Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
There is nothing to prop the SP up until S/C update. Submitting HIV BLA’s all over the world w/o first getting it done in the US isn’t going to move the needle.
There are but two catalysts in the near term pipeline that can reverse this slow bleed.
Complete the US HIV BLA and secure a PDUFA date.
And the home run - SC Covid approval.
Everything else is Nader fluff and that hand is worn out.
Your optimistic timeline is based on Nader changing the 43 days on drug to 14 days and a dramatic increase in the pace of enrollment.
Maybe it will happen. I hope so. Do I think that will happen? No.
With pre revenue biotechs if something can take longer it most likely will take longer. Your scenario cutting against the odds in a big way. I think first half of February is soonest we get the 75% S/C decision from DSMC.
How many times has Nader completed anything on time much less ahead of schedule? Mid February would be on time and that me be a success. If he can accomplish your aggressive timeline that would be a big surprise. Hope it all comes true - especially an approval by January.
GLTU Misiu
Misiu,
You may interpret my opinions as negative, from my perspective I’m just being transparent as to the state of LL and what we can expect over the coming months. Nader all but admitted on the CC that he is all in on the Covid S/C trial because that is LL’s best shot at its first approval.
Next pivot on S/C trial at 75% enrollment is mid February best case. Is that negative? It’s the truth. What will be the state of the Covid therapeutic space at that time? Point is LL looks to have efficacy and safety needed for approval. Downside is it is taking a very long time to enroll the patients to prove our case. On top of that Nader’s optimistic timelines always get stretched so we are into March IMO.
On the other hand I have been consistent w my dissatisfaction in regards to Nader’s inability to effectively navigate the FDA process. In addition he has proven ineffective at assembling a management team because he is always the smartest person in the room.
I’m going to buy back in at some point w a much smaller position in relation to what I held for years. I believe that LL has a legit shot w the S/C trial w a huge potential ROI, however this is not a slam dunk. If Covid is a bust it’s going to be a very long road w penal options for raising the necessary capital to get back on track w HIV and Cancer.
Great science but the clock is ticking and the need for capital is ever present.
GLTU Misiu. I respect you and am pulling for an approval w the S/C trial. In fact I will betting on it.
Nader removes anyone that gets in his way of thinking. That’s the good news and the bad.
As CEO he is called to surround himself w minds that are more effective than himself at various activities and disciplines.
Nader’s track record shows that he views those very people he needs to succeed as threats.
As much as one may think we have a great team the fact is it is not possible w Nader doing the hiring and the firing — he’s like Trump. My way or your fired.
Was this CC any surprise? The Nader dance is completely predictable.
Wonderful, fantastically beautiful, SP should be double digits.
The SP goes to double digits when the goods are delivered. Hope and excitement w/o substance doesn’t wash.
Does anybody on the BOD have any backbone? Obviously Scott Kelly doesn’t. He follows Naders lead like a little puppy dog. Nader needs a strong dose of constructive criticism from some alpha dogs.
This is Nader doing what he does. Squeeze as much as possible out of old news when he has no new news.
Bottom line is the enrollment in the S/C will hopefully hit 293 patients by Jan. 1. Then 43 days for all patients on drug, then two weeks to compile data, the DSMC will take a peak and decide to halt, terminate, or continue. That is mid February at best any way you slice it.
LL works. Time is not our friend. Private raise and more dilution is coming.
That’s a Nader number.
Well said. Hind site is 20/20. The coulda shoulda woulda game is for the insane. The exit strategy is the most difficult part of any investment. Unfortunately the majority of the time it’s not as simple as waiting for a buy out because most of the time it never happens.
Hang in there C-20.
Depends on the substance of the CC. Will Nader deliver some meat or the usual ration of chicken feed? It’s pretty straight forward.
This is all in good fun and the reality of OTC high stakes investing Vegas. I’m just being honest while keeping it respectful. I like the different personalities on this board for the most part. The fakes know who they are. We all have different reasons for laying down our personal opinions. My style is total transparency w no hidden agenda. Unfortunately that’s not true for all — it’s the real world and we have to put up w the good, the bad, and yes the ugly.
