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I don't think Nader is referring to the upcoming pivotal mono trial for the safety data. When Nader says they are using mono trial patients he is referring to the investigational trial. They just needed extra patients at the beginning of the year to add to the 700mg dose patients they already have. It is not clear for sure but claiming the filing of the full combo BLA would not be possible at 2nd or even 3rd quarter if they were waiting for the pivotal mono trial to get the safety data. I know it is a strong desire to use this to claim that this is proof that Nader is lying when he says they are expecting to file the full BLA first half of this year, But I choose to go with the more logical assumption that they already added and pulled data for the safety portion.
um, here are a few links that kind of indicate there was a phase 3 investigative mono trial, not sure how you missed the news.
https://www.cytodyn.com/media/press-releases/detail/224/cytodyn-initiates-phase-3-monotherapy-trial-for-hiv-patients
https://www.marketwatch.com/press-release/cytodyn-reports-treatment-of-first-several-patients-with-pro-140-in-its-phase-3-monotherapy-trial-for-hiv-2016-12-12
https://clinicaltrials.gov/ct2/show/NCT02859961
https://finance.yahoo.com/news/cytodyn-monotherapy-trial-leronlimab-pro-100000799.html
Referring to your own past posts built on your opinion does not make your opinion factual. When an author provided references for support of their work they don't refer to their own past work. it makes no sense. I guess you are hoping that because you put links in your posts that others won't click on them and see it is just a link to your past opinion posts.
You seem to have omitted the entire P3 investigational mono trial, that was started and has generated a huge amount of data. Pivotal trails are based on investigational trials and we all hoped the FDA would possibly convert he investigational to pivotal but they did not. That is not a failure - just wishful thinking that did not happen. We do not know yet what the IND and the FDA will require for the mono pivotal trial, but there is no worry about the data from the trial Buyouts happen when data confirms the claims. We have a lot of data coming our way this year that will confirm what this drug can do.
As likely the investor who has been with this the longest (since 2006) I can say that prior to pro140 and Nader, this company was dead in the water. The ceo had no ability to raise funds or have a plan to develop Cytolin. There was attempts to work on a bird flu vaccine and modify Cytolin for cats, none of which became much. What ever you opinion of Nader, he gave this company a direction. I am not sure what the differences between Cytolin and pro140, but pro140 was further along and came with $20 million in grants that supported the acquisition. It was also revealed that early on progenics realized that the should not have sold it because they did not realize what they had. That was when this was only a holiday drug, not even a combo drug.
I agree, the disconnect in the SP is so out of whack I try and ignore it. For most of the years I've been in this I was under the belief this would be nothing and then a buyout would occur - like a lottery ticket. Now I tend to think there are many developments that will occur to set a value over time. Many separate partnership deals and FDA approvals will each move this SP into reality. I am not crazy about the time these will take. The "go it alone" talk gives me the feeling this will not be a one day we wake up to a complete done deal. However, the threat to BP can very much compel a big deal all at once.
Being on the OTC with very little volume to over-run the warrant holder automatic selling has everything to do with the SP. There is simply no small biotech that navigates this process without timeline delays, lack of funding issues and risk of science setbacks/failure in the future. There is absolutely no uniqueness to this company related to those issues. You could make those statements about any small biotech. This company is an extreme example because the science is so good and how far they are through the trial process while having a dumper of a stock price. Guessing that things are bad behind the scenes is stretching, looking at what is in plane sight is what I rely on.
Or, everyone left this board out of exhaustion replying to trash talkers. It has nothing to do with the company.
also completed combo trial, mono investigational trial, completed safety part of all trials.
Why do you think Paulson and BP is some single entity? Paulson is a group of investors that all individually have their own plan as to how they are managing their investment, just like us. There are some who sell shares and hold warrants, and some who invest and hold. BP is a large group of individual companies that are competing with each other. The thought that these entities are conspiring to control this one drug is just paranoia.
Saltz used an example that this is like the TV show the Voice, where once one judge hits the button and likes what they hear - the other judges hit the button not because they like what they hear but because the other judge did. These licensing deals are important not just for the money, they matter because they send a message to every other investor and BP company that this is being taken seriously. no matter how small the first deal is, it matters because it says that there is a strong interest in investing in the future fda approved drug, not in some financial manipulation.
Excellent perspective, I agree that this is where we are at and the story has not changed. There are frustrations for sure but it will get there. Another factor to consider is that there are only 600 million shares available and there just are not that many left to give away in cash raises. Mgmt has not asked to increase this and it is not an easy process to do so. I am assuming they are anticipating some new form of financing soon.
