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In the investor community, it matters what happens to these 200+ patients. What I said was with regard to the collection of scientific data beyond just the endpoint mortality or discharge numbers. It is in a foreign country; but perhaps Cytodyn in giving these vials for free can request that the hospital collect more info on the specific nature of patient progress. That can prove to be important: knowledge is power.
Lets hope Cytodyn has some scientific leverage from this, that they would get data/results back with a insightful level of detail. Beyond just simple mortality or discharge numbers.
The one thing that was depressing from that Dr. Bream/Been discussion is when Dr. Bream pointed out not only that we may not have option to conduct trial in US but that it will be difficult to properly conduct randomized trials in Brazil, India, elsewhere. If he is correct, that could be a difficult sell with the FDA as well. Nader talks confident of doing such trials in these countries; but looming uncertainty whether such is logistically practical and if FDA will approve (even if assume they are not actively blocking us). Doesn't make sense that FDA is twiddling their fingers for weeks/months and we are waiting to see what trial will be approved next. With a product that we believe will make a definitive impact for people on death-bed!
I hope it is normal in this business that people in these positions jump from company to company like this. Dr Rahman has already left a bad feeling and people said he stayed little in past jobs. Now this hire also seems to have similar pattern of job retention.
In this video
The son said only the doctors can tell which drug worked. Anyone think the doctors will make such information public? Will the journalists there go after this information and not allow it to be buried in deliberate silence? Given that Erap is high profile person, naturally the news agencies should be seek to talk to his doctors and get their honest opinion.
Unless there is understanding and instruction to doctors from their bosses and powers above them, not to throw Remdesivir under the bus and affirm LL as the key drug for his recovery.
Yes this would make more sense. 1 million for just LL would be too much; the reporting was misleading.
It says LL cost was P 1 million. The conversion table in google gives 1 dollar = 48.34 peso. That would mean the treatment was 1000000/48.34 = $ 20,687.
Seems too expensive. The cost might be wrongly reported here.
Got this tweet at Dr been’s site. (Dr Been is a strong proponent of Ivermectin which also is believed to be obstructed by BP)
I asked a doctor in India (a fellow who is on the ground and not compromised - unlike most of those reporting on what is happening in India) about what was occurring there with COVID-19 and #Ivermectin, and this is what he explained to me. pic.twitter.com/5yIwsjWckT
— jay sanchez (@jaysanchezdorta) April 25, 2021
In the Philippines CSPs, I recall they got out of ICU or ventilator much earlier than 50 hours (?). What could that mean? We are hoping LL was the reason; but here you are saying it takes 50 hrs to get to blood stream.
Doing a trial in these other countries I think will be much cheaper and much quicker; and they may get easier access to patients, less competition and greater priority given to LL. We saw how quickly LL has come up in Govt discussions and medical news in the Philippines - with just a couple of eIND equivalents (and even before, to have given to former President). No such hope in the US; too many competing drugs vying for attention, BP control, etc. And FDA needs to wade through different competing interests and sort out needle from haystack. But the other countries typically look at the few that manage to get sorted out here and have to decide from that.
The fact that LL is getting recognition and requests is significant: not every "We have a possible covid drug" company in US will be specially identified in this manner even before the US starts touting it (Like Remdesivir).
Also, we are standing out as the single drug (outside present SOC) that is specially for the critical extreme phase of Covid. Countries with surge right now are most concerned about reducing that phase, ICU stays and deaths; if they ask "What drugs are for Cytokine storm?", well, they are finding LL on their own (without US govt advertisement) and asking for it.
Yes did not recognize the name Selzentry. She is worried about Maraviroc compared to LL, however refers highly of Dr. Patterson who is promoting Maraviroc for LH. But direct experience is the best test. And we know he is informally still supporting LL.
First time I am hearing India as a possible study setting. He said they are getting lots of requests and that CD16 will probably start there. Good to know that Cytodyn has already been investigated and contacted by relevant authorities there, their conversations giving Nader enough confidence to say that they will likely conduct trials in India. Hope FDA approves the protocol and this gets on quickly.
