Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Most of what concerns you and Mr Locke about the Brilacidin Phase 2 trials ignores the fact that this is an adaptive trial and has the ability to add additional patients and even extend the trial to a Phase 3 seamlessly if Brilacidin is found to be safe and effective."

I'm not sure that Mr Locke and I have the same concerns but more importantly, what makes you say that this is an adaptive trial as you describe it?

The few times the Company has used that term have been to reference the scale to be used to evaluate the endpoints, not to describe the trial itself:
"The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale."

There is one element that may indicate an adaptive trial ("After an interim review, by an independent Data Monitoring Committee (DMC), dosing may be extended to 5 days.") but are there any other Company statements to suggest it?

Would you expect the clinicaltrials.gov entry that the Company has promised to file will indicate that the protocol is subject to change contingent on the data as it develops? Have they said that the trial provides "the ability to add additional patients and even extend the trial to a Phase 3 seamlessly if Brilacidin is found to be safe and effective"?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2941608/