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No interim data will mean no blockbuster success of B v C and less hope for shareholders of IP. Time passes for a trial that a) may be the wrong trial to run, and b)is late to the game.
Plus Putin is a corrupt evil character and we shoulda avoided his country- just one opinion.
April 6 2020 Anniv approaches first B v C trial mention by IP. Leo just neglected to mention that he hoped to run the trial mostly in Moscow and St Petersburg. With a couple of token US sites, Toledo and Metairie.
You wanna talk failure?
Umm, yes, I do. Plenty of discussion about success and that is such an easy rosy picture.
failure is more tricky and complicated and ugly
Boris- look, just give the trial a chance already-
Natasha- yeah, all we are saying, is give trial a chance.
Boris- love the Beatles reference
Natasha- Me too. love it
as an investor I would be suspicious if plenty of respected sources kept repeating total obvious nonsense- such as right here as people repeatedly pretended there was a high likelihood of success B v C.
I have plenty of money on the line here and I would rather have a clear eyed assessment
RIGHT NOW- if it works, you mean. Right?
Such an annoying need, that proof of efficacy.
Sigh
pot calls the kettle black
sorry- right on many occasions too
NB- not saying trial WILL fail.
Saying instead the obvious: that saying "very likely success" is foolish.
And was foolish, despite how often it was said
"very likely" to succeed B v C in this trial: I know what you mean. People have finally figured out that such an assessment is irrationally exuberant
It took awhile
When the trial fails what gives? Share price to a nickel and the company hangs on waiting for Alfa Sigma slow cash infusion? Will they even have enough cash for B UC oral trial here in US? How can IP hang on if this happens?
Gird your loins for trial failure and IP fade.
Trial success? The sky is the limit.
Interesting: all those predictions of B v C very likely to succeed seem to have vanished. I wonder why?
Umm, the answer might be: we will see what the results are in the ongoing trial and go from there.
Could that be the answer?
Yes. Since no one knows.
Wait and see.
Another question: if the trial fails, can we conclude that B does not beat C?
Might a differently designed trial show different results? Is there any chance at all at a different sort of B v C trial getting done?
up up and away! No? Shouldn't the share price just take off since we are in a trial where B is very likely to succeed v COVID 19?
Hmm.
Maybe it is not a lock.
High risk high reward for those few willing to buy.
How likely trial success? company worth pennies as trial proceeds. So much for all the predicted rocket launch stuff. It just never happened. Welcome to IP land .
Natasha: How could that be?
****OFFICIAL TRIAL SITE USE ONLY****
Unauthorized users and communication punishable by forced labor
Boris: say what?
Natasha: I am - ha ha ha- just pointing out that the computer generated published list of wonderful COVID therapeutics may be fallible.
Boris: How is that possible? It should be a lock. I mean, generated by computers using AI. Imperfect predictive ratings!!!
What a surprise. What a shame. I suppose that means-
Natasha- The trial continues. LOL.
Hey Doc- could you explain how the *426* will help in the current trial? You know, when the virus is so widespread already?
Jethro: hey Pa? That PR about our drug, pretty good news, right?
Jed: Son, the news is only good cause the company has nothin' better to say.
Jethro: Huh, Pa?
Jed: Don't pretend the model means the trial will succeed. It don't tell you that at all. Not even close.
Jethro- OK Pa. It sounds so good. all important like.
Jed- Sure son. But the trial is real and the trial is what counts.
Jethro: The news don't amount to much, then?
Jed: That's about the size of it son.
Can we stop the trial? Hey Boris, It is me, Natasha. Did you see the big article about predicting Brilicidin should work?
***OFFICIAL TRIAL USE ONLY*** Misuse punishable by poison.
Boris: Yeah I saw it. Sure stop the trial- Ha! LOL.
Natasha- The trial, Who needs it anyway?
Boris: What a joke.
Natasha- Da. We got the prediction....why bother
Boris: LOL
Today's PR reaction proves how bad things are right now-Embarrassing to pretend this is big news. Worth a quarter in the midst of a trial. Instead of actual news IP points to a silly ranking.
Diversion- hey folks look over here. Maybe you won't notice there is no real news to report
Bogus excitement over silliness- the trial is in progress, AI prediction means...next to nothing
Hey I know, let's pretend it is really meaningful and that it means the trial will succeed.
It does not say that at all and of course it could not.
But let's jump up and down as if it really meant something.
LOL
how about a PR where DeGrado discusses immunomodulation with COVID by Brilacidin? Oh that's right- because he has not done any such testing. Nor has anybody.
