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JAMA 311 , 16701683 (2014)

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Role of sphingosine 1-phosphate signalling in tissue fibrosis

The calculation is: PTE = 0.5 (IND period) + 1 (NDA review period), subject to a cap of five years and a maximum remaining patent term of 14 years post-approval

Ice crystal formation during freezing physically damages the peptide structure in solution

Even if a peptide becomes legally eligible for 503A compounding, pharmacies still need compliant API (and for many peptide use-cases, sterile injectable-grade supply) (FDA Law Blog)