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A qualifying reclassification must be to Category 1 of the Bulk Drug Substances List or an equivalent classification that allows interim compounding of the drug
doi: 10.3390/ph16020234
et al (2014) PLOS
Tong WY, Alnakhli M, Bhardwaj R, et al
doi: 10.1080/0886022X.2022.2107936 145
A subcutaneously administered investigational RNAi therapeutic (ALN-CC5) targeting complement C5 for treatment of PNH and complement-mediated diseases: preliminary phase 1/2 study results in patients with PNH
