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What took so long, folks? Is this what you get for $35,000? The preprint is out and it is excellent to have it released. What took so long? Was anyone working on this except a couple people at a very slow pace for IP money? What was the amount of other support? Was there even any money besides the $35,000 involved?(Yes I know in theory just for the EC50, but what was the other funding, nothing mentioned that I saw, but support for Narayanan)
We got VERO 4/1 the lung cell 6/17 the SI 8/24 and B/Rem 9/15 and a paper 10/30. Talk about slow. Mostly GMU and some Rutgers contribution. Lots of other stuff(supposedly) is in the works- don't hold your breath, based on the pace of what we have just witnessed. How much does the government care about B? Why is there no deal with Pharma to push it all forward?
Gilead looks at the data and says what? Lab only- try it in people, then get back to us?
4/6 PR= 6 months ago working toward a human trial and seriously, where were all the slowdowns? No money? No lab help? Other priorities?
Today's PR mostly confirms what some have said all along- the govt moves very very slowly Almost every bit of this news is old already-
share price will not be changed much after small puff of dust settles
really- I thought it allowed you to get more shares at lower prices. Aren't we in this together? LOL- prices low enough already
Big question remains: you have a drug that has been shown in a lab to block entry and yet your trail is on patients whose cells are full of the virus already. How important are the other mechanisms of action? The scientists have no idea yet- none. But that is where a trial is planned, or so it was said. Has IP and the RBL changed plans? Made other plans for a trial?
Much critical info not available
Even so- the game is afoot!
Article mentions testing planned for MERS and SARS- great news too!
Arylamide foldamers unite! Exciting to see this in print. First impressions of a quick read through vs what was known already(PR dates). Mostly old news, as it turns out
4/1 VERO data
6/17 human lung cell data
8/24 SI info
9/15 B/Rem info
The 10/30 preprint sticks with this info, most of which was known months ago.
Much other work hinted at- mechanisms of action, etc
Focus very much on preventing viral entry as CEO has said all along, the rest not known(antiinflamm, ability of B to attack C inside a cell).
Narayanan stresses prophylactic use- remember the planned study involves people whose cells are already full of virus.
No synergy with favipiravir(news), but yes with Remdes...
SO: PR Back on April 6- IP working toward human trial for B v C. Clearly we are much closer now. Seeing the paper is exciting.
Does the CEO owe shareholders any explanation at all for no updates at this critical juncture- 2 months now? Even if the problem is RBL still testing, or the dog ate their prepublished paper- shouldn't we be told?
this is totally bogus
Sept 17 The launch pad. Edgewater Place IP HQ vigil day 17. One might have expected that after 17 days of today is the day that there would be some doubts. How many days could they be expected to announce that revelation was at hand? When would it become foolish? Or sad?
But no. Such was not the case at all. They remained determined and they knew they had to be ready because the news would sweep over the whole world leaving it changed and they knew to be attentive.
With this resolve they began to discuss a special 3 in 1 handshake that could help identify the faithful. They were glad to have such important work to do that day.
3 in 1!
Day 17, the launch pad, Wakefield Massachusetts, continued. Thursday, mid day: if one listened closely, then one could hear the quiet chant of numbers. What could it mean? Listen: 6, 17, 19, 75, 95, 97, 8, 460, 11,552, three in one.
It turned out the explanation was quite simple. In any group, in any cult, There will always be mystics. These mystics Based their faith in part on Numbers, which they chanted, in unison together, with other members of their flock. 6/17 was the birth of that sect. And the numbers were all derived from that text.
Six and 17 were of course June 17- the chapter and the verse, month and date. 19 was for COVID-19. 75 was for the inhibition of the green monkey kidney cell coronavirus growth. 95 and 97 were for viral load reduction in the human lung cell line. 8 was the number of human trials according to the final paragraph in the 6/17 text, and 460 was the number of subjects, already given their beloved brilacidin. Per the text.
The number 11,552 was the number of compounds in a molecular screening study that supported Brilacidin as a promising coronavirus treatment. Three in one, – well what can one say, that was the basis of their faith. Antiviral, anti-inflammatory anti-microbial, three in one, the Trinity.
