Its interesting to explore the significance of Breakthrough...

Its interesting to explore the significance of Breakthrough Therapy designation! What statement is the FDA making to physicians, patients and by extension investors when it approves an application.

The FDA is clearly making the point that for a given serious or life-threatening condition, the sponsor has demonstrated that an investigational new drug offers substantial improvements over existing therapies. Its a bold statement of efficacy albeit a provisional assessment.

Its why John Carroll from FierceBiotech says, in a January 2014 article, Analysts score the winners in the FDA's new 'breakthrough' category, that "[BTD has] proven to be a big influence on investors watching the industry".

It would appear that Neuren is quietly confident about its application. BTD for NNZ-2566 would also make a powerful statement to the pharmaceutical industry.