Enrollment Complete — In Chagas Program Bio-availability Study…

Even so, the stock is off a bit…

But here is the presser — and a bit:

…[The company] today announced it has completed enrollment and follow-up of subjects in its human bioavailability study for benznidazole.

The bioavailability study is a key part of the company’s planned New Drug Application (NDA) package to the U.S. Food and Drug Administration (FDA) in the 505(b)(2) development program for benznidazole as a potential treatment for Chagas disease, a neglected tropical disease. The study’s main objective is to characterize the pharmacokinetic profile of benznidazole.

Analysis of the study has begun and the company anticipates preliminary interpretation of the data by October. The company expects to have the final study report in the fourth quarter of this year.

“The completion of the bioavailability study is another example of the Humanigen team’s ability to execute and to continue to deliver on our program milestones and goals,” said Cameron Durrant, MD, chairman and CEO. “Chagas disease is a neglected tropical disease with significant prevalence in the U.S., high unmet need and unique and complex challenges, which we are working hard to potentially help address.”

Humanigen expects to submit its NDA in the first quarter of 2018. The company received clearance from the FDA in June for its Investigational New Drug (IND) application and earlier this year received positive guidance from the FDA supporting the company’s proposed 505(b)(2) regulatory pathway for benznidazole, enabling the company to use data obtained from previously conducted studies to demonstrate safety and efficacy in the treatment of Chagas disease within the U.S.…

No you know — and Billy is right, in comments — this will be a struggle for a while now, with the Savant litigation pending.

Namaste….