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Of these, 70 NMEs/BLAs (23%) were granted PRO claims.
Of these, 70 (23%) NMEs/BLAs were granted a total of 83 PRO claims.
Ultimately, these improvements could result in an increase in PRO claims granted.
Nine PRO "claims" were granted across 4 of 5 products reviewed.
A total of nine PRO claims were granted across the four mCRPC products that achieved claims.
No other PRO claims were permitted in the US for the products reviewed.
Similar(39)
Relevant information was scrutinized for each product to determine the indication, use of PRO, and PRO claim language.
For analysis purposes, a PRO claim was defined as any mention of a PRO measure or patient-reported endpoint (whether or not the PRO measure was named; e.g., "proportion of patients with pain palliation") anywhere in the product label or SmPC.
'Suddenly a Messiah has appeared out of nothing,' pro claimed the Bayern manager, Ottmar Hitzfeld.
The Act of Reformation pro claimed: "This realm of England is an empire entire unto itself".
All Pro claimed 88 similarities between its plans and the Disney complex and documented more than 200 telephone calls with Disney executives.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com