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***OFFICIAL CYDY/Leronlimab Thread***


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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

Fear is a disease.  Get rid of it or you're doomed for failure.  Though I did hear Leronlimab cures it. This is NOT an investment.  It is a Grand Slam Home Run or a Strike Out gamble in the stock

4 minutes ago, Whyatt said:

You missed my point entirely. Primary endpoint was achieved with corresponding p-value. It’s likely not enough to make a difference.

Right, that’s my point. They set a primary end point that fits their drug but it’s not enough. There was some other drug that had a trial and touted (maybe a week ago) that with Remdesivir it reduced hospitalization time by 1 more day than Remdesivir alone. I mean, really? We need something that reduces mortality. People still dying everyday.

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44 minutes ago, Whyatt said:

You missed my point entirely. Primary endpoint was achieved with corresponding p-value. It’s likely not enough to make a difference.

The primary endpoint for the C/S trial is death after 28 days.  I am talking about this p-value.

Do you think they will not be granted approval if they hit a p-value of under .05 on their primary?

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42 minutes ago, stbugs said:

Right, that’s my point. They set a primary end point that fits their drug but it’s not enough. There was some other drug that had a trial and touted (maybe a week ago) that with Remdesivir it reduced hospitalization time by 1 more day than Remdesivir alone. I mean, really? We need something that reduces mortality. People still dying everyday.

It was actually enough for Remdesivir to originally get approved.  But not many believe it was the actual drug that got them emergency approval.

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22 minutes ago, Chaz McNulty said:

It was actually enough for Remdesivir to originally get approved.  But not many believe it was the actual drug that got them emergency approval.

That was all political and unfortunate because I think there’s a bunch of options that would have save lives by now if given the same treatment. 

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1 hour ago, Chaz McNulty said:

It was actually enough for Remdesivir to originally get approved.  But not many believe it was the actual drug that got them emergency approval.

1 hour ago, stbugs said:

That was all political and unfortunate because I think there’s a bunch of options that would have save lives by now if given the same treatment. 

These post both contain message board conspiracy theories IMO.

Remdesivir didn’t get the pushback that plasma did recently, at least not from reputable sources.

Unfortunately, there is no other drug for Covid with a better p3 result than Remdesivir. None. Zero. It’s an unfortunate truth. There is an good argument that the US government could have pushed trials along faster, I agree with that if that is your point.

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1 hour ago, Chaz McNulty said:

The primary endpoint for the C/S trial is death after 28 days.  I am talking about this p-value.

Do you think they will not be granted approval if they hit a p-value of under .05 on their primary?

The expectation is to hit that value in the full trial, not the halfway point. 

There are other factors also in play. What are other options might be available in the coming weeks? Can Cytodyn actually supply enough doses of the drug? What is the status of the safety data for the higher dose which held up the BLA?

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1 minute ago, Whyatt said:

The expectation is to hit that value in the full trial, not the halfway point. 

There are other factors also in play. What are other options might be available in the coming weeks? Can Cytodyn actually supply enough doses of the drug? What is the status of the safety data for the higher dose which held up the BLA?

Really?  Why bother having a mid-trial look if this is the stance. 

The safety data can be looked at during the peak.  Or they could look at the past 6 years of data.  Manufacturing by all accounts is in place.  Who cares if they cannot supply enough doses for the entire US population.  Are you saying it would get turned down if they could only supply enough of a life saving medication for 50% of the US?

 

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2 hours ago, Chaz McNulty said:

Why bother having a mid-trial look if this is the stance. 

 

Im a little worried about this too, concerned that nothing less than a home run will do it.   

The endpoint being deaths helps though.  There certainly will be a lot more pressure on the FDA if it's saving lives, should they prove to be better than the placebo.

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4 hours ago, Chaz McNulty said:

The primary endpoint for the C/S trial is death after 28 days.  I am talking about this p-value.

Do you think they will not be granted approval if they hit a p-value of under .05 on their primary?

 

21 minutes ago, Dwayne Hoover said:

Im a little worried about this too, concerned that nothing less than a home run will do it.   

