They are using the potency data to link the paediatric product with the product that will be used in the adult trial - why would they do that before doing the adult trial? They would be planning on validating the product with the next trial and showing the two batches work and they have consistency.
If you guys don't believe me that's fine. It's all been stated quite clearly by MSB itself. We will know soon.
It's all in my opinion. Maybe I'm wrong this time
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-346
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