Yeah, yeah... always the Aspire excuse, but doesn't get near to explaining bringing it down from .175 at the last minute with 120 and 100 "shares."

Unless you are claiming those tiny trades are Aspire selling??
LOL




12/01 0.17005 100 OTCBB
12/01 0.175 3880 OTCBB
12/01 0.1651 120 OTCBB
12/01 0.175 31712 OTCBB
12/01 0.1742 5000 OTCBB
12/01 0.1715 42406 OTCBB
12/01 0.17 5882 OTCBB
12/01 0.17 15000 OTCBB

+.00005. Green!

It was only a matter of time before Leo claimed Bril was a cure for the common cold. What is the addressable market for the cold? LOL.

Article title: Are herbal drugs effective in COVID management? A review to demystify the current facts and claims

https://www.scienceopen.com/document_file/c7b5fca6-b094-435c-8c4b-4dd4d53e46fa/ScienceOpenPreprint/Manuscript.pdf
Brilacidin listed on page 7 and 25

Nothing interesting, but, good to see it listed...

Next we need to see whether or not it works for Covid.

To All Longs......I would like to wish each of you a very safe and wonderful Thanksgiving with your families!!

It has been a long journey for many of us but the light at the end of the tunnel is close.

We all believe that Brilacidin will do well in clinical trials. If we are right, we will be financially rewarded for our patience and endurance.

It will be a wonderful feeling to be a shareholder in a company that has a drug that will help save millions of lives while enabling many of us to provide monies to our many charities!!

Between now and the interim human trial report IPIX investors can expect a series of positive PR's which will outline Brilacidin's FDA review, foreign and domestic human clinical plans,
clinical trial protocols, and other details which will lead to press coverage in anticipation of the interim trial report.

Covid 19 is a worldwide scourge which is destroying individual health, health care systems and economies. Unfortunately we are on the verge of expotenial spread of Corona virus which will tax much of the nations health facilities much in the same way New York City and Italy was tested early in the pandemic. If Brilacidin's human trials confirm the in vitro testing it will be the Coronavirus antiviral of choice and a cornerstone of any Covid19 treatment regimen.

The next 6 weeks are going to be exciting for Ipix shsreholders.

Jmo

Glta, Farrell

m RNA vaccines such as Pfizer's and Moderna's vaccines have potential side effects.

Thanks for reminding use of the risks of Monoclonal antibody drugs

Rash, fever, fatigue, headache, or joint pain in up to 21% of patients

https://www.sciencemag.org/news/2020/11/fever-aches-pfizer-moderna-jabs-aren-t-dangerous-may-be-intense-some

https://www.nejm.org/doi/full/10.1056/nejmoa2022483

Autoimmune disease activation after mRNA documented in clinical trials:

"Several different mRNA vaccines have now been tested from phase I to IIb clinical studies and have been shown to be safe and reasonably well tolerated (TABLES 2,?,3).3). However, recent human trials have demonstrated moderate and in rare cases severe injection site or systemic reactions for different mRNA platforms22,91. Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components. A possible concern could be that some mRNA-based vaccine platforms54,166 induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity167,168. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken. Another potential safety issue could derive from the presence of extracellular RNA during mRNA vaccination. Extracellular naked RNA has been shown to increase the permeability of tightly packed endothelial cells and may thus contribute to oedema169. Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation170. Safety will therefore need continued evaluation as different mRNA modalities and delivery systems are utilized for the first time in humans and are tested in larger patient populations.

Will individuals with autoimmune diseases be treated with MRNA ?

"identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken"

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5906799/

Why we can not rush a Covid19 vaccine.

https://www.aamc.org/news-insights/here-s-why-we-can-t-rush-covid-19-vaccine

GLTA farrell








Autoimmune disease activation associated with standard vaccinations

Autoimmune diseases reported after vaccination
Autoimmune disease Type of vaccine Ref
Systemic lupus erythematosus HBV, tetanus, anthrax [17]
Rheumatoid arthritis HBV, tetanus, typhoid/parathypoid, MMR [18]
Multiple sclerosis HBV [19–21]
Reactive arthritis BCG, typhoid, DPT, MMR, HBV influenza [22–24]
Polymiositis/ dermatomyositis BCG, smallpox, diphtheria, DPT [22, 25]
Polyarteritis nodosa Influenza, pertussis, HBV [22, 25]
Guillain-Barrè syndrome Influenza, polio, tetanus [26–28]
Diabetes mellitus-type I HIB [29–31]
Idiopathic thrombocytopenia MMR, HBV [22, 25]
Hashimoto thyroiditis HBV [32]

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5607155/



h

Still time to hit a new low for 2020.

