Don't think it's a "big red flag." Don't think the timing will deviate much, if at all. They must say that their submission timing is contingent on a preliminary meeting, but this only ensures that, once the submission is made, the likelihood is that GIVN will have supplied what is necessary and all will be satisfactory.
Could you please add your comments/thoughts on "What happens if Capso Vision and Catch-cap introduce their Colon Capsules in 2016 in USA"? Impact on price Impact on Market share Legal expenses for Patent infringement(will Given Imaging sue these co.)