Biotech Values

[DewDiligence]

AZN—FDA issues second CRL for ZS-9:

https://www.astrazeneca.com/media-centre/press-releases/2017/astrazeneca-receives-complete-response-letter-from-us-fda-for-zs-sodium-zirconium-cyclosilicate-for-hyperkalaemia-17032017.html

The CRL followed an inspection by the FDA of the ZS-9 manufacturing facility. The CRL does not require the generation of any new clinical data. AstraZeneca and ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible.

ZS Pharma (f/k/a ZSPH) is now a subsidiary of AZN as a consequence of a $2.7B buyout in Nov 2015 (#msg-118292261).