Hope to see you in Vegas at some point Vegas.
Well said Bio. I respect Nader’s passion and drive. He also delivered us Longs from the sub .30 SP to a very nice gain even at today’s SP. We are now at a new level of expectations w a much broader base of SH’s. That’s a good thing.
I’ll stop right there and keep my word from my previous post.
GLTU Bio.
LMFAO! Not my intention. I’ll wait at least another week before I mention Nader in any type of negative context.
Never said you did this or that w your investment. Everyone has to do what is best for there situation. Sounds like you’ve played it perfectly for you - congrats!
Sammie, I keep my posting to a minimum and call it the way I see it.
I’m looking to get back in for 100k shares when I see the risk reward at a level that makes sense w my DD and perspective.
Believe me I have spent a long time here and I didn’t want to hear negativity. I did however welcome objective opinion which is the only benefit of this message board. It feels good to have likeminded investors agree but it is much more valuable to gain all points of view as long as they are respectful.
Longs dislike Hopester because if he’s right it hurts in the wallet and creates doubt. No matter how long and confident an investor is, maintaining clarity is the challenge. Believe it or not I’m on your team not against you. The time gap CYDY is facing until real SP moving news actually hits is my major point of contention. You don’t agree and would prefer to read posts from SH’s that own shares that support the long perspective. I get it.
I know like many here there is tremendous upside potential. With that potential comes risk and to think this is a slam dunk is not reality — the daily SP is the marker that represents the current level of risk as perceived by the market. The market doesn’t lie.
You do it your way and I’ll do it mine, cheers.
GLTU Sammie
Not arguing that our new CSO can’t get it done on the original 350ml dosage. Get it done in the US and everything will fall into place. If we had deep pockets we could do it all.
TRYING to do it ALL has not worked at ALL.
No hope for me? I exited long ago because I saw this coming. Hope for who?
Yes Nader is hunkered down and well protected. It is what it is.
That’s because the news is not what the market is looking for. It is clearly just another hopeful, time consuming, $ burning rabbit hole.
Nader once again is diverting attention away from what he should be doing and that’s completing the BLA in his own backyard. Instead, let’s start another project rather than going all in and finishing. One can say why not pursue the UK and EU with the original 350ml HIV Combo BLA simultaneously because it will be faster and we can get an approval. Don’t kid yourself — in all likelihood the approval will run through the US FDA because that’s the way it works. In addition it diverts time and limited capital away from what should be his core focus. Instead Nader galavants around the world chasing the next fast track approval - reality is there is no fast track short cut. It’s the Nader dance by creating optimism w his latest escapade - just check his past performance and you will see the pattern. It’s a total shotgun approach w no ability to focus and finish.
Some here are are so intoxicated w the Nader cool aid they can’t see the forest for the trees. Visions of grandeur built on Nader’s sand — fortunately there is Leronlimab concrete somewhere below the sand that awaits its day.
Nobody knows for sure. I agree with Dolphin’s chart analysis. $2 could be the bounce and opportunity. At some point there will be a bounce.
BL we have been here a very long time. The last thing I want to do is play Monday morning QB because hindsight is 20/20.
However the redundancy and predictability of Nader’s moves are like clockwork. Having said that yes I think a raise is coming and soon. I am surprised Nader didn’t raise at least $50M a few months back for breathing room.
Beginning in August my gut told me the Covid play would be reliant on the S/C trial. The timeline to results would create a gap where the SP would be left hanging w Nader to do what he is doing and that wasn’t going to fly. With the absence of the BLA acceptance we have now become a binary event hinging in the Covid play. That’s either a $10-$20 valuation or back to under a buck.
I’m going to take another shot in here somewhere as I can’t resist that kind of return w a drug I believe in. Nader has created a huge buying opportunity. The conundrum is he’s the risk wild card not the drug.
GLTU BL.
This latest PR for two patients, one of which is his MIL just adds fuel to the downward trajectory of the SP.
