Ounce, Dean has way more regular, more substantive, and more personal communications with the reviewer than the every 30 days by fax provided for by the Status Program at the FDA. Take a look at what you listed as the information that the Status Program provides for:
"* The ODE or OIVD division or branch to which the 510(k) is assigned;"
Dean knows exactly to which division the application is assigned. In fact, he has regular communications with the actual reviewer. What is a fax every 30 days identifying the division to which the application is assigned going to tell him that he doesn't already know?
"* The last action, and date of action, that ODE or OIVD has taken regarding the 510(k);"
If he talks to the reviewer as often as he does, and he knows the application is still under review, what is a fax every 30-days that says: "application assigned to reviewer and under review" going to reveal that he doesn't already know?
"* The position of the 510(k) in the reviewer's queue;"
He knows where it is in the queue... it's at the top because it is currently under review. He knows because he speaks regularly and openly with the reviewer, so what's to be gained by a fax every 30 days that says: "application assigned to reviewer and under review"
"* The average review time for the division or branch."
These statistics are publicly available. What's to be gained by having the same set of statistics faxed to him every month?
It would be one thing if Dean was sitting there in the dark and the application was sitting in a black hole, but the reality is, he is getting regular updates. He knows exactly where things stand. He talks to the reviewer regularly. The Status Program is not designed to provide any meaningful substantive information. It exists for entities who have heard nothing from the agency and just want to know if there application is off the shelf yet. We know ours is on the reviewer's desk and Dean knows all of the information that the 30-day fax would provide. So what would be the point of it?
I understand your frustration, and what you're really saying, and I agree... we, i.e., the investors here, would like to get some sort of official update every 30 days. But this is not a public process and it shouldn't be. As much as I'd like to be a fly on the wall during Dean's regular communications with the FDA reviewer, that's not the way the process works. But to suggest that Dean is sitting there in the dark, not taking advantage of some "valuable" tool to gauge the status of the DViS application is just not accurate. The tool is hardly valuable because the information that the FDA provides in response is very basic and largely generic, and Dean already knows all that information and more. It's just that you and I don't know it, and while that is frustrating, it's just something we have to deal with. I wish I knew exactly how Merck's latest dealings with the FDA were going in their latest cancer treatment, but they don't reveal that to anybody. We just have to trust that they're doing everything they can to get the job done... and with his own personal 60 million shares, and the millions of shares that he's got his friends and family in for, I have little doubt he is working as hard as he can to make this happen.
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