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Saturday, 10/14/2017 2:42:59 PM

Saturday, October 14, 2017 2:42:59 PM

Post# of 466490
It seems the small sample size is what investors and the street just can't get over. Regardless of the data presented.

Until this approach is validated by the FDA with an approval, most will remain skeptical. Our share price will suffer until then. The small sample size argument would be made even if our data was spectacular.

Only then will BPs start believing and using this new way of trial design. Until an approval happens, the doubters will say. Show me one drug that has successfully utilized this type of trial design to gain approval.

And if no one has done it before, why should we? And investors will say the same. Why should we invest?

That's the reason we will remain here. For the FDA to make this paradigm shift successful, they have to show it works. They have to show the world that this is the easier, more efficient, less expensive path to approval.

If we truly are the first, the FDA has a lot riding on our trial as well.
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