Replies to post #207091 on Biotech Values

[DewDiligence]

ABBV/ENTA—EMA grants accelerated assessment for G/P HCV regimen:

http://finance.yahoo.com/news/enanta-announces-ema-grants-accelerated-090500651.html

EMA accelerated assessment is similar to FDA’s BTD and priority review. As a result of the AA designation, the CHMP could approve G/P as early as 2H17.

Please chase the links in #msg-127281791 for related info.

[DewDiligence]

ABBV/ENTA—FDA grants priority review for G/P HCV regimen:

http://finance.yahoo.com/news/u-fda-grants-priority-review-130000883.html

The exact PDUFA date is not disclosed, but it should be on or about 8/2/17.

In Europe, the EMA previously granted accelerated assessment for the G/P MAA, which means CHMP approval could come as soon as 2H17 (#msg-128090944).

ENTA will receive a cumulative $80M in milestone payments from ABBV for G/P approval in the US, EU, and Japan.

ENTA will receive tiered royalties on worldwide sales of G/P—see #msg-126723412.

Please see #msg-126481635, #msg-126481950, #msg-127727429, and #msg-122031014 for G/P clinical data and phase-3 program.