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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