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Keine Insolvenz. Die haben Cash. Wenn ich das recht überblicke, ist das ein FDA Geplänkel .. die stellen jetzt den 510k nochmal neu, räumen die Diskrepanzen aus und dann gehts wieder weiter.
"Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address concerns raised by the FDA in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current instructions for use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. Atossa will remove existing product from the market until FDA's concerns are addressed."
Mal sehen, wann sich ein guter Preis bildet, um einzusteigen.
Wenn ich das richtig verstehe, handelt es sich nur um Formfehler. Das neue FDA Filing wird es zeigen. Ich gehe davon aus, dass sich hier der PPS im November verdoppelt und bin jetzt mal mit einer relativ kleinen Pos eingestiegen.
Atossa Genetics Inc. Announces Successful Closure of FDA Inspections SEATTLE, WA -- (Marketwired) -- 12/05/14 -- Atossa Genetics Inc. (NASDAQ: ATOS) today announced that it has received "establishment inspection reports," or EIRs, from the U.S. Food and Drug Administration, Office of Compliance, related to inspections conducted by the FDA in 2012 and 2014. Issuance of the EIRs means that the FDA has now closed those inspections. Dr. Steven C. Quay, Chairman, CEO and President, stated, "Over the past 18 months, we have worked diligently to ensure that all observations noted during the inspections were being resolved expeditiously. I would like to thank the entire Atossa team for their tireless commitment to this effort. We will continue to devote significant resources to ensure that our regulatory compliance meets current standards worldwide with respect to our business." About Atossa Genetics Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory services and the Company's medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For additional information, please visit www.atossagenetics.com. Forward-Looking Statements Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa's products and services, performance of distributors, estimated future expenses and cash needs, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time. Source: Atossa Genetics Inc
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