I've lost track of the trials. Long haulers, CD16 and two more critical trials CD17, 18 planned for Brazil. I don't think they have told us how these are different from CD 16, in terms of type of patients etc. Presumably the process is that they ask the FDA to conduct more trials in these hotspots, FDA agrees to accept the data from these places, and we conduct the trials there.
Saw in hangout:
https://twitter.com/GA_born_bred/status/1385576586662002691
She mentions of a Pfizer drug that may be replacing LL for LH
Also from ST, proactive video:
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at 2hour 40 min, a member said to the boss of FDA that he is very upset
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Congressman: We demand Action!
FDA boss (smiling): C-man, you do know who pays our bills and salaries, right? We have to keep in line with our bosses. [US govt, US FDA, US BP]
C-man: Yes, yes. We just have to look right. Just get some CSPs out there.
I do hope the scenario is better than this; but feeling more and more that the Philippines FDA is nothing more than a yes-boy for the US FDA, tied down by all sorts of bureaucratic agreements. Even if they wanted to, they likely cannot conduct a simple trial independently for a cheap drug like Ivermectin; and must rely on trial results from US or elsewhere.
However the increasing awareness is putting increasing pressure and they have left the loophole of CSPs; our results will hopefully come out too strong that they can no longer evade.
[Add: Dr. Randy is careful about asking for the minimum that he hopes their FDA can allow. Not overreaching in what would likely be a futile endeavor.]
Do we know if Philippines is using IV for first dose? Is that part of any of our future trial protocols? I don’t recall in any PRs that we are looking to give IV in first dose.
Well there is an investors presentation dated April 20, 2021
https://www.cytodyn.com/newsroom/presentations
Slid in there without any heads up, we don’t know for whom or why it was done now.. Strange
So there is no restriction in number of doses for the LH trial? FDA must really trust the safety of LL to have allowed 6 doses in a trial for a new indication. Logically then they should approve our request for 4 doses for critical patients.
Not as clear how CCR5 is involved in LH cases. They are not in the cytokine storm of critical patients, yet the same issue must be happening in some prolonged low-level sense that LL is hopefully helping resolve.
Thanks for mentioning her; and crazyjogger for the website.
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There are other trial participants who shared and continue to share their stories across Stocktwits, Twitter, Facebook and other platforms - each of which representing a similarly profound transformation.
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Can you share the links for some of these? Thanks.
Once they start increasing their CSPs and seeing results, they are saying in effect "Bye Bye USA". Ball is on their court now. If the CSP data is strong, they can find ways to approve informally if their FDA lacks self-confidence to give a formal EUA; and CSP can be one such way.
One step at a time. The world is a big place. Philippines, Brazil, India, France, etc. all having Covid patients in ventilators and ventilators not enough. Philippines is important right now because they have the opportunity to look at the data from LL directly for their own patients. That matters and if they can independently reach a decision to approve, then there will be a domino effect. Hopefully Brazil will allow our trials soon as well.
We will see. The story is not over yet. No problem if Lenz works but people here will look forward for the data from Philippines. If LL can find its niche, giving us anecdotes of that UK patient type again and again, we are here to stay no matter what Imperial College thinks.
Yes, assuming they are not being corrupt or deliberately trying to skew the results, they can make an assessment of these 29 patients and add more CSP if they want further evidence. We would have to concoct various doctor-conspiracy theories to figure why their corruption would want them to approve a costly drug if they don't really believe in its efficacy. Either LL works or it doesn't. If it works, anecdotes can tell the truth of it whether US FDA looks at them or not. Given/If safety of LL is already accepted, they (in Philippines) have to determine the reward vs risk - again, approving a costly drug is part of the risk and they would not want that unless they feel convinced by the reward that it works.
We had that UK patient in Dr. Lalezari's paper. We saw the way in which the patient was stuck in ventilator and within a few days of LL showed a remarkable recovery. That is in a published paper. A similar response is seen in a couple of CSP patients. If it repeats in many more of the CSP, and the doctors are able to discern something further about who is being helped by LL most, etc., that becomes a scientific basis for their confidence. Either it works or it doesn't; Dr. BP, Lalezari, Seethamraju, Agresti are all confident about it working; and there is pattern repeating: they all report "dramatic" effect and recovery of certain patients, something that is stark enough that they are convinced LL must have done something to get them off ecmo. They also say what that something is: calm the cytokine storm. "Anecdotes don't come off ecmo".