It should be quite heartening to all stockholders that with upcoming human trials for Brilacidin-CV there appears to be next to no worries about the outcome of the trial, both in terms of efficacy and safety, and the only worries lately were about BP trying to use their lobbyist clout to have govt bury Brilacidin or if the portion of the trial in Europe does turn out to be mainly based in Russia or Russian areas of influence that they don't mess with the results.

As to worry #1, BPs trying to bury Brilacidin. The current share price and trading action sure appears IMO that somebody has a major issue with keeping IPIX share price as greatly deflated as possible. Hasn't worked in years so continuing now seems quite foolish since no real long term holder is going to sell on the cusp of what we have waited for for years, a human trial that will once and for all show the greatness of the defensin mimetic arm of medicine with Brilacidin as its foundational cornerstone.

Also, the pre-peer review release now makes it impossible for BP or any government to hold back Brilacidin from coming to market (assuming trials are all positive) as the cat is now out of the bag to all major virologists worldwide. If USA wants to dawdle its feet (which I think now is not being done)it will have to answer why they did so, especially if IPIX starts dealing with a foreign partner for it. That would set off a round of fireworks IMO.

As to worry #2, the CRO will oversee all overseas testing and results, not local Euro/Russian organizations. CV19 now ravaging Russia and putting Putin in a very bad light. He wants an answer to this problem as much as anyone and so trying to make B-CV look bad is not in his best interests IMO.

All other worries being put forth now is simply FUD IMO. Nit picking everything Leo does serves no purpose. I don't think he is that overly worried about keeping stockholders apprised of anything not required to be reported and I agree on this as well. We are simply stockholders, not part of the management team that needs to be informed daily of ongoing company business.

If Euro trial start announced this week, great! If not, next week would be almost as great. Expect it to be within that time frame but that is strictly my WAG.

Nothing this week but basking in the glory of Thanksgiving. Been a bumpy year, but still blessed to be where we are and how we live.

I remember when Polymedix did a trial in Russia for open wounds. The results looked very promising BUT some of the trial participants stopped showing up for treatment/follow up. This caused the trail to be useless.
I am worried about this Russia thing.

If any old Polymedix shareholders are around please correct me if my memory is in error.

I only own 3000 shares of IPIX.

Personally...I prefer waiting until the first patient is dosed.

Rdunn...YOUR RECENT ERRONIOUS POSTS: (corrected)

YOUR POST #1.
Quote:
Leo's Sunday alert destroyed the stock... Between the grant filing error and issuing a Sunday alert for duplicated news has lost all credibility Leo gained. Should we expect the applications sent this week are accurate? Now, how low will this drop and does Aspire have an out?


...statement: "Leo's Sunday alert destroyed the stock.....for releasing DUPLICATE (EXCELLENT) NEWS..."

RESPONSE: A total "non-affect"...Sunday's alert was a FULL TEXT of abbreviated SUMMARY which the company initially released...
"Destroyed the Stock"...more like disseminating the GOOD NEWS...Your statement is a "fabrication" of an issue. Disseminating GOOD NEWS again and more completely is a GOOD THING ... Your statement and inference is a NON-ISSUE.

statement: referring to a "GRANT FILING ERROR"

RESPONSE: ...there was NO ERROR IN THE GRANT...Grant was filed in anticipation RBL would adhere to its timeframe for completion of Human Tissue Test Results...the delay cause by the RBL/GMU mishaps in the lab regarding short personnel and not meeting its own deadlines is far from a LEO problem. Submitting grant application to meet a deadline for submission, with the right to supplement and amend up to a certain date ...IS NOT AN ERROR. SUBMITTING AND SUPPLEMENTING up to a final deadline one expects to meet (relying on GMU) is good and indicates proactive and aggressive management. Would you prefer LEO not make an application for a grant...because he is waiting for a piece, then gets the piece but cannot submit because it never intially filed full package for consideration?


