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Monday, September 24, 2012 10:17:59 AM
Tough day to say the least. Looking closely at the news I see two things. First Peregrine is saying they don't believe the problem is with the independent contractors that performed the trials but with the single independent contractor that was responsible for coding and assigning the drug. I would think that the contractor for coding would have been a US contractor because it would seem to make sense with half the patient population in the US and it being a US manufacturer. This then means to me that the possibiliy exists that the problem could very well be that the treatment regimens might not have been consistent as they should have been. For instance with a coding screw up it may mean that the active treatment arm may have had patients receiving placebo for one or more treatment cycles and the opposite may have occurred for the control arm, they may have received bavi instead of placebo for one or more treatment cycles. Depending on what the scope of the drug coding screw up is and whether they can unwind it all and still have enough patients left that were treated consistently as they should have been to draw any conclusions is yet to be seen.
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