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The Combo Trial was an FDA requirement to consider a shot at Mono. Here we are years later with the opportunity to get into the big dance. This is what I signed up for 5 plus years ago, I just didn’t factor in a Combo Trial laden with land mines around every corner. It was as if the decked was stacked that management would either become too fatigued or run out of money before completing the trial. Nader, like him or not is a bulldog and he wasn’t going to have any of that.
The result has been costly in terms of being forced to raise $ with Paulson to get through the Combo Trial. I give the entire management team an A for completing the Combo Trial - what I equate to an FDA imposed Navy Seal never ending boot camp to earn the right to show what we’ve got with Pro-140 as a stand alone HIV solution.
I’ve always believed there are positives for everything that happens in life. As painful as the Combo Trial was it has provided a strong foundation for Pro-140 to reveal its many other potential applications.
We are now a very different company than I anticipated becoming 5 years ago. The stadium just got much larger and the possibilities mind boggling.
Obviously converting the current P3 Mono Investigational Trial to a Pivotal P3 is a major event. If the FDA grants the conversion it could possibly be a bigger event to shareholders than completing the trial because a buyout will be likely to consummate prior to trial completion.
It is easy to get lost and loose the ability to see the forest through the trees. IMHO this is not about holding Nader’s feet to the fire on timelines. Missing timelines as a tiny underfunded biotech are the norm. The point is the Pro-140 molecule is not the norm, it’s special and not yet fully understood even by Nader and the Cytodyn team. BP can afford to be skeptical but they are ultimately successful for accurately analyzing the data with the smartest minds in the world. You can be assured they are analyzing and the trigger with HIV is the FDA granting the conversion of our Investigational Mono to a Pivotal. That will be a ticking time bomb the likes of Gilead for one will have to sit on if the FDA grants us the ticket to the big dance.
Throw in the cancer card and we are a multi dimensional wild card. I find it hard to believe BP would not acquire Pro-140 long before the P3 Pivotal Mono Trial is completed. I for one am more optimistic than ever about our future and after all this waiting now understand it’s time to smell the roses and enjoy the ride. The only question to be answered is when and the $ amount. As much as Nader is overly enthusiastic about timelines he is also tremendously confident about his paternal baby - Pro-140. So I will take his bulldog attitude and understanding of Pro-140’s value to insure we get our just reward. He’s far from perfect but nobody is going to steal his bone.
I will come prepared with two ears and one tongue.
Misiu, you are the one to get the answer from Nader. Thank you for your steady hand interpreting the science and ever present values.
My understanding is the FDA wants the whole enchilada before they will begin the review process. Submitting the pieces is allowed but they will not be reviewed individually when they are received. I look forward to your answer from Nader as I would like to understand the advantage of a rolling BLA vs. the normal submission.
Very good point nt2. The FDA is always in control of an unforeseen delay.
Ok understood. Understand this. Treating you to dinner and drinks means we got to the finish line. In that case it will be an absolute pleasure to see how much I can spend on a night out.
Please, keep posting as much as you are able. Mucho Gracias.
Anything but negative. Greater than 60% chance of cashing out between $5 Billion to $20 Billion in the next 2 years. Music to my ears. Although I think your wrong on the 20% chance of being worth zero, going to absolutely be worth something IMO.
BD, post of the day. Your a clear rational thinker that makes a ton of sense. You’ve decreased my need to post by 80%. I’ll treat you to drinks and a helluva dinner when we cash out, least I can do, that is if you accept.
I am just completing reading all of the posts for today. I have been in the air since early this am. Feel like the board summarized today’s trading and CC amazingly well. Thanks to all for the play by play.
I couldn’t resist posting the first couple paragraphs of Mike Sheikh’s SA draft a day prior to publishing. I thought it important to know he APPEARS to be back on board with CYDY although I am cautious in regards to his agenda.
Science continues to impress. Very interested in what will happen with Mono Efficacy with 700ml dosage.
Just a matter of time before the pay day arrives. Patience will prevail.
From: Mike Sheikh [mailto:sheikh@the-lift.com]
Sent: Sunday, July 15, 2018 10:02 PM
To: Nader Pourhassan <npourhassan@cytodyn.com>
Subject: Final Article submission
Gilead’s HIV Franchise Under Assault As It Stares Down Paradigm Changing Drug
Jul. 16, 2018 ...
