the reviewer at the type A meeting may recommend approval for children under 12 while doing the Adult trial. This is common sense. I just can’t understand FDA’s decision!
All the newbies who have come on to this forum are like football supporters. ‘I told you so……need another trial….BLA BLA BLA. NFI
Like, why and how did the FDA come to this decision. There is no explanation, oops there is, it’s a cut and paste of 2020.
Weren’t they speaking, oops sorry, guiding MSB for the last 2 years or is SI not telling the truth!
the reviewer at the type A meeting may recommend approval for...
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