Revive Therapeutics (CSE: RVV) announced major news this morning related to its ongoing study of Bucillamine, with the US Food and Drug Administration recommending that the company proceed straight to a phase three confirmatory clinical trial to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection.
The news is significant as it means that Revive will be able to skip over the phase two clinical study portion of the FDA’s process, enabling the product to get to market sooner than expected if proven effective against the infectious disease. The push to phase three on the study of Bucillamine will enable the company to expeditiously evaluate the safety and efficacy of the drug.
In addition to the recommendation provided, the FDA also provided guidance on the study design and outcome measures for the phase 3 study. More importantly, the FDA identified that as a result of Revive’s previous work with the drug on the treatment of gout, the data provided from that study could be used to skip over phase 1 and 2 of the clinical study process. The firms contract research team, Pharm-Olam, is actively working towards assembling the final investigation new drug (IND) for submission to the FDA within the next 60 days, after which the firm will begin its phase 3 trials.
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Revive Therapeutics last traded at $0.18 on the CSE.
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One Response
Phase 3? Surprised this thing hasn’t ran more? Probably the 50M shares they gave over in the shroom deal.