I hadn't seen 'accelerated development' mentioned in any of the past announcements. Fast track & Orphan Drug Status yes, but not accelerated development.
Taken from the Chairman's Address at AGM....
Secondly, we continue to pursue favourable regulatory pathways and we were naturally delighted to have been granted orphan drug status by the FDA for NNZ-2566 in the indication of Fragile X Syndrome towards the end of last year. Orphan drugs represent an attractive commercial opportunity given the 7 years of marketing exclusivity conferred on them as well as regulatory advantages and potential for accelerated development.
Here's what the FDA have to say about 'accelerated approval'...
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated
Then watch this video....
http://www.youtube.com/watch?v=fzlePvW-Dg4
Tony
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