They would always begin and conclude their meetings with the three in one, even those who were not mystics.
The June 17 PR was responsible for the most part for giving rise to this mystical wing of the faithful, and it was fitting that it was honored on this day, 3 months after it was revealed. They were not troubled that days kept passing without news, in mid Sept, when they had been promised the prepublication .
They knew the day was at hand.
Waiting on the world to change.
6, 17,19,75,95....the chanting continued.
In the absence of actual news, fictional news will have to suffice
Could there be anything more pathetic than the recent lack of news, all of September, and all of October, at this critical moment in the nations history, and in our company history? Truly embarrassing and pathetic
0930 Day 17 The Launch Pad Thursday Sept 17. More than two weeks had passed since the faithful began their wait. They were surprised that nothing had been announced yet, that there was no blastoff. Again, today there was nothing by market open and the PRs always came early or not at all. They resigned themselves to another day without the launch.
This was a day of reflection since it was the 3 month anniversary of verse 6/17, one of the bedrock texts of their faith. When the human lung cell data was announced it was like a great blinding flash of light and truth. And so 11 of the flock held up signs- on one side they had the letters Brilacidin! - with the exclamation mark too. When turned over the signs contained a key part of the 6/17 venerable text:"compelling proof of Brilacidin's impressive ability to inhibit the novel coronavirus"
Let's connect the dots- they chanted. It was a call and response that followed: Is it likely that B will succeed against C?
Highly likely came the response.
Will B beat C?
Highly likely, again the response.
B stomped C in the lab, and in a trial?
High likelihood of success, they said together.
They waved their signs. It would not be long now, for the revelation.
It would be tomorrow, if not today.
Here is a better answer. This is a serious topic, obviously. Had this person with the brain tumor been around the Boston area several years ago, and had they failed standard chemo treatment, they would be given options, including clinical trials such as the treatment with kevetrin in a variety of tumors.
But this is critical: the doses were given far apart. As Cellceutix began to talk seriously about an ovarian CA trial they announced that dosing would be 2-3X Q week, final dosing and intervals to be determined. Not known , not determined, still to be worked out.
And that was where it ended.
Then began talk of an oral dose and you can imagine how well understood the precise dosing is with oral vs IV- a total unknown.
The future of K has yet to be written and has no role in this person's care. These are weighty matters, and I wish them and you well. I wrote this in order better respond to the gravity of the situation. Any of the other MDs on the board- there are not many- would tell you the same.
This is a matter for neuro oncologists and not for emergency medicine docs, my line of work. They will do everything in their power to help.
K is not in their power. Not close. Look: I have written about this a lot. There is not even a dose or dosing schedule that is known to be effective for K and any cancer. There is zero chance that K will help this person. Maybe in 5 years more will be known. But not now.
The oncologist would be happy to consider any therapy. But one of their first questions would be about about established dosing and dosing intervals and this is not known.
Just unB-lievable! The only news is fictional for this company. More chapters will be needed since the company will not tell shareholders what is going on. September - touted by many as the big month for IP-is long gone. Improbably October also on its way out.
Just absolutely pathetic.
(But for those who believe no news is good news, this is ideal)
October 25(cont) RBL at GMU with the shareholders turning to the IP man for answers after the RBL director said maybe they had not been given all the data.
Well of course we have never seen real data, just a few puny conclusions and that's it, said the crowd.
Nothing more than that? said the director. How awkward. That's awkward, right, IP man?
The IP man seemed to be working to speak, willing his mouth to say the words, but nothing- only silence.
The shareholders waited, with a few grumbles, but for the most part in silence too.
Sept 14 2020. The Launch Pad, Monday day 14. Scene: A grassy knoll. Edgewater Place Wakefield MA. Where else ? Where else indeed! The place to be for B-LIEVERS! The assembly begins again...
In unison, they chanted, seated in a circle: I'm a B-liever! We are B-lievers! I'm a B-liever. We are B-lievers. Today is the day. The dots are connected and we know what we own.
