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You Know Tuesday tends to be news day.
What are you seeing? honestly asking
News tomorrow Leo?
Common theme in this new paper (remdesivir synergy):
"The CIs at all the combination ratios fell
below the red line (Figure 7A), and the fractional inhibitory concentration index
(FICI) which was used to determine synergistic effects of compounds are less
than 0.5 at all combination ratios (Figure 7B), suggesting brilacidin has
significant synergistic antiviral effect with remdesivir in the combination therapy."
"Finally, drug combination therapy demonstrated that brilacidin has strong
synergistic effect with remdesivir against HCoV-OC43 in cell culture. Overall,
brilacidin appears to have appealing translational potential as a broad-spectrum
antiviral for coronaviruses including SARS-CoV-2."
Quotes taken from:
https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.27616
NIH combo trials?...
..or how/when to use? Use earlier in infection? yes please. Use as a nasal spray, maybe? - Dammit Leo. I would like to ask but doubt we'd get a response. Reminds me of Bill Clinton saying it depends on what the meaning of is, is.
"Applications" - Does this mean use brilacidin for other viruses or as in to apply to gov't for inclusion in combo trials... Would have liked more clarification.
There is also a search tool in chrome called "verbatim" that can be toggled from "all results". I use this sometimes; occasionally feel I get different results than with quotes. just fyi for all.
Thank you. Seems maybe many people searched on those two things many times (brilacidin & CTAP) and Google made the association? This is why I don't allow Siri in my house. she makes things up. However, I remain hopeful there will be some CTAP related news in near future. I think this is possible.
Odd Brilacidin Google search result: Does anyone else get this result from google (I'm using Chrome browser)- Search word brilacidin, then use search tools to select 'past week' - I get second result returned as
"Coronavirus Treatment Acceleration Program (CTAP) | FDA"
- But I see no mention of Brilacidin on the page.
I find that very odd. I'm not saying it means anything at all, just that it's odd.. maybe something is hidden/in background on the FDA page pending PR? Why would Google make this association - the term Brilacidin with that FDA page?
Attempting to paste my search:
https://www.google.com/search?q=brilacidin&rlz=1C1GCEA_enUS969US969&source=lnt&tbs=qdr:w&sa=X&ved=2ahUKEwjo4rSG6a71AhVEonIEHUFjDBEQpwV6BAgBEBc&biw=1920&bih=969&dpr=1
"after successfully finishing phase II" You are reading that part of the sentence as future tense. I am reading as past tense. So, stating that the phase II was successfully completed, which is true, and phase III pending. It's the "will start soon" that interested me.
New Journal article mention, International Journal of Molecular Sciences, 31DEC2021 publish date. Brilacidin mention page 13/14.
This is a direct download to .pdf:
https://www.mdpi.com/1422-0067/23/1/472/pdf
Interesting statement page 13:
"However, phase III clinical trials using intravenously administered Brilacidin, a synthetic defensin analogue for treatment of skin infections, will start soon after successfully finishing phase II"
This may be the result of a dated reference (or not?) but interesting.
Thoughts?
Animal Reservoirs:
I believe similar info regarding Covid in U.S. Whitetail deer has been posted before (think it was Dud, god save us) but since there is now ample evidence of Covid in animal reservoirs, the need for therapeutics should be apparent. We are not going to vaccinate out way out of this. Are you gonna vaccinate every animal that walks/flies/crawls the Earth? Look at what occasionally happens with influenza (swine flu, avian flu ..potent shit), also other coronaviruses like MERS, that has a Camel reservoir; These virusese go into an animal reservoir, mutates and comes back at us hard. I would like to see an Effective combo drug regimen, even if by IV, available - that at least includes Brilacidin. If B can get into a combo trial then we're possibly off to the races. I think this is possible and part of why I continue to accumulate. - Happy New Year all
https://www.nbcnews.com/science/science-news/covid-rampant-deer-research-shows-rcna10181
https://wwwnc.cdc.gov/eid/article/27/4/20-3945_article
https://virologyj.biomedcentral.com/articles/10.1186/s12985-016-0544-0
Patents; Thoughts about. Has anyone followed the reddit posts for IPIX? I noticed posts about patent applications. I will try to link, apologies if I screw the link up in advance:
https://www.reddit.com/r/IPIX/comments/rnyrhk/new_patent_arylamide_compounds_for_treatment_and/
https://www.freepatentsonline.com/y2021/0379058.html
Thoughts about?
