Overall, it’s one CRO which is also affiliated with other CROs in Canada, Germany, or Britain (similar to United Airline with its "sister" carriers). All these CROs are more strictly regulated than the ones in the US. As for regulatory requirement, I do not think there will be any issues with FDA.
I do not think the issues arose from CROs. The analysis of biomarker, exome, and others delayed the data lock. It’s probably due to Anavex management rather than anyone else. The design of the trial, especially morning dosing, was the culprit. A dizzy patient will not able to perform well in cognition or daily function. Bedtime dosing would have produced “magnificent” results. Hope a big pharma can see this side. I contacted couple of chief science person in mid-sized pharma. They might be receptive to the idea of a new collaborative trial. On the hand, Dr. M is currently a “huddle”.
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