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Why are you here? If you feel the mono trial won't make it, the combo trial is 50/50 at best then this is not a good investment for you. We can all find reasons why anything can fail but we choose to take a chance by weighing the logical possibilities of success. You are not doing that - you are clearly setting up a "I told you so" if this does fail for what ever reason. Nobody needs that attitude and it is not objective or helpful.
BTW, I have clearly told you that WE ALL KNOW THAT A SUITOR IS WHAT MATTERS! Do You think that we are all reading your post and thinking "I never thought of that, Gee if another company buys this company we could make some money! Gosh pears - thanks for enlightening us!"
Nobody has stated that relaxed "N" = sure thing with trial data. Investors here bought in because they believe the science, the ability of mgmt to develop this and get it sold. If that was not the belief they would not invest. Being objective as you characterize yourself does not equal trash talking everyone and claiming to be an expert. If you really feel that N=50 is not good enough, that mgmt will not get the job done or that HAART drugs already on the market are just great then why do you invest in this? When you invest in a stock you are stepping into the boat of optimism for the stock, it is not a 50/50 balance of "lets see what happens". To discredit every bit of information, any optimism by others, flip flop your opinion as it suits your negative attitude just makes everyone wonder why you waste your time.
This was a response to Fred, not you pears. Fred made the insinuation that because mgmt get 1st dibs on assets in the event of bankruptcy, that might be some sort of motivation as to how they manage this company. I don't feel this is in anyway a motivation by mgmt or the BOD. They want this to succeed more than we do and have plenty of skin in the game.
thanks for posting this, really shows how easy it is to go way down tangents with no real support. I guess i'm a bit of an armchair quarterback sometimes.
If this low "N" was such a problem then why did the FDA lower it from 300? Isn't that a more interesting question than why they increased it from 30 to 50? I think we all know that the trial has to show statistical significance to get through the approval process - that is how trials work. If you have such a big problem with the N=50 then maybe you should go work for the FDA and change things. Many things can be said about the FDA's process but like it or not biotechs have to deal the cards they are given and if the FDA wants 50, they get 50.
um, yeah we know. the trials are still going on. what is your point?
Do you really think that myself and everyone else here does not understand the concept of time? I think we are all also aware that a buy-out is important, and the point of this investment. It took many of us posting multiple times after you go off on these rants about how they will never get the funds to finish these trials and make money off pro 140 being on the market to explain that the boy out is the goal. Now you are educating us that this is the goal?
Fred, I don't see how you can say that past insider buys are "irrelevant", What makes it irrelevant? They bought with less information and there was a greater risk. There is no indication that data or funding would now make this a bad investment. If there was a problem there would be insider selling - which there is none.
As for the speed of progress, I don't see any slow down and you have not revealed any support that there is. so, how do YOU know there is a slow down and/or not enough money, what are these "facts"? The company has always said they will raise funds as they need it, there will not be a giant raise all at once so they have a huge balance in the checking account. Why would they raise money at these SP levels? Do you think that the spending on trial is a fixed linear expense? Could it not be that they had to put down deposits months ago to start the trials and now the costs have leveled off? I don't know but this is just as reasonable.
The "something" they need to get warrants to convert is lowering the exercise strike, simple. If they raise funds this way or not does not matter because they have other sources of funds. Did you not read my posts about the # of warrants held by insiders? don't you think that even if they are the only ones to convert it will raise quite a bit of cash? As for the other warrant holders, some might convert, some might not - either way these warrant conversions are non-dilutive at this point. I don't think this is a "we can't get funds any other way" situation. This is a simple way to get warrants to convert to clear up the books in preparation for uplist and/or other deals. Keep in mind, I don't know any of this but it is again just as reasonable as your opinion.
Why is it so hard for you to believe there is no good news coming? what the hell do you think they are doing? Do you think they are faking this whole thing? At some point they will have injected 50 patients with pro 140, they will have data of their 1 week blood tests and they will issue a PR. I don't know if it will be tomorrow or a couple months from now but i do know that they will have that PR and because there has been no history of lack of efficacy or safety then I will strongly assume the data will be great. I hope you recognize that this opinion of mine is completely relying on past information and what i have been told in conversations with the company. Your "there must be problems" attitude is pure conjecture and not "reasonable" just because you feel there are problems.
