And so to put myself in the shoes of somebody, you know, like I've gotten to know Chris Klump really well at the FDA and Chris negotiated the most favored nation pricing on the pharmaceutical drugs
For all four peptides on Thursday's agenda BPC-157, TB-500, KPV, and MOTS-C FDA staff reviewed the evidence under the agency's four-part balancing test and reached the same conclusion for each: do not add them to the 503A Bulk Drug Substances List, the only legal pathway for compounding pharmacies to dispense these compounds to patients
Recent studies have also found promise for the compound in studies evaluating it for MS, various drug-induced cell damage, and traumatic brain injuries
However, the correlation with BMI, Waist circumference, Glucose, HbA1c, Insulin, HOMA-IR index, triglycerides (TG), total cholesterol (TC), Low-density lipoprotein-cholesterol (LDL-C), Systolic BP, C-reactive protein (CRP) and Serum folate was insignificant or weak
The contribution of intraocular pressure elevation in the procedure was also evaluated