They indicate they are still evaluating there options and trying to figure out if trials are an option. I think if they had submitted a de novo petition requesting FDA to make a risk-based classification determination for the device under section 513(a)(1) of the FD&C Act they would of legally had to say that in the 10-Q. I would love to know why they didn't at it seemed a good fit. But I don't see them answering that. They did manage to trade shares for consulting services in Feb. and Mar. which means they convinced someone they had a chance. But no consulting services since. So if they are weighing their options I'm not sure how they are doing it. A flood of stock at a penny or hundreds of pennies a share is not going to go very far.
But frankly I think the company is toast :(
They need guidance from FDA before clinical trial should start. I am waiting on that application and either FDA guidance or NTP. They are toast when they cannot find a partner or funding to go at it alone on the necessary trial/trials. They need the trial outline/design before they can be toasted. There are several steps left to make toast. You might make your toast differently than me though.