×
Title:
· Title should be compelling, succinct, and accurately reflect your main investment idea.
· Do not include ticker symbols in titles; write out company names.
· Use statements, avoid questions.
· Sensational and/or bombastic titles will be rejected. Avoid name-dropping as well.
· Mention the main company(s)/product covered in the article.
Michael Sheikh
Michael Sheikh
Long only, research analyst, biotech, small-cap
Falcon Strategic Research
Summary
Patent fight with Glaxo dampens Biktarvy sales.
HIV franchise losing dominance to new entrants.
Empty HIV pipeline could lead to acquisitions.
PRO 140 represents paradigm changing drug.
CytoDyn acquisition/license is only viable chance of corporate survival.
Gilead (GILD) has annual revenues in the HIV class of drugs of over $14.2 billion and only has only one phase 3 drug in clinical trials to protect its dominance in this category. GILD’s $14 billion annual income stream could be in jeopardy because they are literally one drug approval away from an armageddon they admit in their 10-K is coming. A small competitor, Cytodyn Inc. (CYDY) has been struggling for over a decade to get PRO 140 approved as a salvage therapy to drug resistant HIV patients. After two successful phase 3 studies (pivotal combination therapy & investigational monotherapy), they are in a position to file a BLA for combination therapy, but the real threat is that the data is so robust that it reduces the viral load to undetectable levels and keeps it there without the help of HAART, the current standard of care. A monotherapy filing might come right after CytoDyn’s BLA submission and could eventually rewrite the current standard of care. PRO-140 is much more than a salvage drug and the monotherapy has the potential to wipe out over half of GILD’s total income. This is a potent threat to GILD’s HIV dominance. There have been no real innovations in the HIV field since the disease has become more manageable using a cocktail of drugs known as the HAART treatment so how they deal with this impending threat is of real interest to GILD shareholders.
GILD would be silly not to buy or in-license CytoDyn’s PRO 140, should the drug get Breakthrough Therapy Designation for monotherapy. With over $32 billion in cash and marketable securities this $100 million market cap, CYDY seems like a bargain. Other drug makers like GlaxoSmithKlein (GSK), Johnson & Johnson (JNJ), Merck (MRK) and Bristol Myers (BMY) round out the top 11 drugs for HIV and are looking for cracks in GILD’s HIV franchise to exploit. They are likely meeting with CYDY in anticipation of the approval and if they get wind of a monotherapy filing, this could spark a fight for control of the next generation of HIV treatment. PRO 140 is a once a week injectable that could reshape the treatment of HIV and has a realistic shot at becoming the new standard of care that replaces over 20+ drugs currently being manufactured. Besides its potential dominant use in HIV, PRO 140 is a platform drug that could be used in Multiple Sclerosis and metastatic cancer.
If we are approaching a buy out R/S makes no sense. SP and being on the OTC will have almost no impact on what the Pro-140 molecule is worth. This is about revenue potential, disruption, and fear of loss. Are we approaching the tipping point where one interested party will be like blood in the water with a pack of sharks circling.
Im interested in the tone of the call tomorrow and the strategy going forward. I mean seriously with Combo at 81% efficacy with extremely sick patients and the Mono Trial ticking with CCR5 patient selection shored up and dosage increased to 525ml the HIV BP players have to be contemplating a move. Then we pile on GvHD and the new cancer play with Pestell coming on board. Things are getting very interesting. I’m more bullish than ever.
A big thank you to all the insightful posts on this board.
Totally agree. GVHD could change everything by attracting a partnership or investment deal that would bring in the $ to accelerate our trials that are running on a shoe string. Let’s see what’s happens w the next 10 patients.
TT you sound desperate. From sub
.50 to $33. All your finger pointing at management, wishing, hoping and desperation isn’t going to magically move the SP.
We are playing the waiting game once again because IMO there are NO deals on the table at this moment. Concrete proof from our Investigational Mono Trial that we have a game changer is needed to significantly move the SP. GVHD is also a sleeper that could ramp the stock.
Time for a summer nap - yawn.
Patience TT.