For those that are just getting acquainted w the Nader shuffle you just got another taste. Combine this PR w the Proactive Video and you have a clear picture of Naders strategy — he doesn’t have one. He’d be well advised to step up and take his own medicine.
Taking his own medicine would be to stop talking about non material events and focus on two goals. BLA progress and enrolling 63 patients and knowing he needs to actually focus on full enrollment for the S/C trial. By the time 293 patients have completed the 42 days on drug and the DSMC has had the time to compile the results the trial should be fully enrolled. That would provide a nice backdrop for the interim at 293 patients. With the BLA debacle the S/C Trial results will have enormous consequences.
Telling SH’s the SP should be triple digits w such beautiful fantastic news just adds to the distrust the market has for anything Nader has to say. While the RSI is looking oversold Nader’s credibility is keeping buyers away.
Until the BLA is accepted and/or the S/C trial delivers an approval the SP is going to be under pressure. Fluff PR’s and paid for Proactive Interviews that contain no meat will only magnify Naders frustration and desperation.
It’s time to finish and complete and that is something Nader has not proven he can do. If one likes high risk reward you’ve found your play.
If you want to be initiated into the BP club you need a sponsor. Nobody wants to sponsor or be connected w our CEO. Best he could do was like a midnight dark alley deal w Vyera. Birds of a feather flock together.
A CEO w street credibility and experience opens doors that are currently closed.
Good one!
You’d have to ask Nader.
My take is the 700mg dosage was showing increased efficacy over 350mg. This brought Mono play into the picture. If Nader would have known the monkey wrench that was being thrown into the BLA process w the 700mg dosage he would have never adhered and taken the FDA’s advisement. Now here we are w the BLA floating while trying to complete the 700mg data and address a syringe technicality.
This is not my area of knowledge and obviously hiring people that do get it should have been brought on board during the submission process. Better late than never - fingers crossed they get it right this time.
I see it the same way although I’ve been completely out of CYDY as I liquidated my position from June through mid August. That play finished nearly eight years of staying long and never trading a single share. I simply had too big of a position w a return that made this investment a big winner.
I’m hanging around because I do believe in LL and it’s high probability eventually for S/C approval. My hunch was the DSMC would recommend continuing the trial which was good news but not what SH’s were hoping for.
My thoughts back in late July was that it was time to get out because the MM Trial was not going to get an EUA and the Covid play was all about the S/C Trial. The timeline from my perspective looked to be late 2020 and more likely Q1 2021 for statistical data to an EUA or approval for S/C. Given that I just felt because of the BLA fumble there was nothing to support the SP until the S/C data could turn the tide and that was a big time gap to fill w no catalysts.
I’m going to be patient over the coming months to start building a new position because I think there will be downward pressure on the SP. I want to be averaged in at the lowest SP possible for the next interim analysis by the DSMC. My calculations place the interim at 293 patients all having completed 42 days on drug plus two weeks for the DSMC to compile the data to be in mid Feb 2021.
If I still had my initial full position as I assume you do I’d hang and roll the dice on the the next interim in Feb. I wouldn’t want to trade out now in the high 2’s and get blind sided by a PR that blows you out of the stock.
AIMHO of course — GLTU Blueheel
Nader is not quitting anything. It’s not about the millions he’s made it’s about winning. As much as I want to see him replaced he’s a fixture for now and he’s calling the shots. I’m settled in for the run through the Covid play w Nader because that’s the reality like it or not. If Covid busts then it will be very choppy waters for Nader and HIS BOD.
Don’t put the cart in front of the horse. Uplist is not part of the picture until BLA acceptance or SC Trial EUA or approval. Gotta move the SP forward then the uplist will happen. Why would we want to uplist unless we can play some momentum into the move?
After listening to the CC I like the chances of meeting PE w the SC trial.
