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The current state of politics also plays well for IPIX as the current administration is looking for a major win to help their cause as they seem to be under fire a lot these days.
Finding a broad spectrum virus killer that could be delivered via pill would be quite the feather in their cap.
Not trying to play politics here, just reflecting that it seems the general "perfect tide" of good things to help IPIX/B advance has been growing quite strong lately.
I take the very quiet nature of Leo over the last number of months as to anything regarding the trial and obeying the rules set up by the FDA to the letter, the continuing RBL activity whose results have been confined to a very small government circle, the recent govt CV fund for therapeutics announcement, the upcoming trial results in 6-8 weeks or so with the resulting widespread media coverage I am expecting as a result, the continuing problem with new variants coming on the stage worldwide, and the crescendo of American citizens demanding a fully open society (in regards to CV) for their state all meld to make getting a great therapeutic on the fast track.
I can't imagine expert virologists giving a presentation on their findings over the past year and a half about a drug that has been achieving remarkable results (albeit only in vitro results to date) over a wide, wide spectrum of viruses and organs (liver, kidney, lung, GI tract, head, etc) could possibly screw it up. They even have prior in vivo results (though on a very small scale except for the ABSSSI P2)showing excellent transfer of results from studies to actual human trials and the safety profile has been quite good across the board.
It seems the data will write the presentation for itself.
Anyway, that is the way I hope the conference goes.
Yet others feel all the share price answers are in the charts, bands, or stars.
Takes all kinds to make a market.
Russia could give B a complete OK to distribute commercially if they wanted (at least inside Russia), no need for an EUA.
No need for them to wait for FDA or EU to make a decision should they see fit to get B to their citizens ASAP.
My opinion.
I admit it is a start, but as long as 3 of the 5 SEC Board of Governors (one being the Chairman) are from Wall St (and usually return after their duty at the SEC), the DTCC is allowed to operate, hedge funds are given the rights of brokers with little to no regulation, and the big boys keep getting paid off the old saying of "follow the money" stays in play IMO.
We are talking trillions of dollars here, the amount these underhanded organizations can pay to our "elected officials" (another term IMO for people with votes for hire at the right price) is staggering so I doubt seriously the law will be changed enough to really make a difference.
IMO all we will be seeing is window dressing. I would say putting many, many hedge fund managers, bank and stock brokerage leaders, SEC/FINA leaders, etc in jail for DECADES and those most egregious violators put to death that there will be any chance for true change and so I just don't see it happening (Sen Dodd seems the type of character I am speaking of who did MAJOR harm to America and all Americans with his leadership of the Banking Committee and his staunch support of his largest campaign donor, a hedge fund, and stopping any and all laws aimed at reining in hedge fund powers.
As most things in the world today, the corruption is just too widespread and ingrained to get rid of without a near-martial law form of cleaning the slate and that is just not gonna happen.
How will T+1 be any improvement on T+2? Same way to scam the system IMO so only answer is block chain for T+0.
Too much money being made by non-transparent trades for those doing so to give it up so easily. Also, the collusion has to be at the highest levels to have allowed it to happen and continue all these years.
I was wrong and you are absolutely correct as to the exclusion of patients on ventilators prior to being put in the trial. Thank you for setting me straight.
Boy, have I been off target on this trial. The moderate and severe categories are mainly oxygen saturation and respiratory rate.
I have one question, though, and that is the exclusion criteria stating "invasive mechanical ventilation" which is likely ventilators but how would a ventilator be invasive? I thought they only put on a face mask and breathed with nothing invasive going on.
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Inclusion criteria as follows per clinicaltrials.gov website:
Currently hospitalized and requiring medical care for COVID-19.
Moderate OR severe COVID-19, defined by respiratory function at screening, as below:
Moderate, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 > 93% on room air;
Respiratory rate ≥ 20 to < 30 breaths per minute.
Severe, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 ≤ 93% on room air OR arterial oxygen partial pressure (PaO2) / fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) [corrective formulation should be used for higher altitude regions (over 1000m)];
Respiratory rate ≥ 30 breaths per minute.