$2 for a molecule that has Combo in the bag, serious Mono potential, GvHD looking very positive and many other Cancer applications. Yes management has done a poor job of securing financing that would represent the actual value of where Pro-140 is in the development cycle. To settle for $2 would be a foolish impatient move. Diluting is painful but we are a long ways away from diluting this down to a $2
Buyout. I’m tired of waiting as I have been in for 6 years however securing financing that lets this play out into 2019 is the prudent play.
AIMHO of course.
I’m not saying it’s going to go for $3 per share. It’s worth what the market will bare. Mono is the unknown that will lift value if data is great. We shall see.
I’m in the same range you are thinking. If it’s more great.
A17, I am aware of your opinion. At this juncture no takers on Combo. That does not mean that is the way the Combo story ends. Combo has value because it is safe, efficacious, and if I had HIV it would be my choice if I was CCR5.
Mono Interim efficacy data is yet to be determined. Let’s see if interim efficacy comes in over 70%.
That’s on the HIV front. Let’s not forget about GvHD and Pestell w Breast Cancer. The molecule is unique and applications are growing. Can’t see this just going by the wayside with the safety so clean.
We shall see. I can see you are an intelligent guy and I respect your opinions although we may disagree on the way this ends. I will say I have reduced my expectations in terms of buy out price.
Not from Vancouver, don’t live in Vancouver.
There are some smart minds on this board. The science is very compelling with the expansion into GvHD and Breast Cancer, and I believe this is the tip of the iceberg. The question is can we separate Pro-140 from the Monocolonal Antibody pack. Many here including myself believe we are on the cusp of accomplishing this. What matters is if a proven scientific genius with BP agrees. Validation is all we are missing.
Yes, that is my opinion at this moment.
Remember Paulson takes what the market will bare. They want the best terms for the company that will raise the $ for the agreed upon subscription. Believe it or not there are bigger sharks in the water than Paulson. At some point the science will garner attention and free us from less than conducive financing. The exciting part is that could happen tomorrow because we don’t know what’s in the works. So my opinion is just that with my limited information.
It’s all about financing at this point in time. Bottom line is the Paulson HIV raises are done. Not because we have better options but because the story has been rode hard and is not going to attract $ unless the terms are much more penal.
New story same players IMO. And yes if we can secure a partner $2-$3 over night. Until that time comes raising $ is the priority in Vancouver.
Look for a shift from HIV to the GvHD and Pestell Cancer story to raise $. Hate to say it but I wouldn’t be surprised if Paulson handles the offering(s).
Until someone w deep pockets steps up we will be bottom feeding for $ to keep the lights on. We need a major catalyst to break the cycle.
Major Catalysts:
GvHD- should have 10 more patients in less than 60 days and data out by October. This could be a real sleeper.
Mono Interim - Need enough patients on higher dosage at the 12 plus week mark to know what we have. Company knows from previous studies they will have a clear indication on the outcome at 12-16 weeks in terms of viral suppression and efficacy. Hopefully compelling enough data Q4 2018 to force BP to move.
Cancer- Pestell, Breast, Colon, and more. This hopefully will attract a whole new following.
I think it is becoming clear at this juncture the HIV players have spoken - we are not interested in more Combo solutions - we have plenty. Pro-140 has value but not enough to scare the Gilead’s - Mono is the prize. The Combo story could change in a heartbeat if one taker stands up and makes a move then the perception will become much different. Fear of loss is always the greatest motivator. Let’s hope we wake up one morning to this type of news.
While we need time to further validate the science, time is money. I’m hopeful the Cancer platform can bring in some new financial support - it is much needed right now.
AIMHO
That is a fact Finesand. Sell for 3-4B and hand this off to some deep pockets that can run.
Your post supports my thought that the Paulson raises did not fully subscribe. I’ve heard the company feels very good about the FDA meeting. If only they could transform that feeling into an equally strong PR by demonstrating command of the English language in their PR.
We will know soon...running on fumes.
No need for apology. Past Paulson raises and current financing uncertainty is controlling the SP. If the company could secure 25M at decent terms they’d take it right now. 25M will get them to total derisking/BLA for Combo, acceleration of Mono Trial and GVHD Trial. Somebody is going to buy this company in the next 25M that gets burned.
