My understanding is that another phase 3 trial is required before it will go up for FDA Approval.
Same goes with the CLBP trial... that is why they partnered up for a European trial.
If the current phase 3 CHF trial is successful, next step should be a US partner to fund and run the pivotal phase 3 trial.
Unless the goal posts have changed?
My understanding is that another phase 3 trial is required...
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