Body mass index (BMI) of ≥18 to <40kg/m2 at screening.
Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
In the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.
Exclusion Criteria:
Participation in any other clinical trial of an experimental agent treatment.
Requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) at the time of randomization.
Has explicitly expressed the wish not to receive intensive care support (Do not resuscitate or Do not intubate order) should this become necessary.
In the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure.
Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
Hypertensive urgency (e.g., SBP >220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines.
If has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines.
Evidence of moderate or severe hepatic impairment (Child-Pugh Class B or C).
Estimated GFR (eGFR) <30 mL/min/1.73m2 (based on CKD-EPI formula).
Prior to a participant's study entry, known allergies or intolerance to Brilacidin or formulation excipients.
Any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study.
Pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment.
Sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.
From what I have garnered, Brilacidin Phase 2 is the only trial that has been targeted towards ONLY THOSE PATIENTS ON VENTILATORS.
All other treatments try to prevent CV19 from reaching this stage but don't appear to have any affect on the patients that already have moderate to severe symptoms.
Also, Brilacidin seems to be the only SINGLE treatment not needing additonal steroids, antibodies, etc to be highly effective.
Bottom line - If we get the very high efficacy in these needy patients and the trial shows the SOC/placebo group seems to have had no real effectiveness, that would show the lack of need for Remsdesivir as it would only be able to add 1-2% higher efficacy and the cost wouldn't be worth it.
I believe the current trial has the opportunity to show such startling results in both efficacy and safety that some new rules may be written to get it into use (EUA or Compassionate Use) much, much quicker than any other vaccine/treatment.
I think the fact that the Conference is virtual plays heavily into IPIX's favor. I went over the Conference schedule and the GMU presentation is not listed in the top couple of levels of presentations which leads me to believe it would not have gotten that much attention at an in-person conference due to attendees being overwhelmed with what is considered more important presentations.
Being virtual, the attendees can listen to ALL the presentations over a longer period of time as they see fit. This should allow the GMU presentation to be listened to by most of the attendees IMO.
Many of the top level presentations are quite specific in addressing what IMO are very narrow areas of interest, whereas the GMU Brilacidin talk should be of interest to ALL attendees, being the introduction of a new arm of medicine and a specific drug that has yet to be defeated by any bacteria or virus. A broad spectrum wonder drug that has yet to meet any resistance to it. This is the goal of the conference, to make known the cutting edge of virology and that is spelled Brilacidin.
I think the GMU presentation will gob smack most of the virologists but I also believe they will be looking forward to it based on the earlier peer review that was sent out to them.
Whether the conference plays that heavily into IPIX's favor I have some doubts, but it should make Brilacidin a subject that all worldwide virologists will want to study further.
IPIX entered the CV19 fray for expanded Brilacidin broadcasting to the medical world, this conference should provide a major step in further accomplishing that goal.
And how could IPIX afford a small lab when they have been struggling for years just to stay afloat? It would have been nice to have one, but not necessary for survival at the current time. Thanks to those who crushed the share price for making sure a lab had to be removed.
A lab will come in time, likely later this year if current trial turns out as many of us expect.
There are 16 RBLs. I wonder what they are all doing to keep busy when they know in Brilacidin they have a new arm of medicine that looks promising across many arenas of medicine. Why aren't they looking at this?
What is DOD, BARDA, et al doing about this? It affects the whole USA and national defense so one would think they would be on top of it.
IPIX has an excuse - extremely limited funds. Govt - not so, they have given tens if not hundreds of billions to BP for CV19 and other viral/bacterial threats and I don't see where any of them to date have come up with squat. Reeks to me of a massive payola for generous lobbying donations.
Could there actually be a hint of progress moving forward for GWTI and the prototype plant?
Not counting on it but the trading has changed recently.
Nothing to get excited about yet IMO.
