and the other with UoN.
There will also be FTO biomarker data building from the Israel trial.
All of these activities could be feeding the IND for the US EM AML trial.
For context:
https://pink.pharmaintelligence.inf...arly-In-Drug-Development-Programs-US-FDA-Says
Diversity is another area where the FDA is becoming more strict ( will require a Diversity Plan for trials ).
https://www.fda.gov/news-events/pre...e-racial-and-ethnic-diversity-clinical-trials
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