InvestorsHub Logo

H2R

Followers 42
Posts 2160
Boards Moderated 0
Alias Born 07/17/2014

H2R

Re: markjohn62 post# 4331

Tuesday, 03/27/2018 6:10:11 PM

Tuesday, March 27, 2018 6:10:11 PM

Post# of 4817
No New Clinical Study for Xyosted: Great News!

Based upon this meeting and the FDA minutes, Antares believes that it does not need to conduct any new clinical studies to support the resubmission. The Company anticipates that the resubmission will include re-analyses of existing data, and address labeling and potential post-approval risk mitigation strategies. The Company anticipates submitting the complete response in the second quarter of this year.



(Thanks markjohn62)