Sadly, I thought there were many wealthy people in the energy industry that would be able to see the tremendous opportunity of GWTI's technology, surely one or two very wealthy persons willing to back what will be a revolutionary new source of chemicals, water, and electricity to currently non-inhabitable areas, but they all seem to have their heads stuck where they can't see the light. Guess lemmings are the way of the world nowadays.
Disappointing.
Lots of activity on the board but nothing got thru my filters after lunch. I am happy for low volume, little price movement over the next 6 weeks or so.
July's fireworks will all be 4th of July IMO.
Enough time later in the summer for the IPIX fireworks and they should be spectacular.
This IMO will become huge for IPIX.
They are serious, Brilacidin has to be the leading therapeutic in trials today, and it checks all the boxes in what the EU is looking for.
Seems like the Perfect Wave keeps building for Brilacidin later this summer.
If B can handle Lyme's Disease, that would be BIG as that is a terrible disease. It destroyed my sister-in-law. Sure hope you are correct and Brilacidin does the job.
To think there are those that wish to see Brilacidin not become commercialized is staggering. Closest thing to pure evil I can imagine for all the wondrous good Brilacidin will do for patients around the world.
Russia is a very well respected clinical trial country, far above any country in Europe to include the UK, Germany, France, and Italy based on trial infractions going against FDA protocols.
I think the cause for the heavy sway to Russia was a big patient base in Russia and a small base in the US, plus I think Russia worked harder (just IMO) than the USA hospitals in recruiting. I am hoping Russia was able to get patients with variant infections and also hope they got some patients with the black fungus as well so that we could get some preliminary data on whether B was able to nullify that condition as well as the CV19 virus.
Have to admit I don't put full trust in the US medical agencies running the approval system (too much payola and BP influence IMO) and am happy as a clam that Russia took the heavy lifting and got it done in a short time period.
Believe in the long run this will be a very advantageous outcome, Russia conducting the vast majority of the trial, and IPIX and Brilacidin for CV19 will heartily benefit from it.
Also hope the last couple of days of trading have shown the light to many that cheering little movement upwards in the share price is still far too early to stick and trading is still completely controlled by those agents using computer trading to yo-yo or crumble the stock price.
Our day WILL come, it will just be August at the very earliest IMO.
Most drugs are used for a specific condition. I don't believe there has ever been (or at the most but a handful or less) a drug that has the ability to treat such a widespread spectrum of conditions as Brilacidin and certainly not another drug that has gone thru thousands of hours of being refined on a super computer to maximize benefits and minimize severe side effects. It is my contention medicine is still living in the horse and buggy era regarding clinical trials as to drugs invented using AI/super computers whereas Brilacidin was brought to life in the age of space travel.
With the amount of prior clinical trial success of Brilacidin on human patients that saw no severe reactions and next to no moderate reactions shouldn't that allow it to be given some sort of break after the 29 day monitoring period in the protocol to allow for a decision if the safety level has been reached to at least allow a Compassionate Use decree to be made as to those wanting to use Brilacidin NOW if they are in severe CV19 straits? If SAE's do occur during the 60 day monitoring then a hold could be put until further consideration is made as to appropriate level of use, but during that interim 30 days it could save thousands of lives worldwide. They also would have more corroborating data showing no SAEs should all Compassionate Use patients not incur any.
I don't see how that is possible prior to the start of July when all patients have ended their 29 day testing protocol and I don't even know if it is allowed prior to the 60 day follow up phone call to check on SAEs.
If allowed, it would be wonderful.
Even better if it was PRd that it had received the OK for Compassionate Use sometime this month or in July.
Great that the WORLD'S top virologists will get a presentation on the pan corona indications of Brilacidin just 2 weeks prior to the top line results of the human trial being published.
How is that for getting the world's authorities on viruses up to speed on the new "gold standard" for antiviral treatment?
No possibility of hiding Brilacidin in the background any longer!!
Am taking my cue from the following part of today's PR which I take to read as saying top line after 60 day period.
