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So do I. Kind of reminds me of the RBL's concluding Brilacidin is working so good they need to figure out what else it can work on.
Go Leo & IPIX!
think that theory is very good. A PhII converted into a PhII/PhIII would require the, very, extended timeframe.
TheDane, I think that it will be positive developments because there are so many possibilities/opportunities... There are a lot of people waiting with anticipation or anxiety regardless what side of the fence you are on.
Go Leo & IPIX!
I keep going back over what he said in the explanation for the late filing:
“...delay experienced by the Registrant in preparing disclosure relating to recent developments regarding clinical trials for the Registrant’s lead drug compound, and in particular, developments on or around the filing due date relating to clinical trials in the United States and Russia.”
He referenced trials, plural
He mentioned the U.S. and Russia so it’s not just Russia where the “developments” occurred.
He mentioned the time of the “developments as being “on or around the filing date of Feb.15/16.
What could have developed on or around the filing deadline that was so important it had to be included in the 10Q but could also wait five days to be reported? It’s not likely an adverse event since there wouldn’t be simultaneous adverse events in both the U.S. and Russia “on or around” the filing deadline.
Lol, wait and see. I am sure you have a litany of reasons why we longs shouldn't wait and be grateful for the human covid19 trials for Brilacidin currently wrapping up in Russia and well on their way in the US.
Couldn't open your hyperlink. Please resend.
Go Leo & IPIX!
IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD, with formulation development plans including oral tablets (or capsules) first aimed for the treatment of ulcerative colitis and then Crohn’s disease.
Initial clinical testing in a Phase 1 single-dose escalation trial was conducted in January 2020, which tested a Brilacidin oral formulation in healthy volunteers to assess targeting colon delivery, dispersion, safety, toleration, and systemic exposure/ pharmacokinetics. Data from the Phase 1 trial (NCT03234465) studying the use of delayed-release tablets of Brilacidin showed the trial met its primary endpoints. In the study, the timed-release formulation of Brilacidin was radiolabeled (with complexed technetium-99m) and evaluated for safety and colonic delivery in 9 healthy volunteers (6 with Brilacidin and 3 placebo). Gamma scintigraphic imaging was used to visualize in vivo performance of the enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon. For Brilacidin treatments, radiolabel release was observed in the ascending colon for four out of the six subjects and in the terminal ileum for the remaining two. Following release, dispersion of the radiolabel was then observed throughout the colon. Serial blood samples were collected through 24 hours post-dose to assess absorption of oral Brilacidin from the colon. Blood level analysis, using a sensitive limit of quantitation in plasma of 1 ng/mL, demonstrated no quantifiable drug concentrations at any timepoint across treatment cohorts, and appears to show containment of Brilacidin within the target location of the colon when delivered by delayed release tablets. Safety outcomes showed that Brilacidin delayed-release tablets were well tolerated by healthy volunteers across all treatment cohorts with no serious adverse events reported. Of the 9 subjects treated, 2 subjects on Brilacidin and 2 subjects on placebo experienced at least one adverse event. The adverse events were of mild intensity and none were deemed to be related to study treatment.
Our oral program development will be supported by a modified release oral capsule formulation now in development. Regulatory approval will be sought to initiate a proposed placebo-controlled Phase 2 clinical trial in UC patients, targeted to begin in the first half of calendar year 2021 once drug supply is available.
The Company is collaborating with a Regional Biocontainment Laboratory (RBL) for federal grants to fund continued research on Brilacidin as a treatment for SARS-CoV2. An earlier grant application was unsuccessful. At the time of that grant filing deadline, the only research data available was limited to non-human Vero cells. Subsequent to the filing, human cell line experiments were completed and the data is now available. Additional grant applications incorporating the new data are planned for submission before the end of 2020.
Partnering opportunities with industry and academic partners are ongoing regarding the COVID-19 program. The Company through discussions with industry, academic consultants, and potential partners will also explore investigation of treatment with Brilacidin by inhaled administration for the prevention of COVID-19 infection.
Leo had some real insight when opening the subsidiary in Ireland. Little did he know what he was really setting himself up for. You can't teach those innate urges.
Innovation Pharmaceuticals Inc. was incorporated on August 1, 2005 in the State of Nevada. Effective June 5, 2017, the Company amended its Articles of Incorporation and changed its name from Cellceutix Corporation to Innovation Pharmaceuticals Inc. On February 15, 2019, the Company formed IPIX Pharma Limited (“IPIX Pharma”), a wholly-owned subsidiary incorporated under the Companies Act 2014 of Ireland. IPIX Pharma is a Private Company Limited by Shares. The subsidiary will serve as a key hub for strategic collaboration with European companies and medical communities in addition to providing cost-saving efficiencies and flexibility with respect to developing Brilacidin under European Medicines Agency standards.
I think having so many trial sites in Russia will help prevent information leakage. Nice post falcon74!
Go Leo & IPIX!
Water with Lemon...... excellent well written thoughtful post!