A small girl, walking nearby, asked them: What are you guys doing there on the ground in a circle?
The faithful: Waiting on the world to change. Waiting. Waiting on the world to change.
The child: When will it change?
The flock: Today. It will change today.
Girl: But you have been here for two weeks already. Saying the same thing every day.
The faithful: Faith is always tested. Today is the day.
And so it began, the 14th day of the vigil. The exigencies of the pandemic. Coupled with the multiple therapeutic properties of their synthetic molecule. The 3 in 1 . The coming trial q4- make it so.
They were still chanting at the market open, and - as it turned out-also at the close: 3 in 1. Now is the moment of revelation The time is at hand. So say we all.
There was no trace of irony in their earnest pleas to the heavens for the deliverance , as they turned again, each to a favorite verse: 6/11, 6/17, 7/13, 7/20, 8/26....
Waiting on the world to change. Waiting. Waiting on the world to change.
There would be much less speculation if the CEO bothered to inform his shareholders of key developments. For example, what ever happened to that big grant? For MERS and SARS and alpha viruses not to mention COVID?
Submitted more than 4 months ago. Receiving such a grant with the RBL would change the company's fortunes overnight.
And yet who knows? Not w word, other than DeG saying in August he was hopeful.But an update?? Sorry, folks, don't ask, don't tell.
Unforgivable
So much fun to generate excitement, such a bother to tell the truth.
any day now for preprint? This was true almost 2 months ago, so, Why now?
which is true? Govt researchers with key data in hand for revolutionary drug keep delaying submission of data for many months? Even though 1000 die a day in the USA?
Or we have not been told the whole truth and nothing but the truth?
Or something else?
Fictional news only again today? Pathetic. Shareholders deserve information. Write CEO now.
Group A- Please let him know that you believe news is unnecessary and it can only mean that things are even better for brilacidin than hoped. Please let him know that news is for losers!
Group B-Or, alternately, wake up, and say that this lack of info is totally bogus and insulting.
Day 11 came and went at The Launch Pad on September 11 much to the amazement of the faithful. They thought that day was the most likely day to be the day of any so far. But no. At market close they came together to make a plan. But it was quick and simple- See you Monday before the open, said one, and then another, and another, committing to another block of days to witness the miracle of brilacidin.
By then on Monday it would be two months already since the great verses of 7/13 had been revealed and so they they chanted in unison, with not one needing a text. The exigencies of the pandemic coupled with the multiple therapeutic actions of brilacidin- the 3 in 1- have the company working diligently toward a fourth quarter trial. The strength and clarity and meaning of those words. Could it be more obvious? How could others fail to see it? The words were clear.
What more was there to say? They circled in for a quick shout out "3 in 1, keep the faith" farewell, tattoos tingling, and vowed to return the following Monday day 14 of their vigil.
Manassas VA GMU RBL lawn, October 25: the shareholders were dumbfounded. The prepub was not out yet because of ordinary delays, like traffic lights and shopping store lines? Or cell lines were contaminated, that sort of delay? A refrigeration mix up?
Mr RBL director, said a shareholder rep, the human lung cell data was known on June 17. Over 4 months ago. The fact that brilacidin could work in concentrations already proved safe was known in July. You may have heard that almost 1000 Americans are dying every day of corona virus? Why wouldn't you make a big push to publish to the paper so we can get our drug to trial?
The director stared at the ground. Do you think you were informed of all the results? All of the Brilacidin tests? Your question is a good one. I would think maybe that some of the testing turned out not to be so good for B for C. So some of that initial enthusiasm got dampened. And the paper and the results were not seen as so crucial. Could that explain things better?
The director continued- Think back to that grant submission. Why have you and we heard nothing now for over 4 months? If just a resubmission, wouldn't someone tell you that? There must be more to the story that you have not been told.
Yes sir, that could be it, said the rep. And so all eyes turned toward the company man, who was backing away from the crowd and the Lab.
still hoping it is delays of whatever kind- if so, then why not explain more to shareholders? I realize that is what the last PR was about- paper delayed because they wanted additional data. But the lung cell data was June 17! More than 4 months ago.
