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Did you see this one?
https://www.foxnews.com/us/utah-mom-dies-four-days-after-taking-covid-vaccine
Vaccines help but definitely treatments are needed!
CYDY anyone?
GLTU/A.
Well, definitely gives March madness another meaning. What an SP roller coaster if/when these things pan out. Good news is, there are cumulatively 3 weeks til EOM. CYDY's SP will be in a different spot come the fools day in April.
GLTU/A.
masshysteria - "I don't remember the specifics but believe this is a phase II? Not sure if it's a registrational trial but with Leronlimab's safety, if it shows efficacy, an effective FDA would provide approval or at a minimum EUA to start dealing with the millions of less than functional post Covid patients." - on the call they confirmed it was quick trial (originally 100 but reduced it to 50) and if you look at the PE/SE on clinicaltrials.gov there are tons of endpoints:
https://www.clinicaltrials.gov/ct2/show/NCT04678830?term=leronlimab&draw=2&rank=7
I think they finally realized that going for the whole shebang with CD12 taught them to get more precise with this trial. FINALLY...
GLTU/A.
Long holders - capitulation done? All stop loss triggered that should have been triggered? Ok now lets move up. Not going to pretend I'm enamored with the SP (though the volume is very nice). News takes 3 days for the dust to settle, we'll settle at close today.
Tomorrow's another day. I'm actually looking forward to the LH trial announcement that it's been filled (50% at the moment and first injection a few days ago) and a non-pumper news regarding the CTP from our Philippines agency and that LA funding that S. Kelley mentioned (wouldn't give it much weight TBH if just Nader mentioned it).
What goes down will go up (granted there are fundamentals, and yes we have fundamentals). You can bank on that.
Wheat / Chaff has been separated. Lets eat.
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Amazing post. Wow, thank you! Great job.
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Stickied. Great find crazyjogger and great post Scooter Mccabe.
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crazyjogger925 - yes, my point exactly. Oldest trick in the book, keyword being trick. I remember when I first received one some years back I actually called a few. Some picked up, some didn't. For the ones that did, I did leave my name and number and guess what? You guessed it, nothing happened!
GLTU/A.
No that's not true, they go away on there own as there's no merit. Last year we had 4? 5? Looks like once a quarter. Actually would be slightly odd if we didn't get one or two as we're approaching quarter end for CYDY.
Check to see how many of their class actions against CYDY or any of the other biotechs (google the firm) they've targeted come to fruition.
HINT: they don't make money on lawsuits.
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You both (rockleo, misiu143) - may have made my week with that statement.
Thank you!
"I’ve done something better..I’ve got Misiu 143 involved..Once she gets after something..IT GETS DONE..!!!"
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Great post jimmy667 and sharing of your experience. Respect.
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FWIW I've sent them this info to help with HIV BLA resubmit. Hope you and others do the same.
No use being inactive shareholders, am I right longs?
GLTU/A.
Rockleo - we've been doing this for a nearly a year and always appreciate your posts. Please, would you send him this crucial CYDY HIV/BLA ROT question yourself (obviously address yourself as a DR as such):
skelly@cytodyn.com
npourhassan@cytodyn.com
They have yet to respond to me directly and trust me, I'm a vocol m*f*.
GLTU/A.
We'll be doing a CD16 trial for 140 with PRO 140 (how befitting).
Will it succeed? Yes - 3rd time's the charm, everyone knows that!
The SP will go up and down for you longs, I'm sure some have experienced paper loss' in the tune of 5 or even 6 digits.
This next trial is precise and it will be quick-ish.
Hang on, no need to fret as this one (as you've seen with the 8K) is in the bag.
GLTU/A.
Just like LL, trust the science and professionals that have testimony of the drug. Not a 'data expert' or any pumpers or bashers. We did well with that critical section the new CD16 trial is embarking on, and it's gift wrapped and bowtied with a beautiful card for shareholders. Smart money buys now, weak money always loses, long or short.
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You're quoting buyersstrike?? Wow. LOL..
As a data expert you mentioned you were, wouldn't it make sense to quote from the filed 8-K as the source of data??
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C20 - last post for me, but a few interesting things:
1.NP/SK flying to LA for some meeting with an investor.
2.Possible Philippines 'EUA' type of application being filed (someone correct taht exact type of application.
edit - respect to moneycrew calling this out from the weird Dr Been interview.
All in all, next few weeks will be interesting.
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Damn, from Phase1 to Full approval ALL in 6 months???
That is very very quick, right??
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Good call moneycrew.. Philippines still in there..
RESPECT.
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BlueMan - was more in lines of:
- we did not do this right, so we will correct this wrong like x,y,z
- we know that rem/dex did not hit SS so we WILL apply for EUA given pandemic
- we are moving from Amarex as a CRO to partner with <insert BP name>
- we will focus the next N weeks for Brian Brothen to not sleep and go to the 18 sites and fill up the 140 patients like yesterday.
etc
I have a ton of questions I sent, hope all of you are doing your part.
GLTU/A.
24% chance of a good response back?
Highly unlikely..
Hope CC provides some good data, plans!
GLTU/A.
I've also email buzzfeed and sent all the letters the DR's that have currently written to Janet from various boards. Lets see how this pans out the next couple of days. Haven't seen this type of CYDY unity for some time. Good stuff ALL.
