Blue, FDA does not pamper-diaper companies.
xoma was\is responsible for what research they undertake.
Fda will accept reasonable hypothesis, will assure that ethical issues are met, safety is number 1, and efficacy must be establish.
pII was a failure, they proceed to the debacle, not the FDA.
My point is forget trauma, is a failure. The patients with confirm blood culture about 1 in 20, will be candidates for bpi use anyway.
xoma did not try to screen candidates as per hypothesis, they went in a general way, they try to prevent organ failure, they assumed most organ damage was bacteria or lps (bacterial fragments). It is acceptable to try to prove hypothesis with treatment, it is just very expensive with a non proven drug like bpi, they could have wait for approval in meningo, they decided to go faster, fine, but pII was clear, no difference.
They should have screen the patients, and then prove that it work in septic infected ones, bpi is antibiotic, not blood replacement.
Blood replacement first 24 hours was 5 and 6 units, placebo/bpi respectively, total 9 and 8 units placebo/bpi respectively.
xoma was either heorically courageous trying in these very sick patients, or way out of base. Again, pII was clear, bpi did not work. Post hoc analysis (not pre establish, post trial) is very tricky, they got caught( naive, mismanaged, choose
Move on, just realized that instead of 500,000 subjects a year it will be 25,000 (5 times the meningo group anyway), the ones infected, still a significant market.
Maybe another 25,000 more patients from non-hemorraghic trauma.
Back to wait for meningo.
Waste was xoma's endeavor:
From 1997 till now,
$25 M private placement (and nasty convertibles),
$18 M from IDEC, another
$18M from Sutro (more shorting),
$10 M from Allergan (hopefully Allergan has the money force to eye/bpi),
?$millions for psoriasis from DNA (the money also force to that specific development),
some money was used to pay Incyte.
Take the first three items, $61 millions (take half of that just for trauma, most for the pIII)
Waste is the name, not the FDA.
Result from 25 million shares to 50 million shares, a full 100% dilution!!! |
