Biotech Values

[DewDiligence]

MNTA: in vivo heparin can be immunogenic (heparin-induced thrombocytopenia is an immune-medated side effect)

Yes, of course—in my prior post, I said heparin has “very low” immunogenicity, not no immunogenicity.

As stated in my reply to iwfal (#msg-38682430), the FDA’s request to NVS/MNTA for non-clinical data on immunogenicity is not IMO a sign that the FDA thinks Lovenox has not been fully characterized; rather, it’s a way for the FDA to ascertain the product’s purity.