My key take-out was the non-PR excerpt.
Paradigm Global Head of Safety and MPS, Dr Michael Imperiale commented:
“I am very pleased that iPPS has demonstrated a favourable safety profile, along with significant improvements in both biomarkers and clinical outcomes in MPS I patients. Paradigm is encouraged that iPPS may be an important addition to the armamentarium for treating this devastating disease.”
These words keeps showing up on all the clinical trials. I'm not convinced will see an early NDA via AA for OA but I'd speculate the probability for MPS is much much higher given "favourable safety profile"
Ann: Primary and Secondary endpoints met in MPS I Trial, page-14
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