The trial record on the clinicaltrials website has been updated. The trial is due to start in November.
The eligibility criteria have been modified. This shows that some progress has been made and I would suggest that the trial record has been altered to comply with the IND application. As it is unlikely out CRO would be making several changes to the record, I think we can assume that the IND is only days away from being lodged.
http://clinicaltrials.gov/show/NCT01899092
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