Go to the company's website and listen to the live presentation. Quartz went through each of the FDA'S concerns and indicates they've made major progress in meeting all of them. More importantly, he discussed some new data showing the drug also outperforms its competitor over several chemo cycles. Don't forget, Appa has a unique biochronomer drug delivery system and this is just the first product in the pipeline. Expected submission of the new NDA to the FDA will be 1st quarter 2014 and they're prepared to move very very quickly on sales once approved by the FDA.
While at the company website view the backgrounds of key figures like Quartz and Rosen, both of whom have experience with billion dollar drugs. Ask yourself why people like that would want to come to Appa, as Quartz did 2 months ago.
Franklin Biotech Fund has also increased its holdings in Appa from 10 million to 40 million shares over the last several months.
It seems to me that this an exceptional risk/reward opportunity. When (If) approved, this drug could easily become #1 in its market and $2-3 per share doesn't seem outlandish to me.