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If USA start why not listed in clinical trials site? Still suspect trial start Q4 was for the 12/17 date which was delayed. Will he bother to explain? Probably not.
Why no details out if started?
Bogus, and shady, folks.
NO PR to announce trial start? Totally bogus. Where and how many in USA????
where was the official US trial announced. Lots of talk so much talk and yet, the only word came from excellent DD uncovering a trial that was supposed to start in Russia, that in all likelihood has been delayed for a third time already.
I am sure IP will explain it all(LOL). But when?
Prurisol Leo unfortunately that logic Prurisol of delaying bad news Prurisol makes sense Prurisol.
Let's hope there is another explanation.
But if bad news, er, well, more buying opportunities
sadly worst case = plausible. New date of Sept 1 completion reflects new projection based on failed start 12/17. And then failed start in Jan. And then failed start 1st week Feb. They have moved back completion now to reflect those failed starts. Leo has announced them and they never got started. Not yet.
Let's hope that is not what Leo has been hiding. If so, this will be...yet another buying opportunity for all the believers as the share price tanks.
"Come Monday", or "Tomorrow"- both potential IP theme songs, appear to be playing around the clock.
today's vaccine news- 1 million vaccinated in Mass. Much decreased need for hospitalization in this population
Too bad the company could not move any faster. Window closing for # doses needed. If it even works-
Sure maybe a new variant will change things- in the future. In the now- the B potential treatment pool is getting smaller
And smaller
interesting choice:no reply to anything of substance- how to justify irrational exuberance
Instead- reply to cartoon silliness. Also- it makes me question why I bother. I suppose I think what I write is more entertaining. But that could be delusional.
interesting that there is just IP irrational exuberance and no bother to justify it.
all the Russian site chatter is just to pass the time for all those poor researchers waiting for the trial to start- after the false starts
You can see Kazakhstan and Mongolia from the hospital window!
7 Nobel Street IP LLC HQ
Internal communication only. Not for sharing with the 20 sites.
Comrade Ehrlich: That's why we have 20 sites right? Always a couple of crazies That Martynenko. Mongolia Ha!
Is he just joking or is that the vodka talking? Anybody else in Barnaul we can line up to replace him?
2 months behind already...so much for 12/17...
You can see Kazakhstan and Mongolia from the hospital window!
7 Nobel Street IP LLC HQ
Internal communication only. Not for sharing with the 20 sites.
Comrade Ehrlich: That's why we have 20 sites right? Always a couple of crazies That Martynenko. Mongolia Ha!
Is he just joking or is that the vodka talking? Anybody else in Barnaul we can line up to replace him?
2 months behind already...
Hey look whose #1! Brilacidin trial network communication
Official use only.
Martynenko T.I. here. I bet you never even heard of Altai Region and my hospital KGBUZ City Hospital #5 g Barnaul and look who is Site 1 for the big trial. We're site 1!
Did you know: I can see Kazakhstan and Mongolia from my window, that's how far out we are. Way to go big Barnaul. Way to go #5, g!
7 Nobel Street Moscow, IP LLC HQ: Please calm down out there Timofei. Maybe if you enroll the first patients you can brag. Not yet. Just wait for the trial to begin already. We will let you know
Martynenko: You have already announced the trial start 3 times. So next time I should believe it?
7 Nobel Street Moscow: Look- we know it's a long winter for you out there. Just be ready OK?
Moscow State Medical Univ(Sechenov Univ) Brilacidin trial. Official use only.
Site 9 internal communication.
Moiseev SV and Smolyarchuk EA
Elena: Hey Sergei. What do you think about this company that makes Brilacidin? Their shares are going for is 46 cents each right now. Could those shares be worth more?
Sergei: Well, if the trial succeeds in a big way then those shares are a bargain. And if the trial fails then the shares are overpriced. Could anything be more obvious?
Elena: You mean, company shareholders cannot know what they own now until the trial is done and data is back?
Sergei: Precisely.
Natasha? Boris here. We are already 2 months behind schedule. Any word on that Brilacidin trial?
Natasha Lomakin: Oh...that trial. Oh sure, any day now. Maybe tomorrow.
Boris: Are you kidding me? The trial start has been announced three times already!
Natahsa: It has to start sometime.
Boris: Umm. Er. Got it.
