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Does partnership mean we partner with BP for some indication like Covid or HIV and share profits from sales related to them, but keep full rights to do research and get profits for other indications like cancer? And our BP partner has no further rights to initiate other research with LL on their own?
One of the drugs used in the CD12 SOC was Tocilizumab. Given that it has now been given EUA for also critical ECMO, it would be of interest to know how we fared against it in cd12 especially among critical patients.
FYI, just saw that the LH Data is posted in an 8-k filing.
https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001193125-21-195277/0001193125-21-195277.pdf
I don’t follow the meaning behind the numbers and columns in their tables.
Ok. I did not realize actemra is same as Tocilizumab. Apparently FDA decided finally to reward them for those earlier trial results and nothing else new. We could not compete in the numbers game in US with BP sucking in most of the patients In big trials. While we managed to conduct a small phase 3 trial that was inconclusive in general and "hypothesis generating" for a critical subgroup, all these big Pharma have been enrolling thousands of patients of all types in multiple trials. Even if their results are not awe-inspiring, they are able to check the trial size-box for FDA.
Hopefully Brazil will complete and enable us to show better results in a large enough population that no one can insinuate doubt any longer.
Sorry CORRECTION
This is the link for actemra.. I mixed it up with another trial Roche had done with Regeneron.
https://www.roche.com/investors/updates/inv-update-2021-06-25.htm
Edit: The previous mention of actemra in their news section is of a negative outcome
https://www.roche.com/investors/updates/inv-update-2021-03-11.htm
So, we don’t know what exactly they have shown now that got them the EUA for severe/critical.
Note curiously: for patients “who had not mounted their own immune response”.
What does this mean? Cytokine storm is certainly a bad immune response, but one would think it happens at some level for all severe/critical patients(?).
Their trial with partner Regeneron
https://investor.regeneron.com/news-releases/news-release-details/regen-covtm-casirivimab-and-imdevimab-phase-3-recovery-trial
The drug works on virus unlike LL which works on ccr5. 5500 patients. 20% mortality benefit on severe+critical, they claim improvement in ventilation patients as well but have not given the mortality info specific for that subgroup (whether that by itself is stat sig). I don’t follow the seronegative etc. Doctors here can explain if there is other important info from this study relevant to us.
Right. As I see it, the fact that Leronlimab is not yet approved is our unfortunate situation for this LH scene because Dr. Patterson is doing parallel work with Maravoric that could have been done with LL. It doesn't mean that if he was with Cytodyn, somehow FDA would have approved LL any sooner for the severe/critical indication. Until that happens he would have had to do all this LH work independently.
However if we had good relations with him, we would have collaborations with him and he would have shared his LH discoveries and his guidance for us to build on with LL. Now we are forced to act as if we are completely independent of him and repeat things through other channels. Time and money. Ideally speaking, Nader should resolve any ego or power-conflicts and get him back on the board.
But it is what it is. We are on track now even if behind.
I see that Dr. Patterson is professional and his focus is the science and the treatment. He is not anti-LL or playing a short against us. He mentions LL freely and tweets of its potential if asked. So if Cytodyn establishes its efficacy for LH patients (gets approval) as a CCR5 antagonist, then Dr. Patterson would probably be open to its use as well. Down the road there should be a convergence.
Listening to Dr. Patterson makes me feel how far behind we are in this LH and covid effect, having to retrace his path simply because we have a drug that is not yet approved. He has already gained a lot of bio-marker understanding of what is happening and has designed the protocol which he claims is already working well. We are now looking to discover such knowledge based on how LL works.
It seems that because they are using an approved drug Maravoric, they don't have to go through the FDA to treat patients [even though it is for a new indication "Long Covid"], can experiment and conduct de facto trials and get data etc. We have to go through hell to get any trial going with a comparably minuscule number of patients.
Eventually we have to show Leronlimab does the same job that Dr. Patterson has already established through Maravoric and make a case that LL can either work better or serve as an alternate CCR5 antagonist. Hopefully this will happen within the next year.
Good to know, jbl. You seem to have direct information on what is happening there. Thanks.
It comes down to whether LL works or not. What has Nader done to screw up Philippines if their FDA does not give EUA? I don't see anything handed to him in a silver platter. The regulatory process is not as simple as we wish. We can fault Nader for amping our expectations; but that's about it.
What I would be more nervous about is whether there is not a surge in CSP requests because hospitals there have decided LL does not work on critical patients. No way to confirm that either. They may be giving CSPs too generally, who knows?
