أخبار سلبية وتم توقيف السهم لتأكد من الأخبار
Matrixx Initiatives drops ~$4 after Bloomberg reports Matrixx told approval needed for Zicam, though 'homepathic'; Matrixx told by FDA no proof Zicam products safe, effective (14.39 -4.32)
وهذا الخبر اللي الثاني
11:31 MTXX Matrixx Initiatives: Follow up (9.94 -9.34)As mentioned earlier the FDA has issued a letter to MTXX with concerns about the firm's marketing of the products Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size. The letter says the "... FDA has concluded that these products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 reports of anosmia, (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products. To protect consumers, and in light of the violations described below, we ask that within fifteen working days of receipt of this letter, you notify this office in writing of the specific steps that you have taken to correct the violations. These products are available without a prescription, and they contain zinc gluconate (identified as zincum gluconicum on their labels) as their active ingredient. All are administered by direct application to the nasal cavity and, as described in the labeling, are intended for use in "adults and children 3 years of age and older (with adult supervision)." These products are referred to hereafter as the "Zicam Cold Remedy intranasal products." According to the labeling accompanying the Zicam Cold Remedy intranasal products, each of these products "reduces" the "duration of the common cold" and the "severity of cold symptoms," including specifically "sore throat, stuffy nose, sneezing, coughing, congestion." These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals. We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling. On the contrary, as described below, there is evidence that these products pose a serious safety risk to consumers. Because they are not generally recognized as safe and effective for their labeled uses, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. ? 321(p)..." The stock has now dropped another ~$5, and is down ~50% in the last 30 minutes
وهذا الخبر عن وقف التداول ونزول أكثر من 55%
Matrixx Initiatives trading halted (8.56 -10.68)See our 11:19 and 11:31 headlines for details