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COVID in Russia esp Moscow cases up a lot, as you no doubt have heard. And yet no word from company about atelier data analysis. To me this adds up to : failure. Would Putin let the cure languish in his hospitals' pharmacies and do nothing? Bound to be some extra doses available- if it worked.
Data now! Write your CEO about this bogus nonsense ! Data now! It's only people dying!
Leo: Look folks: It doesn't work- otherwise I would do something. Today. Right now. Can't you figure it out? It mean that B v C failed to meet its key goals
Cardigan sweater Leo says "Won't you be my neighbor ? But neighbors cannot be close if they are all the way across the globe, right shareholders? so if thousands die in India but we do not publish any data, that is just following the FDA rules. Right down to the last letter. Maybe once all of our potential market for Brilacidin is gone we will get around to releasing data.
"You can figure it out, right, folks? I mean if the drug worked then I would be morally bound to informing you and the rest of the planet so we could move forward into mass production.
"But just the very fact that I just announced no data until the fall should tell you something. It tells you that somehow I know that the B v C trial failed. Eventually I will say it more clearly. But for now read between the lines. It would be too sad to let all those people die otherwise. Even if they are too far to be neighbors"
Dear IP- we here at the FDA were shocked, we repeat shocked that the extra 31 days later phone calls were left out of your initial data. Never mind that you found evidence that your dug can save lies or decrease intubations or avoid ICU use. What we care about is adherence to meaningless protocol and that is what counts in a global pandemic. We wish to emphasize the trivial details over the bigger picture - got it?
Sigh.
Sure, let's pretend the FDA would be incredibly offended by Day 29 data coming out if it might save lives around the world, instead of being overjoyed to wait another 31 meaningless days todos i's and cross t's. In the midst of a pandemic? When lives are on the line? Not to mention the desperation inside ICUs and hospitals elsewhere?
perhaps I can remind you of how bad it was allover the good old USA as COVID consumed all hospital resources and its personnel. It was a real struggle.
If IP has a drug that can really make a difference think the FDA could live with Day 15 or 29 data instead of waiting for 31 meaningless days.
To suggest otherwise is just plain silly.
I was trying to figure ut if the FDA was offended by CYDY trial or other behavior as suggested. And more specifically if putting out Day 8 or D 15 or Day 29 data would violate FDA trust in IP and sink potential approval. That was what was suggested, so far as I could tell.
I was directing sarcasm at our fearless CEO for failing to inform shareholders of rational for not doing the interim that he himself announced. If you are right- that the FDA forced his hand NOT to do the interim- then why not tell us?
Because he cannot be bothered to explain himself, one surmises. Just like with Prurisol.
Thanks so much Leo for clearing up the interim data issue! Talk about a CEO's failure to communicate- if this is the correct explanation.
As for the CYDY example- you may be right on track. I know nothing about it but will read.
KMBJN- does he have it right?
Just imagine how angry the FDA would be to find out 31 days earlier that there was a drug that would save lives or reduce ICU admissions in patients with COVID. Or better yet 45 or 52 days earlier.
How angry?
What a total joke.
FDA: You can save lives 6-8 weeks earlier than the fine print stated? What a total outrage. How dare you compromise protocol.
Better- FDA: You are going to pretend that Day 60 is critical to your trial data when earlier analysis could change the world? By all means find out sooner.
Really too funny, and a bit sad, to read about pretend FDA outrage over trivial meaningless wait.
FDA- Boy are we ever angry at saving lives! And getting people out of hospitals sooner! That really stinks.
Still in cardigan mode, Leo faces the camera, seeking his audience, his shareholders.
-We are just going to sit here and wait, everyone, for important intervals, Day 8 and then Day 15 and then day 29. And then finally, one month later we will reach 60 days after the last patient is treated in our company trial.
-But Mr Ehrlich, said a tentative voice. Don't you have a drug that might help save the lives of some who will die of COVID? Can't you help those people?
-Well shareholders, that is what trials are all about. We wait 60 long days after first treatment and that was the plan all along.
-But Mr Ehrlich, don't you think that in these circumstances that you could present some conclusions from Days 8 and 15 and 29, rather than waiting until it is too late to save people ? Help them. If you can help them you should. We should.
-Won't you be my neighbor, and sit with me while we wait? That is all I ask. Some people will die needlessly, sooner than they must, if our drug works, but that is how trials work.
-But Mr Ehrlich, this is a pandemic and we owe it to the world to say if we can help. What you are doing is wrong.
-Another voice, less tentative. But Mr Ehrlich says we have to wait. So that is what we will do. We will sit by and let people suffer and die and maybe help them in October. Or sometime thereafter.
-That's right, shareholders. We just wait. Because I said so. And some of you are just dumb enough to agree. How about a story? Maybe I can tell you a story while we wait?
Picture: Leo in a cardigan sweater, soft voice, looking into the camera.
