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Leo, our phase 2b/ 3 trial designs should relatively parallel CYDY's P2b/ 3 SEVERE sequela portion of covid here in the US, while incorporating any missing microsatellite details added by the FDA, to round ? out and SYNERGIZE everything WITH THE FAST -TRACKED LABEL we got.
I'm super excited about the P2 impending results of our MOD AND SEVERE CV-19! Let's see 5X TO 7X ROI ahead of our before we initially announce our phase 2B/3 TRIAL completion of enrollment.
Since this is fast-tracked, the future P2B results of the P2B/P3 portion could be enough to grant an EUA. Don't forget that phase 2 results from Russia as being included with P2b results. Unless I'm confused that Dec 17, 2020, the trial was a "P2b" and not another Phase 2.
Another VERY likely possibility was the February trial enrollment here in the US that began enrolling in February is the " P2b/P3 enrollment " for both M + S THAT STARTED LAST FEBRUARY! That would make sense!!!
THEREFORE, Russia's TRIAL WAS the P2A (AKA P2!)for M AND A, to explain it's randomized and not a double-blind trial. SORRY FOR THE CONFUSION.
The timeline for P2B from Dec to September doesn't make sense for this to be just a phase 2b trial based on population enrollment. The original March made sense. And if the U.S. enrollment is the same as RUSSIA's sequela(e), why then staggered two different dates internationally? Then you also run into a having different SOC being given for severe in the US v. RUSSIA with Bril.
So the results have to be released soon for this P2b month from Russia ( whether it's M or M/S or not)by next week or so, to possibly justify a phase 3 enrollment that has already begun last Feb in the US? But no details were given yet at that time because the FDA hasn't released the new FDA guidance for therapeutics. IT WAS NOT UNTIL last Monday when they released it.
Unless it's only for Severe P2b cv patients here in the US, and it would require only two arms that started on Feb 1, 2021. If that's the case, results have to be out by mid-May. So phase 3 FOR SEVERE, WILL ONLY TAKE FOUR MONTHS and it has to start in June start date and be done by September? That's enough time with two arms: placebo and severe.
A phase III enrollment for both M AND A here in the US and ending in September is plenty of time to enroll 400 patients and monitor all 28, 42, or 60 days mortality rates for all three arms.
Thoughts?
THIS IS A VERY GOOD CONUNDRUM.
So I'm curious what exactly is the enrollment here in the US? P2B for MODERATE and severe too? but it wouldn't make sense with two trial sites multi-nationally having two separate trial dates for Phase 2b M/S. So is the enrollment here slated for Phase 3 then? Or is it phase 2B for severe only? I hate to be the criminal shorts trying to figure this out. Feb THRU SEPT could be PHASE III? If it's for phase 2B, the length should not take more than eight months. But eight months is more than enough to cover a phase 3 trial for both moderate and severe.
Yes, it's done so expect a pr result. We are at T + 73. If you go for mortality rates in severe using 42 days, it should not take more than 10 to 14 days to enroll 120 patients. One per site, per day for seven days, will enroll 120 patients. For a small sample, you only need three weeks to tabulate the results. So expect the results very soon. Next week possibly!
Nice find. Let's hope we get what is overdue.
I believe Phase 2B in Russian is done. The placebo is intended to treat for mild to moderate only, so I'm not quite sure if this is just moderate trial only, or moderate and SEVERE? However, severe has a different primary endpoint vs NEWS2 for moderate. So could it be that the SEVERE portion trial is held here in the US?
EITHER WAY, it's bad for the short criminals. Three-day dosing should be great for MODERATE. SEVERE sequelae will require more dosing and will include dexamethasone plus O2 here in the U.S., which explains why for "maybe... Up to five days" or verbiage was added to last week's pr.
Anyhow, I'm expecting a PR for P2b results from Russia(T + 73). Something tells me the covid trial that commenced here in the US was severe since treatments will include dexamethasone + O2 as part of the SOC in ventilated parents. I could be wrong. I'm expecting outstanding results for the MODERATE sequela from Russia. But if P2b in Russia includes both moderate and severe, we are done with the trial there.
