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Currently prepping for a P2 as an IV-administered formulation, I'm not seeing practicality with administering IV's prior to disembarking on a flight etc as prophylaxis application?
Given the short half-life and lack of systemic-absorption could be additionally problematic?... BUT I'd wonder about a reformulation into an aerosolized/nebulized delivery option (inhaler)?
My understanding is this is part of the consideration-set already, and GMU has the capability to test (not all RBL's do) for aerosolized delivery of substances. Reformulation forces us back to a P1 which eats up more of the clock and non-existent funding, but following a successful P2 and possible EUA, who knows?
Thanks Lily,
The link you posted was the same one I'd posted and quoted, with material dates referenced for engagement with FDA etc.
Those are my concerns.
I'm clear with my understanding of the RBL's being outside the locus of Leo's control (obviously), and on their own respective timelines.
If Leo's going to announce things like: 'Interactions with the Food and Drug Administration, through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September, along with the selection of a Contract Research Organization to implement the Brilacidin for COVID-19 clinical trial'
... then my point is: shareholders benefit from updates related to progress from the company. How are those interactions going, LEO?
Seems pretty simple. Would you not agree?
(and yes, glad LinkedIn finally verified Leo's part-time new-hire. Not sure why he's been keeping it such a secret either...)
Nobody's forced my 'investment' here. As an investor, I tend to look for growth and progress related to whatever I choose to invest in. I also expect a certain level of accountability and acumen demonstrated by management with the intention to grow the company. This is the first company I've invested in where I feel shareholders make all manner of excuses for distinct lack-of-progress scenarios, that seem to be against their own interests.
I understand the long-game. I understand the complications of developing assets and economic concerns related to funding. What I don't understand is the toddler-like mentality of refusing accountability. OWN YOUR SHIT. Sure, this is BioTech, but why make more excuses for not following best-practices general guidelines for businesses and just implementing basic transparency in communications? That just makes no sense.
Wishing a speedy recovery to you, Shazamm.
THIS is why I'm frustrated by the slow-walking of Brilacidin.
We NEED to get things MOVING. I believe in the science, but the world can't wait forever...
Thank you.
Quite familiar with the PR's.
My concerns are always related to the timelines and Leo's seeming inability to keep track of time (or even recognize it).
It would be great for the research to be wrapped and for results to be public (based on previous PR's). I get it that 'they're coming'... but news is 'always coming'.
There shouldn't be doubt concerning execution of strategy (or even validity of data) with businesses... let alone businesses developing products in this industry addressing this indication, during a pandemic.
Real updates about material events should have a premium placed on them in times of crisis. I don't feel we need more rehashed-BS that's unrelated to actual progress. (ie the last PR)
http://www.ipharminc.com/press-release/2020/8/24/covid-19-drug-candidate-brilacidin-achieves-a-selectivity-index-among-the-highest-reported-exhibiting-potent-anti-sars-cov-2-activity-at-low-concentrations-clinical-trial-forthcoming
Lol, sure patience CAN pay off. How much more patient should shareholders be during a pandemic?
Leo has shown us he has no respect for shareholders by refusing any accountability.
I believe this to be the GMU researcher at RBL: https://cos.gmu.edu/ncbid/people/aarthi-narayanan/#.X2eddNNKjUI
Still, no idea why TF it's taking SO ridiculously long to get any concrete final results from them, whoever the other mysterious RBL is, or the NIH? Why does Leo feel he needs to be so mysterious about this stuff? All it does is further erode credibility at this point (what was left of it)
It IS always another 'week, month, year', while Leo continues to pay himself yet seemingly accomplishes little to nothing. Regular updates would go a LONG way to reassuring shareholders.
Agreed.
The longer this drags out without the IND even being submitted or the RBL issuing 'final data', the less I feel like there's any chance of it actually going anywhere.
I've never ceased to be amazed at his apparent lack of understanding of the time/money value-equation. (being an accountant and all...)
Heh, no worries. I just wanted to clarify. ;)
Non-peptidic structure also helps with simplification for manufacturing.
Hoping post-positive P2 results for SARS CoV-2 (if we get there) this will pay dividends with respect to manufacturing speed on the back-end. If there's a vertically-integrated partner involved, manufacturing domestically in-house should be a reality.
There's also this, pulled from the IPIX website...
GILD could license the COVID indication and have control.