YOUR POST #2:
Quote:
"You forgot .... Aspire as sellers... Even with inside info they have no intentions on holding this POS... They make a profit and they're gone... "


RESPONSE:: FIRST...ASPIRE FINANCE ANY PORTION OF THE $30M IPIX has the right to PUT to them, unless IPIX requires them to do so (PUTTING IT TO THEM)there is NO SALE OF STOCK ! All stock which IPIX "PUTS" to ASPIRE...they are REQUIRED TO BUY (at a discount). SINCE THEY ARE FINANCIERS (not investors) they are expected to sell back to the market immediately at a higher price for their "profit". (
(THIS IS EXACTLY WHAT FLIPPERS ON THIS BOARD DO WHO SELL INTO THE BID OR SUBMIT SIZE AT THE ASK....AFTER they sell...they then talk down the stock on the board to buy back lower from "scared" longs.)

ASPIRE is a financer...the DONT HOLD ANY STOCK...they lend money...how they and all financiers operate...is not a reflection of the fundamentals. They are professional flippers...like the non-professional those who operate here.

YOUR POST # 3.
Quote:
The 8 month RBL testing made B irrelevant now that vaccines are almost available with great results.



RESPONSE:VACCINES are not THERAPEUTICS....Brilacidin is a THERAPEUTIC...the dire need to KILL the virus with a Therapeutic...once contracted... is in GREAT NEED....making Brilacidin far from "irrelevant'....(very obvious)

BUY! BUY! Buy!...Christmas in Moscow (FYI "WSBC" I prefer St. Petersbrug more) smile)

Thank you Karen!

I need this as a reminder, too!


Go B!

I am thinking it’s slight dilution and major shorting occurring. After seeing the 10Q, I do not think Leo will dilute much right now with the PPS being low- Only what is needed for the monthly expenses while keeping the $7+ million cash figure stabile and in place.



Investors will eventually pile in to grab a piece of this possible huge runner when the PR is announced of first dosing of patients. Then you will see if there truly was a large short or naked short position. JMHO

Brilacidin has passed safety benchmarks in multiple clinical trials and, is currently being tested as a covid therapeutic in two US RBL’s.

Brilacidin for ABSSSI is ph3 ready. Ph2 was dosed via IV in hundreds of patients.

Brilacidin for OM is ph3 ready. Ph2 was dosed via swish and spit.

Brilacidin for UP ph 2 POC trial was dosed with water enema. Results good enough that Alfasigma licensed Brilacidin for UP dosing with foam, enema, or gel.

Brilacidin for UC ph 1 was dosed with Oralogic tablet.






Message in reply to:

I’m in a slight disagreement with a scientist on Twitter. Can anyone tell me how many FDA trials for Brilacidin have used human subjects? He claims only OM is the only trial.

Most definitely it is. But what they fail to realize is this - Some Longs like myself did not sell not one single share when this went all the way down to $.05 but instead was fortunate enough to add when it was that low. So I consider myself very fortunate to be able to lower my cost average immensely and have tremendous faith in the company.

Simply and purely hysterical how someone can say dumping and sky is falling when the PPS is being manipulated lower via very small volume!! That is a fact.

As for me, I see initial data or a PR possibly 10 days after initial dosing of first patients overseas. So if the trial gets started next week oversea’s, (since Thanksgiving will not matter) then I could see a PR anytime between December 7 - 11.

That’s my opinion. Reason I say that is because if Brilacidin works as what the study showed which was performed by the RBL at George Mason University, then the Dr’s and patients should see results in the first 24 - 48hrs. So let’s say they start with 10 patients in a hospital with mild to severe and in those 10 patients they see a dramatic benefit. With that, they will look to encourage more patients or patients families to possibly try Brilacidin and join the trial. It will be a snowball type event since the Dr’s would want to give their patients the best possible treatment available to combat this virus since the hospitals in some countries are being overrun with severely infected patients.

