Greetings RK,
I suddenly feel pressured to perform...
These are the ramblings of a man trying to reacquaint himself with a society (XOMA longs) that he had temporarily abandoned in a quest for nearer term profits.
My last posts on Yahoo referred to the differences between filing with the bureau of Biologics at the FDA and standard drug applications. I only really know that the former has higher hurdles. I do not have a good understanding of this process yet, but I will be attending a lecture on the FDA process this next weekend, and plan to press those in the know on their insights. If there is anything of use from this, I will post it.
I do know, as most of you do, that the FDA had a great deal of input on trial design for this phase III trial. I had no idea how much back and forth occurs. Without more information about the endpoint/deaths thing, though, I have never been comfortable with the assumptions about expected deaths in the control group as published in the Phase II trial. Everyone now knows that the standard of treatment for meningiococcemia has improved since those numbers were valid, led by those institutions that see the disease more commonly. The institutions that have the best mortality rates are the same ones that are involved in the trials.
Though someone like Cacaito perhaps could correct me, my hope is that the DSMB, FDA, and XOMA had enough flexibility to exchange "impressions" on the (double blind) trial and correct design flaws "on-the-fly." I wonder if this is what has been strange about their behavior and about the extension.
Even scientists that have experience with the FDA and that follow XOMA had hope of an early halt. Has anyone been able to nail down how this hope proliferated and whether the company ever supported the notion? Or were we smoking something?
Another point that as far as I know was never really resolved in these forums: do we know the importance of morbidity to the trial? Or was the trial designed strictly around mortality? I have heard conflicting opinions. Some say that morbidity was an endpoint; others say that morbidity can not be an FDA endpoint for a Biologic. Yet others believe that by decreasing mortality, morbidity (excluding deaths)may increase as measured by limb loss etc... That would hurt us instead of help us get the drug approved, even if the drug was actually of benefit. Perhaps we will know soon, now.
It seems there is little I can really say to prove my identity. I can't even make the Yahoo search engine find the historical discussions there. Randomly going back two/three years by post number takes too long.
I do want to know though: does BiostockI = Bluegreen? They sound like the same person. I know RK1=RKK. Oh, and I really miss Mirthie... <g>.
XOMA remains the company that shakes my faith in, "It's the science".
And as you say, RK, all IMO: FOR ENTERTAINMENT PURPOSES ONLY.
ProTex
P.S.: Watch out if you are pregnant with toxo, gentleman. |
