It's not meant to be an easy process, this kind of critical review helps ensure safety and future success of the trials. Faster approval won't happen just because you want it to, nor do the delays diminish the credibility of their approval chances. In fact, it's good to know that progress is being made through this back-and-forth with the FDA.
On top of that, I appreciate the fact that they've updated the shareholders along the way, and it is easy to see a clear progression in the PR content. Approval is looking closer than it ever has in the past.
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