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Posted On: 05/20/2022 8:21:28 PM
Post# of 148878
I apologize for the length and format, but I have to respond to everyone in one post: If you've written to me in replies, you can just look for your post in this post and read that only. You don't have to read the whole thing, for Pete's sake. Someone, please get me unlimited!
craigakess:
We are under Non disclosure agreements as per SK.
CDiddy:
They can’t release it. NDA.
Drano:
Thank you.
NICKIE:
No, under NDA, nothing would leak. No whistle blowers.
Riztheinvestor:
I believe it to be true. But, some doubt has been brought to my attention as I will illustrate below. So far, I have not heard the specific words that mTNBC scheduled dosing was stopped, but, even if it was, when was it stopped? 3 months ago or so? If that’s the case, our OS would still have to be over 15 months which beats SOC by 3 months.
Shelly:
Don’t you think CEO is necessary for the building of partnerships? CEO shall bring LL into combination therapy with many other failing drugs on various fields of indications to get them approved by FDA for their companies. LL shall be partnering on combination therapy. CEO will know these other pharmaceuticals and their higher ups and CEOs and that will be the means which bring us the partnerships.
sean007:
love the name! like the reference to possum. I knew that was on the tip of my tongue. I hear the dinner bells a ringing for the feasts slated at the mid & late June dinner parties.
Chazzledazzle:
Definitely NOT. Gilead carried this trial out for over 3 years. The best Trodelvy was able to do was 12.5 months and that’s after 3 years of trying different combinations etc. They used their best OS they could achieve in their application for BTD.
Good to go:
I made the same post on Reddit, and Prestigious-Head-139 commented back to me:
My Reply back to him:
SamaGong:
I described definition of a Type III HyperSensitivity Reaction and gave convincing evidence as to how Long Covid could be classified as such. I believe it to be true and to me, I will understand it as such until a better explanation is given. Therefore, I called it a truth bomb, because to me, it blew me away when I considered it.
It would be great if Ohm gave a one line justification on each indication, as to a mechanism of action, or how that indication was derived at. I have written a very short, or is it a very long explanation of the MOA I described.
Even slowly, say weekly, ohm can update his list, even, with LL mechanism of action for each indication.
craigakess:
Quote:
“What in the world would be the upside of CYDY playing dead and burning cash for 4 months when they could've partnered with a company that knows how to navigate the FDA? I say "none".
The end of June is not "fast approaching" as it is still 5 long weeks away. CYDY needs cash now, as is immediately and seems to have other trials on hold because they cannot pay for them. This WEAKENS the company's position, not strengthens. If there were partners ready to go, they wouldn't be wanting to wait for months and CYDY would be foolish to wait too, as that allows companies time to change their minds. As the saying goes, "Strike while the iron is hot" which is far different from "Sure the iron may be hot, but let's sit around and do nothing for 4 months and just collect a salary and announce a partnership when we feel like it." Again, what would the rationale be for just waiting until the end of June if a Gilead or Johnson and Johnson wanted to partner now? They can navigate the FDA, CYDY cannot.
IF and I say IF the NASH and tNBC results are so stellar and partners are ready to go, the people dying of these diseases need this drug now, not later as later will be, sadly, too late for some.”
We are under Non disclosure agreements as per SK.
Quote:
“Kelly 22:22, so we are in discussions, we have companies under NDA right now. we are advancing the discussions for multiple different applications for LL. But we will have to comment on that when it is publicly available to everybody at the same time.”
The merging companies are doing their due diligence. We are under fast track development for both NASH and mTNBC. Whoever partners with us will still be faced with dealing with the FDA to get it to the patients.
CDiddy:
Quote:
“I sure hope you are correct. I am curious why would they be sitting on the data?
Why not release it? Are they still working on completing the analysis?
We really need to complete a trial with indisputable results.“
They can’t release it. NDA.
Drano:
Quote:
“There are all kinds of reasons why there's been no communication from the company...“
Thank you.
NICKIE:
Quote:
“If this were true CYDY's stock price would be much higher. There are too many people/entities involved to be leak free.“
No, under NDA, nothing would leak. No whistle blowers.
Riztheinvestor:
Quote:
“Wait is this true ?
“In mTNBC, the drug has been continuously dosed as per schedule even past November.”
I wasn’t sure if we were?
Someone please clarify because I thought the ball was dropped on this.“
I believe it to be true. But, some doubt has been brought to my attention as I will illustrate below. So far, I have not heard the specific words that mTNBC scheduled dosing was stopped, but, even if it was, when was it stopped? 3 months ago or so? If that’s the case, our OS would still have to be over 15 months which beats SOC by 3 months.