GLTU/A.
"
Dan Vergano
9:43 AM (1 minute ago)
Just a quick note to thank people who have sent ideas for follow-up studies to look over or other suggestions. This is clearly an active area and there are a lot of people trying hard to help. I'm sorry I can't reply directly. Kind of a full inbox on Monday morning. Thanks for taking the time to write.
Dan Vergano
Science Desk (DC)
BuzzFeed News
111 E. 18th St., 13th Floor
c/o Washington DC Bureau
NY, NY 10003
Send secure tips --contact.buzzfeed.com"
GLTU/A.
So they got it down to $2.70 which actually is pretty impressive. Would have never thought to see sub $3's but alas, we move forward from here. Great recovery in 10 minutes considering.
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FWIW - that's some sexy volume: 3.5M in 5 minutes? Good old days!
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Let me play the other side for a second and if you would oblige. Run your analysis on dexamethosone or remdesivir and tell me they hit stat sig with the number of patients and population in their trial? Mind you, they had thousands of patients.
Hint: they didn't..
GLTU/A.
When bulls see red, they charge! credit to the author on a CYDY reddit post.
CYDY will have it's day in glory, we just hit a speedbump and thought we broke an axle but it was just a lodged rock that fell out.
GLTU/A.
SO simple - P values, data is black and white:
"As a consequence of an imbalance among enrolled patients over 65 years of age and under 65, an “age adjustment” analysis was performed, which resulted in the following primary endpoint analysis:
4. Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.
5. Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
6. Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65."
The new trial for critical will show SS.
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Powerful reddit thread on Dexa vs Leronlimab:
https://www.reddit.com/r/CYDY/comments/lzu5qw/similar_ageadjustments_and_cohort_stats_for/
All the more reason why EUA is a wildcard from the wildcard list.
I'm not pumping here but would gamble that we DO get EUA in the next few weeks. Just my own opinion.
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Just fixed the post. Thanks for pointing that out! Now then we dont have anything in the 'Not in the bag' section!
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Since a ton of us are sending emails, one to this buzzfeed reporter wouldn't hurt as well:
dan.vergano@buzzfeed.com (got this name from this board , but forgot which poster)
I've already sent mine. Lets get the word out. 1 out 4 (24%) critical patients is still a life..
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Here's what we know: (You can disagree or not)
In the bag:
1. HIV PE SS and BLA resubmit off of the RTF received last year, Dr. Rahman to bring it across the finish line.
2. 24% mortality rate on critical patients over all the current drugs used in SOC (dexamethasone, remdes, *mab, co-plasma and the like). Real numbers with real p values.
3. 140 patience CD12 trial extension with PE on hospital stay. CYDY destroyed that with 166% rate versus SOC.
May be in the bag:
1. LH quick trial and interim looks.
2. Next steps on NASH, TNBC current trials and interim looks.
Wildcards:
1. Brazil EUA
2. Canada IO
3. MHRA, EMA EUA
4. Janet Woodcocks' statement regarding we're in a pandemic situation and FDA's p-value.
5. Philippines nod as it's dependent upon approval from any country (thanks for that info Maverick0408)
In the bag options will take time but the beauty of it is, they are 'in the bag'. Wildcards are just that, wildcards, they can literally happen any moment. This is now a waiting game, something WILL matriculate. Don't get caught up in the FUD.
GLTU/A.
Rockleo - janet.woodcock@fda.hhs.gov
"We need this drug before the next wave and yes, obviously we will have the next wave of deaths from COVID:
https://www.bloomberg.com/press-releases/2021-03-05/cytodyn-s-phase-3-trial-demonstrates-safety-a-24-reduction-in-mortality-and-faster-hospital-discharge-for-mechanically"
I don't have a on-going conversation with her like misiu143 :).
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misiu143 / Rockleo - FWIW, I sent one to her last night. Would suggest more do as well. 24% mortality over current SOC is not trivial.
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NP on Dr Been said conference call every week (if lawyers allow) until the trial (140 is done). I can always appreciate full transparency.
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"Huge run up imho!" -- ditto.
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For all of you that think 140 will be tough to fill for the CD12 extension .. may I remind you that the US pretty much froze over in February. The numbers you hear/see on the news, well think about it. Can we get correct numbers if you had 1.5-2 feet of snow and people are stuck inside? I'm very sure that even with the number of people vaccinated, we will see an uptick in Covid #'s around the world. Why? There's a new (and will be more) potent, stronger strain of the virus. We just detected a NY version, similar to the Brazil/ Cali version recently. Those are current strains. We're not even talking about super strains. It's getting warm out.. humans have short term memory.
This trial will fill up fast, IMHO. We will hit stat sig (though even current #'s are impressive vs SOC). The rest is cake.
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oldepro2 - Already did :). great minds think alike. Especially when it comes to CYDY savings LIVES!
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B52T38 - I love our country, but truth be told if they are going to jerk around a company/drug that can save 24% of lives at a juncture where it's life and death for critical patience then give the life saving drug to a country that puts their citizens first.
To very frank, it's surreal that they need 140 more 'data points' to prove their F'ing point.
Damn damn shame.
GLTU/A.