Looks like a routine meeting with FDA was held and it cleared path for ATOS to re-submit 501K application for process update. Appears only one final update will come that application is filed !!! If this meeting had any material implications then ATOS would have certainly updated through SEC filing.
Monday may be a different day and likely time to announce filing day.
...HAW!!!..."routine"????...did you read the FDA letter?...the FDA listed TEN complaints::
"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..."
...and that does NOT include the ADDITIONAL FDA accusations 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."
...I kinda doubt that it was a "routine" FDA meeting...HAW!!!...
I see that short interest has gone up in ATOS. Now any good news is likely to pop the pps and a short squeeze could recover some longs money. Now waiting for Filing of 510 K news. As regards the test, its 8 to 10 years in advance of a mammogram and therefore FDA can only say that the test is not 100% sure that early. But who wants to know that they have full blown cancer needing surgery with a mammogram !! Mammograhy and imaging techniques should now get outdated for the patients cause. ATOS sales are proof that the patients are willing to trust Forcyte rather than faulty mammograms which are too little too late anyways.
Sentiment: Strong Buy
You do not have a scintilla of knowledge about the FDA. They listen to the applicant. They do not tell them the day of the meeting. This is the government you are talking about. ATOS will address every complaint in the February letter and how they intent to remedy each. The FDA will tell them what they want not visa versa. If it was as simple as you believe Quay would have been on the wire telling us how smart he is.
You better pray the FDSA does not ask for a clinical trial. Also is you listen to the CC, the other three tests are all going to be 510K applications. Last year the company was going to market them without asking.
They will gain market acceptance I due time. Just not on your time table.
I really hope you are right. Another interpretation of this "no PR" situation could be that Atossa has to evaluate the complex consequences of the discussion and information derived from the FDA meeting. Nevertheless I think that ATOS would have some obligation to inform investors of the outcome as soon as possible - either way.
FYI: The FDA issued an updated release on 11/12/13..
" The MASCT System Kits and the ForeCYTE Breast Health Tests have not been cleared by the FDA for the screening or diagnosis of breast cancer. If they are used for these purposes as marketed by the firm, women may choose to forego mammograms and necessary biopsies and may experience serious adverse health consequences. These include false positive test results, which indicate the presence of breast cancer when none exists, and false negative test results which indicate the absence of breast cancer when the cancer exists. False positive results may lead to needless patient anxiety, along with further testing and treatment that are not necessary. False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer with increased risk of death."
Screening for precancerous cells in the breast is not the same as screening for breast cancer. ATOS has not proved anything and really relied on the work of others I assume. ATOS made clinical claims that were not done by them. This release coming two days before the meeting with the FDA is a red flag for me. While some of the ATOS literature is murky, I feel there is a better than even chance the FDA will require ATOS to do a clinical trial. The key phrase to me is " If they are used for these purposes.as marketed by the firm." Since the ForeCYTE test has not been cleared for any "indication" and that is FDA speak for clinical trial.
Good luck and I do hope I am wrong.