My biggest concern regarding Brilacidin over the past year has not been whether or not it will be successful, but, being a potential Major Disrupter in the BP industry there are probably several BP companies that want to bury Brilacidin in order to protect their own pipelines.
I believe this is the reason why this company has been attacked so hard for the last several years by a criminal cabal that has been probably funded by a BP or BP's. Hopefully, we can find at least one BP that will want to bring this drug to market to cure people and make money doing it.
100% great post!
Go Leo & IPIX!
My sense is that all these "Buyout!", "Buyout!" posts are by Big Pharma stooges. No one in their right mind would even think of selling what Brilacidin alone has to offer much less Kevetrin at this point. Your post was one of several I have seen implying Leo is old and needs to retire and so I suppose you think someone would be "doing him a favor" to buy the company out and let Leo go play in the sand and paint old people pictures or engage in some idealized retiree paradigm of worthless behavior as long as Leo "gets out of the way".
You spend decades trying to bring a great medicine to market and you get it to the point that all you have to do is manufacture it and sell it ..and then you sell the whole platform off? Why? You outsource the manufacturing ( don't have to keep up a factory or the insurance on the factory, or deal with labor or unions, etc.. ) , you outsource the advertising and the marketing and there you go. That is in fact a very good business model as opposed to keeping up multiple properties. In the trucking industry as one example, Landstar owns no trucks or trailers, leases trailers that they never own, has no maintenance facilities, and has over 10,000 owner operators maintain their own trucks to move freight that independent agents find. A very lightweight business model that rakes in the bucks. Thinking that in order to be a "proper" pharma or business at all one must have lots of real estate, equipment, lots of employees and a huge overhead/expenses is so last century if you haven't noticed. I'll take Leo with so-called 'four guys in an office' or whatever it is now over massive upkeep for lots of real estate, manufacturing, transportation and having to recruit hot looking, perfectly made up blonds, brunettes and red heads to go to doctors offices and give out free samples and make sales based on their looks and charm rather than the efficacy of the drugs.
My sense as well is that if Big Pharma wanted to buy it, they would buy it to bury it as they have whole platforms of drugs that Brilacidin seems poised to displace in the marketplace; whole budgets of advertising and lobbying and such that would be wasted should Brilacidin hit the market. I have read somewhere that there hasn't been a new class/type of anti-Biotic to hit the market since the 80's. This article is just one of many stating the stark situation and places the last new drugs since 2000:
https://projects.iq.harvard.edu/sciencepolicy/blog/less-same-rebooting-antibiotic-pipeline
excerpt
"Every drug that enters the market costs several billion dollars, from research and development through testing. When antibiotic development proved to be the arms race described above, some of the biggest pharmaceutical firms – such as Pfizer, Roche, and Bristol-Myers – dropped like flies from antibiotic research.
The few companies that continued developing antibiotics on mostly focused on this so-called “analog discovery” – modifying the chemical structure of existing drugs just enough to bypass known resistance mechanisms, as with the beta-lactams. From a business perspective, this is safe: side effects and targets have already been classified, and approval processes will be faster. From an arms race perspective, however, this fuels antibiotic resistance by repeatedly introducing modified, but similar enough, drugs."
...Only 15 new antibiotics have been approved since 2000, compared to the 63 put to clinical use between 1980 and 2000 (Figure 1). Out of these 14 new drugs, only 4 of them represent new classes of antibiotics, targeting bacteria through novel mechanisms. Linezolid, for instance, is the first “oxazolidinone,” and it entered the market in 2000. Oxazolidinones are considered last-resort drugs to be used only when every other existing antimicrobial therapy has failed. Still, bacteria resistant to each of these new drugs have already been isolated."
from GOODRx:https://www.goodrx.com/linezolid
"LINEZOLID is an oxazolidinone antibiotic. It is used to treat certain kinds of bacterial infections. It will not work for colds, flu, or other viral infections."
So on the cusp of giving the world, the very real possibility of being the new penicillin as a revolution in medicine, an anti-biotic already proven to kill MRSA, already proven to have great benefits for the whole body, and very possibly to deliver the world from a pestilence, you guys keep wanting Leo to sell. I find that bizarre. Like Wow! bizarre. The sales contracts and the financing will come when the proof is there after this phase 2.
Not to put to fine a point on it, but America needs more leaders like Leo who have stood the test of ceos-of-their-armchairs running him down. You would do yourself a favor to read Teddy Roosevelt's "Citizenship in the Republic" , which Leo, by the grace of God, has exemplified.
an except:
"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."
As far as money, Leo has it made no matter what happens. Why would he continue unless he genuinely had a vision to save lives that he felt no one else could accomplish? William DeGrado is the same. They both could have retired a decade ago.
message in reply to:
"My sense is that Leo is positioning for a buy-out. If he was 35 years old with a starter drug like Brilacidin I could see him building this into a major company, but the best way to make money in the next couple of years is a buyout. If investors want to stick around for everything else you keep your shares in whatever big pharma scoops this company up."
God bless all
I wonder if the amount of trial sites was to try and stop information leakage? Posted again...
Go Leo & IPIX!
