Once the blinded portion is completed, and all receive the drug over an extended time, there is a great value of the OL portion to demonstrate long term safety, for which blinding should, I think, be far less important.
Indeed, if they have reclassified the trial from Ph 2 to Ph3, I believe that will require a regulatory decision of approval. It will be of great interest to learn if the regulator blessing comes from the FDA, Austrailia or the UK, and if they do have regulator approval of the Ph3 and the altered Endpoint priorities, what showing may have been required by AVXL to the regulator concerning AVATOR results and the OL extension.
Some or all of the "delay",IMO, in presenting data may, I speculate, be due to the interface that I suspect is possibly occuring with regulatory authorities, and the handling of the voucher issues.
This is one of the reasons I think the constant negative commentary about allegedly unprofessional delays may be unwise and premature. We shall see.
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