MNTA – It’s now official: the FDA requested that Amphastar furnish information on the immunogenicity of genetic Lovenox. From page 40 of WPI’s 10K filed today:
>> “Amphastar has not obtained FDA approval for its product and the product continues to be delayed by a Citizen Petition, including two supplements, and other factors. Amphastar has submitted comments to Aventis’ Citizen Petition and supplements. Additionally, in November 2007, the FDA requested Amphastar to provide additional data regarding the potential immunogenicity of the product.” <<
MNTA and WPI told investors the above in November (Teva has declined to comment). It’s nice to have confirmation that they were telling the truth.