Send your questions to the President Biden, bulls!
https://www.cnn.com/2021/01/23/health/biden-covid-team-town-hall-questions/index.html
The price to sales or P/S vs PE ratio is not the same!
That's only $24. With potential approval of Leromlimab in all sequelae, the global peak sales will be closed to $5b peak sales! Gilead is forecasting $1b to $3b for Remde for that for Moderate CV19 only. Very limited use.
Btw, as for my model, that's per qtr here in the U.S. $600m with 25% qtrly compounded growth rate usage or in sales.
OTC is the wild west and it's where a lot of the outlaws die young tomorrow and Wednesday morning. Tsk.tsk.tsk. Shorts reckoning is coming. Unfortunately, these parasites will not be able to cover until Wednesday morning. Time for them to find their personalized tombstone, I guess. Thank you for your business!
As I said before, CD12 will achieve statistically significant tomorrow at 5 p.m. ET., and enough to halt and gain an EUA from the FDA in the next few days. The best part of CD12? The company can apply for their CD10 approval as well. Here's what the previous CD10 results were:
Leronlimab (PRO 140), demonstrated improvement in total clinical symptom score at day 3 in patients with mild-to-moderate symptoms from coronavirus disease 2019 (COVID-19). The humanized igG4 monoclonal antibody also induced a statistically significant improvement in the National Early Warning Score 2 scale, a key secondary endpoint of phase 2 CD10 clinical trial, CytoDyn, Inc announced in a press release.
I'm looking for the company to generate $600m-$800m in revenues for CV19 therapeutics with a P/S of 24X. This a game-changing oncology drug. Don't fight it!
R.I.P. SHORTS. THIS IS OTC & NOT NYSE OR NASDAQ.
I'm expecting for statistically significant results for both severe and critically ill patients. Sleep well shorts! Game over!
Those are the mortality rates of SOC and not that of Leronlimab!
39.5% or as much as 53.8% for critically ill patients for Standard of care; and
28% mortality rate for severe.
Leronlimab's ITT in both categories will be statistically significant over the controlled/ placebo subjects, IMO.
53.8% mortality rate in critically ill patients. Leron will easily best that or the controlled group. Both sides. Leron will best them. Standard of care will be Leron. Sleepy for shorts.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7439240/
And the SEVERE is 28% mortality rate.
https://www.thelancet.com/article/S0140-6736(20)30633-4/fulltext
The current mortality rates of Severe and Critically ill patients.
Glad I could help. I can't wait that we have land a home on ST. VERY SOON. Not a fan here since very little or no policing of misinformation by the bears.
But here are the facts, to set it straight so there's no confusion.
The mortality rates are the following:
A. Severe is 28%
B. Critically ill is 34.5% (w/o the follow- up) and higher at 39.5% with a follow-up
About #CYDY 's Leronlimab...A statistical p-value of <.05 in mortality rate is the surrogate endpoint for a long-term outcome to stop the trial, and it could be the reason why they're doing a presentation? Instead of releasing the pr without the call ?NP loves to make a splash so no way on earth he'll skip the WEBCAST to tell the world that DSMC STOPPED the trial based on interim analysis for efficacy of survival vs mortality rate in placebo? ??????
I doubt it's about safety or toxicity issues on Leronlimab, so it has to be on the efficacy side since we are looking for clear clinical benefits on the survival rate over the mortality rate on the placebo group. Now, if this was a bad news, they would have released this same outcome just like what they did on the REMDESIVIR'S study in China last spring. dadada! Tat! Tat! at!
Conclusion: Stat significant! And DSCM stopping the trial to address this unmet medical needs in saving SEVER&CRITICALLY ILL PATIENTS!
Let's get the EIND approval and wrap up this RBL testing! Finding a away to deliver this drug via gi track may help the mild case. Maybe Vaxart's VAAST platform could work and help the po version of Bril? Enteric coating.
Let's not be afraid to target critically ill patients too, where the mortality rate is 34.5% and 39.5% after discharged and a follow-up.