The timeline is the issue. As Nader indicated best case scenario for next interim analysis is 4-6 weeks to enroll 63 more patients plus 42 days on drug. That means 10-12 weeks from today. That tells me by the time data is compiled by the DSMC we are 12-14 weeks out best case. Realistically four months would be a hopeful timeline for the 75% interim. That’s Feb. 20, 2021. If DSMC recommends that trial should run to completion that means going deep into Q2 2021. Those are the facts.
During the wait Nader must come through and complete BLA. Hopefully he has hired a competent and experienced firm/individual to jump on this project full time and get it done. Success on the BLA front in 2020 as promised is essential to maintaining valuation and raising $.
The pursuit of international approvals are nothing more than hope and window dressing. This is about getting it done w the FDA right here in the USA.
We are the little engine that could — and likely will. Strong on science and short on horsepower.
LMAO. People are out of their minds in terms of valuation.
“8 weeks we should be looking at a 8x 12x 16x result.”
So $24-$36-$48 SP coming in the next month or so. That’s some mighty strong cool aid your drinking.
Simply not going to happen in your wildest dreams.
“95% chance hiv Approval 99.9% chance in my option of getting either COVID or HIV approvals and 85% chance we get approval for both. 0.001% that we don’t get approval for either in my opinion.”
Yes you are very optimistic to say the least. I see no where near the probability you profess especially w Nader navigating the CYDY ship —The market doesn’t either.
Couldn’t agree more. I have stated that many times and I like many others long time SH’s have profited from the Covid Cash Cow.
I’m talking about the current position that CYDY finds itself in. The question is would you invest in the CYDY story today at $3? That is much different than having built a sub $1 position. I’ve been there and played that hand.
I’m looking at the story and saying at what valuation would I invest and how heavy. I believe in LL and it’s potential well beyond Covid. I’m also analyzing the odds of getting to some type of end game w Nader running the show. There is $ to be made here but w it comes a level of risk. Any wise investor looks to assess risk by adding up the facts.
GLTU Epony.
I don’t think I would unblind. If we had a CEO w street cred and the network w BP I would consider. This is and has been CYDY’s achilles heal. BP will not get in bed w Nader.
They will buy the company at a reasonable price when LL has been approved but Nader will never be part of a BP package.
Nader has already put the majority of the CYDY eggs in the Covid basket. Keep in mind Nader is a salesman and promoter. Finishing the details of a BLA is not in his wheelhouse.
BLA has to be farmed our to consultants that understand the process and that costs $. That capital is invested in the Covid play.
I understand the logic in the play as a win will finance the numerous LL indications. It is however a big gamble and the SP reflects the risk.
Next stop will be January for a DSMC look at 75% mark.
Nader’s immediate task is to fill the gap between now and hopeful DSMC news in January w the BLA that has been collecting dust. The importance of BLA acceptance and PDUFA date is imperative. Without it CYDY will be a straight up Covid play w no backstop.
If S/C trial is advised to go full term at 75% interim the time line slips into Q2 2021.
As Latane said time and $ are the concern — but thats nothing new, Nader will raise $ meanwhile shares and diluting will increase well beyond the 10-20M shares promised when the A/S was increased from 700M to 800M.
Without Covid approval for the S/C trial this company will be backed into a financial corner. Seems longs are comfortable here as they are all but guaranteeing an approval so no worries.
It’s is however a binary event because of the BLA mess.
Looking forward to another episode this afternoon in Season 8 of the Nader show along w his cast of characters.
I can’t imagine looking at it any differently than you just stated. I’m very familiar w that level of belief.
Good luck to you Rabbit.
You have explained the dilemma that all SH’s face if they stay long enough. The repetition of the same song and dance. It can feel as though your on a merry go round that repeats like clockwork. As much as one believes in the science it becomes clear that even the most disruptive science can be backed into a corner.
I genuinely hope tomorrow’s CC breaks the cycle and LL is granted the ability to make a difference.
Good luck to all loyal SH’s.
Right where it was a year ago.
As I said we all speculate given the info. If the outcome was a known fact we’d be Warren Buffet.
We will know on the 20th.
My logic reads it as you do. Hang in there.