So to all new investors or eyes to the board - Do not be fooled by all the misdirection talk or how the company has failed. Do yourself some DD and make a decision that you can sleep with at night. Just my honest opinion.

williamssc...you are absolutely correct... (Rdunn, incorrect)

If wanted...likely they can produce 100 Million doses (less complicated to formulate) at a fraction of the cost of, and likely infinitely more effective than Remdesivir


Upon first positive CT POC indications, under the Defense Procurement Act: "The federal government can, ...use it to jump ahead of other clients or issue loans so a company can buy all of the supplies it needs to complete the government’s order by a specific date. A rarely used authority of the law also allows the administration to control the distribution of a company’s products and determine where such materials go."

BINGO! J&J and PFE are drug production monsters in U.S. and can be ordered to produce Brilacidin before anything else..."...the Defense Production Act has been used to place hundreds of thousands of orders by President Trump and his administration to ensure the procurement of vital equipment..."


Where will "Overseas" Trials be conducted?

Look at the dynamics and who is likely engaged in IPIX's decision where CT should occur...

Regarding prior CT of Brilacidin, before IPIX's technology purchase, Dr DeGrado (now Scientific Advisor to IPIX), who is a member of the National Academy of Science, the National Academy of Inventors, the American Academy of Arts and Sciences, and a fellow of the American Association for the Advancement of Science, ... a past President of the Protein Society and was the scientific founder of PolyMedix, which discovered brilacidin...also served as President, Chief Executive Officer and Director of PolyMedix, Inc.

Where did PolyMedix conduct Brilacidin Clinical Trials for "successful" ABSSSI indication? RUSSIA Federation...11 sites in Russia and 5 sites in Ukraine

Brilacidin ... ABSSSI Human Clinical Trials...

Sponsors and Collaborators
PolyMedix, Inc. (IP developer from whom IPIX acquired Brilacidin).


Locations
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Greenfield Park, Quebec, Canada, J4V 2H1
Sherbrooke, Quebec, Canada, J1H 5N4
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
Quebec, Canada, G1V 4X7
Russian Federation
11 Sites
Multiple, Russian Federation
Ukraine
5 Sites
Multiple, Ukraine
Sponsors and Collaborators
PolyMedix, Inc. ...

With the highly charged partisan politics of in FDA of not wanting to give Trump any positive news...IMO conducting Brilacidin CT in Russia would be a brilliant decision by Leo and DeGrado...less bureaucratic, with "warp speed" like turnaround possible...

IMO we should be looking for CT to start in Russia by first week in Dec...(if not before)...informal indications within 7 days thereafter...definitive results reported by Certifying 3rd parties (Outside Russia and in U.S. or E.U.) within 30 days thereafter...

Familyman stated: "...mind-blowingly crucial data because it became available one week too late?!?! Unbelievable!!!"

Welcome to "The Bureaucracy"...contrary to KFCyahoo's response implying Leo controlled the RBL reporting results to IPIX (which he did and does not) and the deadline for the rolling grant review passed. But fret NOT...the grant application roles over to the next period and deadline...so my understanding is that the data information (and more) is in the next grant period for review.

Blaming Leo for RBL delays in assembling and releasing data which IPIX has/had no control over is a non-starter...pure BS. Of course, you won't hear from the same critic(s) throwing accolades in Leo's direction for submitting applications for Brilacidin's regulatory approval in two jurisdictions (U.S. and "Overseas").

Regarding IND...PR clearly states IPIX was complying with minor comments made by FDA re: IND application ...so IMO the answer is clearly YES: "...IPIX has been packaged the trial format the way FDA wants it."...and now we wait the 30 days. ... meanwhile IPIX has application in "overseas" jurisdiction for Human Clinical Trials for drug approval in that jurisdiction, which CT results will also be used in the U.S.

In the end..with Leo's strategy...IF INTENTIONAL DELAY...by FDA...after stellar results in Trials in U.S. and Russia and Russia's approval...FDA will have serious egg on its face and support a huge FOX New and FOX Business News campaign.

Meanwhile on the vaccine front PFE and Moderna are locked in "ONE UP ON YOU" trying to push the envelope on representations of efficacy....but SAFETY is far from settled.

IMO...discussion about AlfaSigma is a non-starter...because they are a non-starter with Brilacidin and likely default in its licensing agreement and return it back all of its rights under their limited licensed B-UP...good for IPIX.

