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News from Brazil this morning....
Prob the MM selling shares naked short down low.
Can't let the share price get too high..
An offer for $17 at this point is a bit high in my opinion. With 1B shares authorized soon, that would put it up in the category of Gilead and Immunomedics' $21B deal.
....take a look at the pharma buyouts in 2020.
Eli Lilly to acquire small California biotech for $1.1 billion
Eli Lilly acquired Dermira, a small Menlo Park, Calif.-based drugmaker that specializes in chronic skin conditions, for $1.1 billion.
Gilead acquires cancer biotech for $4.9B
Gilead acquired Menlo Park, Calif.-based cancer biotech Forty Seven for $4.9 billion.
CVS to acquire St. Louis grocery chain's pharmacy business
CVS Pharmacy acquired all 110 of St. Louis-based grocery store chain Schnucks' retail and specialty pharmacies.
J&J to acquire Momenta Pharma for $6.5B
Johnson & Johnson bought Cambridge, Mass.-based Momenta Pharmaceuticals for $6.5 billion, a move to strengthen the drugmaker's portfolio of autoimmune disease treatments.
Acadia Pharmaceuticals acquires Texas drugmaker for $52.5M
Acadia Pharmaceuticals acquired Fort Worth, Texas-based biotech CerSci Therapeutics for $52.5 million, a move that broadened the San Diego-based drugmaker's pain medication portfolio.
Nestle acquires Aimmune Therapeutics for $2.6B
Nestle paid $2.6 billion to acquire Brisbane, Calif.-based Aimmune Therapeutics, a move that broadens the Swiss food company's health science portfolio.
Bayer to acquire vitamin subscription company for $225M
Bayer will purchase Care/of, an online vitamin and supplement provider, in efforts to expand its nutrition and wellness portfolio.
Gilead expands oncology portfolio, acquires Immunomedics for $21B
Gilead purchased Immunomedics, a Morris Plains, N.J.-based cancer drugmaker, for $21 billion.
UnitedHealth acquires competitor to Amazon's PillPack
UnitedHealth Group acquired DivvyDose, a startup that delivers medications in presorted packages and competes with Amazon's PillPack.
Bristol Myers Squibb acquires MyoKardia for $13B
Bristol Myers Squibb inked a $13.1 billion deal to buy Brisbane, Calif.-based drugmaker MyoKardia, aiming to diversify its drug portfolio beyond oncology medicines.
Rite Aid to acquire Seattle-based pharmacy chain for $95M
Rite Aid acquired Seattle-based pharmacy chain Bartell Drugs for $95 million.
Bayer acquires gene therapy company for $4B
Bayer bought gene therapy company Asklepios BioPharmaceutical, commonly known as AskBio, in a deal totaling $4 billion.
Merck to acquire COVID-19 drug developer for $425M
Merck announced it will buy Rockville, Md.-based drugmaker OncoImmune for an upfront cash payment of $425 million to obtain rights to the drug it's developing for patients hospitalized with severe and critical COVID-19.
Gilead to pay $1.4B for hepatitis drugmaker
Gilead said it plans to buy German drugmaker MYR GmbH for $1.4 billion to gain access to its drug Hepcludex, which treats adults with chronic hepatitis delta virus infection
Came in to town this morning for breakfast since the weather is too crappy for hunting and got a voicemail from another shareholder about how difficult it has been to convince long term shareholders to hold the course and give things a few more months for some events to materialize. A long voicemail. Admissions of end of year tax loss selling for some respectable holdings....for many of them, CYDY is just another line item in their portfolio that they're not understanding the potential of how leronlimab can literally change the world. Then there are the shareholders, like most, who have six figure and lower CYDY holdings that care deeply where this is going.
For example, there is one shareholder in Glenpool, OK - the heartland of America - that just seems no sense can be talked into. But who knows if they'll read this....I'm hoping a rae of sunshine can break through the clouds of doubt in their mind and they'll just step away from pushing that button. Hang in there buddy, I hope things will somehow make sense to you real soon. I have a friend, Kathy, who wants to talk and make a convincing pitch.
Now back out to the sticks and no technology. One of my buddy's told me he has his sights on a big ass buck foraging with a doe plus several younger adolescents. Impressive animal and worthy of the hunt.
Just wanted to share something from a recent work/pleasure trip I was able to...[ahem]..."justify" to my boss.
