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? FDA meet without prepublication of data. How possible? Or so I would think. If data ready for FDA then ready for prepublication
Obv pre-pub required for FDA app. Any day now...wait for it...
I hope they get a move on too. Sad to see how this has dragged out.
Lemmings? Would not choose that word. How about the faithful?
aha- fair is fair. I tend to respond to what I view as irrational exuberance, and that occurs on a daily basis. I take it your objection applies to all equally? The same gut response to crazed optimism?
Please, please. Just remember : it is good news when we hear nothing for yet another critical, lost week. Good news, right?It means the RBL people are just learning more and more about B v C.
Even though the dose was chosen MONTHS ago.
Even though ALL that counts any more is the trial.
Even though time's a wastin'-
I have regretted that spelling error ever since the chance to revise was lost.
I appreciate anyone following along with the saga of B v C, believe me.
And in this case fiction expresses things better than fact. IMHO.
how very sad for people to whisper the November word now for IP. Let me see, there was that very big month of September. Then there was the next month, October, our current month, available for emergency back up if inexplicable failure, but now people wanna say November maybe.
November? For what? For the grant announcement? For the papers? For the FDA meet? For the trial?
How to save face-impossible, for now, just to take the grant for one example.
So much hype given FOUR months ago and not a word about it. Epic failure.
Will the next word to the wise be December?
And so it had been sleepless, tossing and turning for the carnival man and the shareholder meeting holdovers . They had all been in the Wakefield area for days now, and another day without any news would take them right to the 4 month anniversary of famous June 17 PR. Tomorrow would be four months...Some losers had said the human lung cell data were too slow to come out and boy were they wrong. He dropped several bombs that day, one of his finest days, as he told the world that IP and B were in the game vs COVID. The lung cell data was big. There would be publications from 2 groups submitted for peer review. The grant was done and submitted for pan corona research and potentially for other viruses. They had started making IV B and would talk to the FDA about a planned trial.
What a day. He liked reading it again, just to catch the excitement. The crowd felt the same way, and they would sit together, in families, or twos and threes, and reread June 11 and June 17 and get swept up in the crazy turn of events. One day IP man was trying to figure out out to scrape up money for a B UC trial and then someone whispered that maybe B could have an impact on corona virus. And US govt labs would do the initial testing- for free. He never expected much from these tests but hey, what was the downside. The company was struggling mightily. Sure, bring on the RBL and the PHRI.
The green monkey kidney data- whatever that was about- was nice, but it was June that was so incredible. The people in the crowd and the IP man knew the words from June almost by heart now, crumpled bits of paper stuck in pockets, ready for a quick perusal. Had they got it all wrong? No, it was all there, the sense of something big happening just when one least expected it.
The problem was that it was four very long months ago and the govt had said the grants would be expedited but there was no word. And those guys were supposed to submit papers and there was nothing in the pre-pub queue. Hard to set an FDA date with no data, as he was discovering.
He would tell them today then, that if Monday had no news they would all band together for an RBL road trip at 9:30 am. Patience? It had worn a bit too thin for all of them, at this point
"High likelihood" of B v C success in a trial? How could this opinion go unchallenged here? Because it is so obviously nonsense? I hope that is it. That is of course the answer.
Let me see: if there were a "high likelihood" the share price would be what?
Maybe $20 instead of 20 cents? Is that about right?
Yeah. Something like that.
Let's not pretend, OK.
Grant? Paper Sept deadline? Q4 trial start? It all means nothing, right? Just the usual business delays.
Someone- who might it have been?- had the ignorance to argue that it was better to keep doing experiments at the RBL, when the trial is all that counts.
Someone- who might have it been?-had the ignorance to argue that there was "a high likelihood" of B v C success.
These absurd positions, untenable, irrational and yet, unchallenged for the most part. I wonder why?
Everyone wants to back a winner and an underdog and wants to see their investment redeemed. Is it that simple?
It was shaping up to be another sleepless night. Sleepless in Wakefield in IP land since the strain was too great. It had gone on too long and the shareholders and the CEO were both at the breaking point.
It was now ludicrous that the company would not supply info. Whom to blame?!
The CEO? Or the RBL? (Or the BBC? And the FBI? Dig it).
Whom?
In fact the CEO could not sleep either. He felt that he had been had as well and that it was NOT the spleen PR all over again. He felt he was the conduit for the govt researchers and NOT their enablers. Not lying or exaggerating to the shareholders but really trying to say how good the data looked for B v C.
The problem of course was that it did not add up.