How about just reposting the last 3 x Leo said the trial would start? Will he ever tell us why he could not get it right? The obvious answer would be that Russia and/orIP had unforeseen delays. Will he ever say one word to clarify? Where will the trial be? Just Russia? Just 106? Not 120? USA trial only if goes well in Russia?
Time passes. The time for the trial was 3-4 months ago. Yes a B v C win will change all of our fortunes and the company's fortunes in a drastic way.
But IP has lost so much valuable time already
what will happen to justify irrational IP exuberance ? Or is this all hype for selling on some OK but not great news? Really, what gives.
Leo announces the trial ran in Russia and the results were great- how to rate this? So unlikely.
Leo announces the company found a partner and the trial has been running in Russia and will start in the USA. Possible, very unlikely
Leo announces that the trial in Russia will start in one week. He says nothing about a trial anywhere else and he does not clarify the 106 vs 120 issue. He will not say a word about getting the trial start wrong 3 x already. Will not explain why the 12/17 start failed to materialize.
Now you're talking- that sounds about right to me. Or, best case he says it began already, officially enrolling patients as of Monday Feb 22
Monday next, then. Got it.
Come Monday- er, uh, no.
Come next Monday, it'll be alright-that's the song for IP
I am interested in your opinion. It is not clear to me that the 10Q will contain a clear sign that things are picking up. For example, starting the trial is good but counts for nothing without a real win ,B v C. The chances of Leo announcing interim data from Russia on Monday would be small. Like nearly zero. So I cannot imagine anything of real importance coming out.
Please spell out exactly what you think Leo might announce in the 10Q that will surprise and delight shareholders. (just starting the trial does not do it for me anyway)I welcome anyone's opinion here.
My interest does occasionally lie in typing up posts that would bring a smile to a reader, every now and then, or, perhaps warming a heart in deep midwinter. Personally I rank Boris and Natasha among my favorite cartoon characters of all time. It does not mean that everyone else finds them amusing. Or finds their musing amusing.
The IP national anthem! Come Monday, it'll be alright.
How long have we been hearing this?
For a very long time-
Boris? It's Natasha.
Site 5 communication with 15. official use only.
Look Sasha is not the problem He and I went to med school together in Minsk and he just pretends the big lifestyle. He skies cross country more than he slugs down vodka at his dacha.
Cannot understand all the delays. Political perhaps? Moscow related? I miss Trump already- what a friend of Russia.
Maybe give it another week and then we check in with Comrade Ehrlich.
Lomanik N to Goloschenkin B
You need someone beaten to a pulp? Oleg here, site 16. Oleg Khelmnitsky, researcher, City Pokrovskaya Hospital.
I know some guys, if you need it. Is it part of the trial?
Oleg out-
Hey nobody needs beating. I am just trying to understand where the trial is and how many people are in it? 106 Russia and 14 here? 106 in Russia and 120 here?
Not that Leo has bothered to clarify any of this-
It's Sasha's dacha, Natasha.(Sasha=familiar form Alexander, in case that is news to any readers)
Official communication, Brilacin trial, Russia.
Site 15 (Goloschekin BM) to Site 5(Lomakin NV)
Boris here. Andrei is not the problem I can assure you. He is a hard worker who will fulfill his quota of 5.3 patients despite your misgivings?
Mu guess is the problem is Site 2. Do you know Alexander Klinov? At the Kirovskaya MB? Sasha is much more the dacha bad boy than Andrei and I don't know how he was selected for the trial. Connections certainly. As always. When I scan the list of 20 his name jumps out. There is always some crazy party at Sasha's dacha this time of year. He has got to be behind trial problems but I don't know how.
I'll get back to you
Boris Goloschekin, site 15
St Petersburg
Boris? This is Natasha. Official communication Brilacidin trial. Site 5 FSBI "Central Clinical Hospital with a polyclinic. Moscow. Lomakin, NA Message to : Site 15 CBUZ City Hospital # 15 Goloschekin BM. St Petersburg.
Is Andrei the problem? Over at City Mariinsky? They said the trial would start 3 times already and then they call it off. What is going on? Any idea? I suspect Andrei is at his dacha and not at his desk. Could he gum up the works this bad? Just by himself? Or is the problem with The Americans? You know that they have never given this drug to anyone with coronavirus, right? Only with cellulitis. But now they choose to come here, the Motherland.
