Emergo, our FDA application consultants (ref. ann. 6-Feb-2017), would not sanction us lodging the application unless they were convinced that the application would be successful. Therefore the fact that the application has been lodged has the potential to influence the market's evaluation of the company.
The estimate of 6-9 months seems conservative but not ridiculously so. In 2016 (the latest figures I could find) 58% of 510(k) applications were approved in under 6 months, while 86% were approved in under 9 months.
The web page gives a few highlight figures, including an average of 177 days to get approval, and 19% of applications being approved in less than 3 months. There's also a link to a PDF with the full results. Page 7 of that report gives the numbers I quoted above.
NTI Price at posting:
13.5¢ Sentiment: Hold Disclosure: Held
