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I was one of those people who bought some at $4 way back then. Completely different product and company back then. I don't feel penalized because the progress since then and what we have is worth way more. I actually bought at the IPO I think 12 years ago. This was a small position back then and has grown over the years. Most of those years I completely ignored it because nothing was going on.
So, instead of looking at all the data from the numerous trials, you feel the best way to determine if the special sauce is legit is to look at the stock price?
Great post! I was thinking the same thing. We are all trying to make some money on this but we longs also know this drug is the difference between life and death for some very sick people that are running out of options.
I wonder if these trash talkers/ small league manipulators will look back years from now and feel proud that they bashed a drug that is so important. Such a small minded mentality!
So the only reason you are unwilling to disclose weather you are long or short on any trades is because you are short and don’t want to reveal your true intentions. The major flaw with your “ they need more money, there are not enough shares to give out, so there must be dilution” assumption is that you are unwilling to accept that there could be major events over the next few months that can drastically change the value of the company. You are simply trying to make a price target based on nothing happening but dilution. Are you able to accept that they could PR the BLA filing? How about the TNBC data? How about a distribution partnership? Let’s also keep in mind that they do not need to do much in the mono trials because there is already a large data set of results from past trials showing this drug is a mono drug. Any BP can look at this data and know what is coming over the next few months. You somehow think that all of this is not important and does nothing in your $.40 prediction based solely on a share count increase.
Nice work captain obvious! you are right - it takes a lot of money to develop a drug. It is hard to raise funds when you are a pre-revenue biotech. When did you realize this? We all knew this for many years. Your in-ability to read through any trial results does not mean that we are all "assuming" that the combo trial is great. The results are great and there a many patients who are facing death from HIV that would strongly feel this is in fact, a great drug.
How does it feel to be someone who is proud to trash talk a drug that is the difference between life and death? We are all good with critical discussions on the path to get there but to simply post garbage is a waste of everyone's time.
I'm not sure I want to bother responding, but...
We DO know that pro140 was the reason for the VL drop because there are many patients only on pro140 and have viral suppression, some of these patients have never had this no matter what other drugs they took. To make the suggestion that one of the other drugs could have been the reason for viral drop and not pro 140 is just you not reading anything in any trial.
The FDA is ALLOWING them to include the 700 mg dose in addition to the 350 mg dose. They are not requiring this, it is a broader allowance to be determined by the doctor as needed. This shows the data from other doses is good and the FDA likes what they see. Again - no idea how you can mis- understand this.
Expectations are all we have in determining what might happen in the future - if you want more than that the please let us all know how you expect to have greater certainty than that word. We are all basing our expectations on reading the trial results and seeing the effectiveness of this drug. I and most here have great confidence that the FDA agrees and feels this will get approved for many indications in the future. It has not happened yet, and many times in the past we had expected to have this occur. Just because it has not happened does not mean it will not. This applies for approvals as well as partnership/financing. If these things were already done, the SP would be higher. I am expecting that to happen in the future so that the stock I own today will be worth more once those things do get accomplished. This is how investing works. I am being very simple in explaining this on purpose - hopefully a light will go on.
I just hate that this can be published on seeking alpha. I know it is far from a reputable financial journalism but there are some very well researched articles on there. It would take less time to research the statements and see the paper thinness that to write the article!
Wow, you really make quite the negative take assumptions on this. First, partnerships are not discussed publicly until the details and the deal is done. So that far more possible to happen than not , it just has not been done yet. The mono trial was investigational and the fda asked for a pivotal with very low requirements. The speed they are moving at for the first monotherapy is not what BP could achieve. Your timeline is just your glass half empty guess that is no more valid than me saying the pivotal trial will be done in 2019. Both are possible, but I feel confident the amount of p3 data generated is very much in favor of my prediction than yours. The cancer indication is not some carrot being held in front of us by the ceo, as you characterize it. Dr Pestell has been studying this for years and not only came to cytodyn, but gave all patents and reader how to the company for shares in the company. If you do a little teaser he into dr Pestell I think you will realize that if the ceo was full of it this dr would not be wasting his time. As for the financing, it has not been pretty but it ultimately may really work to our advantage. If they had partnered up long ago it would have given up a huge amount of the company for cheap. The terms are a very defined relationship with those that put up the money to get us here, it is shares and warrants for shares. Not a huge chunk of ownership or royalties. I’m sure you think that a tiny biotech should het interest rates similar to your home mortgage but that is crazy. This is a high risk investment and you should understand that.
