Sounds like they want the primary endpoints to include whether a person relapsed and the 'long term' effects. Basically the FDA seems to be saying - include additional descriptions for the endpoints and adjust the SAP to match.
Next question is how long will it take RVVTF to do adjust and re-submit and then how long for the FDA to review / rule on it.
This is where having someone in constant contact (at a desk in the building?) with the FDA (this is where the bigger companies have the advantage to interact) would help expedite things.
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