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In our case, Nasdaq going down is probably more like a cover for short-sellers to slam down the price in coordination with uncertain or lack of good news. We are not in Nasdaq yet, so no big ETF type investment would have us included that our price will fall along with XBI etc. That's my logic.
Who do you think is primarily causing the price to go down this week (after the Philippines video)?
Short sellers selling at these prices because either they wish to push down the price by mass dumping or they truly believe the company is destined to fail,
Longs getting out because they are losing hope,
or Something like dilution, due to some deal Cytodyn has with fife etc. (that I don't understand)
?
Add: There were 263000+ shares sold at 14:33 today. Who is dumping? A short seller hedge fund? Curious if people can guess this.
See page 19 of 8-k.
12/43 (28%) for LL+SOC and 7/19 (37%) for placebo+SOC
28% I thought, not 38. 12/43 passed away by day 28; 2/43 by day 14. The long's case is that situation at day 28 will be different if allowed 4 doses. Wrote on this in post 163447 and the earlier one referred there.
Have to check if there is more info that can be deciphered about severe patients.
Of course, I am not giving them a pass if they try and suppress results for these 28 CSP, having made that a point of advertisement. I suggest shareholders ask for this info (or that they address the results in a CC) by contacting NP, SK and/or through their contact weblink. I sent mail to NP on this.
They should tell us if and when any hospital actually applies and gets this ICUP for LL.
Also, as someone else mentioned, what happened to the 28 CSP patients? Why no mention of this? Earlier the impression was that we would get update for these cases. Are we still to wait for this, or is that to be forgotten?
Modi or Macron or Biden. This is more about the virus than this or that leader; yes leader bears responsibility and as in every country, the opposition will not waste the crisis to try destroy the governing party. But the reality is likely not one-dimensional or reducible like that.
Their graph tells a strange story:
https://www.worldometers.info/coronavirus/country/india/
It increased till September, then decreased back till February, then in couple of months simply blew up. The behavior from Sept to Feb, anyone seeing that (especially sitting in US at the time) will think they were doing something very right and it was working; herd immunity or whatever, the situation looked like under control. Likely people and govt let down their guard, all protocol was thrown up in air; the govt did not capitalize effectively on their initial good progress; and virus also pulled out its variants; things got too out of control too quick. Now they are in trouble.
Weird and twisted as it seems, now the fact that US is over its crisis, we find ourselves looking at India with "investor eyes". Its fair as that is the reality; lets hope we help out the situation and validate our drug as well.
"Interaction with India and Nader said they will have news to report on that front. This is hopeful and encouraging."
Dr. Seethamraju is probably a key figure in our connecting with the Indian medical community. Big asset/support for us at this time.
http://www.uniindia.com/apollo-hospitals-joins-with-mmc-to-host-india-s-first-exclusive-conference-on-lung-transplantation-on-saturday/south/news/1585598.html
Good point: Interaction with India and Nader said they will have news to report on that front. This is hopeful and encouraging.
For the recovered Patient:
Heart rate 100 before LL and after waking up next morning was 70.
Oxygen reading 85-86 became 91. Time for this happening may be between 24 to 36 hours after LL.
The heart-rate change seems dramatic; must confirm that it was consistently near 100 before and not wildly shifting around (night and day) even before LL.
The O2 improvement is good but perhaps the medical people here can assess whether this is that big a deal. It seems he had already improved from 75 to 85, so one can argue that the move from 85 to 91 was already happening and LL did not play a role. Can't say.
Cito says that he is the only patient who seems to be "convinced enough and brave enough" to come out and say that he believes LL works, and more needs to come and say that in order to justify or substantiate efficacy of LL. Those comments are a bit disappointing; given Estrada and others, we should have already got such inputs and attention.
Thanks am there ... waiting.
Not seeing any live link inside fb or YouTube page. Anyone else able to get in?
Edit: got it
Ok, just now saw this thread started there. But point is not yet refuted; Nader did speak of possible revenue starting this week.
Scooter was saying this fee for CSP is illegal and hence unlikely or won’t happen. Hope there is a loophole to get around this, if true.
Any reason for this in the PR for the Philippines webcast?:
"Viewers are encouraged to login 30 minutes prior to the start time"
Also what do they mean "login"? I thought this is live telecast for public access in YouTube? I don't have accounts in Facebook or YouTube.
SOC in India
I love that they have added Budesonide and Ivermectin to the treatment guidelines in India. pic.twitter.com/Je8NDT9E07
— Dr. Mobeen Syed (@drbeen_medical) May 1, 2021
Aiims guidance issued April 22 said Ivermectin three to five days for duration. pic.twitter.com/8kZP0agv6I
— Denise T G 13 (@bluebloodguru) May 1, 2021
In CD12, the results indicated positive efficacy for Critical patients but were more or less ambiguous about the other severe patients.
