It was an expected step, but a notable one nonetheless. Revive Therapeutics Ltd.(OTC:RVVTF) revealed they have submitted their Data Access Plan to the U.S. Food & Drug Administration (FDA). The maneuver is the final step required, pending FDA approval thereafter, to allow a company agent to view unblinded data of the first 210 patient data in the company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.
Today’s news was follow-on confirmation to the May 26 press release that Revive “will submit a Data Access Plan to the FDA in early June 2022.” The company announced that following positive comments from the FDA in regards to its request to determine and agree new primary efficacy endpoints, it indeed has submitted a Data Access Plan to the FDA. The plan’s purpose is to quantify which individual or individuals related to the company can view early-study unblinded 210 patient data before deciding whether to switch primary endpoint data to a symptom focus. Currently, a reduction of hospitalizations and death are the primary endpoints for the trial.
The acquiescence by the FDA to allow Revive Therapeutics to view partial unblinded data is an unusual one. Typically, clinical trial data is unblinded in full upon Data Board recommendation or not at all, to protect the integrity of a study. The FDA could have taken the common route and unblinded the entire 715 patient data currently tabulated by the company. However, with the few oral COVID options demonstrating questionable real-world efficacy, the FDA’s action strong infers that they are responsive to Revive Therapeutics in the current study—and receptive to helping new drugs come to market.
Expect A Quick Progression Of Material News
With the submission of Revive Therapeutics’ Data Access Plan (DAP) to the FDA, we expect a quick progression of material news going forward. Assuming the FDA grants imminent approval of the plan, the company can begin reviewing the early-study trial data within a matter of days. Below, an estimated sequence of events remaining between today’s announcement and a potential meeting with the company’s Data Safety & Monitoring Board (DSMB), scheduled to take place soon following Revive’s statistical endpoint review.
Next steps: 1. FDA reviews the DAP + approves Revive's designated party to review the 1st 210 unblinded data. 2. After approval, RVV reviews 210 unblinded data. 3. Revive decides whether to run with symptoms endpoint change thereafter and notifies FDA of decision 4. DSMB meeting
— The Dales Report (@TheDalesReport) June 6, 2022
Furthermore, we don’t expect an extended time horizon between the completion of remaining steps before market-moving events take shape.
For example, FDA review of Revive’s DAP should not require extensive collaboration or inspection before approval. The DAP is simply a written submission of which authorized person(s) in the company will review the unblinded data on behalf of the company. It is not a direct submission of clinical data to the FDA or other data-intensive process requiring a deep review on behalf of the organization. Thus, investors should expect an imminent move to Step 2 on the list, which should then require several days on strategic consultation and number crunching by the company.
Additionally, TDR expects each completion or unfulfillment of subsequent Steps on our list to have an increasing impact on the public market price. The current environment is the company’s best shot to receive Emergency Use Authorization EUA for Bucillamine in the treatment of COVID in a timely manner, without having to restart the trial using existing endpoint benchmarks.
Revive Therapeutics finished its OTC trading session higher by +0.0124, to close at 0.3618 (+3.55%).
This article was originally published on The Dales Report and appears here with permission.