The CytoDyn poster presentation at the San Antonio Breast Cancer Symposium 2021 did not say anything that would be earth shattering to anyone here. Did get to meet for the first time and chat with Dr. Kelly for a brief few minutes between very interested individuals walking through asking questions. When Dr. Kelly had to step away to talk with Dr. Massimo Cristofanilli I excused myself and walked through the other poster presentations which were almost as interesting....ok...I sort of faked that I was interested....see, guys can fake it too.
Despite my disappointments with Dr. Kelly's decisions in the past, we discussed the immediate future of leronlimab and his eyes started to gleam when we talked NASH. And he did reinforce that nothing being discussed wasn't already public information...but ya....standby for some hopefully excellent news from the 700mg study just based on my reading of his body language....but we shall see what reality is....maybe he was just happy to see me.
Thought I share this before heading off for the weekend....it's hunting season right now...got tags for multiple harvests....a guy's gotta do...what a guy's gotta do.
Oh...right...no pictures....not proof....so here....
Have a great weekend !!!!
Sorry....but I'm going to leave this where I ended it and not take any questions...."That's all the time we have..."...as NP would say.
I dunno about that one.
I sort of liked the hot presenter discussing the products in the YouTube links I found.
Oh. You do realize that there's more than just HIV-1 opportunities at stake here.... right???
Wow. That would a wonderful opportunity for CytoDyn with your experience. You open to new opportunities?
Let's hope that we are not dragged down by the Vyera relationship with the HIV-1 deal. That market would have been great to get into two years ago....but "thanks Amarex".
Who knows....Good Pharma Bro Martin could turn things around in the HIV channel in Oct 2022 when he is scheduled for release. He might even be able to jack the price up 5,500% !!
With so many other indications than HIV-1, it would be great if CytoDyn could continue making good choices...like choosing Sidley and their new PR firm....and partner up with a powerhouse that can leverage a "Live Video Detailing" app...I found that the one I was reading about is now this app:
https://www.indegene.com/solutions/clinical
I wonder how pricey it can be.....
With the promise of PRO140/leronlimab/Vyrologix being able to treat HIV-1, COVID, Long Haulers, NASH, oncology, neurodegenerative diseases....the list keeps getting larger every month....CytoDyn needs to put their eyes on the horizon on how to quickly capitalize on these emerging markets. So many out there just aren't aware of this drug's potential in so many conditions. So, I propose this....
CytoDyn needs a leader in online access to and interaction with healthcare professionals (HCPs), to spread the currently known information on PRO140/leronlimab/Vyrologix to HCPs worldwide. We need an industry leader in the field of capitalizing its leading Live Video Detailing service and its ReachNetSM physician access channel, that can instantly connect pharmaceutical representatives with HCPs, including prescribing physicians, nurse practitioners and physician assistants via their smartphones.
Industry research has shown that HCPs are increasingly searching for medical information on their smartphone during their practice day. Using this service on their smartphone, an HCP can be immediately connected to a CytoDyn representative or call center. The HCP and representative may co-browse CytoDyn's content while conversing and viewing information best suited to address the HCP’s specific needs.
In trying to find an already tried and true method that an industry leader has already in place, I found these videos that go over all the aspects of how this could work. The hard work on this has already been done !!! And it's got to be pretty cheap because it's over 10 year old technology !!!!
Check out these videos:
Good timeline to some events quoted here if there needs to be some reminders....
That would be some sort of tort lawsuit asking for damages....probably years in the making for that one.
Right now this looks like we can get the data out of Amarex's databases and get that over to the new CRO to pick up the ball and run.
Yes...but you can view the actual court filings on the real PACER Court Locator site (a US Government site - https://pcl.uscourts.gov/) that I was getting "access denied" on.
The PacerMonitor site pulls their data from the government site and must have ability to read certain data from the document whereas I'm trying to pull the full document.
May have to live with the summary information from PacerMonitor for now....argggghhhh....but I will keep trying to pull the details up....
No. I hadn't considered it in that way.
Just between friends...please explain how that works.
Because I think I'm getting scammed on my "loyal customer" bonus payment.
Phase 2 NASH trials seem to be relying more on the MRI-PDFF and ct1 studies because they're non-invasive (e.g. biopsies).