What happens as we get closer to the 600million OS limit? I would assume they would just increase the # of shares but we are already quite close and they have not brought it up. I would think that the SP could become volatile as there is less liquidity. I think the need to issue shares with warrants must be coming close to its end.
just to piggyback on your response, as much as we need a greater investment community exposure, I kind of think being under the radar might have some benefits. I think that once patients are using this drug after FDA approval, word will spread fast among sales reps in BP that they are not selling as much of their drugs and will be selling far less in the near future. They will be seeing the #'s that matter - lost revenue. Ultimately we don't need a manipulated SP up or down - we need BP to buy this. To get that to happen the drug has to scare BP.
I guess in the state of the union speech tonight, Trump is going to announce a plan to stop hiv transmission by 2030. This likely a plan to get the large number of hiv positive people who are not under any treatment to address their viral load.
Farm mouse tumors? What?
And? I think Paulson, no matter what level of influence, wants to make money. I’m ok with that.
Your cat is licking a 2 sided penny? Don’t all penny’s have 2 sides? Why is your cat licking pennies? Why am I responding to this? So many questions.
I am going to assume the “bank” you are referring to is Paulson. I think you should understand that Paulson, is in reality, a number of investors that put up their money. They are not a bank. As for “ties” to this “bank”, cytodyn has received the money from these direct placements and spent it on trials. That is their relationship. To think that Paulson investors are in control and the bod is just a bunch of puppets is ridiculous. Take some time and look at each member of the board’s background and I think you will quickly see that they have no reason to be manipulated by an investment firm or its investors any more than us investors. Also, the ties you are claiming as some sort of inside scheme, only work if the value of the company goes up, which is what we all want.
Whose bank controls the bod? I don’t understand this. We have a fairly diverse group of directors that don’t seem to be under control by some bank.
Fortunately this is not a craigslist classified ad, offers start as conversations to see where each side is at. I don’t think the bod thinks this is a $600 million company. The board may want to leak that there is an offer just to get others interested.
It is possible that the opportunity for Paulson investors to sell shares and re-invest with futures raises is over and they may be compelled to hold what they have. We might see the sp just walk right through resistance levels with no problems. Or not.
Just to elaborate on what we already know, BP is literally within months of having to explain how their HIV revenue is dropping in their quarterly earnings calls. Can you imagine the CC from GILD showing how their HIV revenue is dropping and will continue to do so and they did nothing? I can hear the fund rep. calling in to the GILD earnings call and asking the CEO how they did not just buy that $150mil company months ago. It will take zero effort for any investor and fund to do the research to see how long this company could have been bought for cheap and they did nothing. BP CEO's will be losing their jobs because of this drug. the 20-20 hindsight of this is going to be unbelievable. As much as we criticize Nader for not building the BP relationship, We have to see that BP has a much stronger responsibility to build the relationship from their side. BP is playing a crazy game and their investors will not see it coming until it is too late.
One thing I think is worth pointing out is that the population for combo and mono overlap - meaning an HIV positive individual might take Leronlimab with other drugs and once Leronlimab is approved as a mono drug that same patient would be taking only Leronlimab. I am not changing the size of the market for combo and mono, just pointing this out. What I find interesting is that when Leronlimab is approved as a combo, the BP industry might look at it as another drug and feel they are missing out on the revenue. However they will also see that the same drug is only months away from not just being another drug to now being the only drug those same patients are taking and all of their HIV revenue will vanish. I know we all know this but from the point of view of BP in HIV this is a very important perspective. The industry will see a mile away that this drug is going to ruin their HIV revenue as it is being approved and then sold as a combo drug.