Just run the trial please. pathetic loser PR for losers. There may still be a market for our drug, whines Leo. We missed the boat, but guess what the variants could still mean B is worthwhile
As if the AI predictions are written in stone- just a chance.
Just do the trial already....
I have done the same search and find nothing about B v COVID immunomod by DeGrado(or anybody)- thrilled to look at the data. what have you found?
please share with the world the DeGrado research on the antiinflammatory and immune modulation impact of B on C. I cannot find any.
Bring it on-of course I would love to hear info to the contrary. You are suggesting that Leo and IP and DeGrado and GMU are hiding the antiinflammatory data? Why would they do that? When they want to see their drug approved? When they want to advance the science?
When I make such statements, in my mind it goes without saying that is only my opinion, or that I know of. I think this goes for almost every single opinion expressed here. I do not believe every single statement requires such a qualification.
Since it is already obvious.
IMHO.
There- is that better?
Hey folks do you all grasp this? The lab studies which were the foundation for FDA approval for the trial were about antiviral impact, esp viral spread, as we have been repeatedly told. Bakovic et al in the Viruses paper describes antiviral data
Biodoc describes the following problem- as the disease progresses the virus has already spread and done its direct damage. Can you make a difference if you start treatment on Day 3? or 5? Or 7? Or 10?
Next to no one would be hospitalized on Day 3 of symptoms and some would be on Day 5. As the disease progresses the CT scans and CXRs will tell you- the virus is very widespread.
Again, The data put forth by IP so far talks about mechanisms of action whose relevance is not clearly beneficial by the time the drug will be given to actual patients. That is why I have advocate from the very start a trial done on people whose symptoms were at the earliest identifiable point. Lots of those patients come to emergency depts- they want to know if they have COVID and how sick they are. Great time for a study of B for C- if you want to impact the virus very early.
The antiinflammatory and immunomodulating impact of B may play a role in COVID patients but THERE IS NO DATA TO SUPPORT IT. The GMU lab and the paper that came out have nothing to do with antiinflammatory or antibacterial(3in 1) role in B v C treatment. It is known that B has some antiinflamm impact but those are not COVID studies. B may have had some antiinflamm benefit in the distal colons of some patients with ulcerative colitis, based on the preliminary study done a few years back now. Recall that there were no controls and obv mechanism not comparable. Also B OM data does not apply
So: antiinflammatory mechanism in B v C? Nothing at all known. All guesswork. No direct studies to point to. Nothing done at GMU to support use in the current trial with respect to immunomodulation.The high SI that everyone is excited about? The 426 reference? It tells you NOTHNG about antiinflammatory benefit. Nothing at all. Because no one has a clue about what level of B is needed to mitigate COVID inflammation.
So the trial is proceeding and there may be benefit from an antiviral mechanism. And there may not be.
B is not in the lab with preincubation. B is in hospitals with patients with many days of illness with COVID already. How relevant will the SI 426 be? We can hope for some antiviral benefit .
But the antiinflammatory impact has no relevant COVID lab data no SI # and NO DOSING INFO AT ALL to support it
Cross your fingers and pray for a miracle- that is where things stand in this pivotal trial. Recall the reassurance of those who said there was a "very good" chance of success? That was just blather.
What can you or anyone say about the inflammatory and immune effects of B in COVID?
Nothing. Because nothing is known.
What can you or anyone say about ideal dosing for such effects in hospitalized patients with COVID?
Nothing. Because nothing is known.
For example(as you know well):The reports of SI were based on antiviral data, of course, as were the other GMU data.
B has a shot in this trial, but we are flying blind.
The lab data would inform an early intervention ED study, as prev discussed, when so many people show up not knowing how sick they really are, when they first get symptoms, and then are sent home to see what the disease course will be.
As you wrote, the antiviral impact may well be small in already hospitalized inpatients.
I am interested in your point of view, but I am aware of no evidence to support it.
Trial=flying blind. what I just wrote is obvious and easy and what you wrote earlier today is thoughtful.
It has bothered me from the very beginning that the trial will be in hospitalized patients who are already quite sick, and in whom the virus is already very widespread. The lab data inform possible antiviral effect and say nothing about anti inflamm.
