Sunday, March 16, 2014 6:01:38 AM
Assuming Germany had the phase three interim data, a little extra logic is in order.
1. The PEI would not have made the decision to grant reimbursement and hospital exemption if the data was futile. This is simply obvious.
2. The PEI would not have made the decision to grant reimbursement and a hospital exemption if they believed the trial would continue.
This is not obvious at first, but it logically follows because Germany knows that its recent decision makes enrollment in Germany for the phase 3 trial impossible. The PEI would not interfere with their responsibility to contribute enrollment to the phase 3 trial unless they knew it was going to be halted for efficacy.
3. Therefore, The PEI fully expects the trial to be halted for efficacy.
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