Scooping some Stop losses! bam...
Go Leo & IPIX!
Very good observation....
Go Leo & IPIX!
They have been trading to 6 decimal points all morning and I think they have it under control.
They are probably accumulating to crush the next pr. It takes a lot of computer programing to protect naked shorting.
Hopefully these chains break free with the right news.
Brilacidin in human COVID19 trials since December 17 2020. Results soon!
Go Leo & IPIX!
4775. Looks like it might be getting away from the MMs’ control. In the vernacular...the Ask is getting slapped.
Copy and past from the website.
A study investigating the use of delayed-release tablets to deliver brilacidin to the colon in healthy volunteers
Phase 1 Single Dose Escalation Study to Study the Use of Delayed-Release Tablets to Deliver Brilacidin to the Colon in Healthy Volunteers
Sponsors
Lead Sponsor: Innovation Pharmaceuticals, Inc.
A source Innovation Pharmaceuticals, Inc.
Summary
This is a single-center, blinded, randomized, placebo-controlled dose escalation study. Up to 9 healthy male volunteers will take part in the study. This study is intended to investigate the use of delayed-release tablets to deliver brilacidin to the colon.
Detailed description
Brilacidin is a fully synthetic non-peptide host defense protein mimetic that has been shown to exhibit anti-inflammatory and antibacterial activity. Two prototype tablets were developed containing 50 or 100 mg of brilacidin. Compliance Placebo pills have also been developed. In this phase 1 delayed-release study, prototype tablets will be tested to confirm the effective and specific targeted release of Brilacidin in the colon and to assess the safety, tolerability and pharmacokinetics of Brilacidin is administered directly to the Colon. Each study cohort will include three subjects. Each subject will receive one treatment at one assessment visit. In each cohort, two patients will receive brilacidin. containing a dose and one subject will receive a placebo. Cohort 1: brilacidin 50 mg or placebo; Cohort 2: 100 mg brilacidin or placebo; Cohort 3: Brilacidin 200 mg (as 2 100 mg brilacidin tablets) or 2 x placebo. Each treatment (drug and placebo) will be labeled with the radioactive isotope technetium-99m (99mTc). The radiopharmaceutical 99mTc-DTPA does not enter the systemic circulation and is commonly used for this type of research. In cohorts 1 and 2, each tablet, including placebo, will be radioactively labeled and contain approximately 4 MBq of 99mTc-DTPA at the time of dosing. In cohort 3, each individual tablet, active or placebo, will be radiolabeled with 2 MBq of 99mTc-DTPA for a total dose of 4 MBq per treatment. Each tablet should be taken orally with 200 ml of room temperature water. hungry state. Gastrointestinal transit and release of tablets will be investigated by gamma scintigraphy. Blood samples will be taken at a predetermined time to allow a pharmacokinetic (PK) assessment of drug absorption versus the time and place of tablet release.
General status Completed
the date of the beginning January 6, 2020
Date of completion 12 February 2020
Date of initial completion 12 February 2020
Phase Phase 1
Study type Interventional
Primary outcome
Measure Time limit
Radioactive label release site 14 hours after dosing
Time of release of the radioactive label 14 hours after dosing
To visualize the dispersion of the radioactive label in the colon 14 hours after dosing
Secondary result
Measure Time limit
Cmax 24 hours after dosing
Tmax 24 hours after dosing
Tlag 24 hours after dosing
AUClast 24 hours after dosing
AUC0-inf 24 hours after dosing
K 24 hours after dosing
t1 / 2 24 hours after dosing
Adverse events 14 days
check in 9
condition
Healthy volunteers
Intervention
Type of intervention: Drug, remedy, medication
Intervention Name: Brilacidin
Description: Brilacidin
Type of intervention: Drug, remedy, medication
Intervention Name: Placebo
Description: Placebo
Intervention Type: Radiation
Intervention name: 4Mq 99mTc-DTPA
Description: 4Mq technetium-99m (99mTc) in combination with diethylenetriaminepentaacetic acid (DTPA), which prevents absorption of the radioisotope from the gastrointestinal tract
Acceptability
Criteria:
Inclusion criteria: 1. Healthy male volunteers. 2. Age from 18 to 65 years inclusive. 3.BMI from 18 to 30 kg / m² inclusive. Body weight ≥50 kg. 4. Understands and is willing to, can and can comply with all research procedures and restrictions. 5. Demonstrates an understanding of the research and a willingness to participate, as evidenced by voluntary written informed consent (signed and dated) obtained prior to any judicial activity. 6. Confirmed to be in good health. Exclusion Criteria: 1.Medicine history 1.Current or recurrent medical condition that the PMI or a medically qualified authorized / responsible physician believes may affect the study or laboratory findings (e.g. liver dysfunction, renal failure, congestive heart failure). 2. a current or relevant previous history of a serious, severe, or unstable physical or mental illness, any medical condition that may require treatment or the subject is unlikely to complete the study, or any condition that poses an undue risk from the study drug or procedures. 3. a history of current or relevant previous non-self-limiting gastrointestinal disorder. 4. is currently suffering from a medical condition known to affect gastric emptying, such as migraines, type 1 or type 2 diabetes. 