This is the dot point that stood out for me.Borrowed from the...

This is the dot point that stood out for me.

Borrowed from the FDA website....

A drug that receives Fast Track designation is eligible for some or all of the following:

* Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#fast

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.

http://www.neurenpharma.com/IRM/Company/ShowPage.aspx/PDFs/1394-78838394/ChairmansAGMAddresstoShareholders

If you haven't watched the video I posted below, here it is again. Then have a read of this page on 'Accelerated Approval'.

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated






Tony