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Re: alerted post# 16525

Thursday, 11/08/2012 9:24:28 PM

Thursday, November 08, 2012 9:24:28 PM

Post# of 19518
I disagree that SR-82 revenue will be a year away. In the USA that is probably true, but not for generators for use in Canada & Europe. Sales could start in early 2013, if not sooner. The generator is approved in Canada, and the EMA has issued waivers and deferrals for the purpose of this study.

In Canada, where Draximage's Ruby-Fill is involved in a non-regulatory PET vs. SPECT study that will last 2 years, involve up to 10 medical centers, and has an enrollment of 6,000 patients.

Estimated Study Completion Date:________June 2014
Estimated Primary Completion Date:________October 2013 (Final data collection date for primary outcome measure)

http://clinicaltrials.gov/
enter NCT01128023 in search box

In Europe, Draximage is involved with another study which is scheduled to conclude by June 2014.

Scope of the application

Active substance(s): Rubidium (82Rb) chloride
Condition(s): Visualization of myocardial perfusion for diagnostic purposes
Pharmaceutical form(s): Radionuclide generator
Route(s) of administration: Intravenous use
Name/corporate name of the PIP applicant: Jubilant DraxImage Inc.

http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500125665.pdf

Robert
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