-Can you say Prurisol? Yes that's it. Prurisol. It's a hard word to say. try it again with me. Prurisol. OK shareholders, that was good! It was a drug we were developing years ago and I wrote a lot to all of you about the big market out there for Prurisol.
-Things do not always work out in the world. You know that, right? Bad things can happen. Well, the trial did not go well. And then there was another little problem. I had a lot of trouble telling all of you what happened and everything just dragged out. It was awful really, for all of you and for me. I know that the agony was endless.
-That is why I am so sad to repeat that sorry performance yet again, but there we are. I cannot bear to tell you that another even more important trial failed. But I do know how to avoid giving you answers. First I am going to tell you that we have to wait all summer for results when all of you know that is a lie. Well, not all of you. There are some of you that simply believe what I tell you. I say wait 60 days, it cannot possibly be otherwise and apparently some of you just accept such nonsense.
-So now we will have another endless brutal wait until you have lost interest and I can tell you the difficult news. Just think about Prurisol- can you say that again?-and you can see what is in store for IP shareholders
Won't you be my neighbor while we pretend we have to wait?
So many buying opps- that is what IP is all about, right? Our CEO has squandered all momentum, again and again, and here we are. A long summer where the world wants a viral fix.
Leo knows B failed v C and he has to string us all along until he finally says, way too late, guess what folks- it did not work.
Can he go back now and try a B v C nasal spray? Or inhaler? Or an emergency dept trial with one IV dose?l I doubt it. Where would the funds come from?
And all that other viral research(LOL)? Screeching halt if trial fails- another reason for delay delay delay.
Leo fiddles while COVID burns. Unethical pathetic Bogus 60 day wait. How sad for the company and its shareholders.
Wait a minute- Leo knows it failed and that is how he can justify this ugly plan.
Yes, it is Day 6 of the coverup, B v C trial failure.
C'mon IP and move on B UC already !
Unbelievable. Positive data- actual honest to goodness increase in survival or decrease in LOS or progression to ICU- would be met by large and sustained share price rise. How could it be otherwise? They do not need a huge immediate licensing deal if they have a cure for COVID
ugh they would get a deal for sure
That is because it is totally bogus and insulting to shareholders not to get data out sooner. And immoral for those infected and suffering and dying. Big immediate market if pushed forward-
BUT data now also immaterial if it does not work: conclusion is that leo -somehow- knows it does not work.
Nothing else makes sense
Not day 8. Not Day 15. Not Day 29. It's only people dying. Why not just sit and wait for (mostly)meaningless data at Day 60?
The only ones who favor this want more time to dump their shares before the price collapses . As it approaches zero.
Day 5 of the cover up: B v C trial failure. Data now. Leo wants to string us along.
But not just us: the entire world is waiting for a COVID therapeutic. That's all- just the whole planet. But Leo says no, not day 8
Or Day 15
Or Day 29
Wait till 60
IP Credibilty ethical and managerial is toast. As reflected in the share price reaction
It's only people dying. By all means wait 60 full days- for no meaningful data!!!
Such a joke.
Data now!
you could be right, of course. Bt what to make of the IP nonsense position of : we will wait 60 days, and then wait a lot more days, and then release data.
It is weak and indefensible.
It is bogus.
That is what tips me to think that Leo knows something. He should not be able to know anything.
And yet I think he does because his position on final data is IMMORAL and OUTRAGEOUS if the drug works.
Data now. Write Leo! Data now ! Write Leo!
If FDA is so down on interim data then why did Leo promise it for B OM? And then deliver it?
If the FDA is so down on interim data then why did Leo promise it for P- but then fail to deliver?
Again, if the FDA is so down on interim data, then why did Leo promise it for B V C and then fail to deliver?
Leo has a pattern of announcing that he will do interim looks.
Gee I wonder how B for C might parallel Prurisol?
Could it be failure? And then the failure to inform shareholders in any reasonable fashion?
B v C cover up already on Day 4
the casual Russian phrase is "Kak dela?"- how goes it, How are you doing?
and the answer should in fact be readily apparent at Day 15 for Tatiana. It is known for the vast majority of patients in the trial already. Data should be out now or in a week and it is a scandal if it it not.
Leo of course will delay and obscure any bad news.
How can he know? When all is double blind? I do not know but I suspect he has not heard of lots of people improving very suddenly in the trial, and I suspect he knows it failed when he sticks to the ugly timeline, the bogus 60 day timeline, the insulting and deceitful 60 day wait
Nice of you to write down the specifics. It is shameful if Leo insists on the full trial protocol- telling, in my view- tantamount to announcing failure
Dialogues: What's IP got to do with it?
-You know, it's only people dying. Right? People die all the time. Why should I fret?
-Umm, if B beats C, then there could be an effective treatment that would save lives and decrease suffering. So why not find out it if works.
- But that's impossible. Look, there it is in black and white- we are waiting the full 60 days after dosing and then at some point in the future, some later date, then we will release the results. IP cannot release the data now. It would break trial protocol.