Still we are once again doing a large trial in Brazil aimed at severe patients, instead of focusing our resources on the critical subpopulation.
Is this a "just in case" strategy, where Cytodyn still hopes LL would work well for severe patients if tested in a larger population? Did Nader give insight into why (apart from greater revenue if successful) they decided to also do the severe trial in Brazil? Is there some way to focus the protocol so that we can better select severe patients for whom LL will work better?
It would have been hard to make a case for this new trial with the US FDA based on the CD12 results for severe patients.
What Philippines video this morning? Can you give the link?
Yes at the least they have to give us full info without masking or hiding on the Philippines situation as it goes and not try push it under the rug. I sent the Cydy team email yesterday:
Quote
This is Q for the Conference Call tomorrow.
Please be brutally honest in your update on our prospects in the Philippines, the number and results from the other CSPs, whether we are still seriously under consideration, and anything else. Is this something real that investors have anything to look forward to?
Same for India. Are shareholders unnecessarily hoping we may get some green signal there, when the red-tape and obstructions are too many for our company to surmount?
Unquote
The snail speed at which all this is happening is mind-bogglingly frustrating. I am happy but how long it will take to enroll, get EUA, for it to get accepted around the world will make a huge difference. Window of time and money may turn out small for Covid, we are past the peak in US just like that; presently Brazil and India are in great need of LL. But who knows in another year? Please Brazil, expedite.
So, CD16 is 300 patients and CD17 is 1200??
Did they tell us what is different about endpoints and patient requirements between these two trials?
They also do not mention a timeline. When is the expected end of the trial?
Nothing is mentioned of US FDA. Is this trial approved by them or a completely independent deal with Brazil?
If this is the webinar https://www.fda.gov.ph/access-to-medicines-during-the-pandemic/
it starts 8:30 AM their time on Thursday, which is Wednesday 8:30 PM US EST. So your original statement is correct. However I don't think Cytodyn not waiting for their FDA webinar means something internal about our progress there. I doubt they will make any official announcements during that; it is a bonus if they speak on LL in any particularly favorable manner. Any official decisions will likely happen later.
Reread my post 155609 and noted below:
14-day mortality for the 62 critical patients
LL+SOC: 2 deaths out of 43 patients (4.65%)
SOC only: 5 deaths out of 19 patients (26.32%)
Mortality between Day 15 and 28
LL+SOC: 10 deaths out of remaining 41 patients. (24.39%)
SOC: 2 deaths out of remaining 14 patients (14.29%)
Leaving aside the question of insufficient trial size for the subgroup and looking just at the numbers:
Shorts: LL-arm fared worse after 14 days because it is no better than saline if not worse.
Long argument: LL's presence in body reduced and the treatment effectively became equivalent to SOC after day 14. Thus we find ~ 24% mortality in the second 14-day period when many of the patients who might have already died in the first 14-days if given only SOC ended up relapsing and dying during the second 14-day period after the effect of LL tapered off.
Recap:
SOC: Days 1-14: ~25% of critical patients died; Days 15-28: ~15% of patients still alive at start of Day 15 died by Day 28.
LL+SOC: Days 1-14: ~5% died. Days 15-28 (when effect was closer to just SOC): ~25% of remaining patients died by Day 28.
So apart from the 5% of patients, LL had arguably shifted the starting point for others by 14 days - after which they followed the SOC pattern. This shift may have been sufficient for some; but for the majority (of those for whom LL could have made the difference) not enough. Had the patients been given 2 more doses, they could perhaps have gained another 14 days to avoid lasting damage on the organs from the cytokine storm and for the body immune system to recover its balance.
How do longs understand the SP move right now?
1. Investors selling due to insider info
2. Investors selling due to fear things are not working
3. Shorts selling due to some extra conviction things are not working
4. Just usual up and down day trading by people trying to play the fear and uncertainty ahead of the CC.
?
What exactly is the principle behind FDA allowing OLE indefinitely for the HIV patients? 4-7 years of getting LL (every week??) for 66 patients from the original trials (and over 1200 patients overall)!
Either FDA thinks the drug is working and should be approved - in which case Approve it!; or they should have sufficient reasons to hold back on it till new trials etc. are completed.
