June 19, 2017 / 8:49 PM / a month ago

BRIEF-Avexis Inc says expects to submit data to FDA in August 2017 timeframe for AVXS-101

1 Min Read

June 19 (Reuters) - Avexis Inc

* Avexis says held a type B CMC meeting with U.S. FDA to seek alignment regarding proposed GMP, commercial manufacturing process for AVXS-101 - sec filing

* Avexis-FDA requested co complete implementation of potency assay qualification plans, presenting FDA with data from appropriate production runs of AVXS-101

* Avexis Inc - expect to submit data to FDA in August 2017 timeframe for avxs-101 Source text for Eikon: (bit.ly/2rwVJH4) Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below