Why all the excitement when there was no follow through? No grant? No paper? No trial?
And so no one could sleep as the weekend approached and the IP man thought of coming road trip with dread. When might it all end? Things had reached a breaking point and the company was basically worthless.
The crowd was desperate too.
The company men were feeling exposed. They had said that all would be wonderful, just wait for tomorrow a time or two too many...
as the days passed it became increasingly awkward. The IP men in the crowd saying the good news is coming were increasingly exposed as the fools, although that was what they called others, who expressed doubts. Because there was never any update about the grant. Or the paper. Or the trial.
Not a word.
Realizing that their position was increasingly untenable, the yes men gave up. They had word from their boss that he had nothing- nothing- to say anymore, to all those people who owned the hundreds of millions of shares that were almost worthless
And it was not just about time to head out to the RBLs themselves for answers.
It had become to ugly for words, and their had to be action.
Do we need news? I mean, it’s just another lost day when every day counts...
And so he marked it on his calendar: Oct 19 the IP man would go on the road with his shareholders- he could no longer look the in the eye and make any reasonable sort of promise and he realized that he was in the same desperate position. Had the RBL and the PHRI conned him? When was the data coming out? The grant? Yikes! He could no longer pretend that news was coming when they told him nothing at all.
He announced this to the crowd on a beautiful sunny afternoon in mid Oct, and they were glad to hear that he too was suffering mightily since they were angry also. Even those who said tomorrow and tomorrow were only too glad to march for the RBLs because they understood they looked like fools day in and day out as they said the big news was coming any day now... any day, but it never did.
And so the CEO and the shareholders and the yes men all prepared to leave town in 5 days, a long march, but they were ready. They were all desperate because so much and been said and nothing had come of it.
It was a moment of clarity and understanding that they were all in the same awful place. A place of darkness and ignorance as alternate treatments gained traction and their beloved B synthetic molecule was going nowhere fast.
He and they could only take so much. After the October 17 4 month anniversary of the big June 17 PR the IP carnival barker decided he would go on the road with the crowd and together they would stand outside the RBL until they got news. He was sick of pretending that answers were coming when it was not the case. It was now halfway through October and the promised prepublication was not available.
He would start packing now, just in case, so they travel together in search of information .
Wrong- it does alter the science. Consider this: what if B were already established as a beneficial treatment for some segment of COVID patients? Then some enterprising researcher would need to include it in their Corona trial, since it would be standard of care.
Turn the tables: someone would have to show that Dexamethasone provided additional benefit to B for hospitalized patients that were helped by it.
Instead of the other way around, right? or will they just have to select hospitalized patients not yet on decadron?
How many other agents might be in the mix by the time the trial is ever done?
If B were standard of care it could alter the science of the trials
New 4 month anniv soon !!! If you thought June 11 was big- and it was -just wait for 4 month June 17 PR anniv. When we were told about the human lung tissue results and hope was galvanized and IP had a new lease on life beyond B UC. On that day, now almost 4 months ago, there was hope that brilacidin might actually have some benefit against COVID.
And yet here we are four months later, with no trial, though the dose is known already for IV B.
Is it really just the RBL sitting around adding a new test here or there? What is the problem?
Of course we have no idea because the CEO tells us NOTHING.
He says there will be a trial but he has missed one key deadline already and there is no reason to expect him to meet the next deadline for Q4 trial start.
What is happening? Do company owners = shareholders deserve to know? Or just continue to cross their fingers and say tomorrow, and tomorrow , and tomorrow....
Pathetic state of affairs
89, 663 days ago another revolution began outside Boston. Could a therapeutic revolution with a synthetic molecule also change the world?
Maybe it was the sunny day ahead and 70 beautiful degrees on a mid October day, after yesterday's dreary turn. But the crowd was much quieter and more hopeful as they once again filled the streets around the IP headquarters in Wakefield MA. The meeting was set by shareholders who were desperate for real information when they had been given none for month after month and they chose to gather to mark the 4th month after the grant submission PR- with no followup news. the company had not called the meeting, since it had nothing to say
And yet there was something about a golden day that provided hope. Would the RBL so badly mislead Mr Ehrlich? He had some scraps of data that sounded good. Surely there was hope? Articles would appear for prepublication and then things might actually move forward.
The world needed a cure, or at least something helpful, against the corona virus. Their company might have something that worked, a new type of drug no one had ever even used against viruses in a human trial. Why the RBL did not use the data and the trial forward was the total mystery that no one could figure, if brilacidin was such a promising candidate.
The IP man in his office could not grasp that either. How could he tell people it might be great when things never took off?