As crazy as it is that BP has not done something yet, the cancer indication has really thrown a monkey wrench into this. Now BP is dealing with a company that will not only steal their HIV revenue, but they want a cancer drug price for it! Cytodyn may have actually aligned events in a very advantageous way. I strongly feel they did not plan it this way but BP is soon going to have a big problem.
I am starting to see a little insight into what happened with tony c, the statement by dr Pestell that the relationship with Gilead did not develop and they were not really getting far up the corporate tree at Gilead. He stated that they are trying to mend that relationship. All 2016 seemed to be under tony c’s control as he started that year running his one and only cc and then we heard nothing most of the year. That was also the year of the the RS and uplist failure. My guess is that tony c did not deliver the connections at Gilead or he did but Nader ruined them. Either way the fear was that they did not have the string of trial and financial pr’s to support the RS and uplist. The operational departure of tony might have more to do with the failure of the Gilead relationship. I really think this is now history and does not matter anymore.
Watch any tv commercial for FDA approved drugs and their side effects and I think the probability of the FDA not approving this is less than 0. I really can't stress enough how FDA approval is virtually a sure thing. A long time ago I talked with Michael (the CFO) and he told me that in early studies they injected 2-3x the weight of the rat with pro140 and it did not kill the rat - it was fine. This drug can't kill anything. The only question everyone has is the financing, the science is rock solid.
I have a theory as to why they aggressively produced inventory and continue to do so. It seems from the wording that they are negotiating deferred payment for distribution and I think this is possible because they are using the inventory value as an asset to ensure payment. The cost to produce the drug is a fraction of its end use value so they are basically taking the investment and multiplying its size and value by building an inventory. The amount of upfront payment they get is based on the value of the inventory, not its cost to produce. If we just sat on the cash raised and used it for trials there is no value until product is sold, with inventory the product has value now, assuming fda approval. The increase in the selling price of the drug supports this.
I was also not aware that this 700mg safety acceptance was even part of the discussion with the fda. I thought the safety arm was done. It is good news and will pay off in future indications for sure but it is not the mono trial protocol approved type pr. I think I’m being a little negative about this but it seems like this is a slow grind progress with new steps of accomplishments instead of the accomplishments we have been hoping for.
I am having trouble understanding what you are talking about. I think it is fairly obvious that having to raise funds at a higher sp would be better. I think any banker would like an increased brokerage fee from a higher sp and I think any warrant holder would prefer the sp to be higher than the excersize price of the warrant.
In the presentation it was very clear that they said they have an FDA related PR that they are reviewing very carefully before releasing. It was related to their meeting with the FDA in December discussing the BLA and Mono trial. Not sure what was decided but I would guess it is more than just the FDA is ok receiving the BLA in full. It must have something about the protocol for the mono pivotal and/or BTD? I find it confusing that a couple CC's ago the protocol for the mono pivotal seemed very developed as to the duration and patient #s but not agreed on by the FDA? It seemed the requirement to even need to do a pivotal trial was not set. I wonder if some if not all of the data from the investigational trial is going to be used in the pivotal and a lot of what is normally required in a pivotal is not needed? no idea but it looks like a clear direction moving forward is likely what we get.
I really was not that impressed by network news wire, all they did was copy and past company pr’s here. The seeking alpha articles have a lot more information and perspective. I wonder if the reason they did not get paid is because they did not do what they were contracted to do. Maybe I’m wrong?
Thanks for going, sounds like a great experience. I wondered how these presentations really are, could be that they are talking to just a few that are there for the free coffee or could be a full room. The funny thing that it really only takes one VC fund to step in.
huh? explanation please
I don’t know of any rumor like that but at some point in a past cc someone asked if a share buyback is an option and mgmt seemed to indicate that will not happen and there are no plans to do so.
thanks Misiu, sounds like things are going at a good pace. I am sure the financing is a giant pile of different options at this point. Until we have a readout on the TNBC, I don't see a financing deal at a better level and I think Nader see it this way also. The licensing of the prostrate test is possibly the key to putting some financial support behind this in the near term.