With successful "overseas" trials and emergency approval...even without U.S. regulatory movement...YES, Kingofsting...IPIX can hit $5.00 by March.

For the Euro part of the Brilacidin CV19 human trial to be able to be used as data for the FDA portion of the trial, I would assume that the protocols for BOTH portions of the trial would have to be the same.

That leads me to believe that since the IND request to the FDA had not been sent in yet per the Mon PR that the final hashing out of final details for the Brilacidin trial did not happen until very recently, maybe the end of last week or a few days sooner.

We may have already had the hospitals and patients targeted overseas (more likely just the hospitals) but the protocols would have to be put into place and I have no clue if that takes much time or not as they seem like they would have to be minor from the originally proposed protocols to the FDA. Hope that means maybe the Euro portion can get started sometime next week.

Does each mutation of the CV19 get its own number, as CV21 or CV22? Since we haven't heard that any other treatment handles PAN-CORONA viruses would Brilacidin get a special designation or would other treatments have to be re-tested for each mutation?

Unfortunately this would be a taint similar to what happened to hydroxychloroquine because Trump liked it. Who’s going to think of Brilicidin (aka, Puticidin) as a go to drug for anything if it’s from the Rooskies?

Having said that, if Putin can get us on the map and up to $10+ I’ll take it.

(I know...that’s bashing! Brilicidin is worth at least $10 billion!)

Putin popularity waning. he appears helpless (vs. strong and powerful) in this crisis. Bad image for him and he wants that to change.

https://ecfr.eu/article/commentary_coronavirus_not_putins_kind_of_crisis/

"Putin’s popularity is dropping because the coronavirus is not his kind of a crisis. It does not cause him to thrive, but leaves him looking out of place: on the sidelines, uninspired and uninspiring. To his people, all this is plainly obvious."

Pressure is on Putin. to respond to Covid-19 in a big way.

Could it be the purchase of Brilacidin Patent for Covid-19 Therapy?

Expecting IPIX to commence launch of Clinical Human Trials in Eastern Europe ...by end of November or first week in December with feedback on preliminary results very quickly...

wsbc cites Russia as the "Overseas" country and with IPIX (predecessor - B- Absssi trials)having past trials there, I would strongly concur...

If Russia, I would not be surprised we get "approval" shortly after 90(+) (-) patient trial is completed. The $ to be made is not the important factor...It prompts regulatory agencies from other countries to review and look seriously at Brilacidin for regulatory review and approval (including FDA).

Russia likely chosen for being both more responsive (if Putin wants it Putin gets it) and a quicker regulatory review /approval process and much less expensive than U.S. trials. (if the Hospitals charge at all...since they are in such a crises)

As per PR...balance of Clinical trials will be in U.S for seeking FDA approval

https://www.bioworld.com/articles/500227-regulatory-actions-for-nov-16-2020


We are on the list!!!!!

Agreed! Let's hope we see the CTAP programme give us some 'fast-track' assistance eh?

My understanding of CTAP was that being a part of its purpose...

I feel like the RBL involvement should bring much-needed credibility along with the specifics needed pre-clinical to expedite...

Between CTAP, ACTIV and the PhRMA guys (https://www.phrma.org/en/About) I can't imagine this just goes straight to the rubbish heap, given what's seemingly been uncovered.

Time hopefully will tell. Hopefully not much more time though...

Quote:
I'm more curious about the timeline after submission. Whether or not it will be accelerated. That's why I made my comment that this could get interesting before Christmas.

Globally the clinical trials are underway to investigate
the efficacy of repurposed drugs in clinical settings. The
major drugs are chloroquine/hydroxychloroquine,
lopinavir/ritonavir, teicoplanin, brilacidin (PMX-30063),
solnatide, remdesivir, meplazumab, leronlimab,
darunavir, cobicistat, rintatolimod, plitidepsin, favipiravir/umifenovir, and IFX-1. Based on the clinical
outcomes, side effects and complications observed, some
of them have been discontinued from the line of COVID19 category. The COVID-19 therapeutics and the disease
target are summarized in Table 1 and is elaborated in
further section of this paper.

I don't want to get into conjecture and timelines.
I literally have paper timelines for this company-progression spread all over the far end of my dining room table, and every single one of them I've outlined has been blown to pieces.

