Biotech Values

[DewDiligence]

ABBV/ENTA—With an 8-month priority review essentially guaranteed by the Breakthrough Therapy Designation previously awarded to the 3-DAA HCV regimen, a US commercial launch in late 2014 remains doable, particularly if the FDA uses less than the allotted amount of time for the review.

ABBV’s and ENTA’s PRs today also indicate that the European MAA for the 3-DAA HCV regimen will be submitted in early May, which should enable an EU approval in mid 2015 if there is no glitch in the review.