Atossa Genetics knallt runter: Bottom Fishing!

Am Freitag kamen wohl schlechte Nachrichten. Rückruf der ausgelieferten Produkte, neues 510k notwendig.

Hier: http://content.stockpr.com/sec/...-13-054080/0001144204-13-054080.pdf

Es ist davon auszugehen, dass das 510k Ende Oktober gestellt wird + 90 Tage.

Mal sehen, wo der Boden ist und wann man einsteigen kann.  

Danke für den Tipp... Droht hier Insolvenz oder kann man mit einem schönen Rebound rechnen?

 

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.  

was ist ein 510k?

http://www.bizjournals.com/seattle/blog/...recalls-breast-health.html

wenn ich das richtig gesehen hab ist das ihr einziges produkt...?!  

Damit kommen die noch 1 Q weit....

Nichts für mich, viel zu riskant !  

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.  

 

geht auch wieder rauf. Aufgrund der eigentlichen guten Kapitalausstattung bin ich mal 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