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Psea, I think you pretty much summed up the situation. I voted NO on every measure in hopes of sending a message to the BOD — Wake the F up and do your job.
“SH expectations were not unfounded. They were cultivated by CYDY management.”
This is at the core of the unraveling of the SP today.
Plain and simple the MHRA did not approach CYDY to discuss EUA. Nader approached them and packaged it very differently by placing Amarex front and center on the previous CC; “ let me read what Amarex has to say about the discussion w the MHRA”. Go back and listen to the CC.
That spin w the MHRA provided a spike from the mid $3’s to low $5’s. The CC yesterday unveiled the reality of what actually transpired. Todays tank is the financial consequence of deception.
Agree Rock. It’s all about S/C.
That is the most critical inflection point in front of us. MY opinion that is based on the DSMC ruling at 149 patients to continue trial. I believe not enough will have changed from patient 149 to 195 to change the DSMC stance. I also got the feeling that Nader is preparing for full enrollment rather than leading SH’s to expect EUA at interim. Just my opinion.
I am going to buy more shares if the SP erodes because I believe the SC trial will deliver regardless of what the DSMC’s decision at interim. It is also within realm for an FDA EAU at interim while continuing the trial.
My biggest disappointment is the fumbling of the BLA. I also feel Nader misled SH’s by building false hope in the Sept 9 MHRA meeting insinuating strong consideration for MM EUA — that was not on the table. That IMO was a play to increase ST SP. Bad move and he paid dearly on today’s CC.
As I have stated numerous times MM was DOA. Neither the FDA, UK, or EU has any interest on mild to moderate patients. No EAU from any country will be forthcoming. An approval for S/C will allow doctors to prescribe for moderate as Nader stated.
S/C is where the opportunity exists for our shot at EUA and ultimate approval in the Covid space. Enrollment continues and now we are well above 200 patients. Nader knows the odds are that we will have to fully enroll. We have a high probability of success w this indication but will be into Q1 2021.
Nasdaq Uplist will not happen w/o an accompanying approval. It would be futile to attempt to do so given the current circumstances.
BLA fumbling is an indication to the market that magnifies Nader’s lack of experience and competancy. This was perhaps Nader’s most detrimental blow to the companies credibility and we are consequently viewed as a high risk investment in the management department.
My overall take is we may well succeed in spite of Nader because of the disruptive nature of LL. Maintaining valuation given the reality of the timelines presented on today’s CC will be a challenge over the remainder of the year. Nader was left with the truth today. He decided to go all in on the previous CC w the MHRA EAU pitch and suffered the consequences today.
My entire bet at this point is on the S/C trial. If we do not succeed in the Covid space it will be years to get back to a double digit SP w HIV, Cancer, or any other indication.
The SP over the coming months will align w the new timelines and risk associated w the changing Covid landscape.
AIMHO.
The point is the catalysts, the timing, and the likelihood of achieving. That’s the risk assessment required to make a logical decision about when to increase position, hold of lighten up.
The most important factor is to stay informed w/o bias and keep ones emotions in check.
This board for the most part is ultra sensitive. When contrarian posts to ones own opinions solicit defensiveness it implies fear.
This is a very objective and realistic article As to the current positioning of CYDY and LL.
https://seekingalpha.com/article/4374307-cytodyn-bulls-continue-to-get-torpedoed-thesis-remain-afloat
This is not a short attack. This is market adjusting to the reality of what is currently on the table.
The reality is very little is on the table w MM regardless of country. The FDA isn’t going to issue an EUA for MM and neither is the UK or EU. Do you really think doctors are going to prescribe an expensive injection to patients that are most likely going to recover on their own? If so at what point? Not until they fall into the SC symptoms which is no longer MM.
The SC trial is a complete different story. LL is the best option to save lives. That’s where the focus is coming from regardless of US, UK, or EU, however the approval runs through the FDA not around it. All agencies talk w each other.
The decision by the DSMC at SC interim is THE catalyst to pay close attention to. Odds are the trial is green lighted as it was at 149 patients — continue enrolling. It may be given EUA but it will still continues to completion as EUA is not an approval and full trial results will be need to gain approval.
The future is bright. Immediate reality is Nader pumped a meeting that was never going to deliver a quick EUA from the UK or EU for MM. Now he’s got to spin the meeting - which he will and will be left up to the market to interpret.
Nader seems hell bent on getting his self enriching comp package regardless of the cost. BOD is in bed with him which is mandatory for one to stay on the board. Why do you think Welch walked? It wasn’t worth the legal exposure Nader creates w his continual demands for more free shares.
