Ann: Regulatory Update , page-6

Oh boy, where to begin... how about the plausible deniability claim ("...EMA process excludes sponsor companies like TIS from direct contact..."). Thing is, they've been able to access and assess the BSI submission in the last 5 days, no doubt in panic, only to discover "oh dear, that's not very good, is it?". If the bureacrats exclude you, fine you can't control that, but at least manage what those putting your case forward are saying - before they submit it, not after!