Hi Dorians,
Not sure one can assume confirmatory trials will be asked for.
Both CHF and CLBP are very large and well designed trials.
I would imagine the strength of trial results would have to be considered by the FDA in order to make that decision.
Iam not saying your wrong just is Ive seen nothing in regards to confirmatory mentioned by the company thus far.
Aloha.
MSB Trading - 2020, page-1266
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