Note 12 - Subsequent Event

9 Months Ended

Sep. 30, 2017

Notes to Financial Statements

Subsequent Events [Text Block]

Note

12.

Subsequent Event

On

October 31, 2017,

we

submitted a New Drug Application (“NDA”) for AZEDRA to the FDA. We are developing AZEDRA as a treatment for patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. AZEDRA has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA. There are currently

no

approved therapeutics in the U.S. for the treatment of malignant, recurrent and/or unresectable pheochromocytoma or paraganglioma.

There can be

no

assurance that the NDA will be approved. See

Part II, Item

1A.

Risk Factors

below for important information regarding risks that could result in delay or denial of the NDA.