What would be a more likely explanation- how about other data - that I did not bother to inform you about- was not so good?
Thanks, Leo, for the careful and timely update. LOL.
"it's just a matter of days"...starting about 50 days ago
Umm, I had heard about the tests which I have written about exhaustively recently. I am talking about news over the last 3 weeks plus which is ZERO.
Funny, the great thing about med school is that it was mostly multiple choice, and pretty easy.
The "exigencies of the pandemic" Can anybody recite/recall this? How important it was to our company? That was PRed as critical to our nation and to our company? And to us shareholders?
What a complete joke the line of communication is. I am starting to feel angry, even, instead of sad.
yawn..once the news starts Better question: is this a scam?
Where is even a scrap of news!!???
What is really happening here?
Of course no news=ongoing pathetic disaster BUT most interesting is prior suggestion that news not coming till November - how was this known? Will it come to pass? How sad for IP to never inform shareholders-
coming up soon = NO info re GRANT for 5 months- five lousy months!
Day 11 at the Launch Pad Friday Sept 11. The vanity plates could be seen near 301 Edgewater Place where they gathered at a green spot near the IP HQ, an office building in suburban Boston, nondescript , and yet current home a to a revolutionary synthetic molecule, one that was about to change the COVID landscape and about to change the world. Most popular plate was PMX30063 from several states, but also a couple of B R US, again from several states. They figured this should be their last day of gathering here in obscurity since the paper was to be published any minute now detailing the massive RBL effort on behalf of brilacidin and COVID lab data. Hints at the data had been given by the CEO but nothing like what the faithful and the world would see with the revelation.
They had given 10 days now of September at the launch pad, waiting for the rest of the world to be let in on secrets they already divined. Now had to be the day. It was 3 months after all that the famous 6/11 verse had been set in stone and so they read together again about the RBL/IP grant for COVID and other corona viruses and the other viruses, alpha(like VEEV, they knew, one of Narayanan's projects) and filo.
It was auspicious. The 11th day of the wait 3 months after the verse of 6/11 was revealed and they felt that surely the time was at hand.
They hoped it would be today, in part so the world could take a giant step forward, but also because they had heard about another group planning on coming to Wakefield, in a month, on October 11, 2020. This was a group of unbelievers who doubted that the day was imminent. The skeptics had chosen the 4 month anniversary of 6/11 as their date of assembly, also here at Edgewater Place.
The faithful flock scoffed at such a silly notion and knew that the day of revelation would be long past by October 11, but still it rankled a bit. There would always be doubters in the world, who could not connect the very simple dots. There would always be those who did not know what they owned. That was just life.
But they knew how the dots connected and knew what they owned and could see the bigger picture that was about to be revealed to the world at large. Today would be the day. They could almost touch it.
Day 9 The Launch Pad Sept 9. The faithful were undeterred . They thought that 9 days of September were too many to go without the expected launch of their revered brilacidin.
But still: it was a synthetic molecule invented by biochemists interested in defensins and it was one of many defensin mimetic designed by Dr William DeGrado while at UPenn. It was PMX30063, part of the stable of synthetic molecules that made up the company Polymedix, which flamed out spectacularly. Assets including PMX 30063 were scooped up by Cellceutix, a small pharmaceutical company in Beverly MA which was developing an anti cancer drug, Kevetrin, and Prurisol. Though K got most of the attention,initially, Brilacidin and many other defensins were also evaluated. The other defensins were cast aside by IPharmInc but Brilacidin was tested for both antimicrobial and anti-inflammatory indications, with some promise. It was not all rosy- after B for cellulitis was a winner the mucositis trial was less encouraging, and 2018 ended on a sour note as P died an ugly death and B-OM did not merit a deal.
This lore was like scripture for the faithful. It was known to the letter and often recited. It mattered not as all was prelude to the astonishing set of circumstances that were the spring and summer of 2020 and now brilacidin was about to step onto the big stage in the spotlight. The corona virus had killed many thousands around the globe and was filling hospitals and ICUs in America and then early tests from at least one US Biocontainment Lab showed antiviral activity for B.
