IMPORTANT note regarding HALO PDUFA date:
HALO noted in a press release dated December 2 2013 that they had refiled their BLA and expected a 6 month review for HYQVIA for Subcutaneous treatment for patients with primary immunodeficiency (PI). On May 21 they noted in a release that the PDUFA date was extended by a further 3 months (3+6 = 9 month review in total). BioPharmCatalyst previously used this timeframe of 9 months from December 2, 2013 for an ESTIMATED PDUFA date occuring by September 2, 2014. However, this date has been removed from the calendar as per a request from HALO Investor Relations who would like to inform that no official specific PDUFA date has been issued by the company except that it will occur during “late 3Q 2014″.
Consequently, the HALO PDUFA date has been removed from the PDUFA Calendar as the PDUFA Calendar requires a SPECIFIC date in order for an entry to be listed.