Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-33

My thoughts on assumption RAC have shared as much information as possible on their plans and also FDA requirements.

1. There will be no future hold (FDA has lifted hold based on information RAC has provided)
2. 1st Israel trial can support NDA [“FDA also confirmed that the FDA505(b)(2) application pathway is a possible regulatory pathway for Zantrene”]
3. 2nd Israel trial can support NDA NDA [“FDA also confirmed that the FDA505(b)(2) application pathway is a possible regulatory pathway for Zantrene”]
4. Some historic trial data can support NDA NDA [“FDA also confirmed that the FDA505(b)(2) application pathway is a possible regulatory pathway for Zantrene”]
5. EM AML trial can support NDA NDA [“FDA also confirmed that the FDA505(b)(2) application pathway is a possible regulatory pathway for Zantrene”]
6. Indicators on number of US patients needed in a trial [FDA normally has requirements for US-domiciled patients to be included ]
7. Indicators on patient populations [FDA normally has requirements for diversity in patient populations ]
8. Feedback on use of IV formulation [RAC would have shared their plans]
9. Feedback on inclusion and exclusion criteria [RAC would have shared their trial protocol ]
10. Feedback on primary and secondary endpoints [RAC would have shared their trial protocol ]
11. Feedback on biomarkers [FDA has requirements for biomarkers]

https://www.fda.gov/drugs/biomarker...m/biomarker-guidances-and-reference-materials

https://www.fda.gov/regulatory-info...nderrepresented-racial-and-ethnic-populations