Longs who think LL does something good in covid will have to stick with that position and hope that upcoming trials and refined data analysis will soon establish efficacy and applicable indications with greater certainty.
Brazil was mentioned. The Einstein hospital there is supporting LL trial, are encouraged from our CD12, and people are working hard to get the process moving. Nader is projecting start date of July end (of course we can criticize that based on trackrecord; but it was mentioned clearly multiple times.)
For Philippines I agree he added nothing new and things may have stalled.
The main new thing about this CC is the great emphasis on bio-markers. Evidently they have found a lot of detailed information on how LL works and believe this can serve as quantifiable evidence on its mechanism and efficacy and from here can focus better on indications etc. Dr. Recknor sees this as very significant stuff.
Nader probably receives a lot of barbed comments or questions from shareholders in frustration; I send my share. My guess is that downed him a bit where he put a mental shield when answering some of the questions.
Question sent:
This link is newly posted on cytodyn webpage.
https://www.clinicaltrialsarena.com/comment/trials-of-covid-19-long-hauler-therapies-could-repurpose-endpoints-from-other-disease-studies/
Concluding para: “ The field is still trying to understand the prevalence of these long-term symptoms and their relation to the initial infection severity, Maher said, adding the unknowns with long-term Covid-19 symptoms makes trial design challenging. Overall, the lack of observational data, including its incidence and possible risk factors, makes it particularly challenging to study the effect of potential therapies, Han and Jackson agreed.”
Hope they are not preparing us with this for Monday cc.
Note article was written February.
Sent IR the following:
Hi, we can't ask questions on the results unless you send a PR on the results before the conference call, which as I recall has always been standard procedure.
Are you going to tell us the results first through a PR? Or is this a sign of bad news that will be revealed in good way during the cc? I would like to know the results in some format before the cc.
Thanks
Market may not react well but the news is not anything surprising. The companies signed an agreement contingent on CD12 or other trials in US. Now we are going elsewhere, so naturally they will annul their original agreement and re-invest their resources and commitments to other projects. This should be understood as standard process given our change in directions.
Thanks for the site.
"Review and approval process by ANVISA typically takes 18 weeks."
Better lower expectations. If above correct, trial likely won't start until well into fall. Management was clueless or misleading in estimating a June start date.
I see "Ethics Approval Date" June 15. Is that same as ANVISA having approved the trial already? Hope there is no space for doubt or ambiguity here, and we know for sure that the trials are approved.
I am concerned about the fact that the May 27 PR said Biomm is going to submit to ANVISA an application for trial authorization in "the next few days". Its been 2 weeks and nothing yet. Before trial gets started, Biomm must submit and then the bigger question is when ANVISA will respond and what they will say. They could just as easily put new roadblocks. Only after ANVISA says OK to a protocol can we really know if this trial will get underway soon or not. I sent Nader and Dr. Kelly a message on this asking for an update.
Verbiage from FDA:
https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
'Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. .'
— Maria Teresa Ferretti (@MaTeFerretti) June 7, 2021
Yes, that was what gave the 24%. Now they are changing it to 31 after stating they had some "new findings". I agree it does not make sense that they should discover new deaths suddenly in the same 62 patients. My only way of justifying this would be if deaths happened on Day 28 which were originally recorded as after Day 28; and later Cytodyn after looking through the details decided they should have been recorded in the 0-28 timespan.
Too much guesswork here, but I wouldn't jump to concluding they were manipulating data or method as "new findings" just for the heck of it. No real need to change 24 to 31 at this point unless they really had something "new" in the mortality data to justify this change.
Running through numbers and assuming they are consistent with their methods, best guess for post "new findings":
Day 28 mortality data:
LL+SOC: 14 deaths out of 43 patients (32.56%)
Placebo+SOC: 9 deaths out of 19 patients (47.37%)
Mortality reduction: (47.37-32.56)/47.37 ~ 31.26%.
---------
Day 7 and Day 14 numbers should be as in posts 169083 and 169085
Actually the number we get if we replace with 27.9 in denominator is ~31.9 % which rounds to 32 %. So if they were consistent about rounding (as they were as per my previous calculations), then their 31% here may indicate something else about "new findings". Its a hope only since the numbers are too close for comfort.
Ok the fact that the 31 comes magically if we replace the denominator with 27.9 instead of 36.8 does lead to suspicion that they decided to alter the method now, at least for the 28 day case. Unless the "new findings" (of deaths between days 15 to 28?) matched this somehow.
