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Completely in bounds. If we only knew. Anything is possible. We are all speculators that measure probability. As Chase CC says “what’s in your wallet”
It’s a positive yet not what Longs want to hear. I’m sorry for your diss appointment. All is not lost as I do believe the final read out will be in line w statistical significance.
Nader buying time until the 20th to spin the DSMC decision to complete trial. On one hand it’s great news to complete the trial, however not the news the market is looking for. No EUA.
Misiu,
You know the science very well. The dosage for the HIV Combo BLA is very confusing. It would seem as you say the increase to 700mg presents a longer road but would seem to elicit a Mono approval. We will never know why Nader decided to pursue the 700mg rather than insist on 325mg dosage.
At this point one has to ask themselves how much patience is wise when we are still looking for our first approval. This is a very precise process and Nader continues to fumble the football at the goal line. I know you like him. I don’t dislike him. I just don’t believe he has the intelligence to delegate and understand what it takes to get the job done at this level.
I will say it again the pressure is on w the upcoming SC Interim. IMO the pressure will be turned up further when the DSMC advises to complete enrollment and finish the trial. Raising $ on future promises is not going to be enough to attract high risk investment forever.
GLTU and all Longs.
I’d like to make a wager notcovidready. I’ll bet you $1M the SP will be above .30 at market close on Friday. In fact lets sweeten the pot and make it $2 instead if .30 and I’ll lay you 2:1 odds.
Point is either post something of substance that resembles reality or give it a rest.
The headwinds have been mounting on the financial front w Nader’s shift to going all in on the Covid play.
Make no mistake both the SC Interim and full trial results will have tremendous impact on the future of CYDY. This result will be a pivot North or South, a black and white scenario.
If Covid busts the coffers are going to be stressed at a level not seen before.
The failure to secure BLA acceptance for the past year has been a gaff that has pushed any possibility of revenue w/o the Covid play into Q4 2021 and that would be on Nader’s optimistic timeline. The reality is Q1 2022 is best case.
I agree w Nader’s emphasis on the Covid play given the strength of the data and the SP is proof he made the right move. His mistake was not securing the BLA as his number one priority in the process. Now time is his enemy everywhere he looks in regards to Covid and the BLA.
At 800M A/S options will tighten up w/o major news. Then we sink into the likelihood of a R/S and the slow bleed is on.
I thank Nader for taking this company from sub .30 to $10 in 2020. The SP is currently up 1000% and lest longtime longs forget where we came from. It’s a tough road fraught w difficult landscape to make it to the big time no matter how disruptive the science.
If Nader could see and accept his deficiencies CYDY would most likely be in a much more advantageous position. It’s now become a binary event w all eyes on the S/C data.
So this is the big news regarding the Phillipines. Vyera looks like a Big Pharma Compared to Chiral and we are only on the first date. Hope I’m missing something.
If Nader says by end of year, it will fall into Spring 2021 as Rabbit said. To me it’s just mind boggling that the most important goal has been kicked to the curb. The focus is on S/C trial interim, enrollment, and most probably completion of trial.
We are staring at a fork in the road. Either we succeed w the S/C trial or we don’t. This is feast or famine. I’m fully aware of our countless potential indications however getting to trial results will be dependent on the S/C outcome.
Either future $ will be a very taxing situation that will handcuff progress or we will be the darling in the Covid therapeutic space w many options.
It’s really a very simple binary predicament for CYDY and SH’s. Could be a walk off home run or a strike out.
Thanks for clarifying the facts. It’s been a sh#%t show. The FDA may have jerked us around on the dosage but at the end of the day it was Nader’s call.
I’ve been invested for eight years and I am well educated in all the other indications that precede Covid.
Prior to Covid we completed a Combo HIV P3 Trial and then have botched the BLA submittal for going on two years. In the process we got in bed w Pestell and the Cancer play and then Nader terminated him. Nader signed a deal w Vyera out of desperation. We have a basket trial and a P1-2 TNBC trial w a grand total of maybe 20-30 patients enrolled total.
