A few thoughts for what it's worth

First thought FDA approval rather denied or approved is a material event
Requiring the company to announce within four days

The fact that we have heard nothing says it has not been denied !
The fact that it is still having hits says it is still in progress

Getting the ticker symbol requires some time and necessary paperwork depending upon which exchange? it will be on

I also believe that this delay will be totally game changer and understood and excepted with open arms by all longs after it is announced what they have been doing
Wile we have been whining they have been helping US with share holder value