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Biotech / Medical : Sonus Pharma (SNUS) ? Opinions -- Ignore unavailable to you. Want to Upgrade?

To: nanoh who wrote (279)	4/3/1998 2:43:00 PM
From: jpgetty	Read Replies (1) \| Respond to of 384

Any comments on this? I got it from the Yahoo SNUS message board: FDA division of Drug Marketing, Advertising & communications said in a March 26 warning letter to Sonus pharmaceticals. 1) "The materials diseminated by SNUS clearly are promotional in tone and contain promotional claims, including comparative claims that promote the alleged safety and effectiveness of Echogen, " FDA said in the letter. " These activities constitute preapproval promotion of an investigational new Drug" Sonus has an NDA pending with FDA. 2) The promotional messages " are false, misleading, or inconsistent with respect to the uses, if any, that may ultimately be approved and the relative safety and effectiveness related to those uses, " FDA maintained, SNUS does not know what indications and other information the final product labeling will contain if the product is ultimately approved." 3) In addition, the letter says " SNUS representations about the drug are overly optimistic, such as representations exaggerate the effectiveness and minimize the risk with respect to such investigational drugs ... Such misimpressions could result in widespread misuse if the product is ever approved for commercial distribution ." 4)The FDA letter highlights several articles presented in the journal supplements that discuss the safety and effectiveness of EchoGen as an ultrasound contrast agent " The letter says. The Slide kit also" presents claims that Echogen is safe and effective for prostate imaging, transcranial Doppler imaging, facilitation of diagnosis of hemangiomas, carotid artery blood flow, and determination of metastatic carcinoma" 5) FDA asked both SNUS and Abbot companies to correct all the false and misleading information before April 9, 1998. As we all know SNUS was hiding this letter and pushing the stock price up by false claims. Good luck