The importance of making good w the SC Covid trial is paramount to CYDY’s financial ability to move the chains. Yes LL has great potential. The clock is ticking and raising $ is going to be much more taxing w/o the Covid play.
To kid yourself into thinking the Covid play is just a bonus is foolish. Nader has bet the bank on Covid. On the positive side the SC play has a strong possibility of rescuing CYDY and LL although it may require the trial run to completion.
“Could” is the operative word. Yes trial could fill faster w UK enrolling. Likelihood of UK EUA is slim at best as they will follow the FDA.
Risk increases the longer CYDY trudges along w no BLA acceptance banking on SC Interim EUA. Nader has many irons in the fire. The problem is he just keeps adding instead of focusing on completion.
The future of CYDY is riding heavily on the success of the SC Trial. You can talk all you want about the Cancer indications and HIV but they are out in the distance somewhere within the Nader fog - hardly at our fingertips.
You are absolutely correct with normal circumstances —continuation of trial to completion is very positive news. In this situation continuation is not baked into the SP. SC Interim is a binary event in which the SP will either drop substantially or increase 2-300%.
The wait to completion at the current enrollment rate will easily place readout into Jan/Feb 2021. That wait will be a stress on the SP not to mention the changing landscape on the Covid front over the next three months.
Just my Humble Opinion.
Latane, you are one of the clear thinkers here. Question is what has changed that wasn’t already known prior to Nader’s appearance on Fox? Nothing, other than much needed media exposure. It’s still all about SC interim and DSMB’s decision. Patterson’s in depth analysis of the MOA and EIND results certainly are compelling.
Conversely Nader’s track record and the FDA wildcard make this a really tough call. Best of luck to all loyal longs.
LMAO! Your Welcome Sammie.
Sammie, you are correct the FDA is responsible for issuing an EUA not the DSMC. My understanding is that the DSMC makes recommendations to the FDA regarding their findings at interim. The FDA then makes final decision.
A Data Safety Monitoring Board or Committee (DSMB or DSMC) consists of experts in the field of research tasked with reviewing data integrity and safety.
A DSMB/DSMC is mandatory:
* If the trial is evaluating mortality or another major endpoint, such that inferiority of one treatment arm has safety as well as effectiveness implications
* If it would ethically be important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not yet fully addressed
Satisfying The EUA Criteria
The FDA has established four broad criteria that must be met in order to participate in the EUA program and be granted an EUA:
1. Presence of a serious or life-threatening condition
2. Evidence of effectiveness
3. Risk-benefit analysis (safety)
4. No other alternatives to address the life-threatening condition
Jacobs, thank you for your perspective. From a pure short interest I concur. What I’m seeing is a slow erosion of the SP absent a short attack the likes of a Citron or run of the mill AF. They are laying in the weeds waiting for the next run up.
I believe in LL’s MOA and high possibility of success w the S/C trial. I was close to pulling the trigger today as the mid 2’s are what I have identified as the first bite to building a new position. I see timing my entry as a total calculated gamble, but a risk I am willing to take. The way I look at it I have two option to buy back in.
Option #1
Buy this coming week prior to S/C interim hoping for lopsided data that favors the drug arm. Lopsided and statistically convincing enough to influence the DSMC to at least issue an EUA and have enrollment continue to gain full approval. I V see this as a 20% probability at best.
Option #2
Assume that the DSMC will simply rule to continue to full enrollment w no EUA. If that is the case the SP is going to erode because of the lag time to full enrollment and readout. In my estimation that would place the news for the S/C into Jan/Feb 2021. IMO this is the safest option to invest but also carries the risk that this option never happens because interim blows doors and DMSC grants EUA and the SP runs away.
Regardless I have much belief in LL and I wish the best for Longs. I will never bash or be part of the negativity and deception of an orchestrated short attack.
