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FDA/SEC partnership might have teeth


Another example of the need to play the field

The SEC dropped the hammer on Vaso Active Pharmaceuticals (VAPH:NASD), halting its stock until April 15th for "questions regarding the accuracy of assertions by VAPH and by others, in press releases, its annual report, its registration statement and public statements to investors concerning, among other things: (1) FDA approval of certain key products, and (2) the regulatory consequences of the future application of their primary product."

In February, the SEC and the FDA announced the two agencies would work more closely in enforcement situations. The headline sounded good because this sector could benefit from heightened SEC attention. However, the actual components of the plan listed in the press release led us to say at the time the program wasn't much more than an exchange of business cards between senior staffers.

Looks like I'll have to retract that quip. While representatives from the SEC and the FDA are not talking publicly, it sure looks like Vaso's claims for its over-the-counter medical products ran afoul of someone at the FDA to such a degree it caused the FDA to involve the SEC. For that matter, it could have been the other way around as SEC attention would have been attracted by a management team that was very vocal for being just a couple of months removed from their December 2003 IPO.

I have done no specific research into Vaso, so please don't take this as a commentary on the company or as validation of regulators' concerns about the company. I honestly have no clue or opinion about the company or the current situation.

I wanted to make Minyans aware of the news for a specific reason: I will be writing later in April about the absolute necessity for the SEC to step in and address how biotech and pharma companies handle release of material information concerning clinical trial data. This news item offered a perfect opportunity to introduce the subject of the relatively recent expansion of a working relationship between the two regulatory bodies with the most impact on the biotech/healthcare sector.
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