Hi,
I highly doubt that the FDA would include the current patients in the next phase numbers.
Hopefully the FDA agree on a registrational trial, hopefully they agree to a compact trial given the unmet need of the targeted disease.
The FDA would want to satisfy the question of efficacy without hamstringing us by creating a massive framework that is both costly and hard to recruit for.
Hopefully Steven and the FDA can arrive on a palatable framework, that cuts through the red tape and gets this drug into the hands of clinicians.
See what happens but I'm still quietly confident of a registrational trial.
Good luck to all,
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