-Umm, didn't they announce interim data plan? Right there in black and white? What about some interim data now. You know, because people are dying that might not need to.
-But cases are down in the US. Down and dropping. I can go out without a mask.
-What about all those other countries where COVID is a major problem?
-But it's not here, is it? It's only people dying and people die all the time. As long as it's not clogging my hospital ICUs and beds, why should I care? Why? I say we follow protocol and wait and wait all summer until whenever. It says 60 days right there in the the trial plans. I cannot believe that you think promised interim data that could save lives is so important.
-Sigh.
Write your CEO and tell him interim data NOW!
Criminal neglect for failure to tell the world if B beats C.
So what? So that tells me that the trial failed and that somehow Leo knows it.
You and I will be told in a couple months from now, and oh- don't hold your breath.
It's only people dying. That's all. In other countries. Should we care?
Should we care to find out if B beats C? Run and release the data, IP. This delay is criminal neglect if the drug works.
Day 4 of the B v C trial failure cover up.
Laughable notion that IP could not release data today or tomorrow, if they wanted.
Remember they promised interim data? Of course they could release data. So we know they do not wish to do so. Because they somehow have some notion of failure.
And so they want to pretend that they must wait 60 full days- and then some, before , releasing data. That is where we are right now. Right in the midst of unwillingness to tell shareholders the trial failed, and this will go on and on.
The funny thing is that some support the laughable notion that it has to 60 full days until even one little thing can be released.
Sadly I agree totally. At this point Leo is only buying time until telling us that it failed. That is the inly way it makes sense. If he thought it had a chance it'd be immoral to not run prelim data.
That tells us: it failed. Day 3 of the coverup.
how could any of this be lost on anyone esp Leo? Nothing could be more obvious. Desperate need plus potential solution=great match.
Just. the pesky problem of does B beat C?
Leo has tipped his hand by not announcing some earlier data prelim eval and is telling the world the trial failed. Just one opinion, but...
... the dots connect
Day 3 of the B v C failure coverup. The world needs data now. If the drug works how is this phony all summer long wait justified?
It is a scandal and it is shameful. Data now!
Any fool knows that most of the key data is already available for B v C. Most patients are well past the 8 and 15 day data points. yet the company says no data until 60 days past last patient enrollment. Sure that is the letter of the law.
Is that how you respond in a pandemic? While so many are dying?
No. It doesn't cut it.
Data now, and some later, is the way to go. The companies not going that way because the drug failed. Of course I do not know this for certain. I was wrong before about the lab tests being as successful as they were. I do not think I am wrong about this, but it is just an opinion.
Data now, please, Leo- write your CEO folks. I would but I was moved to spam by Leo.
So true, so true. I mean, if you cannot figure out that the trial failed, then why would you be frustrated? Just more down days among a sea of down days for a company with a long series of disappointments. Par for the course. Right?
Totally agree. It is like announcing that the trial failed. All the early data points, but no data any time soon
No data=failed trial.
B UC- pivot please leo. NOW
Tired of all the buying opportunities?
LOL.
Buy all the way down to a nickel. If it holds there
We all knew that B v C was a very long shot
No data=failure of B v C.
Onward to B UC! Move it Leo, do something. Already.
Time to announce B UC trial- time to shift focus
Or the company will simply die.
Or do you wanna just sit at the beach all summer Leo?
How about trying to save the company?
Not even vaguely accurate. Oh you want a LONG COVID drug? For those with lingering symptoms months afterward? In fact that may be helpful info to get but it is not what the trial is MOSTLY about- which is: can it save lives can it shorten hosp stay can it prevent ICU admission etc
Can it prevent death and suffering in the trial population? Most of that data from the 120 patients is available RIGHT NOW.
Right now- NO wait till Sept needed for the most critical data.
Give me a break.
yes yes- after announcing they WOULD do and interim they did not.
Let me see let me think when did that happen last- oh yeah: Prurisol.
Prepare for deceit and lies and delays from the company as it attempts to hide the B v C failure-
No data now = no success- just one opinion, but why wait? Why?
As if the time from Day 15 to 29 to 60 tells us anything critical. Mop it up later- data NOW!
When will Leo finally admit it failed...
Get ready to see if the share price holds at a nickel!
Data now! Write Leo! Write him 10 x a day. I would do it but he moved me to spam. This wait for 60 days in COMPLETE NONSENSE.
Get the drug out STAT if it is any good B v C
DATA NOW! Day 2 trial cover up B v C. If the data are good they should be out in 10 days and we shoulda been told already. Instead we are treated to insulting nonsense and the 60 day follow up.
Yes folks- it failed. If there were some big buzz about people getting better faster would they sit on the data? No way.
At least I hope not.
Cue Neil Young folks- It's only people dying. That's all.
Your company wants to drag this out now all summer and when the data are out they will be bad. How can I know this for sure? I cannot. I have been wrong before but I bet not wrong now.
We shall see...in September. Totally bogus and unacceptable