The excuse in December was "they are working hard on the re-submission of the 510(k), no time to work on the Migraine Study." Remember the 510(k) resubmission? the one the company said on Dec. 4th would happen "immediately?"
When the government was shut down in January, the FDA wasn't accepting new 510(k)'s -- what a perfect opportunity to work on that Migraine Study! Unless, of course, it was a failure, in which case we'll never hear about it again.....