Why did Nader sell 4.5M shares at 3.26 when he proclaimed the SP was headed towards double digits? Because he knew he’d maneuver a way to get another chunk of self awarded shares. The irony is Nader specifically stated when the A/S was increased by 100M the most dilution we would see would be maybe 10-15M additional shares - now this. Our CEO is a bait and switch artist that lives on half truths that benefit himself.
He is an expert at accumulating wealth while pushing SH confidence and trust to the edge not to mention providing a target rich environment for the shorts. Nothing keeps Nader from continually tapping into the golden goose at the expense of the SH’s he so vehemently proclaims to care so much about. He makes it very difficult for me to trust his words.
Disruptive science guided by a self serving incompetent CEO.
Have people lost all sense of reality? Anybody that was thinking Leronlimab was going to be mentioned tonight by the POTUS in his moment of reckoning is delusional.
We are not part of the serious conversation... yet. We haven’t delivered the data needed by an OTC biotech to tip the scales. The writing is on the wall — go the full distance w the S/C trial and show the unequivocal data that cannot be ignored. That’s the way the game is played. Especially when your CEO has zero credibility — talks out both sides of his mouth, and can’t dot i’s and cross t’s. This is biotech and you have to be precise to be taken seriously.
I have never doubted the science but you have to have street cred, the network and a basic understanding of the landscape to get to the promised land. Nader has a target on his back because he has proven how incompetent he is at every turn. The latest PI rebutting the WSJ piece is the latest gaff. You don’t take on those that buy ink by the barrel. He drew more attention to a negative article.
The problem is Nader is not being advised because he thinks he’s the smartest guy in the room ALL of the time - you can’t advise somebody that knows it all. Desperation and more paid interviews = decreasing SP. That’s one formula that is going to consistently perform. If you have real news you don’t have to pay a third party to interview you.
We can still prevail in spite of ourselves but it sure is painful to watch.
With no EUA and the never ending wait for a Peer Review Paper from Patterson or the likes what is going to support the SP between now and S/C interim — for that matter between now and completion of the S/C Trial?
You say Nasdaq uplist. Without a strong catalyst Nasdaq uplisting is out of the question. You think we have seen shorting on the OTC just uplist CYDY naked to the Naz. This may be a mute point as uplisting will not be an option because of CYDY’s inability to meet the requirements.
As promising as S/C interim may appear, investors would be wise to be realistic about expectations. If the DSMC ruled to continue the trial at 149 patients It would seem highly likely they will do the same at 195 patients. EUA by the FDA at interim is what we hope for but not likely as the odds are the trial will be required to go the full distance. That’s actually a positive as it means we are in the hunt w a viable treatment. The question is what happens to CYDY valuation over the next 2-4 months in a very impatient Covid Space?
Nader’s default is to turn to his open ended invitation to be interviewed by Christine Corrado. “Thanks for having me Christine, and yes I’m doing great”. Then what? More expected fluff for the enemy which will be picking at Naders credibility and CYDY’s financials relentlessly as investors wait for S/C Trial results.
The science is as disruptive as the forces and barriers that confront Leronlimab — that is until the results can unequivocally force the FDA to finally do what they should’ve done long ago; approve the damn drug.
We are at the beginning of a draught in terms of realistic catalysts to fill the void as we wait for the holy grail. That’s the current downward SP pressure we are experiencing w the absence of EUA for MM and we haven’t even received the formal denial.
I know this is not what Long’s want to hear. It is however the reality of the path we are on. Science remains strong and disruptive. That’s the foundation that is holding this investment up. Nader will be required to hold his tongue and choose his word carefully over this stretch — This is crunch time on the Covid front for CYDY.
AIMHO
Grip is most likely correct. The acceptance by the UK to enroll in the S/C Trial is a telegraph as to how this is going to play out. This move allows the UK to participate and draw their own conclusions when the interim data becomes available. The P2 M/M trial is like an appetizer and the UK and EU are interested in the entree as is the case in the US.
The time line to S/C interim data is a minimum of seven weeks from today.
-Time to enroll 195 patients - 1 week.
-Duration of Trial - 4 weeks on drug.
-Collate interim data - 2 weeks
-Total 7 weeks. Mid October is aggressive.
IMHO Leronlimab’s success as a Covid therapeutic all boils down to the S/C results. There will be no gray area in this trial w mortality as the PE. The P2 M/M trial was investigational as NP stated and would have had to blow the PE away to receive EUA. It did not but it served its purpose by showing efficacy in a secondary endpoint.
Going for EUA abroad is right in NP’s wheelhouse - to create the most spin w what he has to work with - something he’s been doing for a lifetime. In this instance it worked out as it brought the UK to the table w the S/C Trial which is a win that gives Leronlimab much needed exposure outside of the US.