It takes different periods of time for investors to wake up to the Nader dance. This ego maniac considers himself to be more important than the molecule itself. His absence to see the forest for the trees for the companies well being has crippled the advancement of LL and made clear the risk he represents.
The SP is adjusting to reflect the Nader factor. Call it bashing, call it negativity, I call it reality. It is what it is. Selling vs. buying is where the rubber hits the road. There has been zero short pressure on the erosion of the SP. Just disgruntled SH’s speaking their minds w their wallets.
Yes, there are many savvy investors that are on board. Science is stellar w a high probability of success. If your looking for a scam I suggest you find another horse to ride.
As did I.
Agree w all except the C-
I would flunk him. His public speaking is painful to watch and listen to. It’s been eight years for me and no improvement. Great at raising $ and he got a nice run up in the SP. I’m grateful for the profits.
Way overdue for a CEO w street and network to take this to the next level. BOD shake up is the only way.
“The FDA is owned by BP and our only chance to get to market is to partner with one of them. NP will not, and there in lies our dilemma.”
It’s the other way around — BP won’t partner w CYDY/NP package. Change the package.
Vyera deal is all one needs for proof. That’s the best Nader could do - hardly a BP partnership.
That’s fine. If I knew we were going to get approval for Mono at 700mg I’d be willing to wait an extra year. Mono approval at any dosage is major $.
MM was never going to get EUA. It was an investigational trial that missed the PE. It’s also not life threatening as most people recover.
You are right about S/C. We know it saves lives. We don’t know how significant the results will be. That’s the gamble at the moment.
The Lawsuit brought on by former CEO (TC) and SH’s to return shares is pending.
There is also the Pestel suit pending that was filed prior.
IMO those are not the major issues.
Major concern is no BLA Acceptance. The timeline has been stretched to unacceptable proportions. Nader isn’t missing by months he’s missing by years. We should have been a revenue producing company in 2019. We will be fortunate if we produce revenue in 2021. The burn rate and pressure to dilute is coming soon. The S/C outcome - EUA or full approval would solve the financing.
For the ST I am bullish on LL and the likelihood of a Covid play for S/C. The absence of catalysts between now and then will create downward pressure on the SP.
Long term - many promising trials w a ways to go. Get the HIV Combo indication approved and build the pipeline.
The Nader dance is not something I want to be invested in LT and that’s what investors are going to be in for if S/C trial busts.
That’s the story I’ve seen coming for months. Love the science but without approval it’s wait, wait, wait, feed the burn rate by diluting, and erosion of SP regardless of the potential LL seems to demonstrate.
This isn’t bashing this is transparency as to what CYDY is confronted w as Nader does his dance.
As I’ve said much riding on S/C interim. It would be wise as an investor to be prepared to go to full enrollment. My perspective is where will the SP bottom out at to equal the risk that brings in buyers.
Cannot ignore the laundry list. The blatant deception is more damaging than his ability to deliver and finish. He claims to be transparent while his actions are far from transparent.
Can the science be salvaged. TheS/C Trial is boom or bust and we are not going to have the answer for months.
It’s all a matter of opinion. I have plenty of house money. I decided to choose if and when I want to ride.
GLTU Rainbow.
“They are high risk/reward. With an approval you may get rich. Without one, you may lose everything... “
Good post Bio. That’s why when CYDY has the Covid play fall in their lap and the SP runs from .30-$10 one night want to recognize the gift somewhere in the run. Even now it’s been a great play for early Longs.
This is the ultimate binary event w the S/C trial. What a gamble it is especially w Nader at the controls and the FDA deciding LL’s fate. May have to rejoin the poker table at some point for a shot at the jackpot.
Nader always shades the line of truth. He’s a salesman. Oversell and think about what’s next to sell before the questions get to hot about what he just oversold.