Farrell, Do you think these be "cocktail" trials, such as a redemsivir/Brilacidin +/- other drug combo?
You would appear to be possibly correct; extrapolating from today's pr. credit where credit is due. I'll eat my crow with a shot of vodka. skol. p.s., Interested in your current thoughts for the future of this position?
You make valid points, respectfully- from a glass half empty perspective. You seem to have the knowledge and aptitude to make an argument from a glass half full perspective, if you chose. I have only three posts per day and am otherwise in the trenches of Regulatory daily such that I don't have the luxury of an in depth dialog about. However, let's not forget that FDA pre reviewed the trial. I'm not convinced FDA would give input to and then fast track an underpowered trial. There's much more detail to dig into here in the data. The fat lady hasn't sung.
I don't believe the study was under powered. I see p2 cancer clinical trials set up consistently with 120 to 160 subjects. These are sponsored by BP who have deep pockets but yet still use this enrollment size.
This is a very interesting and valid point you make. Had one (1) less patient died on treatment arm then things would look very different now. A much deeper dive into the data is needed here.
However, would BP have partnered if only 1 less patient on treatment arm died. I doubt it until all data analyzed.
On the flip side, after data is fully analyzed, I believe there is some hope BP or uncle Sam will take notice.
Personally, I'm accumulating the meager amount I can. I'm not recommending that gamble. I just can't resist it myself.
Skol
Nasal spray.. All, Interesting article talks about a coming cv19 vaccine resistance and mentions nasal sprays. I know recent company prs have mentioned nasal spray application.
https://www.deseret.com/coronavirus/2021/11/17/22787447/covid-vaccine-resistant-coronavirus-variant-spring-2023
Cheers
Lemon, you are absolutely right about funding,imo. The company can fund OM. Also, don't forget about the Alfa trial upcoming. So, two paths forward, at opposite ends of the body. The oral path and the what what in the butt path. Can't make this shite up. I'm holding AND adding. Never know, could be an inhaler trial funded by a partner or grant. Skol
(Thanks to those that responded privately) Maybe can get a partner or grant to fund. Sounds like things are still in works from pr to move ahead otherwise.
Justfactsmam - Do you think Leo will run another Covid trial using an inhaler for B given the news about this delivery method today?
Trial size is 120. Read the prs and read Trial info on clinicaltrials.gov. Trial size is consistent with phase 2 trials I have personally worked on and size is enough to satisfy fda. FDA pre-approved the trial. Don't let people sow doubt; but do your own due diligence.
OMG, DUD, you told me there was a 20 cent wall... wtf? lo fn l
So, you're covering.
Read previous posts from posters justfactsmam and farrell90
Yes, but would results of compassionate care also cross his desk?
Is it possible Leo knew some results of compassionate care use prior to most recent 8k? (not necessarily the cases discussed on this board, but others, in US or Russia that the board has not yet discovered). I mean, the compensation in 8k would not sit well with most investors in my opinion - unless.. Although trial data is blinded, I don't believe compassionate care use is?
Death toll from covid reaches new daily high in Russia. Brilacidin Trial mostly conducted in Russia. Equivalent of EUA in Russia would be nice. BBC article: https://www.bbc.com/news/world-europe-58937582
Russia, if you're listening...
Perfect. Thanks
Exactly, Bar Is Low for SOC.
Compassionate care use at locations other than trial sites = significant IMO. Does FDA clearance for expanded use mean B is effective? No. Does it mean FDA views as safe (enough)? yes. If also effective (N.B. Only needs to be better than standard of care), then sky is the limit for PPS, IMO. Skol!
Same can be said for merck pill, but yet there it is. You only need to be better than standard of care.
This should be stickied. Puts things into perfect perspective. B still very much needed and there is a definite market for B if proven effective.
I bought more today also. I remain confident in my investment. I've seen some "concerns" voiced here about trial size. I currently work in RA/QA for a NC university, primarily on phase 2 Cancer trials. Number of subjects, 120 for ipix C trial is consistent with what I see for p2 cancer trials, although possibly for different reasons. However, this IS a sample size that will show results either good or not- FDA would not have approved if not a validsize. I've seen other poster say 'know what you own' -well, ..yes, yes I do. Cheers all.
'Financial and Filings' section of company website is down. Possibly this is being updated with new info?
Very well played, I did same yesterday.
No worries, not blaming you for anything. I appreciate your posts here. Cheers.
Wow Loan, you've possibly gone too far down a a rabbit hole. Come back towards the light before the poltergeist get you.