- " Upon review of the dataset received on November 5, 2013, FDA concludes that study AP-003-A can be considered as one of two "pivotal trials" required in support of a BLA."
- "This recommendation is based on the fact that study AP-003-A was adequate (n=329) and well controlled (normal saline), the trial conduct was acceptable and the study met its primary endpoint (change in WOMAC score at 12 weeks)."
- "The strength of the evidence is robust"
- "FDA recommends that Ampio conduct an adequately powered study to confirm the effect size of AP-003-A and design the study to obtain information on the duration of action and repeat dosing."
- "The study to evaluate safety and efficacy of repeat dosing may be conducted post market approval."
Ampio Receives FDA Confirmation That The Spring Study Is Pivotal And Will Initiate The Final Pivotal Trial For Ampion™ Biological License Application (BLA)
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