The endpoint being deaths helps though.  There certainly will be a lot more pressure on the FDA if it's saving lives, should they prove to be better than the placebo.

Agree deaths as primary end point will make a difference for short term chances of approval. 

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On 9/19/2020 at 10:50 AM, Whyatt said:

The expectation is to hit that value in the full trial, not the halfway point. 

One of the more knowledgeable IHub posters claims he has had email correspondence with Nader and Nader said that we won't find out the data from the interim analysis of the first 195 patients unless the trial is stopped.  I knew that the first interim analysis was for safety only and that we'd only hear the results if the trial was stopped.  But I was under the impression that we would get the results from midway point interim analysis of the first 195 patients regardless if the trial was stopped or not.  Was I mistaken?

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HIV

1. We are 6-9 months away from potential approval and that is being optimistic

2. HIV is not lucrative like cancer and Covid treatments

Cancer

1. According to a knowledgeable long who is in correspondence with Dr Lalezari, the basket trial for cancer has been temporarily suspended because they want to up the dosage because they weren't getting the results they wanted.  There is a lot of smoke that the cancer trials aren't going well at all.  But you're not going to hear Nader tell you that.  Instead, he has been mostly quiet on the subject.

2. Cancer approval can't happen for a long, long time from now because trials take a long time unless it is an immediate concern like Covid.  Look at how long the HIV trial is taking.

Covid

1. Bruce Patterson is not considering leronlimab for long-haulers according to Dr Yo.  Dr Yo and Patterson are writing a paper together about other drugs to solve the long-hauler problem.

2. M2M is currently a dead end.  Complete waste of time at this stage of the pandemic when S/C is all any government entity cares about.

3. According to knowledgeable longs on the message boards, we will not see the results of the interim analysis of the first 195 patients unless the trial is halted for extreme efficacy or extreme futility.  Only the DSMB will see the results.  The DSMB already did an interim analysis of the first 149 patients and decided not to halt the trial.  Why is it going to be different with 195 patients?

4. The first 195 patients were enrolled 27 days ago.  There were 210 patients enrolled as of 11 days ago according to the Sept 10th CC.  That is approximately 1 patient being enrolled per day.  At the current pace, it will take about 180 days to enroll the 180 patients to get from 210 patients to the required 390 patients.  Plus 28 days to complete the study and some time for results to be released.  In other words, we aren't going to see the results of the completed S/C trial until next spring unless trial enrollment quickens.

Edited by Don Hutson
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I do want to say that I'm not necessarily advocating selling right now.  $3.40 is pretty low for this stock.  It will likely go up at some point in the next week or two in anticipation of the interim analysis.  Cytonites do not lack in the hope department.

Edited by Don Hutson
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The last CC has drained enthusiasm.

This was posted on the yahoo board by askeptic and provides some hope for LL:

 

Not sure if this has been posted. However, if you are interested to learn about Leronlimab from an unbiased source follow paragraph (copied a section from a review article on Antibody based therapy) might be useful
From the journal Expert opinion on biological therapy: https://www.tandfonline.com/doi/full/10.1080/14712598.2020.1745770

4.3. Leronlimab

Leronlimab (previously known as PRO140) is a humanized IgG4 targeting CCR5 which CytoDyn is progressing through multiple stages of clinical development for a variety of diseases, namely CCR5-tropic HIV infection, metastatic TNBC, metastatic colorectal cancer, nonalcoholic steatohepatitis (NASH), and graft-versus-host disease (GvHD) with a variety of preclinical studies ongoing in an oncology setting [66].

