It is also worth noting that the sunset clause states that the...

It is also worth noting that the sunset clause states that the drug must be approved before September 30 2026 ,just over 2 years so if more data is required for that indication we would have no chance, the trial would take to long....

Some say we have little chance without another trial including ET ..... So can one explain why the FDA would give the indication drug a rare pediatric disease status if they felt the data would not be sufficient for a BLA and potential approval ?

So it looks like it comes down to the potency assay. CLBP has not long back been allowed to start enrolment, they must have a assay reasonable for commercial use before a pivotal trial starts. Then we also have a new guide lines for potency assay. A much broader approach is now considered.

Not a bad back up plan in the event of a third CRL

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs#:~:text=Under%20this%20voucher%20program%2C%20a,the%20voucher%20to%20another%20sponsor.