Rivulet Media Inc (fka RIVU)

[Blushing green]

The regulations in 21 CFR 312.42(c) require that when FDA concludes there may be grounds for
imposing a clinical hold, FDA will Aattempt to discuss and satisfactorily resolve the matter with the
sponsor before issuing the clinical hold order.@ FDA experience is that most potential holds, particularly
those based on inadequate patient monitoring, can be resolved through such discussion.