CytoDyn acquired leronlimab from Progenics Pharmaceuticals in 2012. The mechanism of action inhibits viral entry by masking CCR5, but does not interfere with normal CCR5 signaling thereby protecting healthy T cells; in addition, CCR5 has been shown to play a significant role in cancer and immune-mediated conditions. Another mechanism of action demonstrated by leronlimab is the ability to block calcium channel signaling of CCR5-positive cancer cells intrinsic to the progression of tumor invasion and metastasis. Currently, this mAb is at the pre-registration stage and approval for leronlimab, in combination with HAART, is anticipated in the first half of 2020 for HIV infection, having previously been granted Fast-Track Designation by the FDA. In March 2019, CytoDyn submitted the first part of the BLA application using the FDA’s rolling review process. On successfully gaining FDA approval, this mAb would represent the third GPCR-targeting antibody to be marketed. A Commercialization and License Agreement (CLA) and Supply Agreement with Vyera Pharmaceuticals was completed in December 2019. CytoDyn plans to use leronlimab both in combination and as a monotherapy for CCR5-tropic HIV infection (NCT02859961). Another attractive property of this mAb is that it can be self-administered as a subcutaneous injection, in addition to standard intravenous delivery.

Recent data from an ongoing monotherapy dose-escalation Phase 2b/Phase 3 clinical trial (NCT02859961) demonstrated that patients who received leronlimab maintained viral load suppression at approximately one year and even longer for a number of participants. The estimated primary completion date is July 2020. Leronlimab has successfully completed nine clinical trials in over 800 people, including a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients) where 81% of patients completing the trial achieved an HIV viral load suppression of less than 50 cp/mL, thereby meeting the primary endpoint [67].

In addition to HIV, CytoDyn is evaluating the safety and efficacy of leronlimab in Phase 2 clinical trials of patients with metastatic colorectal cancer and NASH [68]. Fast-Track designation has been granted for use in combination with carboplatin for the treatment of metastatic TNBC (NCT03838367) where strong clinical responses have already been observed [69] and Orphan Drug designation has been received for the prevention of GvHD (multiple Phase 2 clinical studies, e.g., NCT02737306) with results expected in the first half of 2020. Thus, this mAb has significant potential for a positive therapeutic impact in multiple therapeutic areas, including a recent announcement for an IND filing for a Phase 2 trial for the treatment of patients with respiratory complications due to infection with the COVID-19 coronavirus.

Less

(2020). A review of antibody-based therapeutics targeting G protein-coupled receptors: an update. Expert Opinion on Biological Therapy: Vol. 20, No. 8, pp. 925-935.

(2020). A review of antibody-based therapeutics targeting G protein-coupled receptors: an update. Expert Opinion on Biological Therapy: Vol. 20, No. 8, pp. 925-935.

www.tandfonline.com

Article highlights

GPCRs are implicated in many diseases and present valuable opportunities for targeting with mAbs and other antibody-based therapeutics

Significant progress has been made in the generation of functional GPCR-targeting mAbs for therapeutic applications over the past decade where two-thirds of the GPCR-antibody pipeline are directed to Family A GPCRs (half of which are chemokine receptors)

There are now two mAbs approved in the US and EU (mogamulizumab and erenumab) with a third mAb (leronlimab) that is anticipated to attain FDA approval in 2020

Many GPCR-targeting antibodies are now in early clinical studies in addition to the emergence of next-generation modalities, such as alternative scaffolds, bispecific antibodies, antibody-drug conjugates (ADCs), and chimeric antigen receptor T-cell therapy (CAR-T), as successful targeting strategies

This box summarizes the key points contained in the article.

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42 minutes ago, Don Hutson said:

  The DSMB already did an interim analysis of the first 149 patients and decided not to halt the trial.  Why is it going to be different with 195 patients?

 

I believe the first analysis was only for safety though?  They are going to have more to analyze here I believe.

 

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1 minute ago, Dwayne Hoover said:

I believe the first analysis was only for safety though?  They are going to have more to analyze here I believe.

At the time of the first interim analysis, it was said that the trial could be stopped if the results were extremely good.  Maybe @Whyatt could help us understand this.

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2 hours ago, Don Hutson said:

At the time of the first interim analysis, it was said that the trial could be stopped if the results were extremely good.  Maybe @Whyatt could help us understand this.

Clinical trial design isn’t an area I have expertise in, but here is what I think I know. Realize that trials are based on written protocols which can have nuances between them. 

