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robi-1-kenobi

12/29/13 1:09 AM

#77887 RE: Puffer #77885

Yes, maybe I should've included IND for TGA, but...

A year and a half ago (July 2012) there were press releases about retaining Australian Biologics Pty, Inc, a regulatory affairs consulting firm to coordinate regulatory review and approval to conduct the first human clinical trials for FluCide in Australia.

However, there has been no mention of them in the most recent PRs from the company (that I could find). The most recent presentation on the NNVC website from the Dec. 2, 2013 LD Micro Conference (and Annual Meeting?) included a slide with partners and collaborators which included Biologics Consulting Group (RA consulting firm with FDA experience), but no Australian Biologics.

And the Dec. 2 original slide on Goals and Milestones (which I couldn't locate - there is a slightly different version on the website) listed IND submission for FDA and EMA, but left out the TGA submission.

Due to these omissions, I left out TGA in my post as well. That doesn't mean they aren't still planning to conduct the first studies in Australia. They may be. But I am no longer sure of that and was trying to reflect the most recent information.