Food or drug? FDA blasts Flag­ship-backed mi­cro­bio­me play­er’s ‘non-IND’ Covid-19 tri­al

When Kalei­do Bio­sciences un­veiled re­sults from a mul­ti-cen­ter, open la­bel, con­trolled clin­i­cal study test­ing its mi­cro­bio­me prod­uct in Covid-19 pa­tients back in March, the biotech tout­ed it as a “non-IND” tri­al that yield­ed pos­i­tive re­sults and paved the way for an IND.

But it turned out that the FDA was not im­pressed with that tac­tic.

The agency has is­sued a warn­ing let­ter to Kalei­do blast­ing its “fail­ure to sub­mit INDs for the con­duct of clin­i­cal in­ves­ti­ga­tions with an in­ves­ti­ga­tion­al new drug” that falls un­der sec­tion 505 of the fed­er­al Food, Drug, and Cos­met­ic Act. Kalei­do now has 15 days to ex­plain it­self or re­port the ac­tions it’s tak­en to pre­vent sim­i­lar vi­o­la­tions — or else face reg­u­la­to­ry ac­tion.

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