14% of the float is short, the float is only 12 mil shares with 15 mil shares outstanding, FDA approval is unknown, if approved add $300 mil to a negative $22 mil for income within the first 18 months after launch.
I'd say based on the efficacy and the accepted CRL, Zecuity gets approved with the downside being a post approval REMS study. A way to deliver migrain medicine without the risk of nausea is huge, doctors and migrain sufferers will be in force at the PDUFA meeting.
Safe conservative estimate for the S/P and I don't believe a post study will be required based on the safety study announced after the advisory meeting 2011 and the phase 1 study that was completed based on the request of the FDA
There was an issue with dosage delivery but that was solved with the redesign of the patch