Thanks for your insight. Predicting the markets is nearly impossible but that won’t keep us from trying.
My big picture is to reinvest after the major indexes get slammed. Printing money has its consequences. Patience is the key ad it’s easy to get faked out along the way.
Cash looks good right now. I’m taking a break.
Venture, we all have to make choices because we have different circumstances. Your reasoning falls in line w a laundry list of variables. I added them up and said to myself your gambling too much on a binary event w a CEO that has proven to be incompetent. As I said I still like the S/C Covid play but at a much lower percentage of my portfolio. If I can buy in the 2’s I’ll take another shot and get back in.
You have your sources and I have mine.
I respect your opinion and follow your posts as they have merit. As for this particular point it would be valuable to know w certainty. Neither of us do - it’s speculation backed up by our own third party information.
That’s what basically what we get on this forum. Have to pick through the rubbish to sift out the nuggets.
Agree on all points. First approval is the most difficult. As BL stated the fumble of the BLA is crippling. We need that approval to lighten the load, create revenue, credibility and a pathway to more approvals. To say Nader makes me nervous is an understatement.
The UK contributing to enrollment is a big positive. Accelerate overall enrollment and also places them side by side in terms of assessing the top line read out. This positions the UK to think for themselves w patients from their own country in the trial. That will add a new dimension to the decision making process.
I don’t know about Grip. I just add the facts up and make a calculated decision.
I sold my entire position over a month ago starting in the mid 6’s to high 3’s. I was heavily invested at a very low average SP. I decided to roll the dice and guarantee $2M plus in profit. I just wasn’t willing to risk the Covid cash cow that fell in our laps falling off the table and be back to where we were post Covid-betting on HIV Combo, Vyera, and a long ways to go in our promising cancer trials.
I’m still very bullish on the SC Covid indication and will be back in for a 100k shares if it pulls back into the mid 2’s. If it doesn’t I’ll walk. This investment has played me for eight years and I’m not going in for more of what the majority of those eight years were. Delay after delay and increasing shares from 100m to 800m. That can’t go indefinitely and Nader has not proven he can complete a BLA application. That was the breaking point for me as we have been told for years now this would be done very soon, next month, etc.
You will not see me bashing as Nader turned this into a winner. Maybe it will be a really big winner-I hope so even if I miss the next chapter.
With Nader running the show I consider that highly unlikely prior to SC read out.
BP is fully aware of CYDY, LL, and especially Nader. They have passed. Are they passing on the Science or the Conductor?
BP views Nader as a total liability and an arrogant unreasonable CEO. Remember, the best Nader could do was hop in bed w Vyera.
I’m not going to put a laundry list together on Nader because the trail is there for all investors to draw their own conclusions. Bottom line is Nader is rooted in this company as it is his and he will remain through the end of the year to see the Covid play through. If we come up empty on Covid and the BLA is still out in the FDA twilight zone the movement to remove him will intensify and for good reason.
If he succeeds w approval for S/C he will be a hero and all will be good in CYDY land.
What concerns me is the rate at which the trial is enrolling. If the DSMC says continue as is what does that put the time line at for data read out? January 2021?
If Patterson was correct in his observations and the EIND for 60 patients is any indication we should be convincing w the mortality as the PE.
I started looking at the time lag to SC results and the lack of news to support the SP in mid August because I viewed the MM as a non factor. I don’t see any way to support the ST SP other than granting SC EUA at interim.
It’s called the waiting game. SC Interim ruling by DSMC, BLA acceptance, and Nasdaq uplist are on the docket. I don’t see a breakthrough on any of these catalysts for months.
I do believe LL will prevail w the SC trial although it will need to run its full term. I also believe Nader will get the BLA accepted but not until Q1 2021. The uplist will only happen after at least one of those catalysts comes to fruition.
I don’t see how the SP can do anything but erode in the short-term.
Only shot to avoid this downturn is an EUA at SC interim. I’m not holding my breath.