We would have to check if there are alternate possible death counts that will give 78 and 82 under this other method. My guess for now is No since the numbers I got seem to match very nicely; but cannot say for sure. Will send an email to them and ask for exact numbers given this number change - unlikely to get response.
Wait. I have to recheck the topline results, did not know they have now replaced 24 with 31.
I think they are being consistent in this. This should be based on standard methods. They may have been reluctant to state the hard numbers since the numbers can look small; but it is unlikely they are manipulating the methods in these calculations.
When we say mortality reduction, the reference point is where we started, so that is what has to be divided. How much is the change relative to the initial quantity?
So here we start at 36.84 and we brought it down to 27.9, change is ~ 8.9
When we calculate reduction %, we divide with the number we start with, so (36.8-27.9)/36.8 ~ 24%.
Based on calculations I had done earlier (Ref: posts 163447, 155609)
Mortality between Day 1 and Day 14:
LL+SOC: 2 deaths out of 43 patients (4.65%)
Placebo+SOC: 5 deaths out of 19 patients (26.32%)
Note (26.32-4.65)/26.32 = 82.33 % mortality reduction.
[A quick "best guess" calculation I did just now (not checking this thoroughly) shows that most likely:
Mortality between Day 1 and Day 7:
LL+SOC: 2 deaths out of 43 patients (4.65%)
Placebo+SOC: 4 deaths out of 19 patients (21.05%)
Mortality reduction: (21.05-4.65)/21.05 = 77.9% ]
---------
Mortality between Day 15 and 28:
LL+SOC: 10 deaths out of remaining 41 patients. (24.39%)
Placebo+SOC: 2 deaths out of remaining 14 patients (14.29%)
----------
Total deaths between Day 1 and Day 28:
LL+SOC: 12/43
Placebo+SOC: 7/19
“Although the CSP data is not randomized double-blinded control, the numerous case reports from the Philippine CSP are consistent with CD12 prespecified major endpoint metrics showing Vyrologix when combined with standard of care is better than standard of care alone (e.g. antivirals/dexamethasone) and may improve clinical outcome status four times better than standard of care at day 14 (p< 0.021) and reduce hospital stay by as much as 6 days (p<0.005) with a higher likelihood of returning to activities of daily living without limitations vs. placebo control in critical COVID patients."
Having seen the CSP data, Dr. Recknor is doubling-down on very strong outcomes, that shorts love to say are based on data-mining, such as 4 times and 6 days improvement. Would he dare do this if the CSP data does not back such optimistic outcomes?
And would Philippines hospitals make new CSP orders just for the heck of it? They saw the outcomes of the 100 patients, likely as Dr. Recknor says consistent with the CD12 subpopulation positive results, and they believe LL is having an impact on severe/critical Covid patients, hence the Order. And like others mentioned, that Cytodyn makes a special deal with an airlines and issues a PR on it likely means this is not a one-off thing. There must be demand from the Philippines end fueling these next steps.
Any mention of Leronlimab in the video?
Do you know if FDA is legally required to give all this information when asked under this Act? Or are you just taking a chance with the questions to get as much info they may give (if any)?
This is new on Cytodyn website. The article has a “corrected proof” tag on top.
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277
I can believe Biomm will submit by early June. But did not realize we are this far from trial. “Expected start date in June.” ANVISA has to approve a rather demanding protocol, after our FDA letter, and that within a couple of weeks. Who is confident of that happening? Every time there is some stop, the next go seems to happen in months time.
It may happen still if there is already behind the scene communication between Biomm and ANVISA and our protocol was finalized based on such communications, and these present PRs are more like routine to keep investors aware. That’s a lot of ifs to hope for; Nader has to explain.
Then what? Their FDA says NO, or change this and that? I thought we were starting the trial in June! This is getting real scary given the high expectations we had the past few days. How could they post those trials at that site without getting them approved first? Is the process different when doing it in foreign nations?
https://www.cytodyn.com/newsroom/press-releases/detail/535/biomm-s-a-announces-plans-to-submit-authorization-to
What does this mean? I was thinking last couple of days we are already approved in Brazil to conduct the trials with our protocol. Oh Brother!
Still yawning. Funny market.
Shouldn't they have something on the proportion of >65 vs <65 patients to be allowed in each arm? Where they say "Age requirements", I see (Adult, Older adult) but nothing else that makes it clear that the two arms will have equal proportion of older patients. Maybe, they decided Age adjustment calculation is fine enough.