If IPIX can progress IBD and K, there's more value in unloading at those points, compared to selling all now, I believe.
apparently not that hard... or that far away:
https://www.upmc.com/media/news/091420-mellors-dimitrov-covid-ab8
You can read more about the process here:
https://www.fda.gov/media/137927/download
I would wonder about IPIX having the following info in entirety:
...I’d say the vacuum IPIX operates in is largely confined to these boards.
Leo could do something about it, if he engaged with a PR agency to circulate info in a public-space (NOT just the GlobalNewsWire). Then visibility could be significantly better. PrePrint could possibly help organically. 3rd party validation (not coming from Leo, could help).
Traders see volume/momentum moves so they get in/out based on what they see, but they’re not typically investing based on the ‘science’ (to my knowledge).
We see this happen all the time in marketing with foreign companies that don’t understand the ‘American’ marketing/advertising philosophy and trends. Choosing the time/audience for your message and then hitting them with frequency/reach is common to control the conversation for most marCom strategies. Communication is critical, and IPIX ranks low IMO, in terms of publicly visible comms.
News is released. It gets buried on the Wire. Traders sell on the news, as well as whatever swings our current financing arrangement contributes. OTC listing eliminates institutional investment involvement currently for us, so volume is limited to small-retail movements mostly. Public-facing management concerns (optics) /structure lead to lack of prospective investor confidence... etc etc.
The general history of the company may not help, and the historical lack of meaningful capital + no partnerships (AS doesn’t count). Poor business development decisions. A ridiculously lengthy timeline to get trials moving, and absurdly long periods of nothingness all point to poor management. Statistically meaningless trial sizes dictated by gross lack of capital further elongate an already incredibly elastic development timeline.
An outsider-perspective might have historically concluded that investment capital is better tied up in something that’s actually progressing (hence the feeling of IPIX being in a vacuum, because it’s the same Longs and flippers year in/out).
SARS CoV-2 play for Brilacidin could change all of this... let’s keep our fingers crossed.
Others are moving FAR faster than we, which makes me a little concerned, but I feel the field is large enough for many prospective solutions to our evolving concerns.
I've been wondering about a manufacturing partnership for a while now.
There have been several announcements concerning grants-awarded in the space for several BP's for both vaccines as well as therapeutics.
This being the latest partnership announced: https://www.fiercepharma.com/manufacturing/pfizer-signs-up-to-help-manufacture-gilead-s-covid-antiviral-remdesivir?mkt_tok=eyJpIjoiWmpVeFlUWTFNMlUxWldWaiIsInQiOiJqNUVNcHI5clAzT00zTHFydU9YWlJYXC9CMXJjN0VSRG93Rmc3OEtVK1dobzFkdzJZbnBWcG1MUEhqT3V4Y1h5d0ZsenFoRUVpTWJUNjZUYUNlSDJwZlhtM1dYR3lnUGFEZXcxa1V1ZUNTbDVXQ29pUWQ1U21qVUFRenRwMDlSS1VZXC9HdmNoM29iVElQTXpZaGVkVDl5QT09In0%3D&mrkid=74197490
I have a feeling this is coming.
I think it'll be the next PR in the coming 7-10days from the RBL.
I also feel like we might see a comparison between Brilacidin and Remdesivir.
Not sure why they're not giving hard-data, which for a clinical sciences-application is fairly strange (and fluffy), but I think the RBL's will provide that. The final data sheets and then the PrePrint will be super interesting to check out. Impossible to hide as well.
I think Leo announcing the Aspire deal is what needed to happen. IF data showing amazing efficacy for B is announced by the RBL's, I'm of the belief that there's a BP or two ready to make a partnership move. I think the Aspire cash-leverage will help Leo's negotiating position more than the $6M COH currently would otherwise.
No, it might not be enough to run a large P3 trial alone, but I think to cross the bridge from where we are to a quick P2, would serve us well.
This is where Remdesivir is currently: https://www.gilead.com/purpose/advancing-global-health/covid-19/remdesivir-clinical-trials
Topline result data: https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19
Within the C19 space apparently BARDA isn’t finished with grant-awards
https://www.reuters.com/article/us-health-coronavirus-moderna-funding/moderna-gets-further-472-million-u-s-award-for-coronavirus-vaccine-development-idUSKCN24R0IN
...sure would be nice if ipix could get even just $50k at this point for clinical study-completion with the RBL’s.
Definitely having a pretty difficult time trying to understand what the hold-up is beyond just not having drug-manufacturing complete.. .