This is my fear, that mgmt thinks that scaling into a revenue generating company is the plan. On one hand we don’t see a huge effort to build a sales force or support team, on the other they are building an inventory of product. Mgmt has gotten this far with a relatively low cost and has moved quickly (despite their optimistic predictions). However the hand off to another company that can get this drug to those that need it needs to happen at some point. Developing a drug is not easy, selling and distributing it is a whole different skill set. Fortunately we have a bod and investors that will take offers very seriously no matter what mgmt thinks they are capable of.
So, how would you pay to develop a new drug? Generate revenue first and get fda approval later? How would that happen? It is expensive to go through this process and everyone knows it. Knowone will put money enough to get through this process without some portion ownership in the company, same as buying stock. I just don’t understand how you so strongly dislike this and offer no path to an alternative. Better terms and a higher sp to negotiate these dilutive deals would be nice but this is a pre revenue company so there is not much financially to leverage.
I don’t see a big move unless it involves a position taken by a major BP or VC firm. We have had plenty of trial results and fda guidance PRs that did nothing. A third party taking a position proves this has real value and this company is not alone in the woods with great science by itself. This company must get someone to jump in. The trigger will likely be out of left field and nothing we predicted.
Interesting question, if the sp did move that much the short positions would likely get a margin call and have to cover.
I was thinking about the current sp problem and I think the short interest is going to tell us when something is going to happen. PRs have not moved the sp and volume spikes have not either. I am thinking that in order for any serious short position to be held, it has to be based on the ability to absorb volume spikes and control the sp. it also has to be based on a good idea of knowing major news ahead of time. I think the larger spikes in volume might be used as tests to see if the sp can be held at $.50, if so it is safe to hold a short position.
Penny stock otc investors may not really care about the science, I think they have a formula for making money on failure of any small biotech. Because of the small market and their ability to control the sp, they can simply hold a short just in case this turns into a failure. I think when the short interest drops that will be a sign that they fear a catalyst that could blow their potfolio, so they close the short.
No idea if this is what is going on but the volume on Thursday with no sp movements says a lot.. it might be more appealing to short a $2 stock than a $.50 stock so the sp would likely drop after the run to $2, I guess. This is why I don’t read this- too much stuff I don’t know about the sp action. I sit and wait for news that actually moves the sp to where it should be.
Very well put statements, We are fortunate to have Dr Pestell part of this company
I think you are right - we won't know until after hours today at the soonest, could be tomorrow or Monday also. What ever is going on, it must be a "not during trading hours" type news. We have had big increases in volume in the past that did not hold any real significance, maybe this much larger, faster volume really does foretell us something!
the volume is just going crazy, almost over 1 mil already. something is happening.
I have the same problem - not sure Nader has the skills for the buyout/partnership deal or if he is as dedicated to this as he has shown is a huge asset. I will say that Nader's control is really over estimated in this crucial time. He is not running the trials, he is not the only one in the negotiation discussions and he is not the ultimate decider on these crucial points. We have a BOD that is made up of very experienced people and we have large investors/Paulson that do have a big influence on any major deals. Because all of these individuals are under an NDA, they are the first to know and able to voice opinion on the path forward. Nader is the day to day manager and is put to the task of steering around the challenges that come up.
Another thought, If a partner is determined to be a part of this, whether it is a VC firm or BP, They are in it for the same reason we are - the science, patents and the potential. Not Nader, maybe Pestell. No matter the mistakes Nader could make - they will not be deterred once they decide this is a must get done deal. If any outside offer comes in, Nader is going to be hearing from Paulson and the BOD about what the plan is and likely be in agreement with what they and we want.
Lets not think of this as Nader trying to sell a condo in Albuquerque, where he can screw up the deal with one counter offer. These discussions go back and forth with many details we will never hear about. We can bring up similar biotech deals all we want but the truth is those we are looking at with hind sight and the reality for those examples at the time was a lot of uncertainty until everything was clear. To think this is any different is assuming this is just a simple transaction - it is not.
If it is such a bad situation, then why has mgmt not increased the AS? They have in the past with advanced notice and a board vote. For them to announce there intention to increase it would take some time to go through that process. So why have they not done it? Because they are done giving out shares for funds?
An interesting point in this article is the low risk of future dilutive fund raising because they are so close to the authorized share count. There has been no mention from mgmt. to ask to increase the share count and if they wanted to they would need to vote on it.
