Reuters logo
BRIEF-Strata Skin Sciences receives FDA response letter on Sept 5 for possible clearance of dosing technology
September 6, 2017 / 5:25 PM / 17 days ago

BRIEF-Strata Skin Sciences receives FDA response letter on Sept 5 for possible clearance of dosing technology

Sept 6 (Reuters) - Strata Skin Sciences Inc:

* Says ‍on Sept 5 received response letter from U.S. FDA concerning possible paths for 510k clearance of new optimal dosing technology​

* Says FDA response letter proposes two alternative paths for seeking regulatory clearance - SEC filing

* Says ‍first path for seeking regulatory clearance requires a clinical trial to substantiate potential claims for OTD​

* Says ‍second path for seeking regulatory clearance is to seek regulatory clearance with no new claims regarding treatment/ efficacy​

* Says company is assessing alternatives for proceeding and is considering related costs and availability of cash resources​

* Says ability to finance path/combination,other product development through conversion of outstanding convertible debentures due in 2021 Source text for Eikon: Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
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