You have predicted this a few times in the past and have been wrong every single time.
Nothing has changed? Are you kidding? Over the last year we got 90% responder rate, we got prostagene and dr Pestell and his patents. We completed the combo trial and investigative mono trial. The sp is not showing any progress but the development of this company is impressive. I am not a fan of Nader at this point mostly from fear that he does not understand the sp and has no experience in this phase of doing deals and building relationships.
It is kind of nice to know that the seemingly worst case scenario is still worth more than where we are at today. I guess the even worst scenario is that BP just waits until this is totally bankrupt and picks up the patents and technology for pennies. This likely will not happen no matter how mgmt screws this up because there are so many BP that need this technology and the patents that when one jumps in, others will have to react. Nader can be a great ceo or he can be a crap ceo, at the end of the day the drug and its patents is all we need. I don’t see funds completely drying up because there are just too many wealthy people involved and realistically, the cost to get to BLA and TNBC is not really that much. Those individuals are not going to let their investment disappear because funds ran dry. as soon as Dr Pestell can start doing presentations showing results from a p2 trial and showing the world this is a cancer drug with huge potential market, this current situation will disappear. I am tired of trying to figure out Nader, there must be some reason the bod does not seem concerned. Remember a year ago when we were so worried that the trials may not go well and the mono is enrolling too slow, etc. that is all behind us and this will be soon behind us. Progress is being made and even with this crappy fundraising process, it is a cheap investment to develop.
Just because they get funds from outside sources does not mean the employees are paid via those funds. They are government employees and if they are not getting their paycheck they are likely not at work.
I do feel this is not a huge problem. I would rather the company focus on getting results from the TNBC as soon as possible. We can raise the funds hopefully at much better terms to pay for the BLA. Delays are not good but the sequence of events do matter.
We don't know but this is only a phase 2 trial and we don't have the problem of screening patients like we did for the HIV trial. The process of finding CCR5 HIV patients that are resistant to other drugs was what took so long. With the TNBC, it is easy to diagnose and since it is an un-met disease I would think the recruiting of a dozen patients will be easy.
That is an interesting idea, the hiv indication could set a lower price. It seems lately the price tag on this has been changing depending on what it can do an the market size can change quite a bit just from going to $70k per year from the previous $24k. Maybe the government shutdown will help us with getting the TNBC data before BLA and also give some time for fund raising?
shoulda woulda coulda, If we had done the RS and up listed way back when, This whole time we would have been raising funds from a higher SP (even with the RS) and had tremendously greater liquidity. On the other hand, we could have RS and up listed and gotten beaten up down to the pre-RS SP and we would be sitting here wishing we stayed under the radar. Shorters need liquidity more than investors. Maybe the OTC is just a safe place to be as we develop this drug and set a price. BP is looking at the value of this as their product - and that is not related to CYDY share price. My big fear is when we do file the BLA and get preliminary TNBC readouts, the SP just sits there as it always has in past "great news" announcements. The only thing that matters is some BP realizing the threat or desire to have is enough to take action. That is dependent on development, not SP/market up listing. I would really like to be able to see the SP move based on news but realistically, the only news I really need is buyout.
It makes you wonder, who woke up this morning and felt it was time to sell 3k shares? I guess it is possible to do a morning market test to see if buyers or sellers are going to jump in.
Thanks for pointing out the lapse in the RS option, I think that is the nail in the coffin for uplisting. I don't think mgmt. has any desire to uplist. I think they know there will be a deal of some sort and uplisting will be unnecessary. It also leads me to believe the value of the company from mgmt.'s perspective is based on the value of the drug an not the stock price. the stock price is just a number to be used for short term "as they need it" funding until a partnership deal is done. To me it also is supporting of why they did not renew the contract with the IR firm. I really think they know what is likely going to happen and the scale of it and getting there is not a 50/50 likelihood situation.
That is my assumption also. I think it is safer to assume the fda will be conservative rather than surprising us with a larger approval.