Biotech Values

[DewDiligence]

ABBV/JNJ—FDA accepts Imbruvica sNDA in second-line GvHD for a standard review:

http://finance.yahoo.com/news/abbvie-announces-ibrutinib-imbruvica-supplemental-110000585.html

There is no approved therapy for this indication and Imbruvica has BTD status (https://news.abbvie.com/news/abbvie-announces-fourth-breakthrough-therapy-designation-granted-by-us-food-and-drug-administration-fda-for-ibrutinib-imbruvica-for-chronic-graft-versus-host-disease-cgvhd-rare-condition-with-limited-treatment-options.htm ), so it’s curious that the FDA did not grant a priority review.