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Posted On: 12/03/2019 4:20:31 PM
Post# of 149005
misiu, I don't disagree with you that FDA will approve as quickly as possible, and personally I want leronlimab to be approved yesterday rather than tomorrow 
I was just giving a prima facie estimate on how many patients they will require in the studies to grant AA, since they will require a minimum number of patients over a certain period of time to assess safety and efficacy in combination with chemo to grant such an approval.
And I would be very surprised if that minimum number is below 20 TBH with CTC counts reduced over a couple of months... I will try to look through the accelerated approvals in oncology over the last years and try to find out the number of patients involved in these Ph2 trials...
I was just giving a prima facie estimate on how many patients they will require in the studies to grant AA, since they will require a minimum number of patients over a certain period of time to assess safety and efficacy in combination with chemo to grant such an approval.
And I would be very surprised if that minimum number is below 20 TBH with CTC counts reduced over a couple of months... I will try to look through the accelerated approvals in oncology over the last years and try to find out the number of patients involved in these Ph2 trials...
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