"Complete trial enrollment comprised 120 dosed patients recruited across multiple sites. Final data collection for the last patient enrolled in the study is expected to occur in early August (Study Day 60), which will then be followed by the process of unblinding study data and the reporting of topline study results."
Was a bit surprised by the 60 day monitoring requirement in the PR but this is due to the following statement in the trial protocol:
Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
Great news for IPIX, but it shows that while many new investors may start flowing into IPIX, there is still plenty of time for those wishing to mess with stock price to do their thing - so don't get worried over June/July for the share price to go all over the place - both up and down.
Walls as to share price increases seem to be obstacles to overcome when going up but price supports sure dissipate quickly on the way down and what took weeks to overcome seem to be able to be dismantled in a matter of minutes.
I see no reason a price is going to hold above a specified support level until we get BOTH positive human trial results and some word as to a healthy infusion of money for further Brilacidin trials/development/research.
June could prove to be very good for IPIX in terms of share price increase but to play it real conservative I won't be a believer the price will hold until the events I mentioned above come to pass.
Yeah, and that is why CDEL was sitting on both sides of the trading all day.
Bottom line is that whether it is MM, large holder, hedge fund, etc the stock price at this point in time is all pure manipulation.
There may be some accumulation going on, I believe there is, but overall just stock price games.
For some to get bent out of shape over a 3-5 cent rise is ridiculous when the science and findings to date (clinical trials, RBL investigations, etc) point to Brilacidin being potentially a once in a lifetime broad spectrum, new arm of medicine, anti viral/bacterial/inflammatory + strong immunotherapeutic properties drug and when it really comes time for it to shine the 3-5 cent rise will be a pittance.
When the stock starts rising over a dollar a day I will get pretty happy, over $10 a day (as I believe will happen) I will say now is the time to get excited and act like any fool you want to be because you have earned it.
I do a lot of horse racing analogies, so when Secretariat broke his maiden (3 to 5 cent rise) was that the time to wet yourself or was it when he won the Kentucky Derby (happy time) and finally the Belmont (excited time)?
How many times does this BS pattern have to happen before some catch on that it is ALL MM manipulation - both the gains and losses?
If there was a leak or the market in any way was better informed about IPIX/ Brilacidin we sure as hell wouldn't be sitting at less than 2MM shares traded.
So we get this chest thumping, short bashing, constant price talking and then when the MMs pull the rug out all we hear is the whining and the sobbing from the traders.
I find this elation as sickening as the low volume price spirals downward because both come due to the same culprits.
So let's act like we've been here before, let's wait until we get the true top line results which will validate all the winning accolades for IPIX, and until then keep on an even keel.
Poor Leo gets all the grief for timing of trial- of course the FDA , CRO, or trial sites have no input as to slowness of trial- LOL
What damage I has delay caused IPIX? Maybe some dilution.
What has delay done positively for IPX? Competition has almost all fallen by the wayside, trial results should come out very close to Virology presentation. RBL investigation of B has continued and expanded the opportunities for B to expand iinto many new areas, and BP has come to realize Leo will never let B or IPIX go cheap.
I agree, Leo would politely listen, but no way they will offer now what Leo knows both the Brilacidin platform or IPIX as a whole is worth.
I think he would also inform them that as time goes by the value will be rising exponentially so they would be well-advised to open their bankrolls VERY wide now to be able to secure an asset that will be monstrous in the next few years.
I believe there will be some very aggressive Senators/Congressmen/women asking pointed questions to the FDA, CDC, etc. as to why Brilacidin was pushed thru so slowly with such stellar investigational results while BP plays with zero to minimal results were thrust upon the nation.
Hope it points out how the whole govt seems to be a pay for play.
Anyone notice today there was $15 Billion earmarked for Bezos' Blue Origin rocket venture in a new government spending bill? Guess paying $625K in first 3 months of 2021 did his company good. Hard to believe the richest man on Earth is asking for a bailout.
As to Leo lying, there is quite a difference in events not proceeding as planned vs outright lying. I believe Leo has maybe been too optimistic in years past as to expected progress but he said nothing he didn't truly believe would happen. Thus, him being called a liar IMO is uncalled for.
