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In the case of GSAO, a reversible renal toxicity described in preclinical studies at the maximal tolerated dose was not observed in human during clinical Phase I (Horsley et al., 2013)

Brain-Derived Neurotrophic Factor in Brain Disorders: Focus on Neuroinflammation

In our response, we noted that, while the commenter stated that it provided the Hemolung RAS to hospitals free or at cost, and that hospitals were not seeking payment for the Hemolung RAS therapy during the EUA period, additional information regarding whether hospitals charged for use of the Hemolung RAS therapy between the date of its EUA and the date of commercial availability of the De Novo classified device, and how it impacts whether use of the technology may be reflected in the data, would be helpful in determining that data reflecting the cost of the product did not become available until the date of commercial availability of the De Novo classified device

Divergence of duplicate genes in exonintron structure