NorthWest Biotherapeutics Inc (NWBO)

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It is all about level of risk to the patient.
There are still stringent rules that govern medical devices and some devices will be subject to greater scrutiny than others just like injectables are subject to more scrutiny than solid dosage drugs, it is all about the level of risk to the patient and some risk always exists to all patients.
The goal of RA's is to manage the risks toward minimization and proper balance of risk/reward to the patient.