In fairly quick succession chapter and verse had followed: 6/11(antiviral grant) then6/17(human lung cell data) and then 7/20(low B concentrations effective for lung cell C) and 8/26(DeGrado joins the cause).
They reflected on all this on the morning of September 9, as they had for the previous 8 days, and they kept the faith. Many had license plates from their respective states with PMX30063 and they all had tattoos with the Brilacidin structure somewhere - an arm, a leg, or torso. Many other shareholders were concerned that September had nothing offer at this date, as fall was coming, and summer was fading. And early promises were no longer mentioned- had there really been a grant submission?
But the hopes of the faithful did not fade, despite the failure to launch on any of the first 8 days of September. They rallied their spirits.
They chanted again their favorite verses of the brilacidin chronicles and focused on the impending blastoff. That would garner the attention their corona weapon deserved, and they held out hope for influenza and the common cold for the mighty 3 in 1 B.
For they were B-lievers.
Tuesday Sept 8 at the Launch Pad. It was day 8 and now that summer was over the markets were again open the faithful believed the today would surely be the day for the launch. They could feel it. They were excited. They decided to read verses 7/20 and 8/4 aloud together to start the countdown. 7/20 told of low concentrations of brilacidin need to the the dreaded virus, concentrations already achieved in testing with B IV before without serious adverse effects. It told of how B was a big winner in a screen of 11,552 other drugs for a certain MOA- who knows if that had any clinical meaning, but it was computers after all, and they were very smart and fast. Verse 7/20 concluded with a reference- the traditional close, to the 3 in 1 brilacidin action. That always made everyone feel good. They could almost feel their Brilacidin structure tattoos respond with a slight thrill to the 3 in 1 close. Each member had gotten such a tattoo as a sign of faith.
Next verse was 8/4 which told of imminent prepublication of the planned peer reviewed paper.
They read again aloud verse 8/26 about Dr DeGrado serving as an adviser fro IP and his synthetic molecule as it marched forward to the front of corona virus therapy and caputured the public consciousness as a life saving revolutionary therapy.
They would be there to witness the ascension of brilacidin, even if the first week had not borne fruit. They knew the day was at hand and today was a good day to make history. They joined hands and waited for ignition.
How important is the paper? announced aug 4 ready in Sept. Would be a career making paper if as big as promised. I wonder what has really happened and when some one will bother to tell the little people, the company owners the shareholders what happened.
Oh yeah- now I remember- the sept paper did not come out because of RBL"delays". Someone got stuck at a light, and suddenly it is Late Oct and not early Sept.
Amusing, no?
When will the RBL or Leo tell the real truth?
The grant submission touted more than 4 months ago...
The prepublication set for September...
What's the next flop?
Q4 trial start = obvious candidate
So little follow through for so much big talk...ah, the exigencies of the pandemic, so hard to locate now in the rear view mirror...
Friday Sept 4 The launch Pad Day 4. This ought to wrap it up, they thought. Almost an entire week now ready for their synthetic molecule to gain the attention of the world as IP sough to tame the corona virus with brilacidin. They went straight into the texts that gave them hope, that sustained them. 6/17 was an obvious choice: the human lung cell data was announced, the grant submission- with potential extension to other viruses-was affirmed, and the manufacture of IV B had begun in earnest for a trial. Almost 3 months now had passed since that PR had come down and just to read it again was reassuring. It had to be any day now.
They turned to 7/13 which had words that were particular favorites: the exigencies of the pandemic combined with the multiple therapeutic properties of brilacidin had the company working diligently to move toward a q 4 trial. The language was not the language of a PR - it read like the text they took it for. And it closed with a shout to the heavens, invoking the unique 3 in 1 activity of brilacidin- antiviral, antiinflammatory and antibacterial. 3 in 1- had they heard a similar spiritual reference ever before? Maybe. Maybe they had. It was powerful.
That was 7 weeks ago already and how much longer could it take? Not long, they said. Not long. It could be any day now. It will be any day.
