An anonymous director reports
THERATECHNOLOGIES INC./REQUEST FOR RECONSIDERATION IN CANADA: MEETING WITH SCIENTIFIC ADVISORY COMMITTEE AUTHORIZED
Theratechnologies Inc. has received confirmation from Health Canada that it will be meeting with a scientific advisory committee on Aug. 23, 2013, as part of the request for reconsideration process of the notice of non-compliance/withdrawal issued by Health Canada in March, 2013.
Pursuant to the rules governing the request for reconsideration, representatives from Theratechnologies and Health Canada will be asked to present their respective arguments to the committee. The hearing is not open to the public.
Once the meeting is completed, members of the scientific advisory committee will have seven days to submit their report to the regulatory project manager who will have 21 days to review it and send it with his comments to the director general. The director general will then have five days to issue its decision.
If the decision is positive, the review of Egrifta will resume at the same stage as it was before the issuance of the non/w.
Further information on the request for reconsideration process can be found on Health Canada's website.
The new drug submission for Egrifta was originally submitted to Health Canada in June, 2011. It was based on the results from two phase 3 clinical trials, which enrolled more than 800 patients, and follows a marketing approval for Egrifta by the U.S. Food and Drug Administration received in November, 2010.
Currently, there are no approved treatments for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy available in Canada.
We seek Safe Harbor.
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