Have you heard anything?
Cordially,
Natasha Lomakin
site 5 researcher
certainly plausible and that obv is the problem. There are any number of plausible scenarios. It remains to be seen why we are informed of none of them.
Leo said the trial would start
Then he said the trial would start
And then he said - again- that it would start
Thus It is logical to expect him to tell us then when it actually does start and logical to conclude that the trial has faced delays in Russia and has yet to start
Comrade Leo: this is NA Popov, researcher at City hospital #38 named after N A Semashko. I can assure you that we here in St Petersburg remain ready to begin enrollment in the Brilacidin trial just as soon as final preparations are complete. We were also ready to start on December 17, and then on January 20, as well as February 10- as you know, the previously announced starting dates for this trial.
We look forward to overfulfilling our quota of patients, in the best Soviet tradition.
I am writing because by now you must be wondering- as indeed are we- what is holding everything up. There are innocent bureaucratic blunders in any large scale project such as this that will be overcome eventually no doubt.
We look forward to joining you in the great struggle against the corona virus.
Any day now.
A word in private, please. I must express some concern over the choice of AG Mamanov, researcher, over at the City Mariinsky Hospital. Andrei- as you may have already heard- will be only too happy to stop at 3 or 4 patients for the trial because he would rather be at his dacha.
We here at #38 named after NA Semashko will be ready to step up and do more.
Best wishes to you.
Sincerely,
Natasha Popov
I don't get it. Neither does anyone I would bet, big picture.
So what do you mean then? 106 in Russia? and 120 here? any real idea? any real guess? what does it mean to complete the study? 106 there and 14 here?
It has all been so clearly explained by the company that no one has a clue
5.3 per 20 sites a big advantage? Sure if your goal is enrolling patients very quickly. Or if you have very large multi center trials where you need a large N.
Is that the case here? No.
They oughta be able to find 10-20 patients easily at 1/2 to 1/4 of the sites and then life would be simpler for standardization and running the trial. No no need for 20. Too many cooks.
Also- they only need 120 people(or 106). It is not like a very large cardiology trial, just to take one example, where you recruit thousands of patients. Again, no need for 20 sites. Small trial.
Am I personally glad if they run it quick and fast? Sure if it works. Then more news sooner.
If you are right about the start they should know a great deal of data right this very minute.
I think you are wrong and the trial has not enrolled anyone
why does Leo keep announcing the start of the trial? Over and over and over. When the first Q4 start fits with the Russian trial?
So- you are suggesting that there is a separate 120 person trial set to start somewhere else? Or a separate 14 person trial somewhere else?
gee thanks Leo for the clarification. Not.
106 is the plan. the 20 hospitals are the plan. The plan has yet to get off the ground. Where is there any proof that it has? Leo getting the start date wrong x 3 is evidence that it did not start.
How could I be wrong? if the 106 changes to 107 and than 108 as more patients join the trial that would be one suggestion that it's underway.
Just because they list hospitals does not tell you anything about any patient there getting B or being enrolled
How do you know for sure that they are enrolled already? Why does Leo keep announcing the start of the trial, after all? It makes much more sense to me that the trial is not yet underway - back in Russia
Do I get that enrolled patients would be dosed? I kinda get it since I see those patients almost every single day as part of my job in the emergency dept( a month ago it was several patients per day but COVID volume is down)
So when I put it together I think the patients are not dosed because they are not YET enrolled because the trial keeps getting delayed. The reasons why have not been given.
it sounds as though IP keeps getting the delay from the Russian side since Leo continues to announce the start. He was told wrong three times, is my guess
Will Leo ever share the truth of any of this? Ever? Who knows.
actually the most logical explanation is that the Russian trial was the one to start in Q4 and all Leo's failed start PRs are related to the delayed start of that very same Russian trial.
Which has yet to start.
What a long strange trip:These are among the ugliest moments in IP history. IP cannot be bothered to explain what the heck is going on with the B v C trial. It appears that the trial scheduled to start in Dec has been delayed and we do not know when it will start. Also, it is not clear there will be a trial anywhere else. 120 patients in the trial, Leo has said on many occasions, and now it is 108 scattered across Russia.