5. Has untreated hypertension or is being treated for hypertension. 6. Has a diagnosis of immunosuppressive disease or a condition requiring chronic immunosuppression. 7.As a result of medical examination or screening tests and is available before the dosage assessment, The PMI or the accredited / medically qualified physician in charge considers the volunteer unsuitable for research. 2. Medication 1. Subject must take prescribed medication within 14 days prior to assessment visit. 2. Subject must take over-the-counter medications, including vitamins and natural or herbal remedies, for 48 hours prior to evaluation visit. 3. Alcohol / Substance Abuse 1. A recent history (within the last year) of alcohol or other substance abuse. 2. The subject consumes on average over 21 units of alcohol per week. 3. At screening or pre-dosing, the subject tested positive for drug abuse in urine. appraisal. 4. Subject tested positive for alcohol breath at screening or pre-dose assessment. four. Smoking 1. Subject has recently quit smoking (less than 3 months). 2. The subject is currently smoking or consuming nicotine-containing products. 3. At screening or before dosing, the subject tested positive for cotinine in urine. appraisal. 5. Allergy / Intolerance 1. Subject has a history of allergy to any component of the dosage form or any other allergy that, in the opinion of PMI or the Medically Approved / Physician Responsible, is contraindicated. 2.Has an allergy or intolerance to brilacidin. 3. Is allergic to any content of standard meals. 4. Vegetarian or vegan. 5. Suspected or diagnosed lactose intolerance. 6.clinical research 1. participating in another clinical study (including a final post-study survey) or receiving an investigational drug within 12 weeks prior to the first screening visit. 2. Previous participation in this study. 3. A subject whose participation in this study will lead to participation in more than four studies within twelve months. 7. Personnel; An employee of the Sponsor, client or training center or members of their immediate family. 8. radiation exposure; The subject has an overall dosimetry value that the PMI or the responsible commissioner / medically qualified physician believes would contraindicate their involvement. 9. blood 1. Blood donation or significant blood loss within 3 months after the examination. 2. Difficulty accessing the veins of the forearm for cannulation or blood collection. 10. Family planning 1. Subjects who intend to father a child within 90 days of the study or who do not wish to abstain from sex with pregnant or lactating women. 2. Subjects who are unwilling to use a condom / spermicide in addition to their partner uses another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subcutaneous implants or tubal ligation if the woman can become pregnant from the moment examination visit up to 3 months after the examination. 11. Other; Non-removable metal objects such as metal plates, screws, etc. In the chest or abdomen that the PMI or the Medically Qualified Designator / Physician in charge believes may affect the study. ... who intend to father a child within 90 days of the study or who do not wish to abstain from sex with pregnant or lactating women. 2. Subjects who are unwilling to use a condom / spermicide in addition to their partner uses another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subcutaneous implants or tubal ligation if the woman can become pregnant from the moment examination visit up to 3 months after the examination. 11. Other; Non-removable metal objects such as metal plates, screws, etc. In the chest or abdomen that the PMI or the Medically Qualified Designator / Physician in charge believes may affect the study. ... who intend to father a child within 90 days of the study or who do not wish to abstain from sex with pregnant or lactating women. 2. Subjects who are unwilling to use a condom / spermicide in addition to their partner uses another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subcutaneous implants or tubal ligation if the woman can become pregnant from the moment examination visit up to 3 months after the examination. 11. Other; Non-removable metal objects such as metal plates, screws, etc. In the chest or abdomen that the PMI or the Medically Qualified Designator / Physician in charge believes may affect the study. ...
Gender: male
Gender: yes
Minimum age: 18 years
Maximum age: 65 years
Healthy Volunteers: Accepts Healthy Volunteers
General Official
Surname Role Accession
Howard Stevens, PhD Principal investigator BDD Pharma Ltd
Location
An object: BDD Pharma Ltd
Country Location
United Kingdom
Check date
February 2020
Responsible Party
Type: Sponsor
Has extended access Not
Number of hands 6
Armament group
Label: Brilacidin 50 mg tablet
Type: Experimental
Label: Brilacidin 100 mg tablet
Type: Experimental
Label: 200 mg brilacidin (2 tablets of brilacidin 100 mg)
Type: Experimental
Label: Placebo tablet (50 mg tablet shape / size copy)
Type: Placebo Comparator
Label: Placebo tablet (copy of 100 mg tablet shape / size)
Type: Placebo Comparator
Label: Placebo (2 copies of the shape / size of 100 mg tablets)
Type: Placebo Comparator
Patient data Not
Study Design Information
Distribution: Randomized
Intervention Model: Sequential Assignment
Primary Use: Other
Disguise: Single (member)
Great post JFM!
