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I guess the sell off was due to the $15mil raise they just did, how did the seller know? In a way it is good they got this raise out of the way. So far Paulson is making the most off this investment!
Not that anything has gone the way anyone here predicts, but what the hell is going on with the SP? At first i thought is is a low volume day so who cares, but now the volume is fairly high. I know this has been asked before, but who sells at this price and right before a potential significant catalyst? Is this just a re-test of lows?
I don't understand why you think this is a "placebo play"? are you saying that pro 140 does nothing and that the patients, or mice in this case, just believe it is working and the results are just in their head? I also don't know why you criticize the stage GvHD trials are in, it is a step by step process and they are at the point where thy recruit for a p2b human study, simple! Do you actually think that if a company claims a drug does something they should just do a 300+ patient trial, get approved and on the market in a matter of weeks?
Thanks, maybe I’m reading into this too much.
My opinion on what happened is that there seemed to be some confusion between cytodyn and the FDA, the FDA wanted a face to face to resolve something. I feel that cytodyn is asking or expecting a wider label and thought they would get it. the FDA lowered the enrollment to 30 because tai med was allowed to have that trial size but they were looking at a much narrower label. The fact that cytodyn did not really elaborate on why this happened or what the specifics of the discussion suggests there was some sort of misunderstanding that Nader should have been on top of. It could be the 50patients and 300 safety data solves this and ensures a broad label. It could very well be that the FDA could have stuck with the original 150 trial size if at that time cytodyn was asking for a broad label. Either way, I think it is safe to assume Nader was a little loose with the details of the combo trial.
I agree, however i strongly feel the FDA does not have every right to do what ever it wants. It is a government entity whose job it is to monitor trials to make sure drugs do what they say they do, side effects are documented and the drug is safe. I realize this means that they have a lot of responsibility but when there is close to a year of setting the trial protocol they should own their agreements. The FDA said 30 patients for the combo and to think they can and without any explanation change this whenever they want is irresponsible. Cytodyn is a small biotech and these changes could mean a important drug never gets to market. I am sure many past drugs went through this and we do not have treatments available due to the finances required to make it happen. I am sure the FDA is aware of this but they are way behind in terms of solving this problem. Pro 140 has been in existence for 7+ years and it is as close to ever to being on the market but at a cost of many years and hundreds of millions to get here. The FDA has to answer to the HIV population as to why a drug that there is absolutely no safety issues for over 7 years and proven efficacy is being jerked around at the last minute by them.
I agree, your hypothetical sequence of events is possible to some degree. What i found interesting is how open Dr Berger was about the status of the possible partnerships, mostly because there has been no talk ever about partnerships or talks on the HIV side. To me this could mean there are no talks (seems hard to believe) or the talks are more in the BO tone and not a partnership relationship. Any mention of BO potential i would think is very guarded for obvious reasons. Not sure why it is ok to mention possible partnerships, why is that is a much more open negotiation?
My impression at the time and still is that because the timelines overlap so closely is that the extra 10 patients are not to difficult to get. The process of pulling together the data I would think is easy to predict. My guess is that the relaxed criteria allowed patients that did not qualify before, now can so it is not hard to get the trial enrolled at 50. The mood about the extra 10 patients in the CC did not seem to me to be presented as a disaster, and might actually be good because the data may be much more representative of the HIV market.
I'm not sure about that but i am unclear about the extra 10 patients they need. I remember that they stated they would have them before the end of the year. The 4-6 weeks timeline for PE and the end of the year for extra 10 patients seem to be relatively close together. I am mostly unsure if they plan to release the PE for the 40 patients and then the extra 10 or just release the full 50 patient PE. Either way, they can't miss on these milestones or decide to hold data that is past due.
It looks like broker57 was right, a week ago they posted the nature of this raise. It’s nice that tony bought more but depressing that the shares and warrants are 1:1 and the shares sold at .50, much worse deal than in the past. I’m not sure how I feel about the 5 year maturity of the warrants either, it would be nice if warrant holders would excersize so capitol could be raised instead of issuing new warrants. That will only happen when the SP gets above $1. The gap between a multi billion product and the penny stock status of CYDY is widening.
What new 8k? You posted as if you know the details of a raise that has not been released yet. Is that true, that you know the details of a raise? I just don’t understand why there are posts with very little to back up the statements, if you are referring to something, how hard is it to explain what you are posting about?
What are you talking about? the last raise were these terms:
"Each share of Common Stock was sold together with one half of a Warrant to purchase one share of Common Stock for a combined purchase price of $0.65.