So why would Leo even be entertaining ANY ideas of selling currently? IMO it is absurd.
Once we get good CV19 results, take the time to run trials for ALL the coronavirus ailments and the value of B just as a broad spectrum coronavirus killer becomes potentially HUGE!!
Once that is done, there are plenty of other viruses to check off the list - and that is JUST as an antiviral.
What about the anti-inflammatory problems of COPD, Bronchitis, Asthma, Encephalitis, etc?
What about the dermatology related issues, kidney and liver issues, an on and on and on and on.
Oops, forgot the value of taking care of GI tract issues.
It is like we have hit a gold mine and some are saying we should sell after the first large nugget is found.
Thank God Leo is smarter than the average investor.
And how has that worked so far for Brilacidin?
FDA has been studying it since Feb or Mar 2020, have seen a number of trials on 400 patients with no safety problems, and yet took 3 weeks or so to OK the days of dosing in the current trial to go from 3 to 5 (and that was only about 15 patients that had been given Brilacidin in the trial. Breaks down to over a day for each patient to be reviewed).
If we had been BP, maybe it would have taken 45 minutes or so for the entire 15?
Should have named it Turbo Track or Speed of Light track - names are moot if actions don't correspond to name.
And people are continuing to die in record numbers in Brazil and India.
A prior PR or article said that none of the chemicals used in making B are that scarce so I am assuming that the cost of manufacture will not be that large.
Can't remember where I heard it but I thought there was something about $800 per treatment (now I don't know if that is per dose or for full treatment).
Bottom line is that it should be way, way under Rems.... cost.
Add in the efficacy expected and safety of B and that is dirt cheap.
But as to your question, I have no positive info as to pricing. With the need for it worldwide, it would seem to me that offering it to 3rd world countries at a very reasonable cost would really make B become a household name and help it in becoming the "gold standard" for the entire spectrum of coronaviruses and many other viruses. Upcharge those countries that can afford it a bit to help the bottom line. No way in he** Biden gives away the patent rights (as has been speculated in the news regarding CV vaccines and treatments) as B is so much more than just a CV19 drug.
I look at CV19 not as an end game but a great introductory tool for Brilacidin (and IPIX) to the world of medicine.
This scenario makes me believe that at least one and probably several countries around the world will jump all over Brilacidin as an authorized treatment for CV19 in a heartbeat once good top line results are shown in the current trial.
What is there to lose?
You finally have a treatment that shows both efficacy and safety and is reasonably priced.
Even if it only works on 10% of your severe cases, that would add up to a lot of saved lives (and we all know the efficacy will be levels higher than this minimal amount).
Have to believe some countries will care more about their citizens than making sure BP gets their billions from near useless products.
It is a sad day when an American (me and many others) says they are happy that our Brilacidin P2 human trial for CV19 is mainly being conducted in Russia as they don't fully trust our own government's actions in the CV19 situation.
Many of us believe that if the entire trial had been conducted in USA that we could have had delays, made up worries that would have led to less than stellar trial results, or some sort of decree that Brilacidin could only be used if in conjunction with Remsdesivir.
Is this belief justified? Who can say but the fact remains that there appears to be many grey areas in the system.
At least we know that the current trial results, if so delayed in the USA by the powers-to-be for whatever reason, will be known by Russia and will not be kept hidden from the rest of the world.
Let the USA powers push the useless Remsdesivir, the rest of the world will have as an alternative a drug that actually KILLS the CV19 virus, stops the serious inflammatory damage to lungs, liver, and kidney, and prevents the cytokine flood in the body that causes death due to the body fighting the CV19 virus.
Do you really believe it will be an antiviral, anti-inflammatory, and have the immunotherapeutic properties that are needed for CV19 and which only Brilacidin seems to possess?
IMO we will see a nebulizer or nose/throat spray delivery system near the end of the year time frame for emergency applications of B.
