I am not a legal expert and wonder what actually is presented and who goes first in such a hearing relative to "Mylan's inequitable conduct affirmative defense?"
Also, anyone know at what time the trial begins and is there any expectation that some analyst/follower will post "musings" as the trial unfolds?
On another issue, agree with Dew's comments from the other day that Pradaxa has had no significant impact on enox sales. This "bridge therapy" concept is overdone. If a person were to present with an embolic stroke and atrial fibrillation, a vast majority of doctors would treat with either intravenous heparin for a few days and overlap warfarin or treat with enoxaparin and overlap with warfarin. I am unaware of the data in a subset of patients who present with acute embolic event and are started on Pradaxa alone. Doubt if that meets standard of practice. Uncertain if a patient were to receive LMWH or UFH what duration of treatment would be necessary until the Pradaxa "kicks in." With LMWH or UFH, one can follow the INR and decide to stop the LMWH or UFH once INR therapeutic for 24-28 hours.
While "bridge therapy" can also refer to some sort of treatment initiated for afib to prevent embolic events while waiting for warfarin to achieve therapeutic INR, the risk of embolism remains quite low for any 5-7 days prior to full anticoagulation and the vast majority of physicians would not start LMWH as a "bridge" until INR therapeutic in patients who do not present with embolic manifestations.
FYI, based on my clinical experience, about 50% of my atrial fibrillation patients first presented without any cardiac symptoms at all. Often an incidental finding (and usually on a Friday afternoon!).
AI
