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sojourner

06/28/07 7:05 PM

#10777 RE: 1stepahead1 #10776

Re: "Is it possible we had already filed, and DR is just planning to PR the FDA approval? Is filing itself considered a material event?"

An interesting point. It is possible CTUM has already filed the 510(k) with FDA. The FDA website allows for searches of official approval or denials of 510(k) applications. It doesn't host notices of filing, to my knowledge. Not to say such information can't be found somewhere.

As far as material events are concerned, I've seen many cases where a "material event" is released as news before it appears as a formal SEC filing. Indeed, the SEC filing will refer to the PR as documentation.

As aside, I agree with Dane and gamood. Let's have done with this.