"We don't care about whoever gets this suspect drug through OLE - they don't really benefit from the drug though they take it for years together; we will allow such OLE even if we are not convinced about the drug's safety and efficacy; but we care about everyone else who may get it if it is approved; can't let that happen till we are fully convinced and the company crosses its t's and dots its i's correctly." Is that FDA's time-tested logic at work?
https://www.businesswire.com/news/home/20210427005590/en/Amid-Humanitarian-Crisis-in-India-Merck-Announces-Voluntary-Licensing-Agreements-with-Five-Indian-Generics-Manufacturers-to-Accelerate-and-Expand-Global-Access-to-Molnupiravir-an-Investigational-Oral-Therapeutic-for-the-Treatment-of-COVID-19
Still in phase 3, already got a foot in.
correction: post 162919
Do you have any information on what restrictions are on the board in its determination of selected investors? You pointed out that they cannot solicit or advertise (to potential investors). Ok. But how does a company/board select/identify an investor for the purpose of private placement? Not clear if you are saying also that a would-be investor should not contact the company asking for a way to invest in it, and the company thereafter selecting that investor. (Proof for this?)
Add: ref also post 163090 of I_luv_cydy
It was an email exchange. I had posted it at the beginning of this thread; trace back to post #163087
I can't fault you seeing that way. I will admit that the optics here are not good, given that the impression I got through some of his videos is as if he knew of Cytodyn only after Covid and not that he was invested in the company pre-Covid based (?) on its HIV prospects. So, suddenly learning of his getting shares in Aug 2019 makes one feel that he is deliberately reticent of revealing that fact when he talks LL. One can imagine he is projecting a certain controlled image and it may not be entirely candid or honest.
He speaks a bit on his investing in this video posted by D^4 around minutes 9 to 11:
And the last thing he had said was, to quote:
“ You welcome to share my responses with others “
This one, we may excuse him, for the mail (unlike the earlier mails) had “ Sent from mobile”
Hey, Nader REPLIED! On Dr. Randy and the SEC filing.
Email conversation
ME
Dr. Randy Nicolas (same as Richard S. Nicolas?) in the video recently linked to your website says around 5:40, "It was just upon my own volition last year when I ran across the studies of Leronlimab..." and around 10:40 "I am not .. involved in the business aspect of the drug. I have no connections with anything."
In this and as I recall in earlier videos, he came across as a doctor who independently discovered Leronlimab during the Covid crisis and now is supporting its usage for the Filipino people, because he truly believes in its potential (with no financial tie-in with Cytodyn).
Shorts did their homework and found this SEC filing from August 2019 https://www.sec.gov/Archives/edgar/data/1175680/000119312519234045/d731238ds3.htm
where Cytodyn has given 100s of thousands of shares to Richard S. Nicolas, MD and possibly a relation Marie Eleanore O. Nicolas. If true, he has arguably been in the 'payroll' of the company, lobbying on its behalf in the Philippines.
This may be normal procedure in the business side of things. But it smells of dishonesty. What appears disingenuous is the profile that he presents in these interviews as if he is not financially benefited or linked with Cytodyn, that too from pre-Covid times. He has stock from 2019, selected by Cytodyn, but he talks as if it is all anew for him and is an independent post-Covid believer of LL.
Not sure how to process this new gut-punch from the shorts. But informing that that is what it is.
NADER
He has not said anything on the video that is incorrect and he is not on CytoDyn's payroll and has never been.
Lies are always going to fail and the truth will always stand tall.
CytoDyn=Truth
Shorts= Usually all lies
Thank you for bringing this to my attention.
ME
Thanks for the response. "payroll" was wrong usage. The shorts (among other things) were pointing out that the SEC shows
Quote (of a short)
Dr Randy Nicolas receiving 186,400 shares and Dr Marie Nicolas receiving 247,000 shares from a private placement from CytoDyn
...
Every long here received shares from CytoDyn in a private placement?
Every long here publicly claimed to receive no financial benefit from leronlimab while owning stock?
Unquote
And they build on the import of this information, essentially casting shade on the reasons behind Dr. Randy's promotion of Leronlimab. But I take it you do not regard this information as something to be worried about, or as undermining Dr. Randy's honesty etc. I will accept that.
NADER
Any scientist that checks out leronlimab and does not run to his/her broker to purchase CYDY shares, IN MY OPINION, is a very unwise, business-minded person. Just my opinion
I've said before: I don't have confidence in Philippines FDA giving EUA when US does not. Their country is at the receiving end of US $$$. And this would be a very very big deal if they give the approval, overriding the US hegemony, essentially 'thumbing the nose' with a "screw you" at Big Brother. A lot of $$ and power at stake for US. An approval also would mean that Philippines could assess from their CSP data sufficient support for LL's significant efficacy that they cannot afford to play along with US: would be a strong signal worldwide and struggling countries like India will not miss the message. We are talking about a drug especially and uniquely meant for the patients at death's door. I cannot see it happening though it is nice to fancy and hope for. The CSP route is at present the only practical option.
