- Revive Therapeutics Ltd. (RVV), a cannabis and psychedelic healthcare company, has received feedback from the U.S. FDA to help advance its oral drug, Bucillamine
- The drug underwent a clinical trial to determine its safety and efficacy against COVID-19
- The FDA gave positive comments about the study’s potential new lab outcomes such as the rate of persistent COVID-19 symptoms
- Revive believes that with the new dominant variants it needs to treat symptom resolutions in addition to preventing hospitalizations
- Before the next step, Revive will submit a data access plan to the FDA shortly
- Revive Therapeutics Ltd. (RVV) is up 17.33 per cent trading at $0.44 per share as of 4:20 p.m. ET
Revive Therapeutics (RVV), a cannabis and psychedelic healthcare company has received feedback from the U.S. FDA to help advance Bucillamine.
Bucillamine just underwent a Phase 3 clinical trial to determine its safety and efficacy of anti-inflammatory and antiviral properties to treat patients with COVID-19.
Revive stated it received positive comments from the FDA related a request it made about the study’s potential new primary lab outcomes such as the rate of persistent COVID-19 symptoms.
This is to address the shift in COVID-19 clinical outcomes observed during the pandemic and may have more significant study results for a potential Emergency Use Authorization.
Revive believes that with the new dominant variants like Omicron and BA.2, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations.
According to Revive, the FDA agreed that the first 210 studied patients can be unblind the pre-dose-selection data to take a closer look at the new clincal results.
Before this next step, Revive is required to submit a data access plan to the FDA by early next month and submit the amended study protocol with the new primary efficacy endpoints.
After which the Data Safety and Monitoring Board (DSMB) has scheduled a meeting to evaluate the provisional data with the potential to makes recommendation on continuing the study or advise on halting it based on observation trials elsewhere.
Revive stated that during a previous meeting DSMB supported the continuation of the study as there were no safety concerns reported at the time.
Revive Therapeutics Ltd. (RVV) is up 17.33 per cent trading at $0.44 per share as of 4:20 p.m. ET.