It took us three years to address the safety violations noted in the FDA warning letter. That’s 2 1/2 years longer than it should have, when you ponder the risk to patient safety at stake. Who in the world are we to be advising others on regulatory compliance or any standards or competencies we have consistently failed as a company to demonstrate ourselves...such as CAPA, complaint handling, FDA Warning Letter avoidance, or remediation, etc. etc. With our track record in these areas, who would pay any attention to our advice?