The mgmt and BOD do not seem to be the type to cap off their careers with a bankruptcy, They are in this because they believe in it and have for a very long time. You don't even own any shares so I don't understand why you waste your time with these "sky must be falling" posts.
If you took the time to look at the # of shares they have bought in the past then you would know that your statement has already been done. Many have bought when there was a lot less news on the horizon. The only exception is Nader, Who has a large # of options and likely feels that he is invested as much as makes sense but it would be big news if he did by some.
You really are grasping for something to support your glass half full hypothesis, unfortunately it is more work to find truth to your guesses than simply looking at past and current activity. Insiders have bought many shares, The science works, The market is in the billions and growing, It is safe and there are many BP with billions ready for M&A. The company has a cash burn rate that requires raises but they have not slowed down because of lack of funding. They are in fact moving forward with developing pro 140 and creating multiples of value. I hate sitting in the back seat waiting for this to get to the goal but that is all we can do.
I don't think the financial situation has changed any from what it has been for years. They need money to fund trials and they continue to raise funds using what ever means are on the best terms at the time. This has always been the case so I don't understand how you are portraying this as some sort of new situation. I absolutely think that we and you and mgmt would prefer to be raising funds at a higher SP but the SP is where it is, maybe you should buy some.
You must understand that the BOD and Mgmt are in the boat with us investors - the paychecks are not the reason they are in this and if you think that look at the resumes. All involved could be doing other things or retire. They continue moving forward with the plan and nothing is stopping it, it will take longer than hoped. I am just as critical of the lack of communication and the delays but that does not change where we are at or headed.
Can't argue that - they should update us on the status of enrollment and how this warrant exercising is going. At this point i really don't need a timeline update - that has clearly always been a shot in the dark!
I'm not going to say that your theory can't be true but everything you are saying is taking the glass half full attitude. The same information we have now can just as easily support that the company is only raising funds as they need it to minimize dilution. A large number of warrant holders are the mgmt and the BOD so even if the only warrant conversions they get are from mgmt and the BOD that would raise millions. Why raise tons of money now at this SP? Why not go lean until there is data to propel the SP a little and get off the OTC and raise funds at much better terms?
I do like the book idea, I'm sure a lot that has and will happen through this process that we don't know about is good reading!
So did call and talk with Judy who, by the way, is a very nice person. I asked about the delay and why we are getting PR about the IDMC and basically the FDA really has control as to what can be PR'd about data. It sounds like even though the FDA did allow the 40 patient data could be released they decided to wait until the full 50 patient PE. She did say we should get a PR on the enrollment, but no answer as to when that is or if they already have the 50. She did say the criteria was softened alot so enrollment is not as difficult as before. I would assume they are trying to get more than 50 as they did in the past just in case. I also asked about the 300 safety/mono trial and she could not comment on the status of enrollment on that, which i also did not think she could.
I asked about the warrant deal and if this was a sign that there is a problem raising funds or warrant holders are pissed about something and she was very confident that there is no access to funding issues at all and that the warrant deal is meant to raise capital and clear out as many warrants as possible. I took this to mean they are getting the books in order for the uplist.
I did let her know that the lack of information and explanation for the delays really is wearing thin and that I don't expect deadlines to be met but that an explanation for why would really go a long way. She did comment that mgmt is really trying hard to stick with time lines and not throw out guestimates on timelines as has happened in the past.
My take away is that they very much moving forward and funding is not slowing thins down. We just have to wait.