I read it as they have injected the first patient. The wording as to an additional injection to me means the additional injection is pro 140. It also is clear that data will be available soon, I assume 21 days as stated before.
Just to expand a little on this, right now insurance companies are paying for multiple drugs and other drugs to treat hiv and the side effects of the hiv drugs. This will only get more expensive, unless a single drug treatment with no side effects shows up. Insurance companies are going to love this drug. The number of drugs prescribed for cancer to treat just the side effects of chemo and radiation treatment is not exactly cheap. I don’t like that mgmt seems to be increasing the cost of this drug, but the number of other expensive drugs it will replace actually makes it cheaper. Many existing drugs are not to cure the disease, only to ease the pain and prolong life to some degree. A patient that survives is a person who will be continuing to pay health insurance in some way. This might be a blunt statement but insurance works on actuary data, and survival lowers cost to everyone. I remember my mom took an occasional injection to reduce nausea and increase energy during chemo treatments. It cost $1500 per shot.
Good point, to add another monkey wrench in is insurance companies may see this combo approved drug as really expensive because it has to be used with other expensive drugs. The insurance company will really want the mono approval so the overall cost drops. This is yet another market share catalyst. When BP sees that this drug is being prescribed is one thing, seeing a big drop in sales because patients are taking only this drug is another. The insurance companies will be not interested in paying for any other drugs to be used in combination with it.
I agree, there must be something the fda is looking at to be so detailed about the combo trial. They seem to be trying to get the big picture of this drug and the hiv disease. It could be we are so focused on combo and mono being separate entities, in reality mgmt and the fda might be grouping it all together. Originally mgmt wanted to just do the mono trials, the fda is who required the combo trials. It could be that the fda is close to seeing enough to understand this is really a mono drug.
It was Lutz Florida. The only reason was that the ceo lived there, Ken Van Ness. They were trying to buy an office building that Van Ness happened to be broker for. My only theory for this move might be that Dr Pestell might prefer living there?
Exactly, why would they be recruiting 200 for this trial when it is not pivotal? Not that I know anything but the fda must have given some sort of reason for them to continue to collect data on the existing investigational trial. The pivotal trial has only been spoken of as likely, but not set by the fda, no protocol approved etc.. why? ... because they are getting the data the fda is happy with in the current trial. I feel the pivotal will not be needed, or at most be small trial to finalize the label of the mono indication.
Why does this keep being brought up? Who is invested in a company going from pre revenue to revenue? When the combo BLA is filed the world will know this is an FDA approveable drug. The mono data we already have shows the world that this drug will take away huge amounts of market share from BP. When the first data from tnbc comes out, the price for an hiv drug will go to the price of a cancer drug. When this actually hits the market or fda approved for any of these indications is not that important. BP will have to act on the likly hood of approval, the data showing its potential and the ability of the company to keep going. If you are investing in a revenue company, you are missing the point.
I have to wonder, given where this company is at, how does anyone short this? I'm not saying that it is guaranteed to go up or that I know when. The question is how much lower can the stock go to make shorting worth the risk? If there is 100 million short positions and the stock goes down $.10, they make a total of 10 million across all the individuals shorting. I'm not saying this is a small a mount but if the stock goes to $1, they are down $100 million and forced to close with margin calls. Even if I knew with great certainty the stock is going lower - I would never risk this! I think this shorting must be some part of an algorithm and no thought to the investment is even considered. It could also be part of a hedge against a long position. The really scary thing is, If the stock does move substantially higher, there may not be enough stock available for sale. I would think the brokerages would trigger a short covering very quickly because of this. We assume closing these short positions is easy - It may be a very big liquidity problem and the losses would be massive.
I agree, It sounds like the move to test the 700mg dose should have not been done. If they just went with what they had they could have finished the BLA. We only needed 70% efficacy, not 90+%. I think it is obvious the FDA does not want to do anything with the Mono trial until the combo is filed. I don't think we can blame mgmt. for this - it sounds like the "great" relationship with the FDA is really just ok and mgmt. was just doing what they though would be beneficial.
I also wonder why they even had this CC, It is nice that they want to keep us informed but they could have skipped this until they had a real deal in hand. Nobody wants to hear another "in discussions" comment. The fact they are hiring a full time employee to be in charge of this tells me it is not for awhile before we see real deals happening.
I think I'm going to ignore this for awhile - we have beaten the meaning's of Nader's works to death. There is nothing to see until it is right in front of us.
