Not likely, but possible.
Full approval from this meeting is also not likely, but I’ve put it in there.
Efficacy is the hardest hurdle to get over... it’s why most NDA’s get rejected.
SPL are dealing with efficacy, it’s not impossible.
Not likely in this meeting, but if they ask for another trial and that trial fails to meet the new requirements... it could still get rejected.
FDA meeting, page-6
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