Quote from xflat2186:
If the stock goes down on the news the premium will be out of the calls you own before you could sell them. If the stock rallied you'll need to be quick to sell also as volatility will get crushed. You need a couple hundred % move
The stock is up about 56% this week on huge volume in the stock and the options. My calls are profitable but I am inclined to think we could see $10 - $12 pre-approval. I will be selling some before the scheduled FDA ruling - early rulings are also a possibility.
I think I will sit tight for a bit and see what develops.