Biotech Values

[DewDiligence]

EGRX receives CRL on Kangio ready-to-use formulation of Angiomax:

http://finance.yahoo.com/news/eagle-pharmaceuticals-receives-complete-response-105000131.html

In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product. Eagle will work directly with the FDA to determine an appropriate path forward to address the comments.

“We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “We remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, offering multiple benefits for patients and care givers,” concluded Tarriff.

This looks like a 9-12-month delay, but probably not much longer insofar as the FDA has not requested new clinical trials.