Loose lips can sink stocks
Silver Spring's United Therapeutics hopes to receive FDA approval for its first drug in the coming weeks; Until then, mum seems to be the word
You recently reported fourth-quarter revenue that was more than double last years. Do you expect to continue that rate of growth going forward?
So you wont even say when you expect to turn a profit?
What you hope to be your first product, Remodulin, is in testing right now. You recently said you expected it to be approved in 10 weeks. Does that put it in mid-May?
No, we said that the average length of time that it takes to go from the approvable letter to final approval and clearance for marketing is about 10 weeks. We hope that that average applies to us and that well have final approval within 10 weeks of our good news that we released on February 8.
Remodulin is a drug that treats pulmonary hypertension, is that correct?
It is for pulmonary arterial hypertension. For patients that have symptoms classified as class two through four.
What does that mean?
Basically, it means that theyre symptomatic. They have symptoms, and they can have any form of pulmonary arterial hypertension. There are many, many subsets to that disease. Many different types of pulmonary arterial hypertension and, once approved, we would be indicated for all symptomatic patients.
There are about 50,000 people in North American and Europe that have it?
Thats correct. Thats a reasonable estimate.
That includes the daughter of United Therapeutics founder, Martine Rothblatt.
How is she doing?
Shes doing well.
How does Remodulin work? Its described as being in a cassette thats beneath the skin.
Subcutaneous injection is the mode of delivery. Subcutaneous means beneath the skin. Its delivered with a micro-infusion device. Its the same kind of pump thats used by tens of thousands of diabetics who get their insulin by micro-infusion every day. Its a small, convenient pager-size device that a man can clip on his belt or a woman can just tuck into her bra. It holds the drug inside this little device and pumps the drug through a catheter that is inserted underneath the skin.