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no completed efficacy trials of the TB-500 fragment

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Secondary endpoints were defined as pharmacodynamics and pharmacokinetic parameters including maximum serum concentration, time to maximum concentration, half-life, plasma clearance, and volume of distribution, as well as exploratory parameters including bodyweight, glycemic control, and overall hormone profile

The "PDA" counterion argument that arginate salt formulation constitutes a distinct compound outside the Category 2 ruling has not been validated by any FDA guidance as of this writing