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H2R

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Alias Born 07/17/2014

H2R

Re: skypealottery post# 4313

Monday, 01/29/2018 2:53:39 PM

Monday, January 29, 2018 2:53:39 PM

Post# of 4817
Thanks for checking it out.

By the way, I'm still invested, just patient, like most biotech, it takes longer than planned. I do hope this year will be better than last :)

1) Makena Autoinjector PDUFA: (from PDUFA Calendar):
2018-02-14
ATRS Makena - auto injector $2.31
sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review

2) Xyosted Possible Timeline:


* February 18, 2018: Meeting with FDA occurs. I think that the FDA will inform Antares that there is no need for new clinical trial data for resubmission of the NDA. The only new requirement is an absolute commitment for a phase 4 post-marketing observational study.

* March, 2018 Antares briefs investors on the outcome after reviewing minutes from the meeting. This should be bullish for the stock

* April 2018 Antares resubmits the NDA.

* May, 2018 FDA accepts the NDA.


https://smithonstocks.com/antares-pharma-update-on-xyosted-atrs-buy-2-34/

Best of luck with your investments!