Well SI's claims about there being no approved paediatric treatments won't be true any longer.
That is a false statement- it is not a claim by Si- it is just a fact - there are zero treatments- it is an unmet need
It might make the FDA more reluctant to approve it without another trial.
Absolute rubbish, if the FDA is satisfied with the new potency data, approval is likely- if not then yes, a new trial would be required.
Other than that its hard to see any reason it would have a bearing on the BLA resubmission.
It's hard to see any reason posters would believe you are a doctor?
Hey Whytee- any comment on why the Chief Medical Officer has just bought on market?
Reg
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