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Re: Rkmatters post# 63770

Monday, 06/06/2016 9:33:14 AM

Monday, June 06, 2016 9:33:14 AM

Post# of 699486
Rkmatters,

I think I am not connecting my points together well enough. Pseudos and rapids tend to be mesenchymal. If mesenchymal are also more responsive and risk being misdiagnosed as progressors then these patients are being kept out or moved out too early from the main arm which leaves mesenchymal type (most likely to respond) underrepresented in the main treatment arm. This would skew results so I believe some type of review of data might be requested to account for and or rebalance mesenchymal representation. If enough proof is given then this would not be an unreasonable request and FDA may be reviewing the data as it becomes available to verify the alleged concern.
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