TIAB
You are correct... WSBC's post below...He posted on November 13, 2020 below:
Trying to identify the "Overseas" Clinical Trial location* WSBC cited that "Unstable Genious 1" making reference to "What's the weather like in Moscow?...:)" could be a "super-relevant question for us very shortly ;)
*Moscow=Russia...thanks to WSBC "research" (see email below)
Quote:
Quote:
*wsbc Friday, 11/13/20 09:20:12 PM
Re: unstable genious 1
post# 332975 0
Post # of 337336 ("Moscow" added)...could be a super-relevant question for us very shortly ;)
Thanks for replying and your thoughts!
Go Leo & IPIX!
50mg/ml seems too concentrated. The most successful of the phase 2b ABSSSI trial was dosed at .8 mg/kg. So, I think there is a problem in the translation from Russian to English, or who knows?
Can you tell us if the intravenous administration, 50 mg/ml is what we were expecting?
Thanks,
Go Leo & IPIX!
Can one of the real scientist or health professionals on this board tell us if the intravenous administration, 50 mg/ml is what we were expecting?
Thanks for the reminder threebabiesbusy!
Go Leo & IPIX!
IPI-BRIc-201
Protocol name
Double-blind, placebo-controlled, randomized, multicenter Phase II study to evaluate the efficacy and safety of Brilacidin in patients hospitalized with COVID-19
Therapeutic area
Anesthesiology and resuscitation, Infectious diseases, Oncology, Therapy (general), Surgery, Cardiology, Pulmonology, Toxicology
CI start and end date
12/17/2020 - 03/31/2021
RCT number and date
No. 705 dated 12/17/2020
Organization conducting CT
Innovation Pharmaceuticals Inc. (Innovation Pharmaceuticals Inc.)
Drug name
Brilacidin
Dosage form and dosage
solution for intravenous administration, 50 mg / ml
Cities
Barnaul, Kirovsk, Moscow, Nizhny Novgorod, Ryazan, St. Petersburg, Saratov, Yaroslavl
Developer country
USA
Organization involved by the drug developer
IPharma LLC, 143026, Moscow, the territory of the Skolkovo innovation center, st. Nobel, 7, Russia
CI phase
II
KI type
IMCI
The purpose of CI
assessment of the efficacy and safety of Brilacidin in patients hospitalized with COVID-19
Number of medical institutions
20
Number of patients
106
Great analogy!!
Tick Tock....
Go Leo & IPIX!
These efforts now to stem the upward tide is like trying to stop an avalanche with a single snow shovel. Ain't gonna happen and all that will result is you are going to get buried. Hope it happens here.
Sometimes you have to face the facts that you are on the wrong side of the deal and try to minimize loss, not continue to put yourself in a deeper hole.
Going to be very, very expensive for some.
I think the first wait is almost over.
Lets see.
Go Leo & IPIX!
Very sad that IPIX has confirmed ongoing human trials for COVID19 and the criminals continue to suppress the share price. Little did they know they picked the wrong company/guy. No wonder Leo is keeping this top secret. I hope he continues to keep you in the dark.
Tick Tock.... 4 more sleeps...
Go Leo & IPIX!
Please post! There are others on this board who broke promises. We need the help...
Go Leo & IPIX!
Good point. Brilacidin Russian human trials started late December and US trials a few weeks ago. BAM!!!
Ouch, that has got to hurt if you are a IPIX/Leo basher. Tick tock....
Go Leo & IPIX!
If the PR stated Trial start Q4 and then again another PR stating following week, the locations are not needed to be specified. That is a fact.
POST OF THE YEAR!!!! this is going to hurt some but not me....
Go Leo and IPIX!
https://medvestnik.ru/chronicles/Issledovaniya-lekarstv.html
Brilacidin being tested in Russia, listed at #3. Dated January 11.
And... Wait for it..... Trial Registration. Look at the dates.
http://clinicaltrialsregister.ru/search/index1.php?q=%C1%F0%E8%EB%E0%F6%E8%E4%E8%ED&s=
That would be amazing and I believe anything is possible., I also believe the delay is positive.
4 to 5 more sleeps.
Go Leo & IPIX!
Here is my speculation on what the update means...
"..in preparing disclosure relating to recent developments(GOVERNMENT GRANT TO HELP WITH MANUFACTURING AND DISTRIBUTION) regarding clinical trials for the Registrant’s lead drug compound, and in particular, developments (IT'S EUA TIME) on or around the filing due date relating to clinical trials in the United States and Russia...
I believe these two events are the most likely scenario that caused the delay in reporting. I don't think any other combo factors would be timed to our clinical trials. Both conditions mention clinical trials and I place a higher probability on the grant/eua scenario. I bet Im right!!
© 2021 InvestorsHub.com, Inc.
I believe the same thing Here Today... Hence why I thought the share price would not do much until we got closer to the end of the human trials or some type of big news which seems to be coming soon!
Go Leo & IPIX!
What I believe has been happening here with IPIX is sort of what is described in the below link as to what led to the huge GME share price increase. Only exception here is that the Short Interest has been held low due in part to my assumption that the Market Makers are who are truly the ones selling the same shares multiples of times short over and over again without ever truly covering the original shares they first started selling shorting. Will be interesting to see how quick the Share Price rise when actual news of trial results start circulating in my opinion. Could be an epic day when it happens.
https://www.theringer.com/2021/2/16/22284786/gamestop-stock-wall-street-short-squeeze-beach-volleyball-referee
Your math seems accurate and I would agree with you.