See, if they have 29 patients, that is a dataset for the doctors to do a suitable scientific study (in addition to the other anecdotal and CD12 support for LL efficacy). They are not dummies; they can figure out whether LL worked specially for these patients or not. Why, only Woodcock can say "Don't get stuck on p-value" when it suits her? Remember: Dr. BP, Agresti, Seethamraju, Lalezari all are convinced because they saw data (with details beyond just endpoint numbers) directly on a "few" patients; they are also writing letters to the FDA on that basis. But they have no clout higher up and the system may be too rigid (for safety but where a good drug may be unnecessarily stalled and people die in the meantime).
We can't assume countries like Philippines (or Brazil) work in the same manner; they may talk formal FDA talk but when the time comes, they can cut through bureaucratic redtape and find ways to "approve" even if without formally approving. Their FDA should be interacting with their CSP doctors much more carefully now, asking for careful analysis of the patients' responses to LL. This is effective phase-4 for them. We know there is already enough attention after Estrada and pressure on their FDA that they had to make a formal announcement regarding LL. Unless they figure LL is harming the patients, they can always add more in CSP and increase their study till they are scientifically-happy that the correlation indicates cause-effect sufficiently.
That's my thought. We are good so long as LL actually works. Our hope should be that the data for the CSP patients comes out strong. If that happens, the rest of these things will figure themselves out, in Philippines, then elsewhere.
Ok found the translation in the article posted by youssef #159885 earlier: “ There were a lot of medicine given to my father so I cannot credit which one helped him survive.” Seems he has taken the non controversial route for now.
Great exposure; that journalist seems to be discovering LL during interview.
Can someone translate what exactly he says about why he can’t speak on LL’s effect right now? Is it just that it is a cocktail of drugs and he cannot separately speak of one specially, or will he say more on what worked how later on?
Definitely. My thoughts: FDA is not going to go out of its way to specify Leronlimab if the interest was limited to 1 hospital and its 29 patients. There must be serious demand there as Nader already mentioned in the PR. And the + impact of LL in the other 28 patients may also be spreading like fire, mouth to mouth. LL has very quickly acquired a very prominent place in the Philippines medical and patient community, something we are still yearning for here. If the 28 patients ‘trial’ goes well, their FDA that now felt compelled to issue this statement will have to answer the call and cry of their people.
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The people there will likely be looking at more than just end-numbers and watching for the nature of disease modulation post LL treatment.
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In the Estrada relapse, the doctors will have the opportunity to distinguish the inflammation/cytokine phase from the bacterial infection; and we shareholders are also able to follow the sequence of events to make such distinctions. Will the treating docs conclude that the President was going into cytokine storm right before LL (the intubation should support this), then within a day or two post LL he got out of the cytokine storm and inflammation overload (the extubation supports this happening); and that the present relapse into infection is not a negative on LL but about other factors in play? Hopefully Dr. Randy and others will ensure that if LL has played a key role in how the President came out initially, that is not drowned out by simply looking at what happened later due to different reasons (reasons that may be common among +65 patients and hurt us in CD12).
If Estrada was a CD12 patient, all we would have known is when he is discharged or the end mortality status, when such things could have multiple reasons that are not limited to LL alone.
Couple of sites:
1. https://www.fda.gov.ph/wp-content/uploads/2021/03/Checklist-of-Requirements-for-Compassionate-Special-Permit.pdf
This has a slot for "Proof of Payment".
2. https://www.coursehero.com/file/16962645/Compassionate-Special-Permit-032716/
See the Unformatted text preview. (Not for LL but refers to CSP)
"The price to be paid by the patient is determined by the importing company. This could be given out for free, of in LF Asia’s case, sold at the US price ... The patients received them, paid for them, and everything went on smoothly."