Reality is we need to get to the S/C interim and reveal the power of Leronlimab - this is where we have an opportunity to show significant results and gain clear separation from the field resulting in a possible EUA from the FDA or UK. Worst case scenario is all looks good at interim and the FDA and UK says complete the trial.
As I have said the well is dry in the Covid space in terms of momentum because of the absence of real news. Investors will no longer invest on anything other than concrete. Applications, new trials, hopeful expectations, strategy, or any news other than real news will not fly in the Covid therapeutic lotto race.
Nader is certainly no exception as he leads the field in most all time non news PR’s. That translates to a big yawn from the broad market and a big jab to the gut for loyal investors.
As has been articulated consistently in many posts this morning the EUA in the UK is a gamble to say the least. Best case outcome for the Fast Track Application is the granting of FT by the UK but that doesn’t mean approval as it will require a trial within the UK - that’s the way they they roll. How do you think that will impact SP? It means more time until enough evidence can be accumulated to determine approval. Investors are worn out w empty promises and hope and will not risk their capital on anything other than results that translate to increased valuation.
One further piece of information to consider that adds brevity to the odds for EUA is the disappearance of two catalysts that Nader promoted prior to the MM topline report.
1- “Five Big Pharma’s waiting in the wings for the topline report”. Where are the big shots? It now seems obvious that their KOL’s looked at the report and came to the conclusion that there wasn’t enough there to gain EUA in the US or any other market for that matter. If they thought otherwise they would have jumped at a partnership as an EUA would mean instant revenue and global exposure. That is the biggest tell IMO - once again no interest by BP. Our achilles heal w Nader as our mouthpiece.
2- “National media outlets ready and primed to tell the story”. I was told by a source that the day the topline report came out Nader was trying to get on CNN. Apparently there was some type of arrangement that fell as flat as the topline report did on the market. Obviously the whole plan blew up. No BP interest and no media blitz.
Without EUA in US, UK, or EU the SP is going to trend down until the moment of truth which is the S/C interim readout. That by my calculations is realistically 60 days out. If you disagree w the 60 days do your own math and lay your bets down as you see fit. Being able to accurately determine the S/C interim readout date is now the most important investment information to be predicted other than the results themselves. The point is that is a significant stretch of time that will apply downward pressure to the SP in the absence of MM EUA.
I’m convinced that S/C Trial is the holy grail for Leronlimab and CYDY. This is a trial that is designed for success that will IMO exploit Leronlimab’s therapeutic benefits just as Dr. Bruce Patterson has stated numerous times.
In hindsight the most critical error was making the decision to take on the MM Trial. That wasn’t our strength as it was uncharted territory and understood industry wide to be a difficult patient population to show statistically significant results. Hey we hit a secondary endpoint which is better than anyone else, unfortunately it may not deliver the result we were hoping for.
GLTAL’s - this story has a long ways to go.
Nothing would please me more than a M/M approval. You say 60/40 in favor. I say your betting line is way off. We will know soon enough.
The irrational exuberance has settled down. The momentum investing that pushed the Covid sector and CYDY from $5-$10 in a few days has wisened up.
Now investors are sifting through the players to try and find a drug they can logically bet on getting approved. Nader talking about what he is doing and what he’s going to do will no longer move the SP.
Applying for emergency approval w the FDA, UK, and EU is great however the needle will not move until an approval is granted. Uplisting to the Nasdaq will have to actually happen to move the SP.
The smoke and mirrors show is over for the sector as a whole and Nader is certainly no exception.
As a CYDY Long my take is simple. What are the CYDY catalysts over the next two months and what is the likelihood of them coming to fruition.
The number one catalysts I will bet on is the interim S/C Trial results. That’s what put Leronlimab on the map because we have something special w patients that deteriorate to the critical stage. So realistically we enroll 195 patients in the next couple of weeks. Then all 195 patients have to hit 28 days. Then organize data. Looks to me like middle of October at best for interim.
Question to ask yourself is what will prop up the SP between now and then. Best chance for a catalyst is the uplist to the Nasdaq but that is now in jeopardy w the SP. The request for emergency approval for M/M is a long shot IMO.
So when Dolphin says we may retest 2.78 it’s not just the charts it’s the reality of the near term catalyst pipeline that also points to downward pressure.
Very confident in our S/C Trial even if the FDA says complete it after reviewing interim data. I am convinced that the FDA is not going to do Nader any favors as we will have to earn it all on our own - where are the BP’s that Nader talked about that we’re waiting on the M/M topline report? A BP partnership for Covid is the one play that would solve all problems - increased SP, Uplist, horsepower and validation. That is another long shot until S/C interim results.
