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some possible catalysts in the next few months:
1. EUA
2. results from mild/moderate trials
3. interim results from severe trials
4. BARDA
5. uplisting
6. BTD for mTBC
7. approval for HIV combo therapy
8. results from severe trials
9. cv-19 trials with remdesivir in Mexico
10. financing
11. publication of RANTES paper
I must be missing some others too?
no near term catalysts...heh-heh.
I always thought that "OTC" was the abbreviation for "looks like a scam stock."
Most of them aren't; a lot do fail, though. CYDY is legitimately giving it a good shot (not a scam), and it increasingly looks like they are not going to fail.
That is awesome, Marga.
Remdesivir has something leronlimab does not---a LOT of money and political clout holding it up.
Drugs other than remdesivir need to be proven safe and effective.
It hasn't been approved yet because it first needs to be proven safe and effective.
not two weeks. four...minimum.
Yup, it seems like being a jerk is one of the critical qualifications for a big-time CEO. By that criterion, NP clearly doesn't have what it takes.
In normal times, peer review takes several months. Big coronavirus papers move faster than that, but, still, peer review process is never (or at least shouldn't be) an overnight rubberstamp.
...the wrong Vancouver, of course. A little ignorance and sloppiness on the part of reporters is normal and to be expected. But, please, when we are hoping for a little help from Uncle Sam, the difference between Vancouver BC and Vancouver WA is important.
cash IS a requirement...and the one they have the most trouble meeting
not yet! so far it's blah blah blah. nothing interesting beyond enrollment number for mild/moderate up to ~45. also asking for for more eIND and "maybe" asking for eINDs for kids.
so about 2/3 of CYDY volume lately has been shorts. That's higher than average (about 50%) for OTCs. Cash cow for shorts!
Quest is Dr. Lalezari. Period. End of sentence. He helps run clinical trials and has been helping with CYDY clinical trials for awhile and has recently taken on the role of Interim Chief Medical Officer to help kick-start the leronlimab clinical trials for covid-19. [It seems like they are chugging along at a good clip now after what seemed like a sluggish start to enrollment.]
leronlimab is not really an anti-viral but it might well prove to be more effective at reducing viral loads than, say, remdesivir or other antivirals that have not demonstrated any efficacy at doing their real jobs. For covid-19, apparently reduces viral load by helping restoring immune system balance, in particular, increasing CD8 titer & restoring a healthy CD4/CD8 ratio. This is likely to have little clinical significance, but, hey, anti-virals almost always have little clinical success.
That's not where the real action is. Most covid-19 cases are asymptomatic to mild...you don't notice you are infected or you have a runny nose and cough for a few days. No big deal. The real concern is with the very nasty severe cases that seem to be caused by the immune system running amok (e.g., "cytokine storm"), causing serious inflammation in the lungs (and other organs) and sometimes causes clotting leading to stroke and other organ damage. The cytokine storm is very complex and can come in different flavors. With covid-19, it looks like two interferons---IL-6 and IL-1ß---are central players.
How to manage the haywire immune response? An obvious possibility would be an IL-6 suppressor. Enter: Tocilizumab, an FDA approved rheumatism drug, that has been some attention as a possible covid-19 treatment. A preliminary clinical test in France has shown positive results, with reduced need for ventilation and reduced mortality compared with a placebo (https://www.apmnews.com/nostory.php?uid=0&objet=350422). Nothing quantitative has been reported, but they are moving to the next stage, with results due in September. My guess is that tocilzumab is more promising than remdesivir and could be what Dr. Fauci is thinking of for a "cocktail." [But Fauci DID say today he was interested in a mab for HIV that is being tested for covid-19---probably leronlimab.]
Another IL-6 suppressor (sarulimab) does not look like it will help much (https://blogs.sciencemag.org/pipeline/archives/2020/04/27/anti-il-6-for-coronavirus-patients-does-it-work-or-not).
A second approach would be to go upstream and target what produces or regulates the cytokine storm rather than directly addressing the chemokines (e.g., IL-6 and IL-1ß) after they are mobilized. Lenzilumab is a generalist that aims at the granulocyte-macrophage colony stimulating factor (GM-CSF). They have run some trials but are completely mum about the results.
The other upstream chemical that has made some progress through the testing and bureaucracy is leronlimab, which targets CCR5. It's complicated, but the leronlimab prevents CCL5 (RANTES) from attaching to CCR5, which would signal the mobilization of IL-6 and cytokine storm. Remarkably, it seems to work, both in theory (rapidly and drastically reducing IL-6 levels) and in practice (e.g., moving patients off ventilators).
I am expecting remdesivir to fade from attention, and leronlimab and one or two others to pick up the slack. But, really, leronlimab may well have better anti-viral activity than the anti-virals (remdesivir), suppress IL-6 better than IL-6 suppressors (tocilizumab), and help restore a balanced immune system profile. All in a single package. Big pharma HATES that...one small company replacing 3 big, expensive drugs? Ouch!
