It looks like we will have to continue to be patient as the Brilacidin human trial Top Line results are now anticipated to be reported in mid to late October. There was however, some outstanding news announced in today’s IPIX PR that could have a significant impact for IPIX and its investors.
Compassionate Use approval for Brilacidin from the FDA is a big deal. I assume that the data from the human trial is still blinded which would indicate that there has been outstanding anecdotal evidence of success in the hospital sites that were treating patients for the human trial. In other words the participating trial sites must have been seeing a noticeable difference in patient success then what was to be statistically expected. IMO the FDA would not have approved Brilacidin for Compassionate Use unless:
1) The FDA believes there is strong evidence that Brilacidin is both safe and effective.
2) The FDA is indirectly admitting that currently there are no valid therapeutics available to successfully treat severe CV19 cases.
There is a very good chance that there will be success stories that take place where severely ill CV19 patients that had been treated without success using Standard of Care (SOC) treatments like remdesivir, will make recoveries once Brilacidin has been administered. Once Brilacidin proves to save lives it will not take long to get Emergency Use Approval IMO.
Testing appears to be ongoing in 3 separate labs and is proving that Brilacidin is effective in both enveloped and non-enveloped viruses. This testing includes the non-enveloped Adenoviruses which can cause a wide range of illnesses as mentioned in farrell's post #70408 that include common cold or flu-like symptoms, fever, sore throat, acute bronchitis (inflammation of the airways of the lungs, sometimes called a “chest cold”), pneumonia (infection of the lungs), pink eye (conjunctivitis), acute gastroenteritis (inflammation of the stomach or intestines causing diarrhea, vomiting, nausea and stomach pain.)
If Top Line results are positive I believe IPIX will have funding options via grants or partnerships at which time I would expect that additional delivery technologies such as an inhaler and/or depo injection will be developed. This would significantly broaden Brilacidin's market beyond CV19 (which is a significant and critical market in itself) to an even broader market with Brilacidin positioned as a Broad Spectrum antiviral/antibiotic. IMO If we see good Top Line data next month we will all have ownership positions in a very successful company that will save many lives.
Compassionate Use approval for Brilacidin from the FDA is a big deal. I assume that the data from the human trial is still blinded which would indicate that there has been outstanding anecdotal evidence of success in the hospital sites that were treating patients for the human trial. In other words the participating trial sites must have been seeing a noticeable difference in patient success then what was to be statistically expected. IMO the FDA would not have approved Brilacidin for Compassionate Use unless:
1) The FDA believes there is strong evidence that Brilacidin is both safe and effective.
2) The FDA is indirectly admitting that currently there are no valid therapeutics available to successfully treat severe CV19 cases.
There is a very good chance that there will be success stories that take place where severely ill CV19 patients that had been treated without success using Standard of Care (SOC) treatments like remdesivir, will make recoveries once Brilacidin has been administered. Once Brilacidin proves to save lives it will not take long to get Emergency Use Approval IMO.
Testing appears to be ongoing in 3 separate labs and is proving that Brilacidin is effective in both enveloped and non-enveloped viruses. This testing includes the non-enveloped Adenoviruses which can cause a wide range of illnesses as mentioned in farrell's post #70408 that include common cold or flu-like symptoms, fever, sore throat, acute bronchitis (inflammation of the airways of the lungs, sometimes called a “chest cold”), pneumonia (infection of the lungs), pink eye (conjunctivitis), acute gastroenteritis (inflammation of the stomach or intestines causing diarrhea, vomiting, nausea and stomach pain.)
If Top Line results are positive I believe IPIX will have funding options via grants or partnerships at which time I would expect that additional delivery technologies such as an inhaler and/or depo injection will be developed. This would significantly broaden Brilacidin's market beyond CV19 (which is a significant and critical market in itself) to an even broader market with Brilacidin positioned as a Broad Spectrum antiviral/antibiotic. IMO If we see good Top Line data next month we will all have ownership positions in a very successful company that will save many lives.
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