A separate NDA will be submitted for GT2 patients based on the GIFT-2 study (#msg-110425636) if the data (not yet released) support a submission.
ENTA will receive milestone payment(s) from $ABBV totaling approximately $30M for Japanese approval of the two NDAs. Whether this is in the form of a lump sum or two $15M payments for each of the Japanese NDAs has not been disclosed.
Note: ENTA’s royalty rate on ABBV’s HCV sales in Japan will be 50% higher than in the US and EU because the Japanese regimen consists of two drugs rather than three.
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