not the way I read it. it is 6 months from today.
April 30 announcement: it stated "approximately 6-8 months from the completed submission" . Submission was completed April 30, so Nov or Dec for the NDA.
today's announcement : it states "target review period of approximately 6 months from acceptance" acceptance was today, so January 9th 2019..
I was hoping to see the NDA approval this calendar year, but likely January 2019 based on this. Or maybe this is the start of SPL being more conservative with their timeline estimates.
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- Ann: VivaGel BV NDA advances to next stage of FDA review
Ann: VivaGel BV NDA advances to next stage of FDA review, page-13
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