Joe seemed to tip his hand yesterday showing they are planing for a FDA NDI submission. Only a handful of companies would remain if this is the FDA guidance.
Michael Lavery (Piper)
Thank you. Just following up on that FDA note, Gottlieb obviously not still in charge, but certainly well informed and connected and one of the things he had suggested or sort of seemed to be pushing forward was petitions for new dietary ingredients as a pathway. Is that something you've been preparing for, how do you think you’re position there, is that something you think is likely to be a path you would pursue?
Joseph Dowling
It is a path that we would pursue. I think that Dr. Gottlieb was strongly suggesting that that was a regulatory sort of not requirement, but perhaps and that really aligns well with the existing regulatory framework for our industry. So we've been positioning for this for a while.
As you know a couple of years ago we made the decision to invest in all the toxicology work to achieve. And the only company to achieve self a firm [ph] grasp. Obviously that's one component of being able to get an NDIN process going. There are other steps and we are pursuing all of those steps as well. So yes, we are going down that path Mike, and we think that's a good direction for FDA to go"
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