...FDA warning letter?...in the summer of 2012, the FDA inspected ATOS facilities and cited them for various problems that ATOS was supposed to correct...in February, ostensibly after ATOS addressed the issues raised, the FDA sent them a letter citing TEN FAILURES:
FAILURE "to establish and maintain procedures to control the design of the device...to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation...to establish and maintain procedures for implementing corrective and preventive action...to maintain adequate complaint files and to establish and maintain adequate procedures...to maintain an adequate record of investigation by a formally designated unit ...to establish and maintain adequate requirements, including quality requirements, that must be met by suppliers, contractors, and consultants...to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance...of management with executive responsibility to review the suitability and effectiveness of the quality system... to establish and maintain procedures to ensure that device history records for each batch, lot or unit are maintained... to establish a quality plan which defines the quality practices, resources, and activities..."
The FDA then accuses them of "misbranding" because "your websites contain statements that create an impression of official approval of a device due to clearance of a premarket notification submission," because the device's "labeling is false or misleading," and because the "firm failed or refused to furnish material or information respecting the devices that is required."
What is this -- the plot for a Larry, Moe, and Curley Joe start a biotech company movie?
Isn't the same FDA letter the reason why the stock can be picked up at a cost of 75% less than the book value of $5? Recycling old information repeatedly towards what purpose?. we are now looking for information about ATOS approaching FDA again and the outcome of their talks. Preparing for a rebound now which will remain upward bound from here.
....uhhhhhhhh -- NO!...the original inspection was in July of 2012...that's six months BEFORE the thing went public...the letter itself came out in February and was the FDA's response to Atossa FAILING to do address the issues raised in that inspection...they also ADDED a NEW complaint accusing ATOS of "misbranding" and "misrepresentation"!...
...incredibly, the stock RALLIED after that to a high around twelve bucks a share in the month AFTER that news was released!...
...even more incredibly, it appears that ATOS did NOT mention the July, 2012, inspection and the FDA's complaints in their initial prospectus!...however, they DID discuss it in an amended prospectus filed in April 16!!!...they said:
"Our business will be adversely affected if we cannot timely resolve the matters raised in the Letter, or other matters raised by the FDA, to the FDA’s satisfaction or if we are not successful in continuing to market our existing System, reverting to marketing the System using the prior NAF processing method or obtaining an additional 510(k) clearance in a timely and cost-effective manner."
...well, DUHHHHH!...then October 4:
" Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013."
...geez!!!!...they even had the nerve to claim it was a "voluntary" recall!!!!!!!!!...talk about handing a lawyer a case on a silver platter!...and given they didn't even mention the original inspection results in the IPO prospectus, it looks they could even face FRAUD charges!...shareholder lawyers are probably laughing themselves silly!...
You're getting way too excited over simple letter. If the FDA really had serious problems they wouldn't have been sending out warning letters, it would have a recall letter.
Almost all of those ten failures look like boilerplate language to me. Boxes you check on a form as you run through the inspection. In my business I get those all the time from various gov agencies (fed, state, city, county). Everyone has their forms, and some inspectors like to check more boxes then others. Clearly ATOS management dropped the ball in not taking them serious enough. Live and learn.
...what exactly is your definition of "serious"?...to me, failure to mention the July, 2012, inspection in the initial prospectus is SERIOUS...ESPECIALLY when, in an amended prospectous isssued six months LATER, they ADMITTED that if the matters couldn't be resolved, their business "will be adversely affected"!...even MORE especially, when another six months later, they recall EVERYTHING they've distributed so far and have the temerity to call it a VOLUNTARY recall!!!...all that seems pretty SERIOUS to me!...