xomaDna many ongoing Xanelim trials,lots of ROOM for error:
October 01, After failure to prove that xoma drug was same as Dna drug, then the peepeekays were repeated and they were SLIGHTLY different pks, then new trials:
1. 500 subjects ongoing trial to end in Q3/02 with Dna drug to prove efficacy (they still need to prove efficacy, man, that is real back to square one).
2.Open label 300 patients continuing the drug for 1 year ( I assumed is the Dna verion) for additional safety data. Suddenly, that immunoregulator turns into immunosuppresor, UbsW guy talking hypothetically speaking called Xanelim IMMUNESUPPRESSOR, keep it for BlueG records, He is always worry about those poor subjects going in Amevive, now He has to worry MORE with the Xanelim ones. To be completed in Q4/02.
3. Additional extesion study of subjects "switched from xanelim to other treatments" to be completed Q3/02, hmmmm? Is this one design to check how to control "roaring back" flares? No!!! "that is just part of the natural course of the disease" said UbsW, agreeing with BlugW analysis (not with mine, but hey UbsW rhymes with BlugW, not cacaito).
Again for summary, expected competion times of ongoing xomaDna Xanelim trials:
03/02, 03/02 and 02/04, and filing for "end of the year" (again UbsW slips and mentioned "early 03 filing, marketin early 04).
xomaDna needs the Biogen e-mail server so they could RUSH the info for "end of the year", and they better use Biogen rushing techniques "sending incomplete BLA" in record time so they could have their Complete Reverse Response Letter (the new one as per Gw) by "end of the other year". |
