"Potential payer reluctance
to cover a product that does not have full regular FDA approval should itself
present sufficient rationale and urgency to complete a confirmatory
trial."
— Elan Rubinstein, Pharm.D., principal at EB Rubinstein
Associates, talked with AIS's RADAR
on Specialty Pharmacy about Novartis' run-in with the FDA over
alleged "data manipulation" involved in Zolgensma's FDA approval, and
how it may impact other trials.
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