Go Leo & IPIX!
The Registrant anticipates that it will file the Quarterly Report no later than the fifth calendar day following the prescribed filing due date.”
So 2/15 was filing day, but was 2/16 due to holiday, so filing could be anytime between today and 2/23.
Correct?
Yeehaw!! Go Leo!!! Thanks John.
https://www.sec.gov/Archives/edgar/data/0001355250/000147793221000911/ipix_nt10q.htm
“... due to a delay experienced by the Registrant in preparing disclosure relating to recent developments regarding clinical trials for the Registrant’s lead drug compound, and in particular, developments on or around the filing due date relating to clinical trials in the United States and Russia.[\b]The Registrant anticipates that it will file the Quarterly Report no later than the fifth calendar day following the prescribed filing due date.”
Exactly what I was thinking when it happened. Why all of the sudden does Leo need a substantial influx of money. I have a few ideas but will keep them to myself. I hope Leo continues to keep us in the dark. 10Q should be interesting!
Go Leo & IPIX!
The subject has been discussed a lot already. You'd think people would realize/recall that the Aspire agreement makes it difficult to force a large amount of shares on them at once. What we don't know is what the funds were needed for so urgently/suddenly?
More drug manufactured?
Pay CRO all up front?
Something appears to have come up that required more cash at once than could have been pulled from Aspire.
and going into hiding... I couldn't imagine being short on IPIX right now.
Regarding the Post:
wsbc Monday, 02/15/21 01:56:02 PM
Re: loanranger post# 346196
Post # 346198
Since the poster stated in his post today, that he knows and is familiar with Philips" (an insider, in the company)...its obvious he likely got the information to reference the trial site "overseas" as "Moscow" ...
Kind of obvious that Philips/West was his source for the scoop!. (or is it Philip and "Weston", "Westberg", "Weststein", "NorthWest" ... or whatever).
Thanks JFM!
I agree Justfactsmam, I'll place my bets on reputable Dr. Aarthi Narayanan and not someone has it out for the company.
Time is quickly running out and we will see how Brilacidin will do in human trials.
Go Leo & IPIX!
Lets be clear...the truth of this statement...HAS NOT BEEN ESTABLISHED OR PROVEN ANYTHING.
Until and unless OG speaks with ALL involved in the series of RBL Tests, which were ultimately the subject of the Peer Reveiw Artilce...he is makeing huge presumptions...and therefore blowing hot air.
...
As "YOU" WELL KNOW ..Warren Kyle Weston... does not have a medical/scientific background to influence Dr.Narayanan or any serious scientist in an RBL. Non-substantive scientific participation...still get one listed as a "contributor"...
To believe your and OG's "assumptions" and "unsubstantiated conclusions" ... would require one to assume Dr. Aarthi Narayanan, an expert on Remdesivir, was relegated to a cleaning lady in the lab.
Just the opposite likely occurred...Jane and W. Klye Weston contributed by providing prior research or data, etc...menial tasks FROM AFAR...not directing or even influencing the tests and methodology...
IMO Dr. Aarthi Narayanan has a great interest in protecting her reputation from delusional allegations.
Quote:
OG highlighted the influence IPIX (Warren and Jane) had over the GMU in terms of test criteria, structure, etc... I'm maybe less concerned about the protocol manipulation and more just wondering if I'm reading the data correctly.
farrell90, thanks for providing us with some facts! Time is quickly running out and we are going to see what Brilacidin can do.
Go Leo & IPIX!
farrell90 Member Level Sunday, 02/14/21 10:55:12 PM
Re: wsbc post# 346098 0.009
Post #
346149
of 346157
What is most interesting you and others have focused on 1 chart and ignored the whole body of the research. In addition you and others have attributed efficacy to Remdesivir which it does not possess.
The Discussion on page 10 outlines the results of the study:
1. "All experiments conducted in Vero and Calu-3 cell line models were supportive of an early inhibition exerted by brilacidin on SARS-CoV-2, indicating the drug’s impact on viral integrity. The idea that brilacidin directly interferes with the integrity of the virion is further supported by the observation that when drug treatment was limited to the virus alone (Figure 2E), with no treatment of host cells, a robust decrease of viral load was still observed in both the Washington strain and the Italian strainof SARS-CoV-2."
This is consistent with claims Brilacidin is virucidal. It quickly attacks the virus before it enters the cell.
2. "The high CC50 (a measure of cytotoxicity) and low IC50 (a measure of potency) values observed for brilacidin in Calu-3 cells—yielding a Selectivity Index (SI) for brilacidin of 426 (CC50 = 241µM/IC50 = 0.565µM)—strongly support brilacidin’s treatment potential to possibly achieve positive antiviral outcomes in humans clinical trials."
