April 18, 2016 / 11:47 AM / 2 years ago

BRIEF-Telesta currently estimates that U.S.approval for MCNA can not be obtained for a period of at least 5 years

April 18 (Reuters) - Telesta Therapeutics Inc

* Telesta announces type a meeting results and strategic option review

* Co’s questions for meeting were centered on whether fda would permit co to resubmit bla for mcna 1 under accelerated approval

* Fda has ruled any potential commercial approval of mcna to require an additional phase 3 clinical trial to be completed

* Telesta currently estimates that u.s. Regulatory approval for mcna could not be obtained for a period of at least 5 years

* Telesta has determined that it will not pursue another phase 3 clinical trial on its own

* Company will seek a partner for future development of mcna in u.s.

* Working with board of directors to identify strategic options

* Strategic option review includes sale and/or merger of company, sale and/or licensing of assets

* Continue to review and will implement additional cost reduction Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +1-646-223-8780)

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