Arena did say the right things to the Advisory Committee, and got an 18-4 vote recommending approval of Lorqess, or 19-4 if you count the one abstention, according to that voter who said he didn't know he couldn't abstain. With no clinical signal for any side effect that would require a Risk Evaluation and Mitigation Strategies (REMS) filing or post-approval cardiovascular outcomes trial (CVOT), a timely FDA approval seems likely on Wednesday. Based on the materials Arena submitted to the FDA, I also think the Agency will reclassify Lorqess from their preliminary restrictive Schedule II to a Schedule IV or V drug, eliminating the need for a four-month Drug Enforcement Administration process. Lorqess could be on the market after Labor Day.
In this article I want to update my base case revenue model to reflect the additional shares issued since my last article. This model uses a very conservative wholesale price of $1 per pill to Arena's North and South America marketing partner, Eisai Pharmaceuticals. At two pills per day, that is only $2 a day per patient.