Atossa Genetics Inc (NASDAQ:ATOS) Tanks On FDA Report
Atossa Genetics Inc (NASDAQ:ATOS) Stock was panned all round at the markets during trading on 4th March, which led to the market valuation of the diagnostic substance and medical equipment manufacturer taking a 11.3 percent hit during the day’s trading. The sell-off in the stock occurred when the drug maker disclosed yesterday that it had heard back from authorities at U.S. Food and Drug Administration with regards to its ongoing new drug application review for its newly designed breast aspirator equipment branded as ForeCYTE.
FDA Seeks More Data
The FDA has sought additional supporting data and related information from the device making company. Atossa Genetics Inc (NASDAQ:ATOS) disclosed that it will respond back to the FDA request by seeking a relaxation in the 30 day deadline set by the drug authorities, while they go about collecting and generating data sought by them. The request to be forward by the equipment maker is a run of the mill kind, and which FDA has routinely approved in the past for other new drug application review candidates.
Will Buy Atossa More Time
The extension if granted would provide Atossa Genetics Inc (NASDAQ:ATOS) with nearly 180 days to respond. The firm also disclosed that it treats the request for clarifications as an expected development and has indicated that it will try to work with the investigators closely with the intention of getting the device cleared in real time.
The likely delay to be caused by the questions from FDA has made investors of the small capped Atossa Genetics Inc (NASDAQ:ATOS) jittery. The medical equipment firm which focuses on products related to breast related health has accumulated net loss of $9.7 million from operations over 12 months and struggling with sales which is yet to hit the $1 million mark annually.