The aggregate gross proceeds for the sale of the Common Shares and Warrants will be approximately $1.22 million. Subject to certain ownership limitations, the Warrants will be exercisable commencing on the issuance date at an exercise price equal to $0.75 per share of Common Stock"
this is from the 10/11 8k
Why exit? does the science of pro 140 not work with a RS? is HIV become an non-existent problem with a RS?
I understand that many believe and have a long list of examples of when a RS caused nothing but a dropping SP. However, a RS typically is used for a company to stay in a market they may fall off of because of fundamental problems. That is not the case with CYDY as far as we know. Being on the otc has been a major problem for the past couple years and mgmt is solving it with a RS because an organic SP rise has been impossible on the otc. Can you think of a good reason that being on the otc is better? Which would you rather have, the ability to short and allow larger institutional buyers to invest or no institutional buyers and less shorting? More liquidity and exposure to a real market is always better.
You and bucky are right and i'm wrong, I can agree that they have missed timelines by quite a bit and beating a conservative timeline is better than being optomistic. It could very well be they stuck to a theoretical timeline with no accounting for delays in order to keep the cash raises going, i don't know about that. I will also agree that this in the best scenario is a risky investment and mgmt has made it riskier by missing milestone dates. My point is what would you do different? how do you account for what the FDA might do or enrollment sites just not being aggressive enough to get patients? just add 20%? what is the #? I think it is better to rely on the fact that anyone investing in a small biotech should know enough to realize they only control so much and seeing how they come up with timelines based on agreed on protocal is honest, the investor is just as responsible for factoring delays in. I will also say that I did not invest based on mgmt nailing timeline dates, I invested on mgmt achieving milestones.
Would it be better to give a timeline, add moths to certain steps arbitrarily with the rational that the FDA is unpredictable and we have no idea when we will get full recruitment? Sounds a little un-professional and would not give a whole lot of confidence. However maybe it would be better to beat extended timelines, maybe. I still believe it is better to generate a plan and timeline that has some real justification that just assuming and guessing what delays may come. I think mgmt feels that investors are smart enough to realize the timeline can have delays. This is a small biotech company, do you really just assume timeline given by mgmt must be a 100% guarantee? Have you ever heard someone say "oh, it's an FDA trial, it will certainly go exactly to plan"
pro 140 is in a development process, mgmt is pushing forward to show that pro 140 does what it claims, is safe and the market it will be is what they estimate. if you feel (i don't mean you specifically btw) that mgmt is the cause of the delays then what would you do differently? If we were told the combo trial had the # of patients reduced from 300 to 50 and the FDA did not change the protocol would we be in a different position than we are now? We still would be waiting for PE data.
What level control does CYDY have over the timelines? The trial sites must work independently of the company to preserve the relevance of the data, CYDY can't go out and do a marketing campaign to recruit because it might raise questions as to the relationship to the trial site. CYDY has very little control over the FDA, it took almost a year of negotiations to finalize a protocol that the FDA just changed for relatively no reason. CYDY does not have control over the doctors that may or may not recommend this trial to their patients. CYDY does not have control over the independent data collection and interpretation process. The best CYDY can do is look at the time required to complete each step and develop a timeline. Each step however can change dramatically in its required time to complete. If you took the "golden quarter", Tony's second quarter or any other timeline as set in stone means you are being blind to the above variables. At any point in the past 2 years, if you asked anyone in CYDY if the timeline is 100% certain they would say no way, it's only to the best of their and our knowledge. I have been critical of anyone who uses the timeline failures as a measure of mgmt's capabilities because it says more about the trader/investor not willing to consider the timeline can and will change independently of mgmt's actions.
Got it, it sounded like you were poking fun at longs. If I had know this investment would take this long and more I would have skipped it. The decision to invest is half the battle, the decision to close is the other half. I don’t have a reason to close yet so I wait.
BTW, I’m an options trader so this investment is about as opposite as it gets.
I invested over 12 years ago, do you want to make a smart remark at me as well?
See this Pears, FACTS!
Thanks Misiu!
You have posted this many times: "SOC currently at 96% efficacy and drop out rate less than 5%". Don't you think the reason the SOC has a drop out rate of only 5% may have to do with the fact that not taking the current combo drugs means you stand the likely chance of transmitting HIV to others and worse developing AIDS? 96% efficacy is great however this says nothing about the quality of life that is known to be not great for many and will not be great for long in others. Nothing in this slam-dunk statement says there is no need for pro 140, in the capitalist world a better mouse trap is all you are trying to get.
