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Would likely need to begin with RBL testing of a reformulated aerosolized compound. At the rate we're seeing RBL 'progress'... I'd say somewhere between 6-12mo for a possible reformulation. (depending on lab priority)
+
a mandatory P1 with the new reform- 2-3mo?
+ FDA review (2-6mo)
+ P2 for the reformulated compound- current trial: 6-8mo to topline?
+ FDA review etc (2-6mo)
+ P3 2yrs... with a possible interim @ 30-90 days?
Could be as fast as 3yrs?
I feel like everything depends on what happens with the current P2. Hoping this changes hands and is more capably and expediently progressed by an entity with the necessary credentials, funding, sales/distro and stability.
Thanks for the reality-check. :/
...or bury them in a filing at the end of Sept?
a'la Prurisol...
100% this:
You could always do a little research...
https://finbox.com/OTCPK:RLFT.F/explorer/salary/
...wasn't my quote. Only my response to the quote.
THIS is not to be underestimated in importance:
Leo@ipharminc.com
Ask him.
Guessing he's waiting on results.
Might be kinda premature to pump it up w/o knowing outcome?
Trying to predict percentages for movement on the OTC is difficult.
Look at some of the listings on here:https://quotes.freerealtime.com/marketstats/3/D
ROXIF +16233.33% lol...
Crazy stuff can happen all the time on the OTC.
We could literally see 1000% in a day... hell, in a morning, if volume showed up.
Nothing to do with the 'naked shorts' getting 'fried' or whatever nonsense people spout here.
We have what, 68 shareholders of record? Literally, nobody knows about this 'company'.
Visibility and positive results have the ability to change this.
In the absence of solid fundamentals (company, not trading), the SP has no floor, so its subject to wild trading swings. IF The Accountant can put in a solid floor with a substantial upfront payment from a deal (let's call it $500M for argument's sake), then we're bolstered at around $1, and things would likely go up from there assuming no massive catastrophe). THEN the P/E ratio applies and it's onward and upwards... (could be nutty)
I don't see 'the company' leaving the OTC in its current iteration. 'Mgmnt' doesn't want the oversight, and given the way they operate, it makes 100% sense.
Hoping and praying that the patent in question carries us further this time than the flimsy credentials of The Accountant et al.
This has been my core concern related to EUA and The Accountant believing he can 'go it alone'.
IF results are made public, and IF they're positive, and IF there's any BP interest (or otherwise), we would likely need a partnership/license/acquisition for things to go anywhere. Could be a massive grant, direct contract/DPA authorization, etc., but I don't see this happening from the virtual office in Wakefield alone.
Where's the data, Leo?
I'm not in the business of running clinical trials, so I'd like to hear someone's thoughts on this timespan who may be familiar:
From CT.gov: https://clinicaltrials.gov/ct2/show/record/NCT04784897?term=Brilacidin&cond=SARS-CoV2+Infection&draw=2&rank=1&view=record
This is the point of Competitive Analysis and Competitive Strategy (BP's have entire teams devoted to this alone).
The Accountant has been presented with detailed strategy emails and solutions to issues the 'company' was dealing with year after year.
Deaf ears... was my takeaway, in the absence of acceptance.
Accountants typically operate in a fairly binary world. I've worked with a lot of them on various projects, and I can't say I've worked with a single one that was a good listener, creative, willing to try an alternative presented, or open to others perspectives.
Hoping Bill can talk some sense into this one. W/o it, I fear for the worst... as always.
1. Never underestimate the stupidity driving the 'progress' of this 'company'. I've learned this over time...
I have my suspicions, but nobody on this board wants to know about them...(or believe any of it)
...Actually, ideal scenario would be to partner or sell following a P2.
To take the swing at a P3 for most small companies, unassisted, is far too capital-demanding.
Leo's maintained through the years that he's wanted to partner following P2's.
To-date this has never happened in any meaningful way.
We'll see what happens now.
A good reference indicator could be looking at what happens when you make a comparison-search like this:
https://trends.google.com/trends/explore?date=today%205-y&q=brilacidin,%2Fg%2F11csqg56b7,%2Fm%2F03h1_t9
with known variables.
...again, you're comparing actual pharma companies to LeoPharma's PO Box with a patent or two...
As far as shareholders are concerned, it's almost literally 100% inconsequential.
It's all riding on B-covid at this point.
oops, yes, quite right. My mistake.
This is what should've been referred (https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/Nasdaq%205500%20Series):
Start reading here:
https://listingcenter.nasdaq.com/assets/initialguide.pdf
P.4 is where important financial details are.
Specifics (https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-5300-series#nasdaq-rule_5315):
Since people here keep bringing up EUA for B, I thought some might find the EUA doc for Tocilizumab an interesting read.
Of note, the drug appears to have been in 4 different studies (clinical) between April 2020 and Jan 2021'ish with total participant subjects of 5,605.
