RTheo - This can happen, specially when n is low but also the error bands cross over. It's one of the reasons why we need to do a P3, show the efficacies at scale, not just 15 or 56. Having said that the 2mg dose still starred.
m931392 - Not sure if you want me to say it some other way? In answer to who said we aren't in a clinical hold, well Paul did yesterday, he stated that they are submitting a new protocol. Note he didn't say "writing", he said submitting and it was stating that it is in response to the Questions raised in the Type D.
This has nothing to do with a Clinical Hold. A Clinical Hold has no relevance here in my view as that old protocol will be null and void in light of a new one.
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