This is the culmination of months of research and data and a paper and FDA approval, and now the CEO will not- or cannot?-explain what is going on. To his poor befuddled shareholders.
trial delay
Trial delay
Trial delay
That is all that Leo has announced recently until brilliant sleuthing uncovered B v C trial scheduled for Russia(as prev rumored, hmmm, how might anyone know?)
Great expectations for B v C are now being hacked away at as some reality emerges and the rest is obscured.
Gonna be a long weekend as the days just keep rolling by and we are told NOTHING.
What a long strange trip this is.
Here in prev post I have described exactly what caused all the confusion with Leo getting wrong about the trial start 3 x. 12/17 was indeed Q4 and he said Q4 start for that reason. And then he announced two additional and different trial starts- Jan and then early Feb. He did this because he was informed those were the dates. No new word yet because he does not know when it will start- not at all true that it already started. If that were true- the trial began-then why put out additional PRs stating new start times???
Sorry to have forgotten 120(60 plus 60) as the trial number not 160. It does make this all very strange- was the number reduced? If so why not inform us? Is there any trial anywhere else? All this endless talk about institutions and hospitals interested in B and now there is no USA trial??? Just in Russia? Spread out across 20 hospitals allover the country? It seems crazy.
1- Did the Russian trial start yet? I say no B dosing yet for sure.
2-Will there be a B for C trial anywhere else, or just Russia? How can that be the best course for the company and for the B for C trial? Do we need answers- classic Leo and IP. Obfuscation rules. All this imposed by a big Pharma? Why? If you want B for C to be a triumph why treat all the patients in Russia instead of LA or Houston or Boston? What will happen to the short term prospects here if the only trial is scattered across Russia and it has not started? A bit of a worry. Not to mention the long term prospect unless the trial is a smashing success.
Hey comrade Leo- we really need some explanation
Answer: planned start- not started! Why oh why would Leo announce a start in Q4 and then in January and and then announce a start first week in Feb
Because they planned to start and then did not. How else to explain all the misstatements?
The Russians:Comrade Leo- we will start the trial in mid December, on the 17th to be exact
Leo:Hey thanks guys- I will tell my shareholders to expect a Q4 start!
The Russians: Comrade Leo- There is a delay in the trial start. Now it will be maybe a month late.
Leo: Great! I will tell the shareholders that it is a different start from before, but many of them could care less if I get it wrong. So not a problem. Other than we need to get moving...right?
The Russians: Comrade Leo. The trial will now start in the first week of February. Another delay.
Leo: I hate to complain but I have a problem telling my shareholders I have misinformed them yet again about the trial starting. This will be 3 x now. They will think I am a fool.
The Russians: Don't complain. Or we will add you to our list of people to poison. There are always delays in life.
Leo: Not to worry, I am not complaining. Really, I'm not. Just let me know when the trial actually starts and we are good. Sigh.
maybe we have to see if B works in the trial first? Before celebrating? LOL.
I bet the trial has NOT started yet in Russia.
We shall see. At least I think we will, if Leo bothers to explain more
really? someone here seemed to know an awful lot about a possible Russian trial of B months ago. How was that? How quiet was Leo after all?
No trial start yet in Russia is my guess- just planned to start and went off schedule.
I bet this will be the case and that would explain why Leo got it wrong so many times- Q4 was planned and then someone told him Jan and then two weeks ago.
On each occasion the Russians were wrong about trial start, if that as correct, and we and Leo were misinformed.
So much for the decision to run things in Russia. Will Leo explain any of this, if it is right?
54 lousy patients, folks, 54, for the USA, or wherever. The numbers are getting pretty small for that sample to show a difference.
You may recall the small sample sizes that destroyed the reliability of P2b, and led to the Prurisol debacle.
B is going to have to be a blockbuster, B is going to have to stomp C to prove to the world that it works. It will make the task-proof of efficacy- harder to run 2/3 of the trial in Russia.
Just one opinion
Answer the question please: when Russia or China announce their vaccine effectiveness do you believe them deep down in your heart and soul? Of course not. We all have doubts about the US and the UK too, with vaccine data, to take one example. But the problem is worse with certain countries.
Did the Russian trial even start? Planned but delayed?
Just one opinion.
Spacibo bolshoye. Thanks very much
Did the trial actually start yet? Planned but not started?
They need 20 hospitals for 106 patients- crazy to spread it out so much, is that necessary?