So we are flying blind into a key therapeutic trial B v C with so much effort expended when it is not at all clear if there is any basis to expect a positive outcome
the trial is a shot in the dark, really
IF any benefit with this trial then other corona focus-
1-kids with inflamm picture
2-cardiomyopathy/myocarditis
3-Thromboembolic disease
4-Neuro incl stroke and Guillain Barre
etc
also a very early trial too (if IP gets such a chance). Maybe we can do such a trial before the ferret drug becomes(maybe) standard care
Sure- nice to know about the markers and disease progression with and without B treatment for C patients but clinical benefit (duh)is what will count
The problem with all of this is that the current trial will have to succeed, or B v C is history. As are the MERS and SARS grants
Trial then based on completely untested mechanism - the anti inflamm properties of B. lab data all about antiviral and that led to approval.
Cross your fingers- it is all we can do.
Anti inflamm benefits B for C- not known at all, NOT tested even until now
Anti inflamm ideal dosing? B for C? Not known even at all, not a clue.
I think it is mostly the opposite of what you describe. the exuberant talk nonsense for the most part and pretend it makes sense.
your timeline is helpful. have said over and over that the trial we need for B is prophylaxis or very early in its course- an ED study with IV would have been good, when people are not very ill and not sick long at all- earlier in the course of illness. Or prophylaxis with a spray or inhaler - but these may never get developed.
The problem of course is that there is no data about the antiinflammatory impact of B v C- NONE. It is being discovered right now as we speak, mostly in Russia.
We can only hope there will be some benefit in patients who are hospitalized and quite ill. It is totally undiscovered country.
It will just get higher and higher as we have previously noted- statins also decrease mortality-
so late to the game, is IP. Not too late, but sadly very late
explain why unbelievable. the whole point is to help people with COVID with B. And to prove it convincingly. Some of the patients will do badly, in both groups. But you must prove the placebo COVID patients do worse even if it sounds bad.
If there are deaths and intubations and lengthy hospital stays then those patients must be the placebo group or the trial will fail.
Why is this unbelievable? It is simple and obvious.
exclusions for the trial-DNR/DNI. Interesting. Maybe standard for all COVID trials I do not know. Will exclude those who state DNR DNI. That means that I would be excluded if I ended up ill with COVID, since I would say that I would NOT want to be intubated if I deteriorated that badly. All the rest - fine by me. Proning and high flow 02. But I would state up front that I would be DNR/DNI - and many other patients would feel the same I am sure. Do people change their minds, as they get sicker? Sure, all the time.
As you know most COVID patients on vents die. Of course not all, but most.
Up front=interesting exclusion.
I get it- they do not want any patient who becomes that ill to be lost to the trial. Hopefully, they would be in the placebo group
Yes, multiplying by 10 is not so tough, as you note. I try to keep my audience in mind.
The ferret drug! very early treatment or prophylaxis - shoulda been our trial
timeline trouble: 15 dosed in 12 days so for the remaining 145 need about 120 days unless they speed way up. That would be dosing finished as of July and then another month to wait for results. Clearly they anticipate moving faster if trial completion is June .
But IP must move faster to aid dragging this out too long.
Even though the whole enterprise is already an exercise in
non warp speed.
such pretense. The reality is that very sick patients will need to be helped-very clearly- in the B v C trial. And we have months to wait for an answer in all likelihood
IP going nowhere fast
April May June July this will get even uglier
Already VERY ugly
Data after everybody vaccinated? yeesh-
We just had a front row seat to watch IP miss the boat.
IP: the company that keeps giving MORE BUYING OPPORTUNITIES
How sad for all of us. So many years of the same.
Nothing to see here until summer.
Although I am enjoying following the weather in Barnaul- hey it's trial site #1 in Russia!
I suppose at this point the "longs" would have to admit...that this horrendous flop of a big launch is the work of wreckers(Soviet term) and shorts and other miscreants who ought to be poisoned.
So much for launch and take off
IP CEO announces Share price stability for months now.
"Sure there is a very small chance that things could take off here if we get wonderful interim data. But do any of you remember the B OM interim? Well I do. It looked very good until the final data came in to spoil the party.
"So I think it is fair to say that we will trade at a quarter for a quarter or even 2 quarters. And then we will see when and if I ever release any data in the COVID trial.
"We are going nowhere for a very long time so you can save up to buy shares in case we have a winner.
And by the way folks: if B stomps C then dinner is on me in Barnaul Russia. Hint: look for Kazakhstan and Mongolia on the map.
Maybe see you this summer, unless I have to bury or hide the data for months until I finally let you on on the failure..."
Trial road trip!!! Grab a bag! Let's go. We will start in New Orleans for the Louisiana site and then head north. How easy will it be to get a Russian visa? Do not know yet.
Will figure out a way to get to St Petersburg and then it is only 2607 miles out to Barnaul..
Road trip it's on!!!
we have until late June to make the trip. Plenty of time.