In fact when the country authorizes each hospital to stock up for 100 patients with a single CSP, it is essentially a loophole to get around the formal EUA problem. (The US could also have given its blessings for that.) That arrangement may be all Philippiines needs as well since hospitals there are likely not that overwhelmed in terms of number of critical patients that they require more than 100 at any given time.
Unfortunately for us, CSP-type allowance does not equate to a credible recognition of efficacy. We don't have the same leverage to promote the drug elsewhere (India, Brazil, etc.) as we would if we had the EUA; and most likely these other countries (and their media even) will not take the leap of faith. There is some inroad into Brazil; but there also the same bottlenecks will follow. Without EUA, the process is long and arduous and these countries are likely going to back into the SOC.
India perhaps could become a prime opportunity for LL to save people and also get recognition. I like the fact that India has approved Ivermectin again (not for it working or not; just that it shows they can take their own path, though Remdesivir seems to have become a mantra there as well). They make and distribute vaccines including AstraZeneca; their biotech-industry I understand is independent and vibrant. Have their own vaccine "Covaxin" (linked to US company OCGN). All suggesting to me that IF Leronlimab can get a footing inside India and makes its mark at this critical time, that country will not dilly-dally like the Philippines.
But how to get into India is not clear to me, given how hesitant and arduous this whole process seems. Their agencies have to investigate Leronlimab based on some convincing information, though knowing the drug has not been approved by US, basing perhaps on CSPs given in Philippines, and conclude they should take a chance and try it out on their people. Tough. Let us hope Nader's statement that he is getting requests from India is more substantial than like requests from people like you and me; and indeed there is some chance for getting a trial or CSP pathway there (provided FDA will not block!)
Data_Science, try contacting Dr. Been as well. You probably know, he has talked about treatment protocols in his podcast extensively. Not sure what the best way to reach him would be; but this one support@drbeen.com is listed in his education website.
Quote
CytoDyn released that data to the Philippines and they in turn approved Leronlimab for CSP and to be stocked in their hospitals across the country.
Unquote
This says that Philippines govt and medical community are not seeing "failure", rather they have conviction enough to allow CSP and hospitals to stock up on the vials.
Quote
Philippines will approve Leronlimab for EUA.
Unquote
This, I have not confidence in. Not because they don't want to (and would have already done so if they could), but because their hands are likely tied up with the weight of US $$. They won't dare upend the US FDA. I would love to be shown as being wrong in this. If not, hopefully they will do the max possible by easing and find loopholes in the CSP type program.
Leronlimab is returning patients blood markers back to normal , this is remarkable and is something the clinical trial will look at! Long hauler treatment may likely be the future of Cytodyn! $cydy pic.twitter.com/LE8pf8tuRi
— Tom Smith (@TomSmit01069776) April 28, 2021
Brilliant, Brilliant, Brilliant!!! Thanks.
Really appreciate the astute questions by that journalist and Dr. Randy's detailed answers especially the observations of Erap after getting LL. He said he had similarly seen dramatic changes in the other patients he knew. I hope he later would let us know how many and talk about the nature of their responses as well: that is the kind of direct and precise testimony from doctors and patients that will break the impasse. Hope this is soon backed up by the other CSP patients and their doctors.
Ok, I cannot say you are not correct. It is quite possible Youtube is kowtowing to the line of the FDA/Big Pharma, since as I said the doctors were criticizing/questioning FDA decisions and Big Pharma influence. But the moderators at YouTube were pointing to medical misinformation about vaccines as the reason, which seemed odd given what I heard. Perhaps the advice of Dr. Been regarding J&J vaccines based on his reading of data seemed out of line for the experts at YouTube, or some other external parties of sufficient status did not like what they heard and made their complaints to YouTube which then decided to ban the video.
No. Youtube gave their reason: for medical misinformation on vaccines. They don't say what but from that establishment angle, practically the whole talk was slamming the calls made by FDA in the past year. So YouTube had a buffet of things to choose from.
(Correction: talk after the vaccine was like that. I thought they were giving a rational and non-antagonistic discussion on vaccines, assessing pros and cons - but did not hear this part too completely. Yet YouTube decided something was wrong about it.)
Wow. Dr. Been & Dr. Bream talk censored by YouTube:
These dumbos at YouTube have no idea what we talked about. But, they assessed this violation anyways. pic.twitter.com/GS7otpAH9C
— Dr. Mobeen Syed (@drbeen_medical) April 29, 2021
Mom will be admitted again in the hospital today after waiting a week for a room. She was confined already last December after testing positive. Now she again will be back in the hospital due to pneumonia & tested positive.
— JV Ejercito (@jvejercito) April 29, 2021
Intial treatments done at home.
Prayers requested.
) tests positive...That is the new wonder drug that was given to my father.
— JV Ejercito (@jvejercito) April 26, 2021
That is true. But see this video