FTM has addressed two areas that could be relevant.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83130989 How about the mix up occurred more or less randomly between the placebo arm and 1 mg/kg arms, with a number of patients getting the wrong thing, but only once or twice during their treatment cycles. So the number affected could be large, but the effect would be minor for each, however it would be impossible to separate them out since there were a large number involved. I think that could explain it.
If the effect is small on the affected arm, the next question is, why is the control arm MOS so low? He addressed that today.
In the chart, note that only the Fossella trial had the same percentage of Stage IV patients enrolled. Now look at the MOS number in the control arm: 5.7 months. Almost identical to what Bavituximab got at 5.6 months.
You wouldn't expect trials to perform identically for MOS, especially with trials with a small number of patients on each control arm. Which makes credible
1. Bavi's Initial MOS result of 5.6 months 2. the idea that the misdosing had a small affect on the two affected arms 3. the speculation that, without the misdosing, the control arm's MOS might actually have come in slightly worse. 4. the speculation that, without the misdosing, the 1 mg/kg treatment arm's MOS might actually have come in slightly better.
Caveat emptor, such conclusions are speculation. Interesting but, as yet, unproven.
If the discrepancies had little effect then why would you expect the addition of a wrong dose to increase the MOS? The control arm performed below the average. There are always values below and above the average, that is why it is an average. It doesn't necessarily mean there is a problem.