Anavex meets with the FDA relatively frequently: they pay for the privilege and because they have several programs in various stages of execution they take advantage of FDA guidance as PDUFA allows for each one. All life sciences companies with clinical programs do this.
And all life sciences companies miss their milestones. Every single one of them. The big companies simply don't share their timelines because they are less material - but all pre-revenue companies have to talk about is the future so they share their timelines and then always miss their milestones.
Dr. Missling is not "stringing shareholders along" but sharing what he thinks he knows at the time. All CEOs aim for best case - it is the best way to get everyone pushing for optimal results. So far, Dr. Missling has successfully funding the company, built shareholder value, and seen every clinical trial succeed. Yes, it takes too long - but we all know that it ALWAYS takes twice and long and costs twice as much, so this is not a surprise to anyone, is it?
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