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Re: None

Monday, 03/31/2008 1:20:01 PM

Monday, March 31, 2008 1:20:01 PM

Post# of 35633
"In June 2007, we filed a pre-market notification pursuant to Section 510(K)...that we expect to be approved in the second quarter of 2008." From the 2007 10-K.
http://www.secinfo.com/d12TC3.thNg.htm

The above statement goes beyond safer and weaker renderings such as "that we expect to be approved in 2008" or "we expect a decision (SE/NSE) in the second quarter of 2008." Rather, it is: "that we expect to be approved in the second quarter of 2008." CSMG not only expects FDA approval, but it also expects said approval within the next 90-day period of time (Q2). This is a bold statement in a corporate filing forwarded to the SEC and doubtless read by FDA itself. In effect, it is second-guessing the FDA. In its prior filings, CSMG never made any reference to specific expectations regarding FDA approval or even an FDA decision. Why the change? You don't tug on Superman's cape or rip the masque off the Lone Ranger. And you don't second-guess the FDA unless you know for certain what they know for certain. CEO Don Robbins is known for understatement not hyperbole. He is cautious, almost to a fault, in his public utterances. Webster's definition #4 of the word "to expect" is "to consider probable or certain." In my view, given the penalties of Sarbanes-Oxley, no responsible CEO under the sun would ever publish such an assertion if there weren't a greater than 99.99% probability of it coming to pass.

Conclusion: Bank on FDA approval in Q2.






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