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flipper44

06/18/18 7:18 PM

#178554 RE: Lykiri #178553

Yes, the 32 psPD trial is ultimately to be unblinded simultaneously with the main trial according to Dr. Marnix Bosch back in 2015.

We are apparently awaiting the SAB guidance after the current refresh is completed, but some of the SAB were at ASCO 2018, and surely they and NWBO must be updated on the eventing (through the CRO) -- particularly as the refresh continues, so that they could inform NICE regarding their current expectations. As of June 14, 2018, NICE initiated its appraisal timeline.

Here is something not many people think about. For 300 randomizations, August 2018 will move those 300 from approximately a minimum of 23.1 months post surgical to a minimum of 40 months post surgical. The median enrollment for the 300 will be near 54 months. This is incredibly mature data.