George,
I'm just indicating caution. I've been down roads that smelled like this before.
I'm sure Xoma is aware of the legal ramifications of everything they say. As such, they word their press releases very carefully.
Personally, I would have preferred seeing the numbers. If X didn't want to tell the numbers for some reason other than they way the numbers looked, I would have preferred they said nothing regarding efficacy. I.E. "We are still analyzing the data and will meet with the FDA when were done."
I got neither.
I got: In Xoma management's opinion, the drug was effective. This covers the entire gambit from zero to sixteen deaths in the treatment group. But Xoma knows what p value is required for determining efficacy, so they know that a 16/18 split, or a 15/19 split, or a 14/20 split is not statistically significant, so if any of these are the actual outcome, they know they are lying. Lawsuit city.
I also got: But we need to talk to FDA to verify that it is effective. Duh! Is this a standard disclaimer that nothing is effective until the FDA says its effective? If so, why didn't they say it that way. Their wording indicates ambiguity (13/21 or 12/22). But legally, their statement is valid for a 4/30 split.
Maybe I think more clearly in the morning, see you then.
- Ed. |
