Meningococcemia mortality has not changed, even at best centers. Check posts: 8220,8235,7565,7560.
Sepsis mortality has not changed even at best centers. 8599
Biologics do have higher hurdles at FDA.
There were no changes "onthe fly". Xoma got more patients in the early shock group (low Glasgow scores) this on itself decrease mortality.
But it will not impact on the trial (except for need of more patients), the efficacy of the drug will not changed. 8197, 8206,8216
The trial designed on itself corrects for a decrease in acuity of the disease. Trial was stratified from the start. post to protocol 6523
Early halt was speculation from many, born mainly out of the very good data and efficacy from phase I/II trial, originally a phase I, the FDA accepted to go straight to phase III.
M.Murphy was constantly claiming early halt will happen, till it did not.
Xoma, to my knowledge did not promoted idea of early halt. They even discouraged it. I remember they told callers to IR that for early halt only ZERO deaths in BPI group would made it, obviously this is not promotion.
SI thread was always on speculative mood, each DSMB meeting became a disappointment. Good DSMB post 9068.
Xoma did promoted idea of 200 patients and end by Dec 98. For me it was no problem, I used it as guideline, not for enforcement law.
link to UK site post 8449.
Valuation model 8237, 8240.
other sepsis drugs (mostly failures)8398,8403.
some speculation on statistics 8197.
An expected decrease on morbidity and decrease of sequelae is part of the trial design, and the 90 days follow up is mainly to check for neurological evaluation.
If the drug does not decrease mortality I am saying good bye to this one, even if FDA approved.
Results similar to the hem/trauma trial will sent the shares to $0.25 at best, company will become a takeover (actually a leftover) target.
Off label 6097. summary expect big and quick off label uses. ER and intensive care clinicians are aggressive and innovative and they will use Bpi for septic patients. |