This indicates Cytodyn or Chiral will have the option of requiring payment. It may have to be paid for by the patient or their insurance (if they have one); doesn't say that the Philippines govt will cover this expense for Covid patients. The fact that our PR mentions continual requests for CSP means that the patients are willing to pay for them somehow. There is real demand likely from individual patients' families that can afford the 2 to 4 doses; why would we give away for free? If Philippines later decides to buy en masse, then we may give at reduced charge.
Thanks for the details and numbers. A lot is at stake with the 29 Philippines CSP. The people there will likely be looking at more than just end-numbers and watching for the nature of disease modulation post LL treatment. This is their real and immediate trial.
We got such insights from the early eIND cases described by Dr. Patterson and others, in the paper on the UK patient, now in the first CSP and second Estrada.
The CD12 however was just numbers, no way to tell how LL impacted patients early, whether some had dramatic recovery giving definite indication of LL's power, how some relapsed after day 14, etc. This standard approach kept a blur on conclusions and simply postpones to further number trials with refined protocols to bring out the essential efficacy in formal p-value manner; however that is long-drawn and inefficient in the pandemic situation.
That may be the way FDA in US wants to work even now. But the sensible bet of Cytodyn is that other countries are not going to be that obstinate at this point. They have neither time nor money to arbitrarily wait on a number game. If they (Philippines) see upfront the majority of their 29 patients show clear signals of progress after LL, they are likely not going to wait around for US FDA to approve for patients they cannot monitor themselves. (And safety is already established. Low risk, high reward; some will take the bet, even if not US FDA.)
Hopefully the OLE cases are being studied in the former intimate manner and they are able to present case-studies to interested parties (including eventually us) like in the UK patient.
yes I did not follow that messaging from Nader properly. Thanks.
Also interesting is this part of the PR:
"In parallel, we are using data generated from our CD12 open-label extension to pursue EUAs in multiple countries experiencing surges in critically ill COVID-19 patients. "
What do they mean by CD12 open-label extension? I thought the OLEs were separate from the trial. If so, it seems the OLE data is further supporting LL's efficacy (though we shareholders have not been told of this data yet), so they are able to present that data as further evidence that LL is working and working well.
[OK I checked. OLE is "continued prescribing of unlicensed drugs after a randomized trial". It seems our data after the trial is also giving good outcomes. Mentioned here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1200598/ though the article is making a general critique.]
I got it a couple of days back. Till the first night, all seemed well. Then buildup of tiredness, feverish, headache/pressure, cold, sweat etc.; had to sleep it out. It continued till today morning and now is subsiding fast. So expect possibly a bit of roughness for the upcoming two days.
Did Phillippines release other information about their first CSP patient? Age, comorbidity, number of doses... We are hopeful for their 28 new CSP patients, but they should choose the patients wisely to optimize chance of success. Otherwise the results may not be as spectacular as desired, not because LL fails to work but because of careless selection of patients. (like too many over 65 etc.)
Can you post the webpage for this? I saw the video interview where the minister is mentioned and the pr for some patient who recovered. Where is it said that the patient who got the CSP is this same minister?
Do you have a link for this new guidance? Does this mean FDA will likely approve CD-16 only for 60 day mortality readout (and not 28)?
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The CD16 and CD17 protocol have not yet been approved nor are they enrolling. I imagine that CD16/17 will include 4 doses as I don’t think CYDY had the money to run a 3rd trial in addition to CD16/17.
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Thanks for the info confirmation.
Excellent news here. Makes sense to make this modification after the 14-day results.
The PR however does not say if this protocol change is for the CD-16 trial itself or for a separate trial that will start even later; whether CD-16 has already started and hence cannot be subject to this change; whether Cytodyn is going to stop enrollment and wait for the FDA to first approve this protocol change, etc. We don't know how much time it will be before FDA okays this change. Also this means Cytodyn likely would not include the past OLE data.
Time is ticking. I hope the FDA quickly approves this change and discounts the CD16 patients who only got 2 doses; and we can restart it with this new protocol.
Does anyone understand the logic of why LL will work for Long haulers? They are past the cytokine storm stage, whereas our drug is supposedly most effective for critical ecmo patients. Why would blocking CCR5 receptors be of use to long-haulers?