Thanks for the info, I would do the same thing. Why exercise a warrant and face the risk of losing money when you can hold a warrants that was given along with stock as a bonus? I hope you understand where I am coming from as an individual retail investor - We are not getting any breaks when it come to dilution and new special deals for warrant holders. I know the company has to take the deal they can to raise money and keep moving forward but they could at least be a little more communicative as to where they are at. We tend to blindly accept that putting as little info out is part of a publicly traded company but i don't see the harm in a little explanation as to the rational behind these actions. I woke up this morning frustrated that for the most part I only know what I read in investors hub!
I would think it crazy if mgmt and the board expects warrant holders to convert and they do not. It is along the lines of why Nader has not cracked open his wallet and actually bought shares. I have posted recently that the rationale for the strike price being lowered is purely a perk for board and mgmt to exercise at a great price, that seems to be not the case.
Look, I am a big supporter of the product and mgmt, however they need to cut the confusion. The radio silence could be a sign of great news or significant challenges. My feeling is that they really don't understand that us investors deserve more information to get an idea of which side the news is heading. I have 100's of thousands of shares i bought on the open market - no warrants were ever offered to me. I have been with this investment for 10+ years and I have to sit here and get all of my information third hand through this board? Why do all of these warrant holders get the perks? Is lowering the warrant strike price good or bad? How many have been recruited for the mono trial? When will the PE data be released? What is the plan for the RS? so many questions!
I think today's news is good, but not great. It does cut the risk of a protocol change. I have always been in the "it will take the time it takes" person and typically defend mgmt despite missed milestone dates. I feel now that mgmt could/should be a lot more informative about how they develop the timelines. It seems the pattern is they throw out a rough approximation, we determine it as a make or break hard date and then we find out the delay is due to something quite reasonable. If mgmt spent a little time explaining the steps to get to these milestones with information as to what possibly could push them back I think the investment world would be a lot more comfortable with delays. It is really pissing me off that we are in the way-back seat for information. There should be conf. calls to explain what these developments mean. Mgmt should not be creating risk and confusion in a risky investment. I don't expect them to know every step and what may or may not happen but at least be more clear on the steps involved with the development.
Well, it sure is easy to find an optimistic and a pessimistic take on the current actions/lack of actions. The only thing i can add is that in past conf. calls and conversations I have had with the CFO is that mgmt is and will always raise capital as they need it and use what ever creative way to get it that they can to have the best terms. I think the switch from offering shares and warrants to the lowering of warrant exercise might have always been the plan. I think they know really well the cost of these trials and the fixed costs of running the company so the funding plan was likely thought out a long time ago. When the shares and warrants were issued, the warrants would some way be enticed to be cashed in later as needed. It absolutely would be better if the warrant exercise process did not require lowering the strike but they again always said they will raise funds as they need it. Lets face it, getting funds for this type of company often the terms are not great, especially when there are other less risky deals out there.
As for the payment of a consultant in warrants, I would think this consultant is in the industry and know what this product is about. They would rather get paid a warrant today and receive a larger sum of cash later. I doubt this consultant is the trash pickup service or land lord!
The sequence of events and their magnitude is very important and mgmt can't screw this up. there have been great PR's wasted on this otc market and there have been missed delays that did not wipe out the funding channels. I'm not guessing that there is a deal pending, NDA or data being released any day now until I see it. I am sure however, mgmt is not sitting around with nothing to do.
I'm far from an expert on the science but i do think the monoclad antibody nature of pro140 is not the unique aspect, it's that it is a technology to protect the CCR5 cell. There are other monoclad antibodies used for different uses. It is a new developing way of treating other diseases. I did see the $8,500/yr cost as a bit of a shocker but people suffering from migranes of this type need something for sure.
I hope you understand, i'm not trying to attack you, just thinking how mgmt could blow this and it seems way more of a risk than past blown deadlines. The past deadlines in my opinion involved factors that they do not have much control of. This deadline they do, i think. I just feel strongly that if this week passes, even the conference presentation passes with no p3 data that all 500+ investors in this company will call the HQ and ask the same question - WTF!
