There is a lot to digest tomorrow.
We are looking for evidence of efficacy (and safety) in the population with the required endpoints- the change in each child from initial measurements. The trial is designed so that it may potentially provide pivotal data (controlled, powered, right endpoints etc). Whilst these are the main points people will focus on i will be readily running my eyes over the text looking for the side effects. Safety has already been closely monitered and reviewed by an independent committee to approve each dose escalation and age group progression so i am confident the side effects may only be minimal at the highest dosing.
I do feel we will still progress to P3 even if we have a moderate result and for that fact i am not stressed about tomorrow.
There is a lot to digest tomorrow.We are looking for evidence of...
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