All but using the same words -- and certainly employing the same reasoning as I suggested back in January, twice -- the Plaintiffs in Polk, the Vytorin Sales and Marketing Class Action, (MDL 1938, Case 08-285) have laid waste to another over-reaching argument Schering's lawyers had put before Judge Cavanaugh. I'll let the letter speak for itself -- click it to enlarge:
Friday, February 20, 2009
Pretty Much "Dead-On" -- Plaintiffs Slap Down Schering's FDA Defense Arguments
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In case you haven't seen it yet SP has submitted the complete response regarding asenapine to FDA. This typically means approval in anywhere from 2 - 6 months.
In my humble opinion the only possible way that asenapine could have even gotten an approvable letter (and approval) is if these was intentional fraud including hiding, not performing standard drug development studies, and not submitting data. However it would also take collusion and conspiring with FDA officials including not even looking at certain information, and harassment, threats, and firing of any reviewer who tried to pursue the science.
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