Biotech Values

[DewDiligence]

CHRS to rerun PK study for Neulasta FoB—not at all surprising given the failed outcome in the first PK study reported in October (#msg-117437374, #msg-117407131, #msg-117420090):

http://finance.yahoo.com/news/coherus-biosciences-reports-chs-1701-210000692.html

“The recent pharmacokinetic/pharmacodynamic (PK/PD) study is acceptable to support filing the Biologics License Application (BLA). However, given the low cost and relatively short delay involved, it is most prudent to initiate a follow-on study in healthy volunteers. We believe this will remove any residual uncertainty, reduce regulatory risk and potential for BSUFA timeline delays, and ultimately increase the likelihood of first cycle approval of CHS-1701,” said Denny Lanfear, president and chief executive officer of Coherus.

What a crock!

The 351(k) submission will be delayed by approximately three months to 2Q16, according to the PR.

CC at 5:30pm ET.