Leg­end re­veals its hold stems from in­suf­fi­cient IND in­fo; Proven­tion re-files BLA af­ter Ju­ly CRL

In its fourth quar­ter and full year re­port, Leg­end Biotech went in­to a lit­tle more de­tail as to why the FDA slapped it with a clin­i­cal hold.

The biotech re­port­ed Fri­day af­ter­noon that it was not al­lowed to start a Phase I study be­cause its IND did not “con­tain suf­fi­cient in­for­ma­tion re­quired by 21 CFR 312.23” to prop­er­ly as­sess risks to pa­tients. That law, 21 CFR 312.23, out­lines how com­pa­nies wish­ing to get a drug ap­proved must sub­mit their INDs.

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