I'm with ya', and it seems like much of their political woes are due to NP's tongue being a step or two ahead of reality.
My strong sense is that the shorts are dead in the not-too-distant future, but these fumbles are keeping them in the game longer than they should be. Makes for great drama, and the short sucking and spewing (is that the opposite of pump and dump?) has given some of our beloved antagonists buckets of $$ courtesy of nervous longs, but those days are numbered. Methinks it's gotten to the point where those games don't matter anymore. A little short-term volatility is giving some longs some unexpectedly good oppty's for buying.
Dieselpro, your timeline is messed up. FDA asked for the data in March. CYDY knew that but inexplicably did not include it in the April 27 filing. Did they forget? I can't imagine that degree of sloppiness. More likely they sent the FDA an incomplete file to get the ball rolling, but then why say it's complete when it wasn't? The "clarification" NP sent out late last week did not clarify. Only muddled it further in my mind. In normal times, this kind of unforced error might not be such a big deal, but now there are a lot of eyes on them, and they need to step up their game.
You mean that it's surprising how much misinformation and rumor-mongering there is with regard to this company? It is surprising indeed. The most obvious explanation would be that it is a tool for price manipulation to help shorts rake in $$ when they help facilitate drops in SP. Another, more sinister explanation (one that I don't yet quite buy into) would be that big pharma wants to crush CYDY before they grab a chunk of market share for HIV and coronavirus.
Isn't "vyrologix" the trade name just for the HIV indication?
Do you give them more credit than they deserve? Are they really looking for clients, or is it just a publicity fraud to aid shorting?
NP says very limited...can't count on them for more than some help with the trials. Samsung has a lot of capacity. Intriguing is the new discussion with the Japanese firm about setting up shop in SD---Fed aid is often contingent on work being done domestically. Signs of optimism for a grant?
This further muddies the waters for me. Why weren't the requested data sets included in the package sent to FDA last week? It boggles the mind. They initially sent dummy/placeholder data sets? What's the point of that?
Lots of rumors about CYDY floating around, but few os them are rooted in reality.
There's no "lawsuit", only an informal declaration of an "investigation" by what looks to be a shady law firm....big difference.
deceit, fraud, slander...all in day's work for far too many of the shorts
Yep. Catalysts and enthusiasm drives it up, and shorts drive it down. It's all good. Mostly--one of the tactics of the shorts is disinformation with some good old fashioned slander, libel, and doxxing thrown in as well (along with censoring of dissent). That is not good.
Interesting short attack at the end of the day pushed 'er down to 3.07 and kept trying to push beyond that...seems a bit dicey. Are they going to be able to find shares to cover at that price? Let's hope not.
"Idiots" who are making a ton of money right now...each of those daily dips of 10% are manipulated down and turned into gold. Then, the catalysts move the price up a little higher the next time, and the shorts turn it into gold again as they drive the price back down. It's not difficult with a stock like this. One day they will get burned and will move on to something else after a bad spell. No matter. In the meantime, they've made a killing. It'll continue for sure at least until uplisting at which point price manipulation gets much more difficult, so they'll move on to other targets.
You are fighting a noble battle for the truth. Not an easy fight here, but godspeed, I wish you all success!
That's awesome.
Yes, when Nature puts out an abstract, the paper appears that week. But when someone else puts out an abstract---at, say, medrXiv---the paper appears in Nature that week?
Peer review normally takes several months. The paper would get ent to two or three specially selected, anonymous reviewers who are knowledgible about the science to (hopefully) give an expert and insightful read to the work. Finding appropriate reviewers takes time. Writing a thoughtful review takes time. Editor reading a thoughtful review takes time. Authors responding to the reviews takes time.
Big journals like Nature can move relatively quickly through the process, but that only means several weeks instead of several months.
No, he didn't say there would be interim results by Friday. I believe they need data on 50 patients first and there were only ~30 enrolled last week. There's no way there'll be interim results ready by Friday...an update on enrollment maybe, don't expect interim results.
So Yo is the source of the chatter about Nature? I haven't been able to confirm that's where the paper was submitted. And, no, very little chance it's coming out in Nature tomorrow. I hope it does, but that seems way too optimistic of a timeline.
awesome! The doubts are rapidly dissipating. This would give the longs a golden opportunity to load up at a great price.
There really is nothing to see here. Scientists get paid. Rather than crude conspiracy-theory mongering, can you comment about the science?
This is an important event for two reasons. 1) it demonstrates great confidence on the part of management in committing to manufacturing mass quantities before approval, and 2) it was an unusual move, whihc provides great fodder for the unscrupulous to cultivate doubt.
This move would not make sense in the absence of significant new information about the science or progress in the regulatory jungle. The paper provides that jump in the science, and the new eIND approvals give a little good news on the regulatory front.
The science + manufaturing signal is real. The rumor-mongering and distractions by the shorts are not.