Marth claims the ANDA is now at the FDA’s Office of Biotechnology Products (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090470.htm ) to assess immunogenicity, and he implies that this means the drug has achieved sameness to branded Lovenox.
I don’t doubt that OBP has looked at or is looking at the application; what I do doubt is that OBP’s involvement signals that the product is approvable.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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