I'm long on both CYDY AND IPIX!
I'm looking for great things to happen with our Bril drug for COVID-19 trials.
Time to execute, Leo! It's now or never!
It will be Cytodyn's Leronlimab and not any RdPp drug like Remde. Leronlimab is trending to be a potential SoC for COVID-19, and it should once the data comes out.
Remde is ineffective when it came addressing severe and critically ill patients; and due to the specificity of Bril's MOA, Bril could be as good or better than Leronlimab. I am excited to see our Phase II trials get going.
Timing is of the essence so I hope everything is lined up and ahead of schedule. We are a bit slow on the execution part, but now that we have $36M of cash, I hope we get moving FAST!!
Yes! It will be great for your MILD CASES OF COVID-19, who are mostly told to go home and hope to get better on their own. Slowing the infection rate is the key, and this helps immensely! As you know, age, comorbidities, and immuno-suppressed individuals are very likely to progress and die, this will HALT the progression.
And this is why Bril is both a PROPHYLAXIS AND THERAPEUTIC AGENT VS COVID-19. NOTHING has changed with my assumptions on what Bril can do and can not do! :)
We should use REMDE (JUNK) AS A PLACEBO.
Been busy lately. I'm sure you guys did a fantastic job keeping the law and order here. ??
GREAT NEWS, PEACHES!! IT looks like we just pulled a PRIVATE PLACEMENT FUNDING FROM ASPIRE CAPITAL, $1.43B AUM. THEY'RE PURELY A LONG HEDGE FUND and reputable company!https://www.aspirecapital.com/about-us
The paradox of making money! Got to spend money to make "honest" money! With $36mil in the coffer, we can now run four - phase II trials: mild, moderate, severe, and critically ill COVID-19 PATIENTS. ASPIRE will make at least $300m with their investment!
When Leo announces the trial, or when we initiate, our mc jumps over $500m in my opinion. Now we need to get the EIND! LET'S GO LEO!!!!
FOMO RUN!!!
Experiential and background @ HolesInMyPockitz. Anyway, the more politicians get infected with COVID19, the faster and bigger grants funding will come our way.
Covid19 round two is looking bigger and dire than the first wave. Trump will have to put big pharma influence aside and start funding therapeutics AND prophylaxis ASAP.
I wonder if he'll ask for Remdesivir or Leronlimab?!
https://news.yahoo.com/oklahoma-governor-stitt-tests-positive-coronavirus-covid-trump-tulsa-rally-170129954.html
I have revised my estimates for COVID19 therapeutics. The market opportunity size is actually about ~$25 billion market opportunity versus the original $15b to $20b estimates.
Here is the breakdown:
$10B here in the US, $7 billion in G7 countries( less USA ), and $8 billion in China plus the rest of the world.
I also anticipate one big event happening but I will leave that up to your guys'own imaginations.
Great news on the front today with the S-3 form filing! I sense that while grants are being assembled and/or readied to fund at least two phase II trials. Leo has
already got all the funding lined up for the eventual phase III trials with the 60M shelf offering today.
I'd expect to see our market capitalization to exceed $1.2b when the aforementioned events are initiated and we advance to two Phase III trials for COVID19.
Can you imagine if we are able to grants substantial enough to fund all stages of COVID19 for Phase II trials? Now hold that thought for a moment because partnerships might happen too for IBD, ABSSSI, and OM. You just never know what major catalysts are lurking around the corner for us!
Great times ahead. Thank you for the hard work, Leo.
I sense that our Bril will be the cure for COVID19 and other potential pandemic viruses. Jmo. It's time to load up and accumulate more here before RBL results come out and ahead of the peer-review pr. As I said before, this is company is still a risk-free investment while it's under $3 billion dollars market capitalization.
Lastly, the COVID19 therapeutic market could be worth as much as $15b to $20b market opportunity.
That's so hateful but they'll get and will need BRIL!
That Bubonic plague will get to the Yangtze River and spread throughout China!
