Statistically speaking, around 50% of NDAs get full FDA approval upon first review. Odds are better if you've had a product approved by the FDA before, which is the case for Al Mann. So flip a coin.

While I don't expect the FDA to require additional clinical trials, there could be other minor things that delay full approval beyond Jan 16th. These could be related to manufacturing, etc.

It's a very realistic possibility that MNKD may only receive an "Approvable" decision by the FDA on Jan 16th. NO ONE can anticipate how the FDA will decide on anything. Be prepared. It could be another major buying opportunity on that day.

There is no sure thing in life, besides death.