Per the PR:
Testing results observed to date formed the basis for a federal grant application that was submitted last week by the RBL, in collaboration with the Company, proposing to evaluate Brilacidin’s potential as a pan-coronavirus therapeutic, with possible extension into other viruses. The Company is in the process of manufacturing Brilacidin for intravenous (IV) dosing and will be seeking FDA guidance for a planned COVID-19 clinical study.
Questions:
1) What is the shelf life of B IV? Is there a risk of inventory expiring (losing effectiveness) before use?
2) Why mention manufacturing? If manufacturing is starting, it sounds like it is more than a few batches for a clinical trial. Perhaps it's mention because the production will be significant!
3) Where is the money coming from? Is the grant allowing major production of B IV without some prelim data on clinical data?
And then there is this:
Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines.
This all sound like EU to me!
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