This is a Phase 2b/3 trial, meaning phase 2 and 3 are combined together, for speed and efficiency. As phase 2 intends to inform efficacy for phase 3, the sponsor (or DSMB) can evaluate the data around midpoint and try to understand if the full trial can be successful. For example, say your endpoint is death, what happens when you evaluate the data and there are significantly fewer deaths in both placebo and with the drug? You will need more patients to prove efficacy, or maybe you decide you should look at length of hospital stay instead.  That is the primary purpose of the look. The earlier look was likely safety only, where the DSMB looked to be sure the drug isn’t causing safety issues,SAEs, with patients.

The holy grail is when the data at the review is overwhelming to the point it’s unethical to not give placebo. I believe this needs to be well below p value = 0.05. This is rarely done, but when it is, it is to provide great benefit like saving lives. So this trial has the potential to qualify.

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11 minutes ago, Otis said:

Should probably have gotten out at the recent $5 surge. But maybe today is the day....

There is a good chance that it'll get back to $5 in the next few weeks.  But if the trial isn't halted from the interim analysis, the stock price is going to plummet.  It is the last real catalyst for a long time.

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Do people actually believe there is going to be some sort of announcement from NP on DR Been tonight?

I would be happy if there is something substantial, but my guess is the contract with Proactive ran out and he is just itching to spew nonsense again.

This is me being positive, btw.

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16 minutes ago, ChiefD said:

Up to 3.56

This stock is almost worth the price of admission just to watch it. It's like a video game.

:lol:

Lol. I think that’s why I got off. The highs and lows consume you watching it everyday. I think that huge day with the bear raid cinched it. It was up 20% and then down 40-50% and then down like 20% at the end. I hope you guys make out, but it’s a little less nerve racking now.

That said, I had to put some money in another stock (NNOX) that’s also a short target. SMH, I’ll never learn. Pretty close to even right now but I got in after a 60% drop due to the short reports. Been up and down 20-25% past two days. I put in way less, so much less stress.

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8 minutes ago, stbugs said:

Lol. I think that’s why I got off. The highs and lows consume you watching it everyday. I think that huge day with the bear raid cinched it. It was up 20% and then down 40-50% and then down like 20% at the end. I hope you guys make out, but it’s a little less nerve racking now.

That said, I had to put some money in another stock (NNOX) that’s also a short target. SMH, I’ll never learn. Pretty close to even right now but I got in after a 60% drop due to the short reports. Been up and down 20-25% past two days. I put in way less, so much less stress.

Some context here would be nice.  How much did you sell?  Do you regret it?

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44 minutes ago, Caesar said:

Do people actually believe there is going to be some sort of announcement from NP on DR Been tonight?

I would be happy if there is something substantial, but my guess is the contract with Proactive ran out and he is just itching to spew nonsense again.

This is me being positive, btw.

He won't give any hard news that is positive.  He may hint and dance around vaguely at something to get everyone excited but that's about it

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1 hour ago, Caesar said:

Some context here would be nice.  How much did you sell?  Do you regret it?

Definitely don’t regret. Sold about 1/3 at $6.50, that first peak after the huge run up. Sold about 2/3 of what I had left at $5.10 a few weeks ago and then dump the last shares around $3.40 last week. I have no idea what my full cost basis was because I bought some in the 4s and low 6s, but not nearly as much as I bought at first around $1 and then another chunk just under $3. Total profit was @ $45k. On “that day” I believe my paper gain was over $100k for a few minutes, but I think the biggest real gain I had where I was ready to potentially sell was around $70-75k.

I haven’t fully invested everything I sold but planning to keep adding chunks of companies I want to own and some SPACs that haven’t merged (have had good luck so far). For instance, I bought some FVRR last week at $121.

Edited by stbugs
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1 hour ago, stbugs said:

Definitely don’t regret. Sold about 1/3 at $6.50, that first peak after the huge run up. Sold about 2/3 of what I had left at $5.10 a few weeks ago and then dump the last shares around $3.40 last week. I have no idea what my full cost basis was because I bought some in the 4s and low 6s, but not nearly as much as I bought at first around $1 and then another chunk just under $3. Total profit was @ $45k. On “that day” I believe my paper gain was over $100k for a few minutes, but I think the biggest real gain I had where I was ready to potentially sell was around $70-75k.

