Biotech Values

[DewDiligence]

EYEN—The Optejet micro-array print delivery platform is not regulated as a medical device or drug-device combination, which streamlines the therapeutic registration process.

The above sentence seems misleading insofar as the drugs to be delivered using Optejet will be reviewed under the FDA’s 505b2 (reformulation) pathway, which includes an implicit FDA review of the delivery method.