Shelly:
Quote:
“My belief , and I know it may be just me , is that a CEO right now , unless they bring a major catalyst with them, like a partnership, money or pics of Fausti taking cash from Gilead to tell the NIH and FDA to screw us ....
Then a ceo doesn't matter”
Don’t you think CEO is necessary for the building of partnerships? CEO shall bring LL into combination therapy with many other failing drugs on various fields of indications to get them approved by FDA for their companies. LL shall be partnering on combination therapy. CEO will know these other pharmaceuticals and their higher ups and CEOs and that will be the means which bring us the partnerships.
sean007:
Quote:
“MGK...well done on the post and the declarations...there are many animals that play possum...until dinner is close enough.”
love the name! like the reference to possum. I knew that was on the tip of my tongue. I hear the dinner bells a ringing for the feasts slated at the mid & late June dinner parties.
Chazzledazzle:
Quote:
““Take it that it was continued as per schedule, LL overall survivability becomes 18 months and counting.”
I’m guessing only here…that SOC has also continued past 12 months.”
Definitely NOT. Gilead carried this trial out for over 3 years. The best Trodelvy was able to do was 12.5 months and that’s after 3 years of trying different combinations etc. They used their best OS they could achieve in their application for BTD.
Good to go:
Quote:
“In mtnbc how do you know that Leronlimab has continued to be dosed since we received the results end of last year? I remember Scott Kelly on the last cc basically downplayed our chances of breakthrough for this indication and that was a factor in the drop in share price. I’ve been wondering for months how many women are still alive and if they are still on the drug? What do you know and how do you know it?”
I made the same post on Reddit, and Prestigious-Head-139 commented back to me:
Quote:
"Unfortunately, many of the patients who were receiving Leronlimab stopped taking it after 12 months for mTNBC. If they had continued receiving Leronlimab after 12 months, our overall survival data would blow the competition out of the water. Dr. Kelly clarified that on last call when responding to question about BTD for mTNBC. That's the reason we didn’t have adequate additional survival data beyond 12 months to support BTD. Nader was mistaken when he said he thought most mTNBC patients were continuing to receive Leronlimab.
"There were some patients remaining on Leronlimab". That's exactly what Dr. Kelly said with regards to mTNBC. "Some" wasn't enough for BTD.
Please elaborate on what mTNBC results we're waiting for. That would be great news if true."
My Reply back to him:
Quote:
This is what SK said during the conference call:
Scott Kelly 9:00: "2 cardiac events led to pausing CD16. they don't know if these patients are LL or placebo. They want to pause the trial b/c our experience w/LL was in healthy volunteers and not in critically ill Covid 19 population of sick individuals. They have a preplanned DSMC meeting data safety monitoring committee in early April for both studies. So upon clearance of the DSMC we plan on removing the pause. We are in communication with ANVISA and the FDA and reported the events to each agency, but this was CytoDyn's decision. Full clinical hold on US IND Covid 19, and partial clinical hold for IND for HIV. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this. We believe this is a solvable problem. We have contracted with a new pharmaco-vigilance CRO to move forward. So we expect about an 8-12 week, (June-July 2022), timeline and seek advice from the FDA."
He was talking about Covid 19 in Brazil, not mTNBC. But I failed to acknowledge the word "all" that I bolded.
In my transcription, I did not record the question and answer portion.
SK did not say he stopped the mTNBC trial. He said full clinical hold on the US IND Covid 19 and partial hold for IND for HIV. He did not include mTNBC in this statement.
He said FDA wants aggregated safety data across ALL indications, but he said that it was CytoDyn's decision for full hold and partial hold, not FDA's.
But, even if they did stop the scheduled administration of LL, it wasn't stopped in November of 2021. It probably continued into January, February or March and if that was the case, we had to have reached 15 months of Overall Survivability.
Are you saying 15 months was not sufficient. Is SK saying that?
Do you have a transcription of what SK said? Do you have a transcription of what NP said? or a video and a time stamp?
SamaGong:
Quote:
“Goose, we agree: Opinions are opinions.
Here's part of Post #123439: "No, the info I sow are truth bombs, ..." That's what I pushed back on. Wasn't your post. Onward and upward, we hope”
I described definition of a Type III HyperSensitivity Reaction and gave convincing evidence as to how Long Covid could be classified as such. I believe it to be true and to me, I will understand it as such until a better explanation is given. Therefore, I called it a truth bomb, because to me, it blew me away when I considered it.
It would be great if Ohm gave a one line justification on each indication, as to a mechanism of action, or how that indication was derived at. I have written a very short, or is it a very long explanation of the MOA I described.
Even slowly, say weekly, ohm can update his list, even, with LL mechanism of action for each indication.
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