Follow Us GraphicFacebook IconTwitter IconLinkedIn Icon
Search Graphic

Expert Financial Analysis and Reporting

Antares’ Response to Complete Response Letter on Xyosted is in Line with My Expectations (ATRS, Buy, $2.05)

Antares Pharma announced on December 21st that it had submitted a request to the FDA for a type A meeting in response to the CRL that it received in October on Xyosted. This action and timing is in line with what I have been expecting. See my note of November 9, 2017 My Hypothesis on Issues that Resulted in the CRL for Xyosted and Potential Timing of Approval.

In that report, I laid out my thinking for potential approval of Xyosted.

December 2017: Antares submits detailed briefing book and requests a meeting with the FDA. (The Company has just met this timeline. So far, so good.)

January 2018: Meeting with FDA occurs. FDA informs Antares that there is no need for new clinical trial data for resubmission of NDA. The only new requirement is an absolute commitment for a phase 4 post-marketing observational study. This would be extremely bullish for the stock.

February 2018: Antares resubmits the NDA.

March 201: FDA accepts the NDA. If the review is classified as a class I (two month) review, the PDUFA date is May 2018. If the review is class II (six month review), the PDUFA date is September 2018. In my opinion, this should be a class I review, but in dealing with the FDA there is no certainty and the agency is overworked and missing deadline after deadline. Hence, there is a very  good chance for a class II review and this is my best guess.




Tagged as , + Categorized as Company Reports, LinkedIn


  1. Well I had to send Jack an email to get on the damn ball, lol


You must be logged in, or you must subscribe to post a comment.