We have no idea with Leo, when things will get filed and what the response will be. I'm feeling like the FDA is moving faster than usual through CTAP to review IND submissions currently.

I'm also feeling like the results from the RBL are pretty comprehensive and compelling. Possibly more compelling (significantly) than many other prospective molecules coming before the FDA?

W/respect to foreign review processes... I don't even want to hazard a guess. All bets related to timelines are off for RU I think.

In places where speed can be 'negotiated', the sky is the limit.

Given pandemic-urgency, I'd like to think that time-is-of-the-essence.

Were it me, I'd consider some sort of license percentage-contribution for the country stockpile as a percentage of Net, perhaps... in lieu of cash-upfront?

Quote:
The Russian regulatory environment for obtaining clinical
trial authorizations is relatively complex and somewhat
unpredictable. The regulations often lack descriptions of
specific requirements for certain documents or processes,
which leaves room for various interpretations of the
regulatory requirements by the industry and regulatory
authorities. Despite the fact that regulations define
specific timelines for review of regulatory applications and
issuance of approvals, the regulatory timelines are not
followed on routine basis.

If I were to guess (and I hate guessing about anything related to this stuff), I'd like to think that built into the trial-design, the Bio-Markers likely placed will be fairly close-in, so after a reasonable number of days elapsed from dose administration (let's say 5 days, for example) samples pulled would be subject to viral-titer analysis, whereupon efficacy could be determined to some extent. (B is either reducing the viral load or it isn't, in humans...)

Leo's CRO would likely have a certified lab contracted to do the sample analysis for 3rd party unbiased verification.

I'd think that upon sample-data being compiled and updated for 'interested parties' based on bioMarkers being placed, that some prospective 'partnership' interests might be resolved... (this wouldn't necessarily mean that results would be made immediately public, however.)

FWIW, there was some BP entity that was granted an IND earlier this year, something like 36hrs after package submission (I'm drawing a blank on the company currently). So it CAN go quickly... if the package is super-comprehensive and complete and assuming the pre-IND process was as detailed as possible (is my understanding).


Quote:
If they submit an IND this week, doesn't the FDA have up to four weeks to approve/reject?

Why do you think we'll have interim results in mid December? It seems like we can barely be assured the trial will start by then.

Pete... you seem to be confusing the PRE-IND component with the IND component, based upon your post.

Our IND wasn't submitted previously, and hasn't yet been submitted. Only the pre-IND package, to which a 'written response received' by the FDA was announced.

Just because people on this board make assumptions that things like the 'IND was submitted', doesn't make them so.

I'd been saying for weeks (literally) that the IND hadn't been submitted yet, and nobody wanted to listen.

https://www.fda.gov/drugs/investigational-new-drug-ind-application/pre-ind-consultation-program

Quote:
Note: Pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate. Additions or modifications to these communications may arise as additional information becomes available, during follow-up pre-IND interactions or when an IND is established.


https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

Quote:
An IND application may go into effect:

-30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or

-on earlier notification by FDA that the clinical investigations in the IND may begin.

This timeline is what matters currently for here in the US and getting a domestic trial moving.
Overseas, no IND or FDA approval required to get things moving, so overseas will likely lead, since getting this IND package together and submitted seems to be a colossal hurdle for Leo.

Additionally, there have been tons of posts on here related to the IND/Pre-IND process over the last several months.


____________________________________________________________________
Quote:
My view of FDA remains that they are a bunch of friggen' dolts.

Even in grade school teachers are quick to note the fast learners and put them in accelerated classes.

But FDA, unthinkable. Put every drug in the same line and they all go thru the same wait, wait, wait BS (of course payola moves you to the front of the line, especially for grants)

FDA already responded to our IND and that was suppose to be some minor matters to clear it up.

One would think you don't resubmit the IND, you just advance the old IND with the corrected minor details so an OK could come about nearly immediately if all matters squared away. But then if we don't have 10 levels of oversight and signing off, we don't have the layers of govt employees needed and the passable deniability to cover those that slow things down for payola or should something amiss happen with a drug. Sometimes the amount of waste in these govt departments and agencies and all things they do in general is beyond even one's wildest imagination. We'd be a lot better off to pay all Congress members $5MM/yr if they would just play fair w/ the American public.

