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Replies to #54899 on Biotech Values
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DewDiligence

02/25/08 9:34 PM

#59562 RE: DewDiligence #54899

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:

http://www.sec.gov/Archives/edgar/data/884629/000095013408003261/a38293e10vk.htm

>>
“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.