B needs to be better

Pharming Group N.V. (Euronext:PHARM) lost 31% of its value last week after FDA refused to file a BLA for Rhucin conestat alfa to treat acute attacks of hereditary angioedema, and must hope a Phase IIIb trial begun in February will be sufficient to meet the agency's demands.

FDA said the application lacked enough subjects who received the proposed dose of 50 units/kg and lacked prospective validation of the visual analog scale (VAS) used to measure the clinical effects of Rhucin...