The FDA will have their own guidelines for patient approval for the trial and for data collection. The independent study will help give the submission more credibility but I doubt it will count towards the study.
The advantage is current patient studies allow the market to see results before we get the FDA trial. That's the negotiation advantage. if we get take over offers once FDA trial is approved WP has a lot more bargaining power because there are results that aren't speculative he can hold in his play book.
Plus the experiences from these trials will be invaluable and any non critical changes (like doctors wanting different packaging to make opening in theatre easier and all those insignificant significant things) can be made before we get started.
There are huge advantages to what we're doing now, regardless of if we can or cannot add data to the FDA trial.
We've moved at incredible speed to get from valve concept to here and we should appreciate that. In the scheme of things for the industry, we are still moving fast.
exciting times
AVR Price at posting:
$29.30 Sentiment: Hold Disclosure: Held
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