In this powdered form, the molecules are locked in place, far more resilient to temperature fluctuations
Anisimov VN, Khavinson VKh, Popovich IG, Zabezhinski MA
Chemical Properties Purity (each peptide): 99% (HPLC-verified) Form: lyophilized powder Components: BPC-157, GHK-Cu, TB-500 Molecule classes: peptide fragments & copper-peptide complex Solubility: water-soluble after reconstitution Color: characteristic due to copper content (GHK-Cu) Research Relevance GLOW is used to analyse peptide-mediated mechanisms and multi-molecule interactions in preclinical systems
While Alnylams Phase III APOLLO-B study hit both key primary and secondary endpoints, the FDA stated in the documents that the effects of patisiran compared to placebo on both endpoints were small, of questionable clinical meaningfulness, and may not be detectable by patients. Major discussion points during the adcomm meeting included whether these key endpoints were appropriate to ascertain clinical meaningfulness in the ATTR-CM population, and panelists expressed varying opinions on whether the magnitude of the benefit seen in trial data was clinically meaningful
The FDA concern is not just lack of approval