This is for the IV monoclonal antibody, with similar delivery (IV) and endpoints as Brilacidin... so I thought the read was an interesting one.
https://www.fda.gov/media/150748/download
Your link:
https://www.fiercepharma.com/pharma/europe-probing-link-between-pfizer-biontech-moderna-covid-vaccines-and-skin-condition-2?mkt_tok=Mjk0LU1RRi0wNTYAAAF-1gAZPZ7xDawaPOg49UaROpecmjLlEZoo0i9doXeb2jWrG8jHLqQIebxA6I0_6XTi80fkZBxeuBkqrwQm7j2ZWNCeyDbX2rmeoJgWSurhgbkaDI2RHw&mrkid=74197490
Pfizer, Moderna COVID vaccines face new safety probe in Europe over possible link to skin condition, 2 kidney disorders
1. The only thing that matters at this point is topline data. Literally nothing more. The longer the wait, the more concerning.
2. I don't see an EUA no matter who says what on this board. We've been over this, and a dosed-60 patient cohort straight to EUA would be ludicrous. IPIX has no manufacturing/distribution/sales etc to meet EUA requirements. (been over this as well)... people are screaming about the vaccines not 'being safe' (even on this board) yet they've been in literally hundreds of millions of humans... 60 dosed people with B? Are you f*king kidding me?
3. Note: IPIX is a PO box run by an accountant and his clinical trials assistant. NOT a swiss BioTech. Relief Therapeutics is run by business people with post-grad business degrees, PhD's etc. They're serious. They're getting things done and going places. Not a fair comparison. NNVC might be a more appropriate comparison I think?
4. Nothing this company has *ever* done in its history has been expedient (except dilution, and payment to The Accountant).
5. There will be no in-house P3 from IPIX without significant outside assistance (grants/partnerships/license etc). There's no current funding to do this and the existing finance agreement isn't large enough to support a P3, to my knowledge, unless the SP magically (and unprecedentedly) went to $5/s. (If it cost $6M to dose 60 people, imagine the cost for 350-500 humans?)
Please let this IPIX nightmare end.
...the gift that keeps on giving...
I'm not sure to whom this was directed (rhetorical), but maybe a better question is: Why hasn't Leo done more? Is he doing more?
Where are the results? Like you pointed out, these are extraordinary times calling for extraordinary measures and here we sit.
The wait is more 'classic IPIX' we've become accustomed to... but during a pandemic?
You'd think something would change around here...
Boggling that 'The Gold Standard' of Wakefield sits parked in an empty parking lot... lights off... gathering dust.
Odd? Too many red flags associated with share ownership here, too lengthy a history of 'POC' trials, obfuscation, massive shareholder dilution etc.
Company has close to zero visibility, Owner isn't connected meaningfully (demonstrated by lack of partnership execution etc) and has zero credibility.
Why would the movement be considered 'odd'?
$130M is a LOT for a PO box to be worth that's managed by 2 humans, paying on 2 patents.
Traders trading in/out while data lags...
IMO
Topline data in October?
2mo away, in the middle of a pandemic?
Seems a little far out from completion?
Not sure I see this as a possibility that could be entertained w/o a major partnership that's vertical and could manufacture + distribute.
UNLESS Leo has a DOD contract or similar.
Still... I don't see it happening.
P3 + partnership.
I'd prefer to see it licensed, or the company acquired honestly.
Insanely difficult for me to imagine anything resembling an EUA for Leo without a partner. He would need massive manufacturing and distro to be in place and would need to demonstrate this.
A BP would easily be able to facilitate this.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#conditions
Couldn't agree more.
We're but a nano-particle of plastic afloat upon the sea in terms of the anti-viral/SARS CoV-2 field.
Leo can't move fast enough, and personally, I feel like leaping on whatever's possibly awaiting pending positive results is the best possible case to progress this company.
Insufficient data-set related to IBD to-date to garner BP interest could be offset by closing a large anti-viral deal NOW, and then getting that UC indication closed out and licensed ASAP.
(to say nothing of Kevetrin)
The path to revenue shouldn't be this absurdly complicated, which just fuels my ire with Leo.
No, not yet.
I feel like time is of the essence for Foot-Dragger-Ehrlich though. The space is heating up around here:
https://www.fiercebiotech.com/biotech/alnylam-vir-plan-year-end-trial-new-rnai-covid-19-antiviral
Alnylam, Vir plan year-end trial of new RNAi COVID-19 antiviral:
Welcome to the IPIX shareholder experience...
Neither Kyle/Warren nor Jane are Phd's. Not sure why they're referenced as such.
...right.
My response to the concern was largely rhetorical.
Unclear.
IF the CRO is working within the approved trial guidance cleared by the FDA, then I'd be inclined to believe the trial would dictate Remdsivir. I believe it to be the 'SOC' for the US and FDA, and not to deviate to Russia's 'SOC'(if different) compared to the US SOC.
lol, I'm not the one with the question.
Curious about his answer of course, but Sunspotter lit this fire.
Personally, I feel like because we're testing 'in addition to SOC', that we're going to see + results from this trial for the Primary due to a relatively low bar seemingly having been set.
With Remdesivir, I feel like even a single day less duration is to be considered an 'improvement', which will be translated as a 'success'...
The resulting BioMarker data will be interesting to see.
I still feel like a larger trial size would've been significantly more compelling. We'll see how it shakes out shortly.