>I assume that PHRM has no intention of going before EMEA w/o the OS data.<
Correct again. It has been PHRM’s intention all along to supplement the MAA with the OS data during the MAA review period. This, IMO, constitutes proof that GPC has been dishonest about the timing of the OS data maturity.
>Does the EMEA even have an equivalent of accelerated approval?<
They do, but it’s a relatively recent ‘modernization’ and it is not often used. PHRM’s MAA requests a full-fledged approval based on the entire data package including OS.
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