From what I have seen BP over hypes and under delivers - don't see any reason for a change in this with the PFE pill.
Brilacidin is not a drug IMO, it is the spearhead of a whole new arm of medicine.
A flip phone was a new "drug" for communication
The Apple I Phone was a new arm of communication.
Brilacidin will be on the same scale of being commercialized as was the I Phone IMO. It does it all in different areas of medicine as the I Phone did to comm. - phone, text, email, camera, GPS, hundreds of apps, etc.
CV19 will be but the first step, then the whole coronavirus platform, then ALL viruses, and so on and so on and will take years to come to full fruition. I don't see IPIX owning B down the line, it is just when Leo wants to sell to a BP that is the question.
For stockholders, not a question of make or break, but rich, richer, or obscenely rich.
You consider increases per day in the .000XX range a take-up? I think it is more of someone with an extra $20 trying to jerk around the market for a cheap laugh.
FCCDC is located at the Pennsylvania Biotechnology Center (PBC), and is affiliated with the Pennsylvania Drug Discovery Institute. The PBC is a 112,000 square foot campus that houses nonprofit research organizations and commercial start-up companies in the same facility, located in Doylestown, Pennsylvania (just north of Philadelphia). Founded by a Dr. Reitz who does not have a background with Temple U.
Fox Chase Cancer Center is proud to be an integral part of Temple University Health System. Along with offering our patients the best in cancer care, we also provide unparalleled access to a vast network of physicians, specialty clinical care for a variety of other healthcare needs, and groundbreaking clinical trials and treatments.
Though both are in Pennsylvania (Doylestown and Philadelphia) and deal with universities and other medical research facilities. I don't see a relationship. My opinion only.
The Federal Register article listed below that deals with a public docket for peptides and which ends 13 July seems quite coincidental to the ending of the Brilacidin P2 human trial.
But Brilacidin is a non-peptidic small molecule defensin protein mimetic and, as such, I thought it was much better (far more safer, more laden with benefits) than peptides.
Not sure how all this fits together. Maybe someone with a medical background (or peptide background) could comment.
https://www.federalregister.gov/documents/2021/05/14/2021-10179/evaluating-the-clinical-pharmacology-of-peptides-establishment-of-a-public-docket-request-for
What I take away from this is that for all the current trials for CV19 treatments and any other CV related trial, almost the complete totality of them were known by the BPs before starting them to be extremely marginal at best and more likely to be complete failures. All they accomplished was slowing down the possible good one or two trials in seeking patients. Thus the ending effect was to prolong and exacerbate the CV pandemic.
No way CV19 was going to be able to handled by a repurposed old drug. If they were able to work on viruses to any measure, they would already have been in use prior to CV19. They sure as hell weren't going to work on this new demonized form of coronavirus. Was going to take a new class of medicine working in a new way to take down this virus.
Kind of like saying something needed in the way of fashion so BP pulls out its entire wardrobe from winter parkas to summer beachwear and expect it to handle some new problem never seen before by Mother Nature.
I would label it as "money laundering" to the BPs - govt gives them gobs of dollars and they give back reams of useless trials that show seemingly effort on their part but not much financial input.
Your post shows why Brilacidin/IPIX is in such a strong position in regards to the Rems... liver problems.
Thanks for clearing that up.
Since in our trial Brilacidin is only being given with Rems... how will the trial be able to distinguish what caused the liver problems should quite a number arise? Wouldn't want Brilacidin to get hit with a notice of causing liver problems when in reality it is the Rems... doing the dirty work.
Only about 8 weeks until Virology Conference presentation.
In the midst of a seemingly long drawn out trial this news today was a welcome harbinger of good results - increasingly faster patient enrollment, no AE's to date, continued wider B investigations in RBLs, etc.
We could get additional good news between now and V Conference but if we don't we know we have nothing to worry about in regards to trial.
Time to focus on the goal line - to me that is top line results for human trial. Don't get sucked into worrying about the share price prior to that news.
Great day for IPIX IMO.