The US response to the pandemic via its Operation

The US response to the pandemic via its Operation Warp Speed initiative has had mixed results. The emphasis was to put a majority of funding towards the rapid acceleration of vaccine development while investigating existing therapeutics for other instances as treatments for CV19. IMO both an effective vaccine and effective therapeutics are critical to ending the pandemic. It is easy to play Captain Hindsight on decisions made but we are living in unprecedented times that require modifying strategies as knowledge of the CV19 virus continues to improve.

The positive result is that vaccine development is indeed taking place at a record pace but initial results for both safety and efficacy are far from proven. IMO we will not know all of the safety issues for many months and possibly for years. The entire science of RNA based development has great promise but encoding and modifying human genetic code could have potential significant and possible undesirable long term issues. There is also a major concern with overall effectiveness as viruses mutate.

The Operation Warp Speed initiative strategy of using existing repurposed therapeutics has proven to be a mistake. The current leader for repurposed drugs is remdesivir, which is only marginally effective. As hundreds of thousands of people suffer and die there is little to offer sick patients beyond basic supportive care. There is a tremendous demand for an effective antiviral, especially with the additional benefits that Brilacidin provides.

Today’s PR has major significance in that the FDA has finally cleared a path for Brilacidin COVID-19 human trials (B-CV19). The fact is that sites (International & US) have been identified, dosing protocol agreed upon, patient profiles (degree of illness, demographics etc.), proof of funding, CRO’s in place have all been communicated and coordinated with the FDA as required for IND approval. Trial recruitment and the actual human trials could happen very quickly. Having exposure both in the U.S. and internationally will increase worldwide exposure and demand for Brilacidin.

I like Brilacidin’s odds of success based on previous trails showing efficacy and safety across multiple instances with hundreds of patients. I also am encouraged by the extensive testing completed by the RBL specific to CV19. The RBL spent months studying the biochemistry and the immunology impact of Brilacidin and its superior mechanism of action to effectively and specifically treat CV19.

We all wish that the FDA would have moved more quickly but I am guessing that interim results from human trials will now be announced sometime in January which is only 7 weeks away. If interim results resemble the outstanding RBL results, I am confident that government grant funding and Emergency/Compassionate Use will follow. We will know fairly quickly if Brilacidin is effective in treating CV19. Many of us on this board have a large bet that it will be and the long term payoff could be very substantial.