FDA will be under strong pressure to approve the ABBV/ENTA 3-DAA HCV regimen in the next 4-5 months.
As for today $20M milestone to ENTA, it has increased Enta Market Cap by 3%. The EU submission will also increase Enta Market Cap by 3%. And finally, the approval in US and EU will increase Enta Market Cap by another 23%.
Things are becoming very interesting taking into account that there are lots of money to be made in the HCV treatment areal
Priority review was expected insofar as the 3-DAA regimen has BTD status. The PDUFA date is on or about 12/21/14 (8 months from the 4/21/14 submission date), although there’s a pretty good chance (IMO) of approval before the deadline.
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