…since levels of [heparin-PF4 complex] antibodies are felt to be linked to heparin induced thrombocytopenia, i don't think the FDA will allow any flexibility on this issue.
FDA leniency on this score is unlikely insofar as antibodies to heparin-PF4 complex are associated not only with HIT per se, but also with a poor survival prognosis in such Lovenox indications as orthopedic surgery and ACS.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”