Also, what’s happening with IBD P2?!?
Interesting article here:
https://www.nature.com/articles/s41586-020-2571-7
Dr. David Ho is a pretty smart guy (understatement) and is the CEO of: https://www.infectiousdiseases.cumc.columbia.edu/research/research-centers-and-programs/aaron-diamond-aids-research-center
Insightful breakdown here, worth checking out (from back in March, in case you missed it):https://www.caltech.edu/about/news/tip-iceberg-virologist-david-ho-bs-74-speaks-about-covid-19
Hope we've got product to get into human trials sooner-than-later.
There are some brilliant minds grinding away at this for a solution.
- https://www.nbcnews.com/news/asian-america/famed-hiv-researcher-race-find-covid-19-treatment-n1197631
If there's a dire need (and I believe ICU's are there now or will be shortly in some areas), then my understanding is the hospitals came to us looking for solutions previously, but we didn't have drug on-hand.
We also didn't have cash to fund a trial if it wasn't hospital funded.
Everything is changing once again, and my thought is: IF a hospital didn't sponsor a trial now, then there are other entities to assist now.
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
How do you know he's not? ;)
This will be interesting to watch:
https://www.cnbc.com/2020/07/14/moderna-will-begin-late-stage-coronavirus-vaccine-trial-on-july-27.html
Hoping Leo can get something moving this year.
I feel like we're WAYYyyYyyYyY beyond $1, if we can break the Curse of IPIX. (it's all about the opportunity-cost-over-time situation that Leo seems to struggle with)
The C19 indication alone is beyond what I'm comfortable with speculating... Awaiting words on an IBD P2 trials which is another big-swing, and then taking B-OM in-house shouldn't be an issue.
...and then Special-K.
Bingo. I wish more people understood this...
Thank you ;)
How do you know what the ‘mechanism’ is?
I didn’t see any terms or structure disclosed anywhere. (Or even an interested party for that matter)
Can you please direct me to where I could learn more about the ‘mechanism’?
You seem to be conveniently forgetting that:
1. IPIX is run by an accountant... not a ‘biz-dev/strat’ guy.
2. Kevetrin has what some would consider ‘statistically insignificant’ results. (And no, we don’t need to argue about this, I understand the significance of a cohort of 2 with respect to a P53 modulator and the MOA)
3. You’re assuming that Leo’s not had conversations with entities showing interest or been subject to offers.
4. You’re also assuming that Leo is ‘connected’ in a way that likely he is not.. with respect to waging partnership negotiations.
I’m betting there’s a reason he’s working towards tox-study completion, and it might not be just in the interest of advancement of the indication.
My understanding was that the tox-study on K is 1/2 way complete and has been sitting idle.
It wasn’t a big-swing to complete it (financially) but in the throes of BK, it was last-priority with the IBD and then C19 indications garnering attention.
If i had to guess, I’d think Leo paid/will pay the money to have the study completed with this last round of capital, and I’m hoping we hear something about it sooner than later.
LOTS of possibilities for action now, thankfully.
Hoping for the IBD P2 to get moving abroad, C19 and K.
Could be something here if Leo wanted to get an assist...
https://www.fiercebiotech.com/biotech/big-pharma-joins-forces-1b-fund-to-shore-up-struggling-antibiotics-makers
TONS of funds out there marketing themselves as ‘being there to help the smaller guys out’...
I wonder why we never see them involved with IPIX?
Meanwhile...
https://apnews.com/dab8261c68c93f24c0bfc1876518b3f6?utm_source=Twitter&utm_campaign=SocialFlow&utm_medium=AP&utm_source=Twitter&utm_campaign=SocialFlow&utm_medium=AP&utm_source=Twitter&utm_campaign=SocialFlow&utm_medium=AP&utm_source=Twitter&utm_campaign=SocialFlow&utm_medium=AP
Speaking of grants and the lobby.
Maybe not the worst thing for Leo to be sitting on $6M.... but i was sort of hoping we wouldn’t have to use it for COVID applications (beyond drug manufacture for trials, obviously).
What a mess this is.
Not sure that's 'their website'.
Dig further: https://whalewisdom.com/stock/ctix
https://whalewisdom.com/dashboard2/search/stock_screener
https://whalewisdom.com/info/about
My understanding of the scope of LW's relationship with IPIX is confined to working to source a partner for B-OM only.