The Launch Pad Day 3 Sept 3 Thursday. They thought maybe this would be the day. They did not expect to have to wait much more than a week. Not after all the big news. Especially with DeGrado coming aboard on August 26. That was big and confirmed their expectations from June and July. They had not minded waiting the first 2 days given the magnitude of upcoming events and they were tense with excitement.
They read through the PRs together that told them that IP was on the verge of something big. They read them aloud, starting with June 11, since that was so hopeful. They knew the B background backward and forward and had read the company statements on justifying B as a molecule to watch for in corona tests. Then out of the blue: B maybe to be tested against corona viruses like MERS and SARS not just COVID 19. And the grant that the RBL and IP would submit would possibly study alpha and filo viruses too.
The enormity of the promise of B as it trounced all those viruses! What about the common cold? What about influenza? It was starting but where might it end?
So that text that was enough for the day, just reading aloud the June 11 PR, a chant really, of the faithful, as they waited. June 17 and July 13 could wait for another day, if such sustenance were even required. Today could be it.
It's Monday right? The big news? The launch? We hear about the paper and the FDA and the grant? This is so exciting. I mean the company has to say something sometime.
Right?
Back to Manassas: It was Friday now, and the shareholders and the IP man had bee trying to get answers from the RBL for a week now. It was not so easy , but the director had been looking into things and now they back together on the Biocontainment Lab lawn, ready for discussion. A sampling:
"Well folks, and you too Mr Ehrlich, I have been on the phone trying to figure out what happened to the Brilacidin testing and that report you were promised." said the director.
"Report? You mean the article? The prepublication we have waited for since September 1? Since it was promised last month, weeks ago now?" said the shareholder rep.
The very same, said the director. It has been a bit hard to track down since a PHRI was supposed to be publishing something and somebody sent a few dollars to a lab here(Dr Narayanan) and maybe there is another RBL involved too? Hard to know, but anyway-
You got that right, said the rep. The company never bothered to clarify anything. You almost begin to wonder if they were confusing us on purpose.
Well, said the director, it has been hard to figure, I agree. At any rate, I found somebody who said it was their job to get the article ready for print and it turns out they wanted to do another test or two, and then there were delays. The tests were with those pesky fibroblasts- they are trouble with a capital T, you know.
But a lot of it just turns out to be delays, everyday sorts of stuff. They had to look after kids doing school from home, and then there were long lines at the grocery store, on multiple days ,and they tried switching lines, you know like anyone would, and that just made it worse, as it always does. And just the other day when somebody was going to put the data in the mail, the line at the Post Office was a mile long. Said the director.
Seriously? said the rep.
Are you kidding me? said the IP man.
We have a month long delay of potentially life saving data due to nonsense like that? they said in unison. One thousand people are dying every day. Our competitors are gaining every day. And we have been going nowhere and therefore backward and it is on account of lines at the grocery store and the post office?
C'mon now folks- you know how these things happen. This is the government after all too, you know, said the director.
But the crowd was restless, and angry.
as another day and another week was lost- at a time when there was not a day or week to be lost, at a time when every minute counted-our company has failed again to deliver.
Blame it on the RBL, blame it on whatever- it is an ongoing disaster. Other companies are moving forward and IP is saying nothing.
What are you doing Mr CEO?
This is pathetic, and a shocking failure
keep the faith! no news is good news!
The grocery store line problem! You got it! That has to be it: instead of getting the article out, and introducing the world to a potential cure, and trying to prevent 1000 deaths a day, the researcher just wanted to do a few more tests. Even though the dose for the trial was already set. Plenty of people had already died and so what was the big hurry? The researcher probably was delayed too. They kept getting in the wrong line at the grocery store. They had no luck with stoplights. They forgot their phone and had to run home to pick it up. Soon, before you know it, those delays can add up to what- a month lost! They were going to prepublication with the paper of a lifetime but there were so many delays. After all- it was just 1000 deaths per day, and so much can happen to keep that final draft from getting done. Ha- that line of thinking might be helpful in a work of fiction.....