Biotech Values

[mouton29]

<<Am I correct to think that the FDA requested the purity data only because of the heparin and lovenox recalls that were happening at that time?>>

Not so far as I know, although it is possible the record before the district court is to the contrary. But the FDA request for immunogenicity data came in early November 2007 (see http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=273369), while the heparin contamination seems to have come to light some months later. See, e.g., http://www.fda.gov/NewsEvents/Testimony/ucm115242.htm, Woodcock's testimony before Congress describing Heparin recalls starting in January 2008.