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Friday, May 29, 2020 3:38:20 PM
What everyone is missing on this thread is that the voluntary hold placed by NWBO on trial sites outside of the US, especially Germany, was never lifted and remains in place to this day. This is what so many have just let fly right over their heads and it's a huge clue. The FDA hold kept at least most, if not all, unenrolled SOC patients out of this trial during the time that the last 31/32 were being enrolled in support of what was shared on this board about a German patient randomized to SOC but not allowed to enroll. Lykiri believes an SOC patient or 2 may have been enrolled during this period in Great Britain or elsewhere but the balance kept 17 out which is very close to the 1 part SOC to 2 parts treatment that remained to be enrolled. Pretty obvious that NWBO and FDA wanted to keep the reason for this a secret even though FDA always pointed back at NWBO as having the final say to avoid spilling the beans about their part. I believe a German imposed hold would have revealed the reason for the hold and would have caused irreversible damage to long term trial data and integrity. Best wishes.
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