Basically TIS's product was already approved, until some medical beaureaucrats got power hungry or didn't like someone, I don't know exactly. But they did make an error in judgement. However, rather than admit it, they covered up by calling for more information to make themselves look like they were doing a good job.
If this isn't approved they will look very silly indeed. But the medical industry is full of silliness....so one waits in anticipation.
TIS Price at posting:
23.0¢ Sentiment: Hold Disclosure: Held