Seems to be a industry thing now...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877451/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3969008/
Being validated with this clinical trial:
https://clinicaltrials.gov/ct2/show/NCT03743272
Now, for a Phase 3...ya...going to need the biopsy "gold standard" assessment. But there's always a catch....the biopsy may be taken from locations non-conclusive from each patient since fibrosis is not uniform throughout the liver. Even the different technicians performing the assessment can influence the reading. But, biopsy will not doubt be in CytoDyn's Phase 3 NASH protocol....if not...[facepalm].
https://doi.org/10.1002/cld.740
Thanks for the update on this.
I guess that means there is even less of a reliance by "Quest Clinical Research" on CytoDyn as a source of income. Must be the other 15+ trials that "Quest Clinical Research" is generating income from.
Yes. I did see that Amarex is still the CRO on those records. I think they're still officially the CRO for the existing CytoDyn trials but not for the new ones in the works.
Maybe Amarex is still listed pending the outcome of their court case.
But the other 15+ clinical trials listed with "Quest Clinical Research" as a trial site supports that it doesn't look like they are hanging their hat on CytoDyn as their primary source of income.
Since CytoDyn has endured several unflattering hit pieces thrown at it by Citron and Culper Research, plus the recent DOJ/SEC investigations against "short activists", this is certainly something to follow to see if the courts will allow this type of "investor activism". But I'll check up on the case to see which direction things head.
I did a quick lookup and it looks like LIFEMD and LAMARCO et al are still tangling. Last document filed on 17Nov21 by LifeMD declaring no corporate parent or other affiliate.
There have been a couple of "Notice of Removal" and "Motion to Dismiss" by Lamarco et al, but Judge Stickman (wow...wonder if he got a lot of kidding when young with that name...) is keeping it on track.
I think the judge is still mulling things over after Sep/Oct/Nov filings over if the case has merit or not with a bunch of Motion to Dismiss responses by both parties.
This must be costing Lamarco et al a pretty penny. I don't see a "GoFundMe" donation on CulperResearch.com to help offset these costs...wonder who's paying the bills....
I encourage everyone to go over to ClinicalTrials.gov and see what current trials are underway that list "Quest Clinical Research" as a participating location.
https://clinicaltrials.gov/ct2/results?term=%22quest+clinical+research%22&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&age_v=&gndr=&type=&rslt=
Many of the trials complete in the 2022-2025 timeframe...but there are some that end in 2031 and 2033 !!!
Gilead (3 studies)
Calimmune
Sangamo Therapeutics (2 studies)
City of Hope Medical Center
California Institute for Regenerative Medicine (CIRM)
Enanta Pharmaceuticals
Pharmaceutical Research Associates
Assembly Biosciences
Boehringer Ingelheim
Novo Nordisk A/S
Intercept Pharmaceuticals
AbbVie (6 studies)
...and then there's CytoDyn (2 studies)
Just wanted to remind everyone the definitions of these terms:
Active, not recruiting = The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Recruiting = The study is currently recruiting participants.
Meaning both status indicate being paid to conduct the patient studies/trials.
Here's an interesting comparison.
A phase 2a LIFT trial of TERN-101 (Terns Pharmaceuticals) for the treatment of patients with nonalcoholic steatohepatitis (NASH) was recently published on 28Oct21 with their promising results.
https://www.gastroendonews.com/Hepatology-in-Focus/Article/10-21/Data-on-TERN-101-Show-Promise-for-NASH-Treatment/64811
So, I compared them to CytoDyn's results.
It will be VERY interesting if 700mg leronlimab dosage shows even greater results.
Interesting is that both CytoDyn and Terns used the same measurement methodology as CytoDyn.
Both, it would interesting to see how accurate research can be shared.
Have a wonderful day !!
I'm not familiar with the screenshot you're referring to.
Care to share a link to back that up?
Sounds like fun. I look forward to a slanderous and non-fact filled report from Culper Research. It's been a while since Culper published something on CytoDyn. I think May 8, 2020 was their last dump.
Where is it documented that:
I know. All those companies I'm either currently invested in, or was, could be so careless in putting the future of their drugs in the hands of "Quest Clinical Research".
If all those BP companies were duped, no wonder that CytoDyn possibly blindly handed over millions of dollars for naught.
But...if "Quest Clinical Research" is in fact a legal and viable business, as is shown by their Fictitious Business Name registration with the County of San Francisco....getting all lathered up about it is going to cause me undue stress in life....oh my.
Interesting on wanting to know what specific date the HIV-1 BLA (BLA 761144) was submitted....seems that a certain individual is also curious....
https://www.fda.gov/media/154586/download
This is from the "November 2021 FDA FOIA Closed Logs" which are FOIA requests submitted to the FDA that were completed and the reason they were closed. "Withdrawn Closed w/o Charges" means that the requestor withdrew their request and was not charged any fees by the FDA in the process of fulfilling the request.