This statement reflects the low toxicity and high potency of Brilacidin against Covid 19. The high SI number supports positive outcomes in human clinical trials
3. In the combination studies Brilacidin and Remdesivir 2.5 um demonstrated synergy in vitro
https://www.mdpi.com/1999-4915/13/2/271
The reality is the 2.5 um dose is easiy achievable in vivo by Brilacidin which obtained a median C-max in the ABSSSI study of 7.67 um and is well above its IC 50 of .565um.
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Remdesivir IC 50 in vitro is .77um, but it has to enter the host cells to prevent intracellular viral reproduction. Remdesivir is a prodrug and is converted inside the cell to its active metabolite, Nuc-TP, which is estimated to have an IC 50 of 38um to 231um or 7.7um in other studies, well below that of Brilacidin's IC 50 of 565um.
Its pharmacology explains Remdesivir's poor clinical performance in spite of a relatively good in vitro IC 50.
In addition Remdesivir's hepatotoxicity limits higher dosing.
"Assuming similar distribution and accumulation ratios of remdesivir and Nuc-TP in the lung between humans and monkeys, an optimistic estimation of Nuc-TP in the human lung tissues is 2 to 3-fold higher at a steady state than that observed in the monkey lung tissues [1]. This suggests that an IV dose of 200 mg remdesivir in a human may only achieve a suboptimal concentration of active form of Nuc-TP of <?2–5 µM in the human lung tissues (TableIII). Given that the intracellular volume (0.54 l) is 46% of the total volume of the lung (1.17 l) [17], the intracellular concentration of Nuc-TP in the human lung may be only at 4–10 µM (TableIII), which may be below the estimated intracellular IC50 and IC90 of Nuc-TP. Unfortunately, systemic adverse effects such as hepatotoxicity preclude escalation of the remdesivir dose to more than 200 mg/day."
The following article demonstrates these findings in great detail.
https://link.springer.com/article/10.1208/s12248-020-00459-8
GLTA Farrell
Awesome post and factually based! Tick tock...Thanks you
Go Leo & IPIX!
The truth is that a pre-"Peer Reviewed" article is reviewed by a number of experts in the field for both accuracy of reporting of the data and conclusions being drawn.
TWEEKING OF THE ARTICLE FROM THESE INDEPENDENT REVIEWERS...REGARDING ARTICULATING THE DATA and THE CONCLUSIONS REACHED IS AND WAS EXPECTED...LIKELY 100% OF THE PEER REVIEWED ARTICLES ARE MODIFIED.
Furthermore...the independent review reached the same conclusion of the independent research...BRILACIDIN "Exhibits POTENT IN VITRO ANTIVIRAL ACTIVITY AGAINST SARS-CoV-2"
Statements that Pre-Print was never going to be published, or that if it were published, it would be in the equivalent of "MAD Magazine", AGAIN IS WRONG!! We can agree to disagree but there is no doubt….I repeat … there is not doubt there is a NAKE SHORT position in IPIX. Eventually, the world will find out that this statement will be proven correct.
FACT…..Brilacidin has exhibited 97% viral load reductions in INDEPENDENT U.S. Biocontainment Lab Tests...with significant antiviral confirmation.
Individuals can disagree with the facts and state misrepresentations regarding the trials, but I believe the truth will come out when Leo releases his next PR regarding the trials (starting last week as PR'd) and other positive developments.
Lastly, when LEO releases the Clinical Trials sites, status reports and "other" positive developements...IMO, there will be a significant upturn in the share price as no forces will be able to hold the share price down!
Within a very short time, we will know whether longs like myself are correct.
Just "know what you own!"
I agree 100% Pete. We will know soon where Brilacidin stands and how IPIX will be moving forward.
Go Leo & IPIX!
I asked what numbers people had in mind recently as to a partnership for CV, partnership for entire B platform, buyout, etc.
Didn't receive many responses but the ones I did reflected IMO that many stockholders, even longs, appear not fully aware of the value of Brilacidin, Kevetrin, or the entire IPIX company and if they do they don't expect to wait around for max value.
It is my firm belief now that most penny investors are really traders, though some are long term traders. They don't want to wait for their investment to maximize or even approach anything close to maximizing their return, they just want a decent (albeit very small compared to total value) return and will let those with more juice take the company to the stratosphere if it indeed is to get there.
Not saying anything positive or negative to investors, just describing what I see as the average mindset of penny investors. Day traders and very short term traders are a whole new segment of their own and I don't worry much about them as they seem to like what they do and many seem to do OK with that investing plan.
I was shocked, though, how much investors were willing to give to a BP when the BP is ONLY providing logistical distribution. They would gladly give away the lion's share to BP as long as they could get a few dollars a share in return (and the BP gets Billions yearly in return).
I am in love with IPIX because I have already assumed it is going to make me a lot of money and I now am more engrossed in the story behind how it struggled to get to this point and to a successful ending in the future.
We have stars in Dr. Menon, Dr. DeGrado, Leo, and criminals in Congress, FDA, FINRA, SEC, Market Makers, Hedge Funds, Wall St in general, and toxic financiers. MANY tremendous posters I have met or have been blessed to be able to read their posts are probably the highlight of this trip and negative paid help the dregs of this investment.
