ATOSSA GENETICS vor Turnaorund?
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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
http://www.thermofisher.com/en/about-us.html
heute wieder Mega-Umsatz, jedoch (noch) ohne News...
da geht was
die haben nen neuen Partner, bald werden wir über 5 sein
The company's management is not trustworthy.
The only product generated little revenues after over 2 years since approval.
The company's cash is running out soon after Q1 2015.
Atossa Genetics (NASDAQ:ATOS) went up over 40% in early trading when it announced Henry Schein will offer Atossa Genetics' FullCYTE Breast Aspirator on Feb 26th, 2015. Traders and investors have been repetitively trapped by this type of trivial news over the last year. As investors and traders are chasing the stocks, we would like to remind you of the spotty history of the management and the cash hungry status.
Atossa's management is not trustworthy
investors were burned badly in Oct 2013 when Atossa initiated a voluntary recall of the ForeCYTE Breast Aspirator. The stock price dropped from over $5 to 2'sh instantly.
Specifically, the FDA stated that the Instructions For Use (IFU) in the original 510(k) submission stated that the user must "Wash the collection membrane with fixative solution into the collection vial " while the current IFU states " apply one spray of Saccomanno's Fixative to the collection membrane " and that "this change fixes the NAF specimen to the filter paper rather than washing it into a collection vial."
(click to enlarge)
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Wertpapier: Atossa Therapeutics Inc |