Random thoughts and a very important link.
<Does Sonofa Bitch ring a bell?>>
I know that reporter! Keeps following me too, as a matter of fact, though often in disguise and sometimes in drag.
<<There is no way XOMA can tell anyone outside of XOMA if the data was statistically significant>>
This is more difficult to believe unless either:
(1) Someone at the FDA was consulted specifically about what to say -- a request I would expect is rarely made of the FDA and almost never honored with a reply.
Much as Xoma or some posters here may not like the FDA, or even fear it, there are no facts to support the supposition Xoma asked the FDA what to say in the c-c or to Bloomberg. By contrast, there are many companies that have announced their belief that the results of a P-3 are statistically significant but go on to caution that the FDA's analysis is the final word.
As for the overly sensitive who get the heebee-jeebees just thinking about shareholder suits, the company could always arrange for a Greek chorus of lawyers to stand around in a semi-circle chanting rhythmic, basso disclaimers while the CEO sings his statistically soprano melody.
---------------------- OR -----------------
(2) There is another, much more serious possibility which George's link late on Bad Monday hints about: there may be afoot in the scientific world a new and rather serious effort to rethink the whole statistical methodology for testing complex variables for compounds treating infectious diseases. See -- chestnet.org
Here are some tantalizing excerpts from George's link –
* * *
<<Economic evaluation of antisepsis therapies is also desirable. Full economic evaluations consider both clinical consequences and relevant costs of competing alternative severe sepsis therapies. Agents that lack evidence of therapeutic efficacy on mortality but have other proven clinical benefits may still be useful if cost savings are significant and no safety issues exist.>>
* * *
<<Mathematical and statistical modeling could be more widely applied to risk stratification at entry, defining more homogeneous subgroups within sepsis populations, and measuring trends over time in the study. In cooperative multisite studies, mathematical and statistical modeling is critical to assure consistency in case-mix, overall observed-to-expected mortality rates of placebo and treatment groups, and use of nonstandardized protocols regarding admission criteria to the ICU, antibiotic therapy, and resuscitation.>>
* * *
<<Models better suited for severe sepsis are needed since the general ICU models are not well adapted for severe sepsis trials owing to differences in (1) study duration, (2) lead time bias, and (3) necessity of approximations. In response to this need, specialized models for severe sepsis were modified from existing databases and include the following: APACHE III sepsis model, MPM II customized for sepsis, SAPS II customized for sepsis, and Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT) model for patients with multiorgan failure and sepsis. Most of these models are not externally validated (the APACHE III sepsis model is). They do provide a 28-day mortality estimate. For patients admitted to ICU with severe sepsis, MPM II sepsis, SAPS II sepsis, APACHE III sepsis may be useful predictors of outcome.>>
* * *
There is more, including a numerical list of recommended reforms. Now, THIS is something that could explain heightened FDA interest in and control of Xoma's analysis of its P-3 data. The link is worth reading in full. Here it is again:
chestnet.org |
