Hanna Tokkie schreef:
A pre-BLA meeting should be held about 6 months prior to the planned NDA or BLA submission date.
Leiden, The Netherlands, December 9, 2009. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) today confirmed its interactions in a pre-BLA meeting with the US Food and Drug Administration (FDA) on a proposed marketing application (BLA or Biologics License Application) to obtain marketing approval for Rhucin for the treatment of acute attacks of HAE (Hereditary Angioedema).