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To: Cal Gary who wrote (8545)1/28/2002 1:24:17 PM
From: Mark Bartlett  Respond to of 14101
 
Cal Gary,

<<Assume he knows what analysis is done at the
end, all checkpoints should be in place to follow protocol or process.>>

Bottom line -- it take time even if you have everything in place.

Many here are assuming the worst i.e., results are marginal to poor, hence the delay. What if it is just the opposite -- i.e, they are exceptional and that is causing the delay. I have no idea what way it is going to fall, but either way they have to be very careful with the analysis.

Also -- there were about 25 centers running these trials all over the US and Canada. That means reviewing the data collection nuances from many different participants. Sure -- they all have the same forms to fill out under the same protocol, but there will be human variances within those parameters and they will have to be accounted for.

My own personal feeling is we will have a drug and likely a pretty decent one -- but life is full of surprises.

MB