The share price has no idea what the risk of rejection is, and...

The share price has no idea what the risk of rejection is, and if it did, considering we are up well over 100% then it believes we will get approved.

If you look at the transparency from the company, which they have repeatedly said they have passed us everything, and that they have changed the label exactly as the FDA have asked.

In my opinion there are only 2 possibilities for rejection grounds.\

1. Earth shattering new data comes to light from Ecclock sales in Japan - like huge cases of serious, well documented side effects spring out of absolutely no where. Utterly no evidence of this whatsoever.

2. The FDA take issue with the design or way the human factors training was conducted. The result is beyond reproach as there was a 0% misuse rate, so the only issue I can see here is an FDA thought up overnight requirement where they decided that 10,000 people need to be human factors tested instead of 300 or however many, or demographics need to change. It sounds like the HF training was done standard, so I highly doubt new requirements will spring up overnight. P values with a 100% success rate are obviously good.

In short, this is the surest FDA approval I have ever seen based on the companys' transparency in the CRL and what it is has done to rectify ....... barring one of the above unthinkable scenario's happening. Take your pick.