In this week’s Trade To Black Podcast, TDR Founder Shadd Dales and lead financial writer Benjamin A. Smith interview Biomedical Engineer and Revive Therapeutics Ltd. (CNSX: RVV, OTCMKTS: RVVTF) investor, Arri Morris. The guest appearance follows this past week’s announcement that the company has received “positive comments” from the FDA in regards to its request to amend new primary efficacy endpoints for the current trial. Revive is currently undergoing a Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral anti-inflammatory and anti-oxidant drug to treat COVID.
On the agenda for conversation is everything related to Revive Therapeutics in regards to recent news flow, analysis thereof, potential trial scenarios and where it all leads.
Trade To Black Podcast Cliffsnotes:
@1:37 Why is there so much interest in Revive Therapeutics right now and what makes their oral drug candidate for COVID, Bucillamine, different from other drugs competing oral drugs being developed?
@3:30 Now that we’re over two years into the pandemic and a lot more in known about the virus, how is the FDA adapting its attack plan to quell future outbreaks? Evidence is mounting that oral anti-viral therapeutics are failing because they become less effective as the SARS-COV-2 virus mutates.
@4:44 The FDA has noticed that the current oral COVID therapeutic options have issues. This could be the reason why the FDA is amenable to Revive Therapeutic’s symptoms endpoint change request.
@6:48 On May 26, Revive reported that it has received “positive comments” from the FDA in regards to its request to amend new primary efficacy endpoints for the current trial. At this stage of the trial, why is there interest to change endpoints from the current hospitalizations standard to symptoms?
@8:05 The FDA went the extra mile by allowing Revive Therapeutics qualified statisticians to view unbinded data of the first 210 patients before deciding whether to pursue a primary endpoint change. This was an unusual step.
@9:49 The FDA allowance for Revive to view unblinded data before rendering an endpoint change decision is like looking at the answer key before you take an exam.
@10:48 Many people assume the FDA shows favoritism towards Big Pharma, but that isn’t necessarily the case.
@11:48 Next steps upon Revive Therapeutic’s Data Access Plan submission to the FDA—scheduled for early June 2022—and how it relates to the upcoming Data & Safety Monitoring Board (DSMB) meeting shortly thereafter.
@14:47 What happens next if Revive elects to move ahead with symptoms endpoint change after reviewing the unblinded first 210 patient data? Is this the big shot on goal for the company?
@15:38 What will the DSMB be looking for if they meet to review symptoms endpoint data?
@17:02 What happens to the current endpoint standard of hospitalization reduction if the new endpoint standard shifts to a symptoms focus?
@18:10 Why reviewing 210 patient data before making a primary endpoint decision change is preferable over unblinding the entire 715 patient data outright.
@18:56 In the event there isn’t compelling data, Revive Therapeutics has the option to continue the trial as before by sticking with the current hospitalizations endpoint standard.
@19:30 Arri explains how the process for Emergency Use Authorization (EUA) would work after the DSMB meets following potential endpoint change. A potential DSMB decision to unblind the full 715 patient data is key.
@21:20 Do you think there’s a real opportunity that Bucillamine could receive EUA for the treatment of COVID in the next 30-60 days? Non-affiliated ancillary studies lead to strengthening confident in the data.
@24:03 Several studies have shown that N-acetylcysteine (NAC)—a thiol drug similar to Bucillamine with a similar mode of action—is effective at reducing symptoms of COVID. Yet, adjacent research also shows Bucillamine is a more powerful version of NAC, with more oxidative scavenging power, for example. Is it possible Bucillamine could actually be less effective at treating COVID symptoms than NAC?
@25:43 Arri Morris is seeing a consensus in the scientific community that we’re likely to see another COVID wave. Could we see a variant as string or stronger than the Delta variant, responsible for much of the early death count at the beginning of the pandemic?
@28:10 Although this isn’t being tested as a primary endpoint right now, Bucillamine’s attributes lead many to believe the drug will be effective for ‘long COVID’.
@30:49 What is Revive doing differently in comparison with both Adamis Pharmaceuticals and Veru Inc.