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Posted On: 12/19/2020 4:17:16 PM
Post# of 72441
I have zero concerns that any delays in the upcoming B-CV19 human trial will be due to IPIX not being ready to proceed. On 11/2/20 Leo clearly stated that IPIX was ready to roll including having ample drug manufactured for the Phase 2 B-CV19 trial. On 11/16/20 Leo stated that both International and U.S. submissions had been completed and await approvals. My guess is that we will hear about either/both International and U.S. formal approvals by end of the month and worst case early January. Leo has the CRO’s, sites and drug ready to go IMO which would allow patient recruitment a few days after formal approvals are in place. IMO once a hint of efficacy is observed in this Phase 2 trial additional manufacturing of Brilacidin will take place if it has not already, as Emergency Use and Phase 3 requirements dictate. I think the latest $5M funding was implemented for post B-CV19 Phase 2 for the above as well as to get a separate pill based formulation of Brilacidin manufactured for upcoming B-IBD UC trials.
From 11/2/20 PR
Contract Research Organizations have been secured to expedite trial enrollment with many clinical sites expressing interest in participating in the study.
And
“Getting to the point of being able to advance Brilacidin as a potential treatment for COVID-19 required an enormous amount of time, resources, and team effort,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “From the manufacturing of drug supply, to researching Brilacidin’s mechanisms of action in vitro against SARS-CoV-2 in infected cells, to now preparing and planning for the COVID-19 clinical study—was an extraordinary effort.”
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From 11/16/20 PR
an overseas Clinical Trial Application (CTA) has been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
From 11/2/20 PR
Contract Research Organizations have been secured to expedite trial enrollment with many clinical sites expressing interest in participating in the study.
And
“Getting to the point of being able to advance Brilacidin as a potential treatment for COVID-19 required an enormous amount of time, resources, and team effort,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “From the manufacturing of drug supply, to researching Brilacidin’s mechanisms of action in vitro against SARS-CoV-2 in infected cells, to now preparing and planning for the COVID-19 clinical study—was an extraordinary effort.”
==========================
From 11/16/20 PR
an overseas Clinical Trial Application (CTA) has been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
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