I believe Brilacidin will show successful results in the B-CV19 human trial for moderate/severe patients. This patient population does not have an effective therapeutic treatment. Remdesivir is the U.S. SOC and has not proven to improve mortality rates or reduce viral load.
As important as this Brilacidin CV19 trial is, I think some investors are underestimating the importance of Compassionate Use (CU) which IMO could prove to be just as valuable in getting Brilacidin closer to an NDA and could possibly be even more important in getting Emergency Use Authorization (EUA) for Brilacidin approved very soon.
To best understand this, ask yourself what is your biggest fear of you or a loved one getting CV19? The easy answer of course is death. If it can’t kill you, CV19 becomes a lot less frightening. Park that thought for a minute and think about who dies from CV19? The answer is critical patients. Mild and Moderate CV19 patients do not die from CV19 unless the disease progresses and the patient symptoms worsen. Think of the progression of Mild, Moderate, Severe & Critical. The number of cases is highest starting at Mild and decreases throughout the disease progression. The death rate is very low until cases get at least to the Severe stage. At the Critical stage a patient only has an 8-10% chance of survival once intubated with CV19 complications.
Brilacidin is being used to treat CU patients who have already exhausted SOC treatments (remdesivir in the U.S.) which have been unsuccessful in treating the patient. The last ditch effort is to try Brilacidin. After the unsuccessful remdesivir SOC, what if Brilacidin only saved 2/10 or 20% of the intubated patients? That would be double the current SOC rate of 10% for a 100% improvement in mortality rates. That statistic alone would be more than enough for the FDA to approve Brilacidin for EUA for Critical patients.
Take that example to the next logical step which is to treat patients earlier in the disease process. Why not start all hospitalized Severe CV19 patients immediately on a Brilacidin treatment protocol? Now rather than saving 2/10 patients maybe you could save 5, 6 or more out of 10. What is it worth to the U.S. to cut CV19 deaths in half? There have been an estimated 738k deaths in the U.S. alone from CV19. What if Brilacidin had been approved and available for Severe/Critical patients and it would have saved half of those lives or 369,000 people?
Once word gets out that Brilacidin safely kills the CV19 virus every hospital in the world is going to want to give it to treat every CV19 patient. The government knows that EUA is needed to support this demand. Big Pharma knows that Brilacidin represents a revenue gold mine for them.
Whoever steps up to partner with IPIX is going to want to also go after the huge revenue numbers associated with the mild/moderate patient population and will want to quickly develop a delivery mechanism for non-hospitalized patients. Examples include an inhaler that you could pick up at your local pharmacy that could easy get Brilacidin into your lungs and/or a depo injection you could give yourself at home. Think of the mass market for Brilacidin to safely and effectively treat CV19, bronchitis, flu and many other viruses and diseases that the RBLs have been testing for the past 17 months.
Think of the above as a top-down approach where you treat the highest severity patients (Critical & Severe) and you continue to gain approval for easier to treat but a much higher patient population (Mild & Moderate). IMO IPIX will have strong data for the most Critical cases via CU, as well as strong data from the human trial for treating less critical patients that need hospitalization (Moderate to Severe).
A successful B-CV19 human trial will be a huge milestone achievement for the advancement of Brilacidin. Don’t sleep on what IMO is an equally important milestone of Compassionate Use success. The combination of these 2 milestones will naturally lead to major funding via government grants and/or BP partnerships which will all IMO take place by EOY 2021.
As important as this Brilacidin CV19 trial is, I think some investors are underestimating the importance of Compassionate Use (CU) which IMO could prove to be just as valuable in getting Brilacidin closer to an NDA and could possibly be even more important in getting Emergency Use Authorization (EUA) for Brilacidin approved very soon.
To best understand this, ask yourself what is your biggest fear of you or a loved one getting CV19? The easy answer of course is death. If it can’t kill you, CV19 becomes a lot less frightening. Park that thought for a minute and think about who dies from CV19? The answer is critical patients. Mild and Moderate CV19 patients do not die from CV19 unless the disease progresses and the patient symptoms worsen. Think of the progression of Mild, Moderate, Severe & Critical. The number of cases is highest starting at Mild and decreases throughout the disease progression. The death rate is very low until cases get at least to the Severe stage. At the Critical stage a patient only has an 8-10% chance of survival once intubated with CV19 complications.
Brilacidin is being used to treat CU patients who have already exhausted SOC treatments (remdesivir in the U.S.) which have been unsuccessful in treating the patient. The last ditch effort is to try Brilacidin. After the unsuccessful remdesivir SOC, what if Brilacidin only saved 2/10 or 20% of the intubated patients? That would be double the current SOC rate of 10% for a 100% improvement in mortality rates. That statistic alone would be more than enough for the FDA to approve Brilacidin for EUA for Critical patients.
Take that example to the next logical step which is to treat patients earlier in the disease process. Why not start all hospitalized Severe CV19 patients immediately on a Brilacidin treatment protocol? Now rather than saving 2/10 patients maybe you could save 5, 6 or more out of 10. What is it worth to the U.S. to cut CV19 deaths in half? There have been an estimated 738k deaths in the U.S. alone from CV19. What if Brilacidin had been approved and available for Severe/Critical patients and it would have saved half of those lives or 369,000 people?
Once word gets out that Brilacidin safely kills the CV19 virus every hospital in the world is going to want to give it to treat every CV19 patient. The government knows that EUA is needed to support this demand. Big Pharma knows that Brilacidin represents a revenue gold mine for them.
Whoever steps up to partner with IPIX is going to want to also go after the huge revenue numbers associated with the mild/moderate patient population and will want to quickly develop a delivery mechanism for non-hospitalized patients. Examples include an inhaler that you could pick up at your local pharmacy that could easy get Brilacidin into your lungs and/or a depo injection you could give yourself at home. Think of the mass market for Brilacidin to safely and effectively treat CV19, bronchitis, flu and many other viruses and diseases that the RBLs have been testing for the past 17 months.
Think of the above as a top-down approach where you treat the highest severity patients (Critical & Severe) and you continue to gain approval for easier to treat but a much higher patient population (Mild & Moderate). IMO IPIX will have strong data for the most Critical cases via CU, as well as strong data from the human trial for treating less critical patients that need hospitalization (Moderate to Severe).
A successful B-CV19 human trial will be a huge milestone achievement for the advancement of Brilacidin. Don’t sleep on what IMO is an equally important milestone of Compassionate Use success. The combination of these 2 milestones will naturally lead to major funding via government grants and/or BP partnerships which will all IMO take place by EOY 2021.
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