There is no way to sugar-coat today’s PR. The trial results are extremely disappointing. As much of a disappointment as today’s results are IMO IPIX is still a viable entity.
Pre-CV19 IPIX had multiple opportunities for science advancement with B-OM, B-IBD, B-ABSSSI and IMO a valuable asset in IPIX’s cancer drug Kevetrin. These assets and market opportunities are all still valid and have value. Safety and efficacy were successful across these indications through multiple Phase 2 trials. Funding is the limiting factor in advancing any/all of the above. I would expect Leo to communicate IPIX’s strategy to advance these opportunities in the near future.
CV19 appears to be a much tougher nut to crack from an efficacy perspective. With the previous human trial success combined with the extensive RBL government CV19 testing, I had believed that there was a high probability of success in human trials. I believe Leo ran the trials by the book per the FDA’s strict guidance. We have yet to hear of any safety issues which could indicate that dosing could be possibly increased to a higher level as long as safety requirements are maintained while determining if efficacy could be improved.
The next important news IMO will be in regards to B-CV19 Compassionate Use (CU). If there is success with CU, my guess would be a coordinated effort with the FDA to increase dosage to determine if efficacy could be obtained. This could be a pivotal milestone for Brilacidin to get approval to treat Severe/Critical patients if increasing dosage could be safely and effectively administered. It is also possible that there is some significance of Brilacidin's MOA that would be beneficial in the CV19 disease progression. This could be explored further anywhere from prophylactic use throughout disease progression leveraging antiviral, anti-inflammation and antibiotic properties.
IPIX share price (SP) and volume is obviously still controlled by the criminal hedge funds and their cabal of Market Makers (MMs) and paid Stock Message Board (SMB) trolls. Unfortunately today’s news gives these criminals more time to continue their compression and volume tactics until IPIX executes science and/or partnership advancement.
I have been accused of being an IPIX pumper but a true pumper also has a dump strategy. I am guilty of being overly optimistic but I have never sold a single CTIX/IPIX share. I have never pumped and dumped. Right or wrong I have bought, added, held and have yet to sell a single share. At this point I am of the belief of letting my investment ride either to a worst case of zero or an upside of when IPIX is bought out. I realize that some investors do not have the luxury of waiting this out and may have to cash in some of their proceeds at a loss which is very unfortunate.
In summary today’s results were extremely disappointing but there is still a glaring need for a valid treatment for hospitalized CV19 patients. I am hoping today is a setback but not a dead issue. Keep in mind that the current standard of care (SOC) for hospitalized patients in the U.S. remdesivir, did not meet successful end points of mortality improvements or viral load reductions. Gilead could not raise dosing on remdesivir without significant safety issues. The FDA approved remdesivir on decreased hospital day stays. The Merck drug failed it’s hospitalized trial as well and due to efficacy and most likely safety limits changed their focus to an easier to treat Mild/Moderate patient population. The antiviral market is huge and Brilacidin still has an opportunity to be successful in the broad Spectrum antiviral market as well as the previous markets that IPIX was pursuing prior to CV19.
Pre-CV19 IPIX had multiple opportunities for science advancement with B-OM, B-IBD, B-ABSSSI and IMO a valuable asset in IPIX’s cancer drug Kevetrin. These assets and market opportunities are all still valid and have value. Safety and efficacy were successful across these indications through multiple Phase 2 trials. Funding is the limiting factor in advancing any/all of the above. I would expect Leo to communicate IPIX’s strategy to advance these opportunities in the near future.
CV19 appears to be a much tougher nut to crack from an efficacy perspective. With the previous human trial success combined with the extensive RBL government CV19 testing, I had believed that there was a high probability of success in human trials. I believe Leo ran the trials by the book per the FDA’s strict guidance. We have yet to hear of any safety issues which could indicate that dosing could be possibly increased to a higher level as long as safety requirements are maintained while determining if efficacy could be improved.
The next important news IMO will be in regards to B-CV19 Compassionate Use (CU). If there is success with CU, my guess would be a coordinated effort with the FDA to increase dosage to determine if efficacy could be obtained. This could be a pivotal milestone for Brilacidin to get approval to treat Severe/Critical patients if increasing dosage could be safely and effectively administered. It is also possible that there is some significance of Brilacidin's MOA that would be beneficial in the CV19 disease progression. This could be explored further anywhere from prophylactic use throughout disease progression leveraging antiviral, anti-inflammation and antibiotic properties.
IPIX share price (SP) and volume is obviously still controlled by the criminal hedge funds and their cabal of Market Makers (MMs) and paid Stock Message Board (SMB) trolls. Unfortunately today’s news gives these criminals more time to continue their compression and volume tactics until IPIX executes science and/or partnership advancement.
I have been accused of being an IPIX pumper but a true pumper also has a dump strategy. I am guilty of being overly optimistic but I have never sold a single CTIX/IPIX share. I have never pumped and dumped. Right or wrong I have bought, added, held and have yet to sell a single share. At this point I am of the belief of letting my investment ride either to a worst case of zero or an upside of when IPIX is bought out. I realize that some investors do not have the luxury of waiting this out and may have to cash in some of their proceeds at a loss which is very unfortunate.
In summary today’s results were extremely disappointing but there is still a glaring need for a valid treatment for hospitalized CV19 patients. I am hoping today is a setback but not a dead issue. Keep in mind that the current standard of care (SOC) for hospitalized patients in the U.S. remdesivir, did not meet successful end points of mortality improvements or viral load reductions. Gilead could not raise dosing on remdesivir without significant safety issues. The FDA approved remdesivir on decreased hospital day stays. The Merck drug failed it’s hospitalized trial as well and due to efficacy and most likely safety limits changed their focus to an easier to treat Mild/Moderate patient population. The antiviral market is huge and Brilacidin still has an opportunity to be successful in the broad Spectrum antiviral market as well as the previous markets that IPIX was pursuing prior to CV19.
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