Nothing further.
Not sure why Leo wouldn't look to pursue this?
https://www.cnbc.com/2020/07/09/new-1-billion-fund-aims-to-steer-antibiotic-companies-in-a-tough-market.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Message
Could bode well for B, given recent results from RBL's...
Reading for comprehension would be helpful, as opposed to reading to make a response.
I was pointing something out that was stated in a previous post that was inaccurate.
I hear what you're saying for sure.
As to Leo 'Having skin in the game'... his shares were given to himself with a cost basis of zero (if memory serves,... LR can verify). He's loaned $2M of his own capital to the company over time, many years ago.
Yes he's got sweat equity, but he's also been paying himself $400k/yr for over a decade if I recall?... so YES, he's got 'skin in the game', but as to the comparison against other shareholders, I can't accurately comment based on others' holdings.
Also, I agree on your point of streamlined corporations in the Age of Covid. No, we don't need to have high-priced this-or-that and in-person-everything currently (or maybe ever again) with respect to BizDev/productDev.
I was reading something a while back concerning the industry strategy-shift within Pharma and how Biotechs are setup currently to serve as R&D arms of BP's and it's all about positioning for an M&A post P2 (or earlier) depending upon pipeline etc.
My biggest looming concern relates to timeline and the 'Lobby'. We're seeing the connected companies with products unproven receiving massive amounts of cash for 'duds'. Leo doesn't have lobbyists. Hell, he didn't even have an operable phone for weeks on end. Remember? So the endless waiting while a pandemic rages, additional RBL test results, a possible grant (only one applied-for to-date to my knowledge), no product available until September'ish, etc... it all just compounds the opportunity cost we're witnessing here.
BUT... I think the $6M will go a long way to running that IBD P2 trial, which would hopefully garner some BP action on the other side of an interim. I can't imagine it'd cost north of $2M just to execute, and we'd be on our way.
So who knows? I just watch these other companies grabbing literally billions of $ within the Covid space with products that aren't demonstrating efficacy worthy of approval. It's endlessly frustrating, knowing what B could be capable of providing to the world.
CYDY is a functional company with living/breathing/functional employees, a populated C-suite, and a functional board, and they have R&D Capability.
We've been down this discussion-path before with comparison to IPIX.
Apples/Oranges
Again...my comments and argument related to WarrenThomas’ post were written purely from the perspective of a prospective Grantor. Period. Nothing more.
Looking at the grant-worthiness of the two based on their public-facing personas and structure.
I’d LOVE it to happen, but I don’t know how realistic it is currently?
I’m 100% in agreement concerning your views on Polymedix and the investment in Brilacidin!
I WANT this SP to move as much as you do... and more importantly I want B to be addressing COVID in real live hooomansss....
Heh, actually yes!
This may come as a surprise, but I'm actually anticipating the next PR being non-COVID in nature and a return to the IBD P2 update with a potential trial-site and loose details concerning getting it moving.
I'm feeling like we may have something on the order of $2M COH if my hunch is correct. Feeling like $1.5M or so could see a small P2 into action if done off-shore.
There wasn't a 'job' done on Leo.
Someone here made a comparison to Moderna and grant worthiness, and I pointed out that I didn't see the similarities and why.
Leo's written his own Bio... not I.
I'm not responsible for his history or company management style.
I'm very familiar with the properties of B (to the extent we as the 'public' can be) and it's the reason I continue to be invested here As I continue to mention in every post: I WANT B to succeed! But it needs to do so QUICKLY given the current pandemic concerns!
As I mentioned in another previous post: Good science dies at the hands of bad management. This isn't a 'job on IPIX', this is a blanket statement concerning business management practices. It's pervasive in the BioTech space.
I agree! Thank you!
Lol i love your energy and insights on the board here. A breath of fresh aire to be sure!
So again... my post wasn’t intended to reference anything beyond ‘grant worthiness’ and ‘ability to execute’ as viewed from the Grantor’s perspective.
I agree concerning Moderna’s C19 candidate, but the decision is not mine to make.
Good science dies at the hands of ‘bad management’ constantly in Bio-Tech, so it’s a real concern here as an investor in IPIX, related to Leo’s business development decisions. The timeline and funding are the 2 super critical components that seem oft overlooked.
The world needs Brilacidin now more than ever. I really hope it gets its time in the sun sooner than later. Lives could and likely would be saved, and the world would be a better place for it.