"So the pre IND meeting is still pending, and as f
Post# of 72447
(Total Views: 504)
Posted On: 07/14/2020 1:19:55 AM
"So the pre IND meeting is still pending, and as far as I know, hasn't yet been requested."
You may be right that I'm projecting.
My thinking is deduction from
6/17 PR-" 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."
And
7/13 PR "the Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. "
IMO announcing a P2 test w/o running it by FDA first would be a reckless move. If FDA then said "uh Leo we want to see P1 for Covid first " well you can imagine the effect on SP.
Also IMO the P2 will be a small study to confirm IV proof of concept without toxicity, with manageable adverse events. Results should be available to IPIX within two weeks of final injection if the endpoint is virus reduction.
Agree on no peer review until in vitro experiments are complete. I imagine papers will be written then passed around, refined and then submitted for publication. Articles will be re-reviewed then included in journals as relevance and space allow.
IMO grant news importance is the result of exaggerated expectations. More than likely the application was made by an RBL with IPIX input and if approved funds will go directly to the RBL for further study of Brilacidin. The RBL will inform IPIX that the lab is ready to move forward upon receipt of test substance.Then IPIX can release a PR. The psychological boost cannot be discounted but financial aid will not go to IPIX.
I am pleased that the CEO is not sitting on his hands nor moving sedately from one event completion to the next PR.
You may be right that I'm projecting.
My thinking is deduction from
6/17 PR-" 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."
And
7/13 PR "the Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. "
IMO announcing a P2 test w/o running it by FDA first would be a reckless move. If FDA then said "uh Leo we want to see P1 for Covid first " well you can imagine the effect on SP.
Also IMO the P2 will be a small study to confirm IV proof of concept without toxicity, with manageable adverse events. Results should be available to IPIX within two weeks of final injection if the endpoint is virus reduction.
Agree on no peer review until in vitro experiments are complete. I imagine papers will be written then passed around, refined and then submitted for publication. Articles will be re-reviewed then included in journals as relevance and space allow.
IMO grant news importance is the result of exaggerated expectations. More than likely the application was made by an RBL with IPIX input and if approved funds will go directly to the RBL for further study of Brilacidin. The RBL will inform IPIX that the lab is ready to move forward upon receipt of test substance.Then IPIX can release a PR. The psychological boost cannot be discounted but financial aid will not go to IPIX.
I am pleased that the CEO is not sitting on his hands nor moving sedately from one event completion to the next PR.
(3)
(0)