I have posted this a couple times before, the lowest revenue currrent combo drug (of over a dozen) generates $700mil/year in revenue. The largest drug is a little over $3bil/yr. Even if, pro 140's market is to take over the smallest revenue drug it is a 7x multiple. There are many drugs, if not a vast majority that are only a little better that SOC, have side effects and may even have some level of safety concerns and yet they do get FDA approvals. To say that pro 140 is different and that it MUST be perfect is really just making the case that anything less than a multi-billion BO is a dismal failure. To me the worst case scenario is that this ends up being a $2 SP, or a 3x SP based on a $700mil BO. It is possible, that the absolute worst case is that funding dries up and/or the data is horrible (Pro 140 makes thing worse, patients die, etc..). But this has already in my mind been ruled out because pro 140 has been around for years, injected into 100's of HIV positive people and not one has come out and died, or shown a negative response.
Please understand, this is all without even talking about the mono trial or GvHD. Setting the bar high (perfection) and not accepting that a much lower threshold that is still great is really narrow minded. We must all look at the entire picture here, the data does not need to be perfect, it does not need to be the only thing that makes mono a worth while trial. GvHD is not an insurance policy because the HIV trials will fail. Those are all unsupported "sky is falling" scenarios. This is a $100mil company in a multi billion market just with the combo trial. Even $100 million dilution is small in comparison to the smallest percent of the market.
It is sad that this is represented at this SP level. I can say however the biggest criticisms are the cost of dilution and time it takes to get to catalysts and a BO. The 2 types in this are traders and investors. Investors really have very little to worry about because pro 140 does do something and is safe. the FDA trials don't have to be home run perfect to get approved, they just need to be safe and effective to some degree. The funding to get through the trials is there, it costs dilution but the multiples are still there in a big way for the investor.
For the trader, the negative vibes are from not being able to confidently pick a timeline for a long position entry and exit. This is purely due to mgmt missing milestones and the FDA changing things. Mgmt has very little control over the FDA and there timelines are very dependent on the FDA and trial site enrollment rate. This is true for any drug going through any stage trial, not unique to CYDY.
So, who are you? trader or investor? I'm an investor and as depressing as it is to see the SP where it is at, the reason i'm in this has not changed at all. I also really don't sympathize with an individual that only wants to jump in right before good news and short with no conscience to profit from what is a typical day in the small biotech world.
Thanks for posting this, Pearsby has a history of repeatedly posting the same mantra claiming that the current care is great, pro 140 has little value, mgmt is terrible, etc.. Your questions are pointing exactly to the weakness in Pearsby's negative position. the standard care even if going well will not go well for ever and most treatments have terrible side effects. The other treatments in development are only minor improvements on existing or in the early stages of development. Pearsby has copy and pasted their opinion so many times, others here have explained why this opinion is missing key points or is flat out incorrect and yet pears still posts the same opinion. It is as if pearsby has no ability to accept others opinion or factual information. Many here believe pears is a short seller looking to make a quick buck.
It is difficult to prove this is the case but it makes logical sense - hold warrants with no risk. The SP situation on the otc and a sub $.75 SP really has been my biggest problem with mgmt. I am a big supporter of mgmt and the science but the current level of this publicly traded stock is really not where it should be. I really don't know what to do differently in the current situation and can't say I would know what to do over the past years to have avoided this, 20-20 hindsight is not productive. The fact that the SP is priced at a level assuming pro 140 will fail, dilution will hammer every bit of good news and that the prospect that the SP will never rise organically beyond $.75 and hold it is really not a reflection of where we are at. This is how the SP looks for a company that has weaker science, unclear path, history of short selling etc.. If you just look at the science, the market size/growth and current status and where pro 140 is in clinical trials there should be way more risk takers betting on this in a positive way. I don't think mgmt is purposely trying to keep the lid on this but the dis-connect in SP/potential is crazy wide compared with most other biotechs. My only guess is that the bigger the potential the greater the fear of failure. The pressure is huge with this, the lack of volume to me shows the longs are waiting, the shorts are taking only small defined trades just in case something happens.
I was giving an example of why a warrant holder would exercise when the SP is above the warrant strike. I know the SP i below the lowest warrant strike.
The problem with the warrants is that some investors that are involved in the capitol raises get stock and warrants. This is a problem because everytime the SP gets above $.75 there is selling of the stock for little to no profit but the warrants are held with no risk to the down side. I have no proof of this but it has been brought up to mgmt and many here have seen the same thing repeatedly. It is frustrating that this is really the way the company has to raise cash and that all good SP momentum meets this wall. I'm not saying this is true of every private placement investor but the company thinking that the SP would rise organically is a little crazy when there are so many warrant holders looking to unload there shares.
Because if the SP is above a dollar, the warrant is exercised and that investor can sell to book the profit. If the investor just holds the warrant the SP could drop and make the warrant out of the money.
I don't know the details but my understanding is that it is the same stock and warrant offering deal that has been the primary cash raise deal in the past. Also, don't be afraid to call/email CYDY, they are happy to answer these questions in detail. I have talked to Micheal (the CFO) a couple times in the past.
