Theralase Technologies Inc (TLTFF)

[123414]

Ann Oct 5 2016:



‘Theralase filed an ITA application with Health Canada on July 29, 2016. On September 16, 2016, Theralase received a formal response, which consisted of a series of 6 questions from Health Canada seeking additional information on the ITA application.



Theralase compiled a comprehensive written response on September 23, 2016 and it was received by Health Canada on September 26, 2016.



Health Canada has indicated that they require approximately 45 days to review the written response and as a result Theralase is not expecting a formal response from Health Canada until mid November 2016.



Theralase expects final ITA approval at this time, but Health Canada possesses the ability to ask additional questions, either as a clarification request, resulting in an additional 10 day review or request new information resulting in an additional 45 day review.



Pending Health Canada approval of the ITA, Theralase will immediately commence enrollment of patients into a Phase Ib clinical study in the treatment of NMIBC. ‘



ITA Approval granted on the 20th of October 2016

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