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the diabetes trial explicitly noted that dose-related gastrointestinal events could be mitigated with slower escalation

Individuals with severe liver disease (such as cirrhosis or hepatic encephalopathy) or severe kidney disease should not take L-Glutamine, as their organs may be unable to effectively clear the resulting ammonia, leading to dangerous neurotoxicity

- They need safety and quality controls

For such medical device innovators the De Novo pathway presents a significant opportunity to gain sustainable competitive advantage, in part due to the interaction between regulatory realities (i.e., the joint operation of the De-Novo classification with the 510(k) clearance pathways) and IP (i.e., patent protection of core technological characteristics tied to performance standards)