I agree, many positive PR’s in the past have been accompanied with Paulson cash raises the same day negating any upward momentum in SP. this has taught me that mgmt really has a disconnect with PR’s and normal business operations. The lack of any timing of these tells me not to read too much into the sequence of events. Likely the pay raise in mgmt’s mind has absolutely no correlation to what will be disclosed in the cc. There have been many past cc where tremendous news has been released. The quitness of the FDA is interesting to me, I feel the meeting in December has lead into some decisions on some issues that were discussed. There has not been much discussion of the mono trial, this possibly gets some update. I do not think the first injection for the tnbc trial is not too news worthy, in the past we have been told the first injection for past trials will be pr’d and ultimately was not. We could have already collected data in the tnbc trial. There are many opportunities for new info and I am just going to wait for it and not jump to conclusions.
I do have to agree that seeing the company simply raise the cost of the drug to sweeten the potential revenue is depressing. the thought that to treat a horrible disease is $70k a year is sad despite our in-depth knowledge of the cost to develop.
However I can honestly say that hearing of someone I might know taking this drug and living, not having to rely on toxic drugs of the past and knowing doctors may not have to give the death sentence speech to patients will make me very proud of our involvement.
I disagree. The cost to develop a drug and get it through trial takes huge money. Investors of any sort do not just write checks unless they can hedge the investment and know they have some sort of market to sell shares. Open market investors are the ones making it possible for direct placement funds to happen. Open market investors help set a stock price for raising funds. Traders provide the liquidity on a daily basis so the company can have access to funds as they need it at a price that is reflected I the market at that time. I feel strongly that if you want to be a part of helping very ill people, supporting a small biotech is one of the most direct ways to do so. Going to fund raisers and giving to charity are very in-efficient ways to help. Most of that money does not get to those in need. The thought that the financial support from share holders is not a big part of helping people is just short sighted. We should be thankful we have all levels of public markets to support companies that have no way to turn revenue until hundreds of millions are spent.
As a side note, I just checked the web site and cytodyn has a new investor relations company. It is the Edison group in New York. I guess this partially explains Nader’s trip to New York a few weeks ago.
What I really like about how things are happening is the clear path they are showing. First the combo Hiv is at the BLA stage, tnbc data is next, mono after that and then we can see that the expansion is in the early stages for so much more. Any BP can see from miles away what is coming. They need to act soon. I strongly feel the timelines for when these indications get full approval don’t matter, this will get bought way before then.
So, you would not spend $1.5 million to test a drug for some of the worst cancers? Really? Do you not look at any past trial data for the ccr5 drugs to see that this should be looked at? This is peanuts cost wise.
This sounds good, I like that this is assumed to be sold next year. I have to wonder if this is putting the cart in front of the horse however. We do not have FDA approval or the BLA fully submitted. Is this a requirement for the BLA? Is the $25 million needed to build inventory in preparation for FDA approval? Kind of scary that a company has to do this prior to knowing the drug is approved. Sorry if this is an obvious step in the process but I really don't know if this is required or just strong confidence of the company.
good point, I just am taking the attitude that the product is a thousand times more important to this investment than the CEO - at least at this point. It is possible for mgmt. to screw this up, but the drug is worth more as it sits now so worst case scenario is that they fail somehow and another company buys the drug and patents for cheap - which is more than $150 million. Mgmt can also prolong the inevitable believing they have a $200-300/share company and wont take less, meaning we are in this for many years further. I just think BP will jump in for the drug, patents and Dr Pestell, not for Nader. What Nader and Micheal could have done is small potatoes compared to the whole reason we are here. It is also possible this crappy financing and OTC prison is of huge value to us. We have a very defined relationship with the funds that got us here. Would you rather Nader made some huge percentage ownership deal a year ago and we now are looking at a giant chunk of the company owned by some company that put in very little funds?
Well put, I agree. The pressure is on and most here have been in this for longer than thought. However if we look at the total cost and timeline, It really is cheap and done quickly considering the typical cost and time for any drug to get through this process. At this point, what Nader gets paid does not really matter much. I have been critical because it does not seem fair for the CEO to not be in this as much as we are, but all I really care about is that we get to the finish line.
He could have turned down the stock options and bought stock in support of the company. He could have asked for a lower salary also. I don’t dislike Nader, I think he is a very driven and motivated person. However this is his big flaw as a CEO. It would be nice if any investor considering buying in would be able to see the CEO has a position based on their own money like the rest of us.