Replies to post #172063 on Biotech Values

[DewDiligence]

One nuance to the discussion is that absence of efficacy CAN be considered a safety issue by the FDA.

IDIX’s NM283 was an example of such FDA thinking.

[jq1234]

One nuance to the discussion is that absence of efficacy CAN be considered a safety issue by the FDA. One such example would be requiring a trial design that allows nonresponders to "escape" to treatment with an agent with proven efficacy

This doesn't apply to combination of investigational drug with approved drug vs approved drug.