They are raising capital as they need it and have access to a $100 mil shelf for funding. This is dilutive but most biotechs do not have such quick and efficient access to funds. Operating cash does not take this into account. They have the funding, unless something changes, to finish the mono trial. The longer it takes the more dilution but the thought that they will run out of cash is not a concern.
Mgmt has estimated the total cost for the mono trial at $60mil, at these stock prices that is a lot of dilution. However if the multiples for just combo are the offer in a buy out then we don't have to worry about it. The lowest combo treatment on the market now is $700mil/ year revenue. Even if the value is only that at a 1:1 market cap to revenue potential we are looking at a 10x rough multiple. Do you really think that over the next 1-2 years, worst case scenario, the money raised/dilution will wipe out this very conservative offer?
I must also say that Saltz example of the Voice really got me thinking that once some partnership is announced in the GvHD that may be the tipping point that gets others to jump in. GvHD might be far more important than we think. The fact that Dennis specifically said there have been talks with multiple parties tells me that even if the partnership is small in scale it will do more than crack the door open.
Thanks Saltz for this post, your example paints a picture of the BO scenario rather than just looking at it as a black/white event. I must assume the pharm. industry is aware of pro 140 and is watching its progress from different points of view. Every BP has people on the payroll whose job it is to know what is going through clinical trials. Those employees must bring up the treatments that have a large potential market and can take market from existing treatments or there jobs are pointless. How would it be possible that a treatment that is in a multi billion growing market simply disappear with know one ever at any point seeing value from some perspective? The thought that pro 140 will continue to go through p3 trials, complete trials, file BLA and be on the market with not one pharmaceutical wanting to be a part of it is insane. It does not matter from what perspective the pharm is interested, protecting their market, getting into the market or replacing their current declining pipeline. Pro 140 can only fail if there is bad results in the data, a safety concern or they run out of money. Not one of these has been a problem in many years of injecting patients of all types and there has not been a rumor that CYDY is having trouble getting money.
I think your timeline is realistic and your explanation logical. Not sure why cytodyn mgmt can't seem to articulate in this detail, possibly they have info we don't.
My big question is because I don't feel there is any chance they are going to hold this through trial completion, what is the tipping point for a partnership/buyout? If Dennis claims there have been talks for GvHD already and that rial is just starting human data, why the lack of any talk for the hiv indications? I am guessing that fresh data from combo and safety will paint the picture to the value of pro140. All I care about now is how quick we can get the data.
I have to be honest, i was hoping for more details about where we are at with mono enrollment and what the details of how this # of patents required for both combo and safety came about. Nader left me with the impression that the FDA wanted 50 patients for "clinical relevance" and "statistical power" and that we are really just going along with it as if that was always the plan. Both of these reasons seem to indicate that they want bullet proof data and that the protocol is really just a guess as to what will be ultimately required. I guess when experts say there is no guessing what the FDA will want that means this very scenario we are going through. I hope there are not these types of surprises in the future but i have to wonder if the 24 week data might again raise questions about the details of the trial protocol. My hope is also that because we are so close to putting out real current data that the story about pro 140 is greatly de-risked and the significance of the FDA changes is far less of an issue in comparison to the almost certainty that pro 140 is what they say it is.
I agree, but it could be the enrollment process was not very steady. I think the 11 were enrolled right away and then there was a lag to get the next batch. I would guess that there is a large percent of the patients getting close or past the halfway point to the full 25 weeks.
thr MM is out to lunch at that time. I am kidding but that actually might be why.
I would like to know what the relationship is with the FDA, are they on our side or can we look at any timeline with a grain of salt? I think mgmt has to really count on timelines that incorporate some sort of FDA changes.
In the past they have given some level of an update on trials. I would expect some sort of update on # enrolled in mono and some idea of the data from combo. I think the main topic will be what happened in the meeting with the FDA and what the future schedule is.
You take pride in declaring yourself a visionary about where stock prices are going to such a degree that you enjoy sticking it into others face? Does it make you happy to see others loose money in a product they believe in, a product that can greatly improve the lives of so many? Before you respond with some comment about how its not the product but the mgmt that you are poking fun at, re-read the high level of disrespect you have shown to others here. I and many others here choose to be optimistic and you revel in guessing short term SP moves.
This is totally possible, however that slide deck is from June 6th. We don't know where they are now but it could be further along than you think. I think combo is very important not because of the eventual market size, mostly because of the data it provides for patients who really need another treatment option.
I could see that in the meeting the FDA and CYDY discussed how many are enrolled in the mono trial and decided to use all for the safety part of the trials instead of just 100. My guess is that there are way more than 100 in the mono trial already, possibly very close to the 300 needed.