And even so it was going to be sunny and 70 and hope was in the air outside Boston for a revolutionary synthetic molecule.
But he recalled the spleen PR, and realized he had only himself to blame. The famous PR about Kevetrin- remember that drug. Can you? From so long ago-despite the bogus recent PR he chuckled. Because he still knew how to work the crowd, how to raise hopes.
He hoped that no one remembered how he released the info about one patient with metastatic ovarian CA whose spleen had cleared up. That patient was not mentioned further- left the trial with a rising CA 25, so what did that say? Pathetic. Embarrassing .
What did it say about the CEO and his big foolish mouth? It spoke volumes and it was coming back to haunt him again as the September deadline for prepublication came and went and he could feel the q4 trial start promise fading too.
But was it his fault really? after all the RBL has told him what to say. It's not like I am a scientist, thought the CEO. If those science guys say it will be September, should I never tell the shareholders? Those poor suckers- I kept telling them how excited they were at the RBL and all about the grant and those other viruses and on and on and now look where it has gotten me and the company.
Absolutely nowhere and stuck at 20 cents with nothing happening at all. Despite what those company men are saying to the crowd.
"Any day now- what a laugh!" he thought. "Four months gone since bringing up that grant- ugh. I should've known better. I don't even know a filo from an alpha virus. Such a mess.Hmm... Filo- it's a dough, right? Baclava and puff pastry. I'd like to study them "
What to do? How to salvage anything from the swamp? Time now maybe finally to go on the road to the RBL. If he could only remember where the lab was, anyway. Was it the same place they did the B UP trial? No, no, that was another secret location. Why all the secrets? Why all the disappointment? Where had his employees gone? Why was the company worth nothing? Why was financing impossible to obtain? Who was paying for Beverly? How could he just keep printing all those shares? They were worth less and less as time went by and it all seemed so wrong. Why? How?
Question after question, the relentless questions facing him every long night.
The crowd had the same bad dreams and the same relentless questions.
At least he was not outside in the rain, like that crowd, that would not go away.
The very long wet day in Wakefield was drawing to a close, almost 12 hours after the market open, almost a day after an NIH review of COVID treatment, after weeks of nothing happening, nothing at all, despite the promises of summer.
The shareholders were angry. They were clumped in groups, wearing hats and shirts and colors displaying their favorite MOA for B v C. Most wore the Antiviral kit, but there were some anti-inflammatory supporters as well. Few represented the antibacterial 3 in 1 effect, most had conceded this was possible, just not very likely to help in the coming trial.
But was a trial coming? That was the question on everyone's mind. They were cold and wet and they knew that the grant had never come up again, and that the papers were late. And now maybe the trial was going to be late as well.
The IP CEO man was warm and dry but also very worried. He realized his big dreams were just a sham now, and wished he had offered up a different timeline. Or maybe not say anything at all.
Keep trying and one day you may be right...eventually. Recycled predictions of shock and awe...
Helpful link. Hope B trial starts soon. RBL knew a reasonable dose months ago based on lab data. Are they doing a B plus dex study in the lab? I wonder what the delay is all about. If they believe B is extraordinary why not prepublication and get the trial going?
It'd be nice if there were no guesswork and IP would simply state that RBL has delayed their article because of x y z and anticipate Nov 15 instead. Or whenever.
The IP company men, spread out in the crowd, were busy, too busy. They had to slow the restless crowd so they called the restive people fools. Fools for wanting quick and easy answers. Fools for expecting more information. Fools for wanting to know more when all they had to do was wait.
The realized that what they said was nonsense. How could someone be a fool for expecting information that had been promised so long ago? For wanting to hear about those grants? For wanting to read those preprints?
But they said it anyway. They had bought into the company too long ago and had too much at stake now to even see the truth.
By now the crowd knew there was nothing happening today, even though it was only 9:30. The anticipation was over- again- and they were mad.
"Tomorrow!" some voices said " Tomorrow! Or the next day! The news will come and things will be magnificent. All that was promised will be revealed"
The problem of course was that the RBL had already hung up the phone, even as the IP CEO begged for help
"I told them to expect a trial start in the 4th quarter this year. How long can I string them along? How can you let this happen to me???"
But the line was dead. And the carnival man, the IP man, his company was dead too.
But then he had an idea- what if he finally revealed the RBL and PHRI locations? Why had he ever kept it hidden in the first place? Maybe all those people would head out on the highways of America to the actual testing sites, those labs that kept doing extra experiments instead of giving him and the company results.