AIMHO
Bee, I understand nothing is in place w Paulson at the moment. I’ve participated in three of their raises. My point is I’m not convinced Paulson is completely out. Company has to have another option lined up or Paulson will be back in. So my hunch is the company is trying to hammer out an alternative deal as we speak. We will see which way this goes. Praying Paulson is out.
I’m interested to see IF they have another financing option lined up. As much sense as it makes that they must, I’m will not be convinced until one is PR’d.
My question on the last small raises w Paulson were they cut short because that was all that Paulson could attract? Or were they cut short because they were close to hammering out a better financing/partnership/deal? Or were they thinking the short term news would be enough to significantly derisk and swing the SP to a level that would impact potentials on the sidelines?
So are we hanging wide open or looking pretty with a deal at hand?
Yes it is Misiu.
You would think so. Will know soon.
Let’s add Breast Cancer to the menu.
https://finance.yahoo.com/news/research-supports-potential-cytodyn-pro-100000657.html?.tsrc=applewf
Seems GVHD may be the ticket to a deal. The data in the cancer space is revealing just how powerful this molecule is in addition to HIV.
I sure hope their is a deal lurking to bust us out of our financing woes.
The SP is so coiled if we get validation from a partner we would realize Finesand’s valuations immediately.
A17, your like a wet towel. Your smart and experienced at this but you are pissed because you gave up on a story that you bet on. If your out your out. Sounds like your in the middle holding a small position. That’s kind of pissed of land. Your posts support your position.
I feel your pain. The major milestones have not yet been met. BLA Acceptance by FDA and Mono Interim Data above 70% and conversion to Pivotal P3. If those milestones don’t break the Paulson cycle I will be dumb founded.
Keep the faith. Finesand’s valuations don’t lie.
This board is not the only people interested in this stock. There are many investors with large positions that don’t follow or care about this board. They are as PO’d about the SP as anyone here. We just don’t hear their noise however I can tell you the company gets an ear full. None of these people are selling as noted from such low volume. The SP is owned by the fundamentals of the Paulson raises. Eliminate warrants and the SP will run. Keep raising with matching warrants with no restrictions and here we shall stay.
So, we know the FDA meeting took place yesterday.
We also know a PR is coming shortly w the results of that meeting and managements optimistic perspective on the future.
Regarding the upcoming PR:
Bottom line is to read between the lines in terms of realistic timeline for BLA Combo Acceptance by FDA. Are we going to follow our past and encounter delay after delay or is this going to happen in 2018. BLA Acceptance (not BLA submission) is an event that eliminates all risk in terms of approval. If we don’t get attention from a partner and significant SP appreciation at that juncture it’s time to do some serious soul searching as to the value of Pro-140 in the Combo space.
Mono update is the other piece of information I’m looking for in the PR. Do we have enough data to convince the FDA to convert to Pivotal P3. Remember this is a big deal for the FDA as nobody in the HIV space has been able to pull this off. It will send a message that the likes of Gilead and other BP in this space don’t want to deal with-but they will have to and that is the biggest trump card we have.
Time is money here as we continue to get raped by Paulson, our only channel for raising $.
My hope is we can reach a tipping point, an event if you will, preferably sooner than later to break the Paulson cycle. It is apparent that the SP will continue to decline and the terms will be more costly if we cannot surface another option. This is not a knock against Paulson. This is the reality of the current situation.
Who isn’t getting a little impatient?
I would look for a PR this week. I don’t know if they met today. I heard the meeting w the FDA was on for June 18-20.
Probably because they are meeting with the FDA right now.
A17, your experienced w the process. You get it. This is a meeting to determine if they are on the same page w the FDA regarding BLA submission. The last thing Tony wants is some big delay because they overlooked details that will kick the can down the road an unforeseen six months or so. And while they are meeting face to face let’s get the Interim Mono data on the table and see if it’s strong enough to convert the Mono investigational to a Pivotal Trial. Rumor has it the meeting is this week. Maybe it will happen maybe it won’t and I will leave it at that. If it does we will know soon as the results will have to be PR’d.
Your a smart guy and I don’t blame you for playing the devils advocate here. Difference is my vision and intel sees this playing out quite differently. We are out of the woods, the only question is how much. There will be no bag holding here for the Longs.
AIMHO.
My dad was a lawyer. He had the same attitude. Nice post Lawman.
Will do. Have a great weekend??