Time for the US HHS to take a lesson from early stage venture capitalists re accelerated approval.

Recent case: drug found to have proof of concept but not of benefit (ie does not pass the “so what” test — yet.) So we permit full commercialization in exchange for a promise of eventually completing a confirmatory study proving the thus far hinted at benefit.

Full commercialization means premium pricing, co-pays — the works. With the usual “we don’t negotiate drug prices” hands off on the part of CMS. A great term sheet, if you can get it.

Substitute an early stage…

David Sable

bio fund manager, Columbia prof, ex-reproductive endocrinologist, roadie for @PriyaMayadas

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