So there it was: the carnival man and the crowd both had something in common. Both were stuck endlessly waiting. The crowd knew that if there were no PR from IP then the day would bring nothing.
Another wasted day. Others moved forward, but not Brilacidin.
The IP man too was becoming desperate. He had said a lot of pretty words to these people and had nothing to show for it, nothing, and he knew that people would explode at some point.
And what about him? When he was on the phone with the RBL what was there to say?
"But, but- you promised me prepublication in September" he said to the RBL, "and now I look like a liar. When you are the real liar. What do you expect me to do? Keep stringing them along? Keep printing more shares? The company will collapse. Those people will riot. I never shoulda given out the Wakefield address. They would be better off milling around in Beverly. This awful . I need data! I need papers! I need grant info!
"Don't you care about me and my company? Why give me those p values and nothing more? Why keep testing when everybody already knows you decided on the proper dosing months ago? Why?
"Can't you see? Either we start the trial or we miss the boat. Either prepublish now or IP and I perish."
It was a moment of real anguish. It was mystifying. If the RBL said B looked good- and they had said so- then why not get on with it?
3 way foods were- unsurprisingly- extremely popular at the food carts that lined the edges of the crowd. The 3 way chili was a predictable stalwart. 3 way breakfast sandwiches were popular too, especially on a rainy morning such as October 13.
That was not all of course. How about a 3 way? T shirts were seen in the crowd, those words on the front. To be sure there was no confusion, on the back it said, in large letters, antiviral, antiinflammatory and antibacterial.
And then a punch line: Anti Up!
Ante up indeed, thought the carnival man, enjoying the play on words, as he continued to print shares in his company, although they were almost worthless now, just pennies not dollar. That had been a long time ago. And two lousy dimes would buy you a share.
Oct 13 2020 A cold hard rain fell on the assembled shareholders that early dark morning. Whatever auspicious was- this was the opposite. It was cold and wet and miserable and many of the the faithful who had stayed on after the shareholder meeting expecting news were miserable as they gathered in the darkness, just outside Boston, in Wakefield MA the headquarters of the company they had pinned their hopes on. They had been told over the spring and summer that a rich harvest could be expected this fall.
Although such a day as today seemed unpromising , especially after the beautiful sunny gold days Saturday and Sunday, those announcing that today was the day were still out in force.
"It will happen today, you will see. This company will take off like a rocket when the papers come out and the world learns of Brilacidin," said one man.
And another:" Just wait- the moment is upon us when we show the world what a small defensin synthetic molecule can do in these times of cowering behind masks and hiding indoors. We will crush the viral plague at least 3 ways and maybe more ways, too."
"What were the ways? " a child asked.
"I don't rightly know" came the reply, " but I am a believer in computer generated MOA and we came out near the top of more than 11,000 tested."
The time is now, was the general sentiment, despite the misery of the day. The problem of course was that the same people had already been saying that every day was the day for over a month. It was beginning to sound silly. It was beginning to sound foolish, and even those who had said it day after day seemed a bit less certain.
The IP man knew this to be true, as he looked at the crowd, gathering on a cold rainy October day, soloing after all the promises of spring and summer.
Figured I may well be writing the wrong response- not following so carefully over the holiday weekend. Cheers!
I have written here carefully about the problems of the whole 3 in 1. I have again taken the trouble to write that dexamethasone is approved already, so it'll already be given to patients with a lot of inflammatory problems. B will have to benefit those patients beyond dex benefit.
Am I aware of other 2 in supposed benefits? Can I count? Have I already written a bunch here about this very topic? Umm...yes.
No one knows what to think, they can only guess. Recall please, that for now, those in hospital that are "fighting the storm" will be given Dexamethasone as their first drug. Will B have any effect beyond that? No one has the slightest clue.
I did not see that study come out yet(in vitro B + Dex). Just as no one knows the least little thing about the correct dose for the anti inflammatory effect, nothing, zippo.
We may know soon if a trial ever gets off the ground...
The RBL ought to be finishing the data for prepublication . We were told in June there would be separate PHRI paper but who knows. The RBL(1 or 2? who knows, we are never told anything helpful by Leo)has yet to submit their papers(s) and that is the reason for the the delay
Too little known to respond. Did he have COVID? What was his O2 sat on room air? His CRP? His co morbidities? Trend of illness? Most patients with corona virus are much better off at home and not nearly sick enough to be hospitalized. The overwhelming majority, in fact.
That is in part why B v C will not be an easy trail to show benefit. COVID patients are pretty sick if they are sick enough to be hospitalized. Obv: most people never get the treatment Trump got. Did he even need to be in the hospital? Clearly they were concerned he might get worse.
