And another thing...
The more one thinks about this total-deaths-and-endpoints business the odder it seems. Let me see if I can think this through while you watch...
Correct me if I am wrong, by all means, but wasn't Neuprex given an orphan drug designation last summer and doesn't that depend to a substantial degree on some sort of finding that, if efficacious, the drug would meet a critical need suffered by a limited population?
Assuming the criticality finding is based on the real threat of death from meningo, if the P-3 has been extended because the total death rate has slowed, as many suppose, because of better diagnosis and nursing care, doesn't that undercut the finding about criticality that got us the orphan drug status? Or, might it be the case that the criticality finding was based on endpoint(s) other than threat of death, despite what Ellen is telling everybody this week? If so, why in heck aren't those endpoints factored into the study's duration, too?
Logically, there is perhaps one other possibility. (This will make George's day.) You don't suppose, do you, that in projecting total deaths the FDA naturally assumed a certain fatality rate among test patients as well as the control group receiving the placebo, and the delay is due to the fact that NO ONE TO WHOM BPI WAS ADMINISTERED HAS DIED.
No. On second thought that can't be. It would be too much good luck for Xoma, too much good fortune for the rest of us.
<<Xoma currently has less than 1 year of cash remaining>>
Good grief. |
