Replies to post #331095 on Innovation Pharmaceuticals Inc (IPIX)

[roiresearch]

the hospitalization rates are on the rise. 120 patients won't be hard to accomplish. we just don't know the dosing/treatment plan. Is this a one time iv, several times over a certain period, etc... when is the interim analysis

i am glad the ceo used enough comments in the pr such as they are in agreement and that Q4 human trial is still the target now that the fda pre-ind comments are in

[petemantx]

Note the bold highlighting I did in this partial text of the PR today in regards to the P2 B-CV19 human testing:

"The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. The Company is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19."

The use of non-USA European (my guess as to non-USA site) patients in the study means that the data acquired can be combined with the USA patient results to submit to the FDA for the advancement of B-CV into a P3. It also means that there can be no political shennanigans to slow-play the human trial in the USA and it will lower the overall costs. Smart move by mgt IMO as it may also lessen any anti-American feelings around the world that we could be fudging the data.

The patients receiving Brilacidin should see positive results within a day or two so there should be excellent feedback by the interim data date. As to timing, the article states

"Contract Research Organizations have been secured to expedite trial enrollment with many clinical sites expressing interest in participating in the study" so it is apparent that setting up the basics for the trial have already been established. All that remains are the patient enrollments and again the article says that should be very quick due to many sites expressing interest. Makes me believe we may see the start of trials (or at least a partial start at the non-USA site) by Dec. but that is strictly my WAG.

As to EUA, if B-CV shows efficacy on patients with severe symptoms one would assume that information would get MAJOR coverage to other hospitals around the world in a very expeditious manner.