I haven’t fully invested everything I sold but planning to keep adding chunks of companies I want to own and some SPACs that haven’t merged (have had good luck so far). For instance, I bought some FVRR last week at $121.

I think he was messing with you. 

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6 hours ago, Dwayne Hoover said:

He won't give any hard news that is positive.  He may hint and dance around vaguely at something to get everyone excited but that's about it

Yes he has to appease the base and hype the stock. What can he hint. suggest, intimate that will keep the fires burning?

BBB? NASDAQ? UK? BLA? Partnership? EUA? 

The interim data is likely I think.

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49 minutes ago, Moonlight said:

Yes he has to appease the base and hype the stock. What can he hint. suggest, intimate that will keep the fires burning?

BBB? NASDAQ? UK? BLA? Partnership? EUA? 

The interim data is likely I think.

I think he is going to utilize the Lou Bega approach:

A little bit of BBB in my life
A little bit of Nasdaq by my side
A little bit of UK is all I need
A little bit of BLA is what I see
A little bit of EUA in the sun
A little bit of partnership all night long
A little bit of M2M here I am
A little bit of interim data makes me your man

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Just finished watching Koolbeens and seems like Nader is already setting some expectation that we likely are not gonna be approved in the interim analysis.  He's basically said that he will be really happy if they are asked to finish the trial.  If Nader is already downplaying approval for interim results, then I have to imagine he's already accepted that as the truth.

Finishing the trial means end of year for results if we are lucky.  There are likely going to be other drugs potentially approved by that point.

I imagine its going to be rocky unless there are some surprises along the way.  Perhaps there is some published data but I have to say I'm not excited right now.

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38 minutes ago, Dwayne Hoover said:

Just finished watching Koolbeens and seems like Nader is already setting some expectation that we likely are not gonna be approved in the interim analysis.  He's basically said that he will be really happy if they are asked to finish the trial.  If Nader is already downplaying approval for interim results, then I have to imagine he's already accepted that as the truth.

Finishing the trial means end of year for results if we are lucky.  There are likely going to be other drugs potentially approved by that point.

I imagine its going to be rocky unless there are some surprises along the way.  Perhaps there is some published data but I have to say I'm not excited right now.

Yeah he seemed to be promoting the HIV approval more than before.

Stated there was a 100% certainty in his opinion that there would be HIV approval. All in all it was more of the same talking about the possibilities and potential.

Also compared to the previous Dr. Been interview there was a great deal of snarky, mean spirited, disrespectful commentary going on as the interview progressed. The natives are restless and a focused attack on NP's credibility.

Edited by Moonlight
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15 minutes ago, Moonlight said:

 

Also compared to the previous Dr. Been interview there was a great deal of snarky, mean spirited, disrespectful commentary going on as the interview progressed. The natives are restless and a focused attack on NP's credibility.

I watched a replay but I didn't see all the comments.  That's not surprising at this point.  I imagine there are a lot of people that are getting impatient.

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8 minutes ago, Dwayne Hoover said:

I watched a replay but I didn't see all the comments.  That's not surprising at this point.  I imagine there are a lot of people that are getting impatient.

A thing that was weird to me was NP in talking about finances and having enough money to run the trials seemed to be bragging about turning away $40 and $  50 million deals for financing because they in some way did not reflect in his eyes the true value of the company.

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1 minute ago, Moonlight said:

A thing that was weird to me was NP in talking about finances and having enough money to run the trials seemed to be bragging about turning away $40 and $  50 million 

deals for financing because they in some way did not reflect in his eyes the true value of the company.

The whole finances convo was odd.  He didn't seem to be worried that they were running out of money though.

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1 minute ago, Dwayne Hoover said:

The whole finances convo was odd.  He didn't seem to be worried that they were running out of money though.

I had the impression that NASDAQ approval is going to be conditioned on having more financial assets than what we have now. HGEN had to do a reverse split and sell 8 million more shares. NP said that if needed he could raise more money if needed in a few days. Just like that. 

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