My opinion on the number of B-CV19 trials is as fo
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Posted On: 02/24/2021 1:11:57 AM
My opinion on the number of B-CV19 trials is as follows: I believe Leo decided to have an overseas component of the Phase II B-CV19 human trial for 2 main reasons. The first reason is a significant cost savings without jeopardizing quality and the second reason IMO is to get additional international exposure for Brilacidin. The fact that Brilacidin was researched in great detail by the U.S based RBL and has several successful FDA trials for separate instances should be a strong foundation for U.S. based demand once successful trial results are available.
Having an overseas component of the trial will help to attain non-U.S. exposure and demand. IMO once successful results become available there will be international demand for Brilacidin which will give Leo additional leverage to negotiate grant funding from multiple government agencies which will in turn give Leo leverage in negotiating any BP partnership deal if that is the direction that Leo decides to go. I strongly disagree with those who claim IPIX is too small of a company to get government grant funding. There is an enormous amount of demand worldwide for an effective CV19 treatment and this demand will dictate international government grants. The gigantic BP’s have yet to produce an effective CV19 therapeutic and the government’s plans to fund repurposed drugs has proven to be a terrible and costly worldwide mistake. It has been publicly admitted by Dr. Fauci, Dr. Kessler and others in powerful positions that an effective therapeutic is necessary to complement CV19 vaccines to defeat the current pandemic and future pandemics.
I believe that IPIX was extremely diligent in preparing for this important B-CV19 human trial. I believe that IPIX worked very closely with the FDA to ensure that any overseas component would be 100% compliant with FDA guidelines for the overall trial. With this in mind it would not matter if for example whether the patient population ended up being 90/30 or 30/90 Russian vs U.S. as all of the details and overall structure of the trial will be the same regardless of location. My belief is that Leo hired an international CRO that has a U.S. based CRO leading the trial and a sub-contacted CRO that runs the Russia component. The Russian CRO may work for the same company as the U.S. based CRO or could be a completely separate company and act as a sub-contractor. Therefore IMO there is one B-CV19 trial in 2 separate countries each having multiple locations.
A POSSIBLE situation could occur however where the Russian component of the trial could request to expand the scope beyond the initial agreed upon patient population that adheres to the FDA guidelines. For example let’s assume that there is indeed 106 Russian patients treated within the FDA structured guidelines that satisfy the overseas component of the initial FDA trial. These initial Russian patients would be included in the singular FDA trial along with U.S. patients using the same FDA guidelines and be in the final database as part of the overall trial results. If there was interest in testing any additional functionality outside of the FDA guidelines by the Russian Ministry then this additional scope would not be included in the FDA approved trial but would be in fact part of a separate Russian trial starting with patient 107+.
I have no idea if this will happen but if the Russian Ministry witnesses impressive Brilacidin results they could certainly fund their own expansion that would be considered a separate trial by all parties involved. This separate trial could have a variety of what project managers would call “scope creep” that could include drug combination treatments, alternative delivery mechanisms, different patient population, demographics etc. As I mentioned this may or may not happen but I do believe once word gets out that Brilacidin is effective and kills the CV19 virus I believe Leo will have to prioritize demand that could very well include EUA either in the U.S. or overseas. This will be a very good problem to have.
I personally will be looking at IPIX PR’s and FDA based information as trusted resources. I will not personally rely on any Russian based document that needs to go through Google translation as a reliable source of information. If there are IPIX related material events that occur, they will be PRed by IPIX.
Having an overseas component of the trial will help to attain non-U.S. exposure and demand. IMO once successful results become available there will be international demand for Brilacidin which will give Leo additional leverage to negotiate grant funding from multiple government agencies which will in turn give Leo leverage in negotiating any BP partnership deal if that is the direction that Leo decides to go. I strongly disagree with those who claim IPIX is too small of a company to get government grant funding. There is an enormous amount of demand worldwide for an effective CV19 treatment and this demand will dictate international government grants. The gigantic BP’s have yet to produce an effective CV19 therapeutic and the government’s plans to fund repurposed drugs has proven to be a terrible and costly worldwide mistake. It has been publicly admitted by Dr. Fauci, Dr. Kessler and others in powerful positions that an effective therapeutic is necessary to complement CV19 vaccines to defeat the current pandemic and future pandemics.
I believe that IPIX was extremely diligent in preparing for this important B-CV19 human trial. I believe that IPIX worked very closely with the FDA to ensure that any overseas component would be 100% compliant with FDA guidelines for the overall trial. With this in mind it would not matter if for example whether the patient population ended up being 90/30 or 30/90 Russian vs U.S. as all of the details and overall structure of the trial will be the same regardless of location. My belief is that Leo hired an international CRO that has a U.S. based CRO leading the trial and a sub-contacted CRO that runs the Russia component. The Russian CRO may work for the same company as the U.S. based CRO or could be a completely separate company and act as a sub-contractor. Therefore IMO there is one B-CV19 trial in 2 separate countries each having multiple locations.
A POSSIBLE situation could occur however where the Russian component of the trial could request to expand the scope beyond the initial agreed upon patient population that adheres to the FDA guidelines. For example let’s assume that there is indeed 106 Russian patients treated within the FDA structured guidelines that satisfy the overseas component of the initial FDA trial. These initial Russian patients would be included in the singular FDA trial along with U.S. patients using the same FDA guidelines and be in the final database as part of the overall trial results. If there was interest in testing any additional functionality outside of the FDA guidelines by the Russian Ministry then this additional scope would not be included in the FDA approved trial but would be in fact part of a separate Russian trial starting with patient 107+.
I have no idea if this will happen but if the Russian Ministry witnesses impressive Brilacidin results they could certainly fund their own expansion that would be considered a separate trial by all parties involved. This separate trial could have a variety of what project managers would call “scope creep” that could include drug combination treatments, alternative delivery mechanisms, different patient population, demographics etc. As I mentioned this may or may not happen but I do believe once word gets out that Brilacidin is effective and kills the CV19 virus I believe Leo will have to prioritize demand that could very well include EUA either in the U.S. or overseas. This will be a very good problem to have.
I personally will be looking at IPIX PR’s and FDA based information as trusted resources. I will not personally rely on any Russian based document that needs to go through Google translation as a reliable source of information. If there are IPIX related material events that occur, they will be PRed by IPIX.
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