So, what's a "Form FDA 356h" everyone asks?
Wow!! This is not only a potential problem for CytoDyn - it is a travesty for all humankind.
I think the first thing that should be done is notify all the current sponsors of trials that Quest Clinical Research is currently "illegally" participating in and let them know that their trials are at risk of being invalidated.
Great work compiling all the supporting documentation but there's one more step so I've provided a helpful list with contact info to help things along:
CytoDyn
Might want to do even a hint of research on that for everyone's benefit....or would that be counter to some sort of agenda?
Contact Quest on Monday....I'll take that under advisement.
Interesting that the ClinicalTrials.gov site update deleted Amarex and paired down the contact info for Quest Clinical Research
https://clinicaltrials.gov/ct2/history/NCT04504942?A=1&B=2&C=Side-by-Side#StudyPageTop (Latest update 29Sep21)
And this ClinicalTrials.gov update just updated dates and left the site/contacts intact
https://clinicaltrials.gov/ct2/history/NCT03838367?A=4&B=5&C=Side-by-Side#StudyPageTop (Latest update 29Sep21)
Just checked the calendar to make sure....but 29Sep21 comes *after* the Aug 2021 PR cited:
https://www.cytodyn.com/newsroom/press-releases/detail/551/cytodyns-final-mtnbc-report-indicates-as-much-as-980
Ssssuuuuuuurrrrrrrrre.....got it....
https://www.questclinical.com/study-participation
But I guess since Quest Clinical Research was dissolved a while ago they wouldn't be updating their web pages....??
https://www.questclinical.com/media
But wait...here was a page with a link added on 11/29/21....and...what's that? It has a link to an email that Dr. Lalezari wrote to a US Senator, a couple of Congresspersons...and the NIH/CDC/FDA also...talking about...get this....ya...Leronlimab for Critical Covid-19 Patients.
Nothing to see here about Dr. Lalezari not commenting on any thing CYDY in some time......
I don't want anyone to keep reading down the page for links in 2021 concerning CYDY/Leronlimab....you might find five or so there....
Oh...forgot to add...since Quest Clinical Research is dissolved...why do they update their web site's SSL certificate....
I just threw out a juicy steak....and it's being disregarded?
oh....this hurts me deeply....
But hey....if there's not documented proof with the Secretary of State for the State of California....then this case really doesn't matter, huh?
Pick one or the other.
One choice is real, the other is denial of reality.
https://unicourt.com/case/ca-sd-estudysite-vs-cytodyn-inc-869369
Go have fun with this one....it should be a fun journey....
Dr. Kelly's voice seems to be giddy when talking about NASH....
https://www.cytodyn.com/investors/news-events/press-releases/detail/581/leronlimab-350-mg-weekly-use-for-14-weeks-in-open-label
Seems that there are soooooo many websites that must incorrect about "Quest Clinical Research" being acquired by EstudySite....which in turn was acquired by "Velocity Clinical Research"....
http://www.celeritypartners.com/news/press-releases/20151001-estudysite-acquires-quest-clinical-research/
https://www.zoominfo.com/c/velocity-clinical-research-inc/459117938
https://biopharmguy.com/company.php/Quest%20Clinical%20Research
There's even someone who used to work at "Quest Clinical Research, a subdivision of eStudySite" listing it on their LinkedIn job experience... must be guilty of "pad'n that 'ole resume" with lies to support my observation...
https://www.linkedin.com/in/noradarago
And the status of "eStudySite"....
https://www.prnewswire.com/news-releases/velocity-clinical-research-acquires-estudysite-inc-to-increase-volunteer-recruitment-from-hispanic-communities-in-san-diego-301170989.html
https://www.crunchbase.com/acquisition/velocity-clinical-research-acquires-estudysite--1ccb97dd
https://app.mergerlinks.com/transactions/2020-11-11-estudysite-inc
....it really should be a lesson in kindergarten that "the lack of confirmation is not proof"....
Let's get even more explicit on things here....if there are any naysayers in the cheap seats....
https://mergr.com/estudysite-acquires-quest-clinical-research
Go ahead...click on that link...then click on the link in the upper right corner "Quest Clinical Research"....check out the address and phone number....
Anyone have any questions on the topics I have covered today?