IMO the only saving grace for IPIX is the overseas trial that will put Brilacidin CV19 on the news worldwide. Otherwise, I could see BP winning the day in the USA and burying the small startup with the treatment that will cut them a new one.

I hope IPIX goes w/ a foreign BP and tells US ones to stick it as to the best drug to come down the pike.

Since this started, seems like big medicine is as rigged as Wall St. Oh yeah, they pay big lobbyists as well. Who da thunk?
© 2020 InvestorsHub.com, Inc.

For those that aren't aware, keep in mind during research that Brilacidin and PMX-30063 are the same drug. Some issues that were present in PMX-30063 ph2 ABSSSI trial were solved in Brilacidin ph2b ABSSSI trial via lower dosing.

PMX-30063 was tested in clinical trials by PolyMedix.
Brilacidin was tested in clinical trials by Cellceutix that is now Innovation Pharmaceuticals.

ABSSSI trials are the only ones to have been done via IV dosing which is expected to be done in the upcoming Brilacidin covid trial. Other indications in clinical trials with Brilacidin were using various other means of dosing. Swish & spit (OM), enema (UP), and oral tablet (UC)

Aerosol and Intramuscular are untested dosing means for Brilacidin at this point in time.

An officially unnamed company has tested Brilacidin for biofilm use. Many believe it is a part of J&J.

Following are some related bits of data, not all, but, I only had time to grab this without doing a full search:


Population Pharmacokinetic Analyses of Brilacidin Using Data from Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections

23rd Poster No. P 917 European Congress of Clinical Microbiology and Infectious Diseases, Berlin, Germany. April 27-30, 2013

https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f849d1b631be3d85bd2a5/1480557726468/B00292_brilacidin_ppk_ECCMID13_19apr13-1.pdf

*****

AAC Accepts, published online ahead of print on 16 June 2014
Antimicrob. Agents Chemother. doi:10.1128/AAC.02955-14
Copyright © 2014, American Society for Microbiology. All Rights Reserved.

https://aac.asm.org/content/aac/early/2014/06/11/AAC.02955-14.full.pdf

*****
ECCMID 2015 Copenhagen, Denmark 25 – 28 April 2015
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f8286d2b85731b8713a36/1480557192947/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf

*****

Application of Pharmacokinetic-Pharmacodynamic Models for Brilacidin Dose Selection Support for Patients with Acute Bacterial Skin and Skin Structure Infections

American Society for Microbiology Microbe 2016, Boston, MA. June 16-20, 2016
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f831e579fb3daf479520c/1480557343791/Application-of-Pharmacokinetic-Pharmacodynamic-Models-for-Brilacidin-Dose-Selection-Support-for-Patients-with-Acute-Bacterial-Skin-and-Skin-Structure-Infections-.pdf

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In my opinion, I truly believe that the Trial locally will happen and happen very quickly once started. I also believe we may even see the trial happen Oversea’s at the same time.



My reason for thinking this way? Simple. I believe that even though we have not seen or heard anything about Alfasigma’s progress since Covid-19 exploded onto the scene, I believe they have now looked at the
Pre-Print and all the RBL testing that has taken place and might be one of the Oversea’s Pharma players looking into trying Brilacidin as a Therapeutic against Covid-19.


Think about it - They have had the agreement with IPIX for its use of Brilacidin for another indication but due to not being able to recruit healthy patients for their trial, they have been in stand-bye mode. Italy as a country got hit very hard during their first wave and now since Italy has started their lockdowns again while possibly beginning in the midst of a 2nd wave, the public unrest has started to ensue in their country with lockdown protests spreading and becoming violent. So in my opinion, it would be pure due diligence on behalf of Alfasigma’s company to at least look into utilizing Brilacidin as a Therapeutic against Covid-19. Alfasigma would be Italy’s and frankly all of Europe’s laughingstock of a Pharmaceutical company if they had contracted to test Brilacidin for one indication and not request a contract negotiation for its trial use in Europe against Covid-19.

I think if he did, we would have received a grant....but you are right, we don't know whether he did or not!!!!

I still often wonder why Leo did not go for an EMA grant!!!! Just does not make any sense!!!!