Time is still ticking but it is now getting to the good part of the trip so everything looking bright and optimistic.
Epic! Thanks for the laugh!
Sent you PM with information.
From JFM.
Gas...
You are hitting Brilacidin's SWEET SPOT...
"What is more valuable a ... a therapeutic that will work 90% of the time against This virus and other ones to come in the future? Pretty easy to answer. Imagine how much a company like Pfizer would be making right now if they owned our drug.
FDA/Barda...is not giving to priority to a "one trick poney"...the big bucks are and will be going out to Therapeutic Compounds/Drugs that can be developed to hit and Kill MULTIPLE VIRUSES...
Leo noted in PR that (and that should be a hint regarding FDA/Barda interest) that further studies are being conducted for Pan-coronaviruses
...
follow the money...
IMO...it will lead to funding announcement (timing?) for Brilacidin R&D Funding and utilization.
Awesome summary and reminder of Brilacidins potential Pete ! Thank you,
Go Leo & IPIX!
For all new eyes:
It is apparent that the current human trial for Brilacidin in regards to CV19 is paramount to the success of IPIX, but for those not familiar with the IPIX story let's once again reiterate why Brilacidin is different from EVERY other drug going thru trials today and likely different from any drug EVER to go thru trials and why these differences are what makes every stockholder know that we are sitting on a gold mine with this stock:
1. Brilacidin was conceived by a medical genius, Dr. William DeGrado, who has published over 400 papers, won about every medical award that can be won, is the leading authority on the new arm of medicine that he brought into existence (that of defensin mimetics), and who currently runs his own lab strictly for defensin mimetic studies at the highly acclaimed UCSF, a public research facility associated with the U of CA system. UCSF has no undergraduate programs, every student there is working on advanced degrees and only gets accepted to work on a specific program. So all of Dr. DeGrado's graduates become proponents of his arm of medicine and further exploration of this arm of medicine. Dr. DeGrado is not a medical doctor, he is a phD specializing in pharmaceutical chemistry. This is why he was able to conceptualize the structure of the small molecule that would become Brilacidin.
2. Brilacidin was developed by humans (around 2002) but refined and improved by the closest thing to AI (artificial intelligence) as it spent about 6 years on the super computer (known as Big Ben) in Pittsburgh ramping up its benefits and eliminating its weaknesses which would lead to worrisome side effects. Compare this to all other drugs that went thru labs and one can understand why Brilacidin is seemingly light years ahead of its time.
3. Brilacidin has never failed a clinical trial and it has gone thru a number. It is anti viral, bacterial, fungal, inflammatory, and possesses unique immunotherapeutic properties and ALL of the above features are used to kill CV19. In these prior trials on over 400 patients it was also shown to be well tolerated with no discernible side effects (almost unheard of in todays pharma market, just listen to TV ads for drugs and one sees in most cases the side effects seem as dire as the problem it is supposed to cure).
4. Being that it kills viruses in a completely new way from all prior drugs, viruses cannot build up a resistance to it. Please note that Brilacidin KILLS the CV19 virus, a feature very few, if any, competitive products can claim
5. In testing at government run regional bio labs (RBLs)IPIX had no input as to running the tests or interpreting the results)so all data was derived and published by those RBLs. It was shown to have a Selectivity Index (SI) of 426. This index evaluates the ability for in vitro testing (in a petri dish) to transfer with the same results in human testing. Anything over 100 is considered good and Remsdesivir received about a 129. Thus, it looks like Brilacidin should be a lock on working in humans as effectively as it did in petri dishes and on human tissues. To refresh your memory of human tissue results, Brilacidin killed 97% in lung tissue within a few hours and 85% in kidney tissues within a few hours. The IV being given in the current trial (I believe it is for about 1 hour but not positive) should help raise these numbers IMO as it keeps B in the system a decent amount of time.
6. Brilacidin is made from common materials, does not require special handling (as frigid cold as do other CV drugs/vaccines),is very cost effective compared to other methods, and is currently being developed for a nasal spray or nebulizer (sprayed directly into the lungs via the mouth)as additional delivery systems.
7. Brilacidin was shown to be so effective in the RBL testing that one requested funding for a PANCORONA investigation since it appears that Brilacidin could prove effective against ALL corona viruses to include The Flu and Herpes as just some of the other uses.
8. Brilacidin has yet to meet a bacteria or virus it couldn't kill.
The above points of fact, all derived by non-IPIX sources, should give all stockholders a feeling that what we own is extremely special. Each stockholder must come to their own conclusions as to the point at which they will sell their holdings in iPIX, but all should be aware that though this is currently a penny stock it is not because our products are not worth a FORTUNE and could very well lead to generational wealth in time for those that bet on this company early. I consider .45 still extremely early for all stockholders and hate to think some will be bamboozled to sell way too early and lose out on a possible golden ring stock that comes along only a few times in a lifetime.