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

Published 2016-04-18, 07:43 a/m
© Reuters.  BRIEF-Telesta currently estimates that U.S.approval for MCNA can not be obtained for a period of at least 5 years
TST
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April 18 (Reuters) - Telesta Therapeutics Inc TST.TO
* 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: ID:nPn73y4zKa
Further company coverage: TST.TO

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