Remdesivir did get a head start on us due to its Hepatitis C and Ebola trials. Even though it was not approved for either indication the FDA and NIAID were familiar with it. They fast tracked and approved a compassionate use EUA for Remdesivir because it seemed to be the only antiviral early it the spring of 2020 readily available for Covid 19 treatment. The early trial results were questionable in terms of efficacy, but Gilead and its lobbyists did a masterful job of moving it further into clinical trials. At this point Remdesivir will be in every clinical trial for Covid19 until a better antiviral comes along to unseat it.

IMO when Brilacidin is able to show what it can do it will replace Remdesivir as the Covid19 antiviral of choice.

I haven't given up on an EUA . IMO the path to an EUA would include a short clinical trial. If efficacy and safety of the RBL in vitro studies are confirmed I would expect an expedited path with multiple clinical trials and an EUA similar to Remdesivir's course.

https://www.fda.gov/media/137564/download
https://www.gilead.com/remdesivir

In vitro studies to date suggests Brilacidin has the potential to be a more potent antiviral than Remdesivir. Remdesivir has one mechanism of action which is to inhibit viral reproduction.Brilacidin has three antiviral effects.

Brilacidin is an virucidal which means it can kill the virus on contact and has the potential to rapidly prevent signs of infection in individuals exposed to the infection but are not clinically ill and rapidly reduce the viral load to reduce complications in moderately and severely ill patients. In addition any virus which escapes is prevented from entering the cell by Brilacidin's action against the S protein to prevent attachment to the cell wall ACE protein.. Brilacidin also can enter infected cells to inhibit viral reproduction by neutralizing the M protein.

This triple antiviral mechanism of action is unique to Brilacidin and has not been reported in any other antiviral. Coupled with Brilacidins long half life and excellent pharmacodynamics demonstrated in the ABSSSI study Brilacidin has the possibility of
quickly killing the virus outside the cell as well as inhibiting viral reproduction and entry to the cell, a trifecta.

In addition Brilacidin's ABSSSI study confirmed its abilities as a broad spectrum antibiotic and its safety. Compared to Remdesivir's reported complications Brilacidin has been shown to be much safer.

As many as 20% of Covid 19 patients develop secondary bacterial infections with the possiblity of severe complications such as bacterial pneumonia and sepsis.Brilacidin has shown the ability to stop many of these bacterial pathogens.

Brilacidin's anti inflammatory properties are unusual for an antibiotic or antiviral. These immunodilating abilities could help reduce pulmonary inflammation, exudation and bronchiolar fibrosis which result in pulmonary failure and is the most common cause of death in Covid19. There is controversy if Remdesivir can lower mortality in Covid 19 or even reduce the viral load.

Of course these probable effects of Brilacidin will have to be confirmed in clinical trials. IMO an EUA appears very likely.

While it is frustating waiting for clinical trials while so many suffer, in the end the truth will not be denied. I expect Brilacidin's path to clinical trials to be accelerated soon.

All IMO

GLTA Farrell