"Hey," said a man in the crowd. "Says here the markets are open even though it's a holiday. We need news now.
The crowd surged, angry at learning next to nothing for days on end. The shareholders meeting of October 2020 was turning ugly, as the yes men working for the carnival barker began to lose sway.
Many hospitals and EDs across the US had a baptism by fire with COVID patients this spring. We all still wear masks at work and access to the hospital is restricted in terms of traffic and guests are limited and must wear masks. This is in suburban Boston. In MA testing + rate under 1% be we all expect things to keep picking up as it has picked up a bit just recently
The crowd in Wakefield was not optimistic about news on a holiday, but they believed that prepublication of scientific articles could occur on any day, so they had some small hope. Didn't IP desperately need to move forward? Yes the answer was obvious. October was slowly slipping by and news about a grant or papers or the FDA or the trial was worth waiting for.
So they waited, just as they had since June 11, for more than 4 months.
They waited.
Bring it on IP man indeed . Four months and no grant update- pathetic
BIG 10/11 Shareholder meeting now, as the people gather in Wakefield, this morning. It is the 4 month anniversary of the exceptional June 11 PR announcing that RBL and IP were submitting grant for corona viruses and others. The big anniversary day is upon us !Four entire months have gone by but the CEO cannot be bothered to provide any update. Was it a simple scam?" the people asked, as they arrived on. beautiful October morning outside Boston." Could you least tell us something, anything after waiting so long? "
"If the results are so great," said the people, "then why keep doing experiment after experiment when so many people are dying? Why not start the trial? You already said you know the dose of B to give and that it does not damage the lung cells. Even though it wrecks the corona virus. Right?"
The carnival mad smiled broadly and raised his hands to quiet the crowd."Ah, the trial. Exactly. The trial will prove the extra ordinary power of brilacidin to destroy the virus. The trial is what we should focus on, the trial is what counts."
"But we cannot have a trial without any papers showing that Brilacidin even works. And you were wrong about when that was coming out. How do we know when a trial will start?" The crowd was restless.
"Ladies and gentlemen, esteemed shareholders, you know the government. They never deliver when they promise they will. After all, they are just doing a few more studies to show how great B is, just putting on the finishing touches before we take the world by storm."
" But sir", said a voice in the crowd " we ain't leavin' here until we get some answers. We have bought up all those shares tyou have been printing and you said all those pretty words and we have lost faith. Four long months and nothing more about that grant, that sensational grant you brought up. And no publication, or prepublication, or whatever. And no trial in sight, at all.
"We are going to stand here until you deliver, because we are sick and tired of the world changing any day now, only it's always tomorrow, or next week. So bring it on IP man."
If B is helpful with C only, the company will be worth a fortune. Adding in other viruses? To infinity and beyond. Still hoping it pans out, but they are losing time, and need to start the trial. To do that they need to publish the data, pre- pub just fine, while we wait for peer review. Is a grant still possible? For other viruses ? After initial paper(s) out? I am nervous as we all are that q 4 will slip for the trial, just Sept slipped for the paper. Very hard to be confident in IP-
Tamiflu a famous low bar, agreed
Chapter 4 Carnival Help: The carnival man could not do it all on his own. When he told people to step right up and buy some shares in the future of viral illness treatment- as hundreds of thousands died, and the world wore masks-many still wondered if they were just being played for suckers.
Because he told them on June 11 that he and the RBL has submitted a grant for pan corona research, and more; it may well include other types of viruses. It offered a glimpse at the future of medicine.
There was the problem that the weeks and then months just went by, now four months, and the IP man had nothing to tell them, the small and large shareholders, who had been so glad to support his company. Nothing to say at all, as time passed.
People begin to grow restless as the carnival man dropped the grant idea and sold them new shares based on articles coming out- only the articles did not come out either. People grew more restless, so the carnival man switched the topic again and told them the story of the coming trial.
Some in the crowd were disgusted and angry. But the carnival man had helpers, sprinkled through the crowd, to tell folks that it would all be just fine and to simmer down. To not ask questions or demand answers and to just wait and see. And wait some more.
Any day now, those helpers said, there will be a meeting with the FDA. Any day now, heck- it might be tomorrow!-the papers would come out and everything would change. Just be glad you are a part of it and hang on, a better day is coming, a new day. This calmed some in the crowd. But after four months there was increasing doubt that the whole thing was a charade, after all those days went by, and all those weeks.
The saga continues....