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Included in it is "Material threat medical countermeasures (Congress added in 2016)"

This would likely be the criteria being satisfied by B-OM.

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That's a bit of a stretch and definitely against the spirit of the PRV incentive.

See page 3 for a definition if you didn't see it yet:

https://www.fda.gov/downloads/regulatoryinfor...592548.pdf

If you did, then realize everything on that list is a low profitability (small number of patients or large number of patients in dirt poor countries). Material threat countermeasures need to be developed but my go 10, 20, or 100 years without being used so the market is essentially 0.

B-OM is different from everything on that list as there are billion dollar markets available and many people pursuing treatments. No incentive necessary outside of market forces.