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Biotech / Medical : biotech firesales -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (3129)5/3/2014 10:17:03 AM
From: El Canadiense  Read Replies (1) | Respond to of 3661
 
Interesting comments on Yahoo ECYT board...this might be far from over and the slightest glimmer of hope might send this back soaring.... things can turn on a dime pretty fast with these strange bio-tech creatures!!!

That's one way of looking at it. But, in reality there is only one way for the treatment arm to stay the same and control arm to have better results than in P2. The control arm data got corrupted.

It can happen from several causes. It can happen when the data gets dirty and someone tries to clean it when they do the data entry (it happens). It can happen just from honest data entry errors that never get caught, it doesn't take much. It can also happen if someone at a trial site, in a small but significant number of cases (maybe just 10%) mis-handles the study drugs and gives a control group subject a dose of the good stuff. It may be that they get better instead of staying the same when they are not supposed to. Oops, there goes the integrity of the control arm. Or, a batch of drugs could have been mislabled and swapped. The treatment arm subjects would get slightly less good drugs and not be noticeable, the control arm would get better. I suspect it's one of the last two.

So, will Merck be able to figure it out, will they re-start or start from the begining again? It's hard to know but they do have a conditional approval from EMA, that's got to be worth a serious batch of data review.

I would have bought today but I needed to look at the studies and think about how and what happened. Can't wait for Monday. Less

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