Replies to post #233200 on Biotech Values

[DewDiligence]

NBRV PR on Contepo CRL:

https://www.globenewswire.com/news-release/2020/06/20/2050894/0/en/Nabriva-Therapeutics-Receives-Complete-Response-Letter-from-FDA-on-NDA-for-CONTEPO-fosfomycin-for-injection.html

Nabriva Therapeutics plc…announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) resubmission seeking marketing approval of CONTEPO (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

…In general, previously identified product quality and facility inspection related observations at our contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL.

[DewDiligence]

Whenever possible, please post a link with a news item. Thank you for your cooperation.