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Posted On: 07/10/2020 12:27:48 AM
Post# of 72440
I am in total agreement with you Ultimate. Also note that your comments regarding Emergency Use Authorization (EUA) on post #65249 may be a reality in the not too distant future as there is now a section on the IPIX website if you click on “About” and then “Expanded Access”. In regards to your post #65368 note the term “Pan Coronavirus Therapeutic” heading on the 6/11/20 PR with the text:
“the Company and researchers at a U.S. Regional Biocontainment Laboratory (RBL) are collaborating on a federal grant application to be submitted this week.
The proposed research aims to evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing. Longer-term objectives include potentially performing additional research to develop Brilacidin as a broad-spectrum antiviral, with possible application beyond coronaviruses, e.g., treating other viruses, such as encephalitic alphaviruses and filoviruses.”
I believe Brilacidin for COVID-19 (B-CV19) will be implemented with grant funding directly from the federal government. Leo currently has $6M in cash and MIGHT decide to use some of this cash to pay a CDMO for enough Brilacidin to supply a smaller Phase 2A B-CV19 trial INDEPENDENT of the grant/grants process. A success on this small trial would be an additional proof point to justify a much larger grant to roll out a parallel B-CV19 Phase3 which could include EUA. From the 7/7/20 PR: “Steps have begun with the Contract Development and Manufacturing Organization (CDMO) in preparation for upcoming manufacture of the drug product for COVID-19 clinical trial use, to be followed by interactions with relevant Health Authorities to obtain input and guidance on trial design.”
IPIX does not need Big Pharma for CV19. As I have stated before I believe B-CV19 will be the first Brilacidin instance to be approved by the FDA. B-CV19 will be the initial domino that will trigger a much faster approval process for other Brilacidin instances including B-IBD Oral, B-ABSSSI and B-OM. There is a $1B award being dangled by DRIVE AB for a new antibiotic which may influence prioritizing B-ABSSI which may be able to heavily leverage B-CV19 approval using the same delivery IV mechanism.
IMO license deals with BP WILL be made for most instances of Brilacidin that are NOT CV19 related as well as license deals eventually for Kevetrin. Some of these deals will occur prior to Phase 3 trials and some will be after Phase 3 trials which will be more lucrative long term. Leo will be dealing from a position of strength once negotiations take place on what I believe will be a multitude of BP deals unless a BP makes a monumental franchise offer for Brilacidin licensing that Leo can’t refuse. Some of these future Brilacidin license deals IMO will be for new instances and possibly entirely new non-biotech markets (including devices and industrial use) which may not have been previously planned or yet to have been publicly discussed. Exciting months ahead for IPIX investors and to borrow a quote from farrell “This time next year IPIX will be a very different company.”
“the Company and researchers at a U.S. Regional Biocontainment Laboratory (RBL) are collaborating on a federal grant application to be submitted this week.
The proposed research aims to evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing. Longer-term objectives include potentially performing additional research to develop Brilacidin as a broad-spectrum antiviral, with possible application beyond coronaviruses, e.g., treating other viruses, such as encephalitic alphaviruses and filoviruses.”
I believe Brilacidin for COVID-19 (B-CV19) will be implemented with grant funding directly from the federal government. Leo currently has $6M in cash and MIGHT decide to use some of this cash to pay a CDMO for enough Brilacidin to supply a smaller Phase 2A B-CV19 trial INDEPENDENT of the grant/grants process. A success on this small trial would be an additional proof point to justify a much larger grant to roll out a parallel B-CV19 Phase3 which could include EUA. From the 7/7/20 PR: “Steps have begun with the Contract Development and Manufacturing Organization (CDMO) in preparation for upcoming manufacture of the drug product for COVID-19 clinical trial use, to be followed by interactions with relevant Health Authorities to obtain input and guidance on trial design.”
IPIX does not need Big Pharma for CV19. As I have stated before I believe B-CV19 will be the first Brilacidin instance to be approved by the FDA. B-CV19 will be the initial domino that will trigger a much faster approval process for other Brilacidin instances including B-IBD Oral, B-ABSSSI and B-OM. There is a $1B award being dangled by DRIVE AB for a new antibiotic which may influence prioritizing B-ABSSI which may be able to heavily leverage B-CV19 approval using the same delivery IV mechanism.
IMO license deals with BP WILL be made for most instances of Brilacidin that are NOT CV19 related as well as license deals eventually for Kevetrin. Some of these deals will occur prior to Phase 3 trials and some will be after Phase 3 trials which will be more lucrative long term. Leo will be dealing from a position of strength once negotiations take place on what I believe will be a multitude of BP deals unless a BP makes a monumental franchise offer for Brilacidin licensing that Leo can’t refuse. Some of these future Brilacidin license deals IMO will be for new instances and possibly entirely new non-biotech markets (including devices and industrial use) which may not have been previously planned or yet to have been publicly discussed. Exciting months ahead for IPIX investors and to borrow a quote from farrell “This time next year IPIX will be a very different company.”
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