As long as we are speculating here. I believe we should have had some type of regulatory easing in our pathway to approval. Especially given all of the advantages the 21st century Cures Act provides for small innovative companies like ours.
My hopeful speculation is that we are awaiting some type of advantage; expedited pathway; etc. That we are collecting and providing the FDA or whatever other agency internationally with the data needed to take us through the path of least resistance.
Frankly, I'm surprised that we haven't received something already. Obviously we are on the radar. We are working with the FDA in trial design, they have given us orphan status, we are using the adaptive design they created. We are using the latest FDA approved analytic tools. What better way to show forward movement in the way trials and the approval process is evolving.
Couple this with the urgent need and strain on our health care system. We may be waiting for the new FDA chief to give a blessing. It would be a win for the administration as well.
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