AIMHO.
As I said “I hope Nader and the BOD factored all this in w the decision to go in a different direction.” They have the information to analyze to make the best decision. I don’t.
I do know Nader has a history of eliminating thunder stealers. My point is I think this was a factor as much as economics.
Conflict of interest. I suppose it can be looked at it that way. But I’ll take the conflict of interest for the upside. If it increases our likelihood of success in future drug trials. Its worth the conflict of interest and the high price of his services as the results come back in spades.
I hope Nader and the BOD factored all this in w the decision to go in a different direction.
I think I’d pay top dollar when you look at all that goes with the Patterson package. Not to mention the patented technology IncellDx possesses. The ability to screen patients blood work to increase likelihood of positive outcome is unique. His company is going to be successful even at luxury rates.
He put us in the map w Covid and he can keep us there in addition to the cancer trials.
You pretty much summed it up KC. No need to sugar coat it. Nader eliminates anyone that is a threat to his domain.
There isn’t another investment w this kind of spark. You found the right vehicle. Guaranteed to entertain and likely a very nice return.
Good point Chuckles. I don’t have that in. Maybe your the man for the job.
No question I was very disappointed w Naders dismissal and moving away from IncellDx. This is where you have to table your ego and do your job.
We could however I think it’s therapeutic to add a little humor right here. Hope I’m not offending anyone.
It’s really simple Nader doesn’t like being upstaged. Listen to Nader on PI today bumbling his way through his interpretation of the MM results. Today on the CC needing to take the lead to once again textrapolate the results rather than hand off to Kelly and Lalezari. Nope he had to take the meat.
I’ve been witnessing his inability to delegate to more capable hands for so many years I’m numb. Patterson was just too good for Nader to bare playing second fiddle to. This is CYDY’s achilles heal. A successful CEO strong suit is vision and delegating. Nader has decent vision but flunks the other side of his responsibilities. Hard working guy that has brought the science far but very ineffective with communicating the science and attracting a Big Pharma deal. I pray he proves me wrong on the Big Pharma deal but the other weakness is fact.
I’m in big because I think the science can succeed in spite of his deficiencies.
Your guess is as good as mine. If I knew the answer to that question I wouldn’t be having this conversation. I’d be on the BOD.
That’s the rub. Lack of street cred, arrogance, it’s all part of the Leronlimab package. It’s like a Christmas package wrapped by your child that is definitely not wrapped by mom or the department store — but the present itself makes you forget about what it looked liked before you opened it.
The question is can Nader get this across the Covid approval line? I’m reading opinions on this forum and it’s a split opinion. Can game changing science overcome a somewhat incompetent management team?
The SP is the daily confidence score.
NP owns the BOD. He eliminates anyone on the board that doesn’t see things his way. That’s the way CYDY rolls.
Despite a group of major SH’s desire to remove him it has not happened because the BOD is impenetrable. Depending on the way the SP swings in the near term pressure may reach a new level of urgency. NP has a very large base of support that he maintains. If SP sinks, no uplist, and no headway on Covid front the tide may take Nader out.
I am very encouraged as I digest the results. They are impressive on a very difficult subset of patients — Mild to Moderate. To be statistically successful here bodes very well for the Severe trial. Somewhere in here there is an uplist coming that will increase the momentum.
Once again the science continues to perform. Who else in this space can say that. The flies fall one by one and we keep marching forward.
It appears that Leronlimab is more than Covid ready.
“Seems”= Speculation not fact Please bring facts and value rather than a smear campaign.
Very good point Badge.
He’s a very good writer and knows biotech science.
I don’t know about the thread. Just saw Chuckles question and answered it.
To be clear I was not referring to OHM although I consider him to be one of the most knowledgeable when it comes to the science. Though I too would like to know who else he likes.
I was answering this question that Chickles asked;
“and just who is "Sheikh" ? He’s a very talented biotech journalist / investor that know his s#*t.
Nice bit of research bluefish. Way to go for the jugular w just the facts.
He’s a very talented biotech journalist and investor. The guy has been around the block and knows his s%#t.
I can’t tell you how many investors I know w large positions that deal w their wives letting them know it’s sell time. We laugh together as we know our wives are pretty intuitive or we wouldn’t have married them. Now we will know soon if we will be bachelors or very happily married.
“We have this, hang in there as efficacy needs to be written up perfectly!”
That is my interpretation also.
Speaking of “convergence” —In the pre revenue biotech world that word is the most elusive of them all. However do believe you are right as the convergence is upon us.