I'm glad you are finally on board with IPIX. :)
I'm guestimating that at 25c warrants, that's about 24mil dilutive shares, which is great! At 30c, only about 20mil shares. Those guys will get at least a 10x ROI at a minimum. Maybe Armistice? Just a pure speculative guess.
https://www.nytimes.com/2020/07/06/world/asia/china-bubonic-plague-inner-mongolia.html
The criminals are worried. Lmao.
Politicians are now getting COVID19. 320M population here in the U.S. A charge of 3k a pop for Brilacidin on 1.2M people treated in the US, that's $3.6b in gross revenues! A net profit margin of 45c on the dollar, that's $1.62B EBITDA. You tack on 10x to 12X to that EBITDA, THAT'S A VERY CONSERVATIVE VALUATION OF $16.2B OR $19.44B.
Big pharma such as Gilead will be very stupid to not pay $10b minimum. Jmo.
The criminals are worried. Politicians are getting COVID19.
BOOM!!!!!!!
You should be the first to volunteer and see if downregulates the tau kinases enzymes to prevent neurofibrofibrillary entanglements. If everything else fails, the old ECT approach might be a little more appropriate. This beer is really good. I'm feeling a good buzz. Cheers!
Happy 4th of July, George!
"BARDA is not for IPIX, it is for big pharma. Big pharma literally pays the government to get grants from the BARDA slush fund." LMAO.
ARE YOU SURE? BCRX 's mosquito drug GALI, which I'm sure will have kidney and liver toxicities did receive $35mil in 2015. Altogether it received 43mil? Read the link below!
https://www.globenewswire.com/news-release/2018/09/17/1571581/0/en/BioCryst-Receives-Additional-3-5-Million-to-Fund-Clinical-Trials-of-Galidesivir-in-Yellow-Fever.html
I won't be shocked if IPIX gets more $80mil. Does that sound fair enough to you? Bril will be the cure for all flu pandemics. And so far, my assumptions but the drug have less faulty.
I personally think that cumulative grants that are coming will be much bigger. The second wave of COVID19 is upon us. Leo will have no problem selling this company for $10 billion.
https://news.yahoo.com/coronavirus-updates-us-reports-more-38-800-cases-082530219--abc-news-topstories.html
Thank, JFM. I am very familiar with what restrictive shares pertaining to the sale of control and restricted securities. All under rule 144 that also affect affiliated persons. 90-day restriction applies (held and paid for) and the sale cannot exceed more than 1% of OS or avg trading volume in the last four weeks.
Trust me, brother, I got this portion of department covered too besides science ;)
If there have been ATM sales of those authorized shares for going business operations, which you have failed to account for, it can only also account for increased #of OS shares. Extra supplies can be shorted too!
The scary part is, when sp trades over $1, folks can go long and buy on margin too which could add to a great SQUUUEEEZE!
No free trades, besides the spread between the bid and ask, MMs have to make their money! And they do! And it's through naked shorting by loaning out your shares when you have day traders, who are also on margin accounts, and others who agreed to hypotheticate their IRA accounts in exchange for 16% to 24% income paid annually.
When a penny stock hits $1, those who were shorting this stocks get a margin call. Higher equity is needed to be maintained per stock. And it goes much higher when it jumps to $1, then to $3, and then above $5! Squeeze!!!
Here are the thresholds in ascending order:
$1
$3
$Below $5
Forb example, we may have only say 220 million shares. But if that shares jumped to 297 million shares like it is today, but no additional authorized shares were freed up by Leo, then you have an additional 70 million excess shares that were shorted and are floating around.
That extra 70 million shares are eventually swallowed by smart bulls going long on this company.
Thus, you create an illusion of having 297 million shares as your OS as opposed to the actual 220 million shares. It's why they call it SHORT SQUEEZE.
Those who have margin accounts that own IPIX, they are inadvertently loaning their shares for naked shorting. That's a fact!
WARNING! THIS IS A VERY TERRIBLE IDEA TO SHORT THIS COMPANY, IMO. THIS COMPANY WILL GET FUNDED BY THE GOVERNMENT!