More vivid images of the difficult trial, but mostly what we knew.
The trial cost $10M (new to me), the trauma study cost probably double that. xoma knew from trauma II that it did not work in that indication and they dumped the money on it (a bigger market, therefore they went for it). That they now come with their cry that "jack wanted it done" does not move me.
Again, Giroir repeats that he did not agree with the "composite" that xoma and the Fda did. He wanted to go for the decrease in amputations. Again xoma failed.
Giroir cries out the lack of a compassionate use program, BUT who will go for it, first xoma will have to carry the expenses and they probably do not have the means, and the baxterds do have the means but not the will.
I have learnt a lot from the imcl debacle, one thing is that the fda allows some compassionate use for drugs like Iressa (from AstraZeneca) and planning for Erbitux (imcl) despite their extremely poor results. Also, the experience with Scios drug (expensive and so far very minimal benefits, forget mortality) and the prostaglandin for Pulmonary hypertension (small pharma, I do not remember at this time, maybe United Med?) is another example of approval with minimal benefit.
All of the above, to conclude that: 1.- Neuprex deserves approval for compassionate use. 2.- A large trial, with institutional informed consent (Baxter did one like that with a "blood substitute"), for definitive prove must be done. And 3.- I think neither will happen, and xoma plus any partner (bax isanything but) should developed it for your long ago idea, early bacterial killing, not waiting for shock, but xoma is busy with Millenium dust. |