I also am still of the belief that this investment is about accomplishments not timelines. What the data says is a 1000 times more important that when we get it. The fact that the conference presentation happens to be at a calender point that aligns with having the data might be just a coincidence.
from the Amarex website:
"AS A GLOBAL FULL-SERVICE CRO, AMAREX CLINICAL RESEARCH HAS EXTENSIVE EXPERIENCE SUCCESSFULLY PERFORMING CLINICAL STUDIES ACROSS ALL PHASES OF RESEARCH AND DISCOVERY, DEVELOPMENT, VALIDATION AND APPROVAL.
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OUR LEADERSHIP TEAM HAS OVER 30 YEARS OF COMBINED EXPERIENCE AND EXPERTISE IN CONDUCTING BIOMEDICAL RESEARCH, STANDARDIZATION OF DATA MANAGEMENT PROTOCOLS, OVERSIGHT OF CLINICAL TRIAL OPERATIONS AND TRIAL MANAGEMENT OF PHASE I - IV STUDIES OF DRUGS, DEVICES, BOTANICALS, DIAGNOSTICS AND BIOLOGICS."
I honestly don't know the process but they have 40 patients worth of blood tests before and after 1 week on pro 140 to put into some sort of format. I would guess there is some sort of review process but how long can that take? Also, they have been very open about the fact that Cytodyn may only be 6 employees but there are dozens of outside contractors working on this.
even a blind squirrel finds a nut sometimes.
So what? by that rational every Micro presentation from here on out they will present the same p2b data? Nothing will ever change because in the past 2 years that is what they presented? How can you think that given the unlocked status of the 40 patient p3 PE data 6 weeks ago that mgmt decides to just sit on that and stick with the p2b data?
I don’t know but how could mgmt present the same data from last year? It seems absolutely impossible that they would do a presentation and not present the p3 pe data.
I also get disturbed with the claims that are being made without validation, which is why i dispute your claims so often. I this very post you claim a larger mono trial will show lack of efficacy and rebound, yet you have no evidence that that is the case. You do know that pro 140 has been in the phase 2b trial for over 2 years with no lack of efficacy or rebound, right?. I'll admit it is only 10 patients but to claim that 300 patients must show lack of efficacy and rebound is just guessing on your part.
Here is my opinion of your post, sentence by sentence:
"PRO 140 will have side effects, serious ones, time will tell pending ongoing data and usage."
- There is nothing in past trials that support this. this is an inflammatory statement presented as if you have some information the rest of the world does not.
"Discontinuation rate may be more due to lack of efficacy(rebounds). Dosing titration up to B.I.D. or even T.I.D. weekly may be necessitated. If this becomes the case, the convenience component and injection site interactions will be compromised greatly. Obviously, the FDA may be requiring more time on drug and with greater numbers for a more comprehensive assessment of AE's and efficacy."
- This entire statement is pure speculation, again nothing has shown this to be true and past trials do not support this as a reasonable possibility.
"Mono therapy in the counterpart trial will further clarify these unknown potential issues."
- This is another reason why cytodyn is doing a mono trial, the other reason is because pro 140 has been in mono trials for years now and shown very positive data. You have many times in the past claimed that the mono trial is a waste of time and pro140 will never get approved as a mono treatment, why now do you think this trial is of value?
"BTW, have not heard from our celebrity (Charlie S.) advocate in a while. He is not one to stay quiet. Interesting."
- Why don't you send him an email?
I think this lowering of warrant exercise to $.50 is very interesting and I don't necessarily understand the meaning of it but here is my take:
1. A large # of the warrants are held by the BOD and employees, so the fact that the $.50 excersize offer was a very narrow window of opportunity tells me this was a way for the internal warrant holders to get in now at a very low price and raise cash efficiently. I don't think this was a "lets see how many warrant holders take the deal" situation. they already know how many are taking the deal. I also think the company has a close relationship with the outside warrant holders and can know fairly well how many will take the deal before it is offered.
2. In the past good news did not move the SP much at all because warrant holders were selling their stock on any uptick and keeping the warrants risk free, this large volume of shares in this situation really put a ceiling on the SP. Many here (including me)have been critical of the cash raises being stock and warrant combos creating this scenario. I don't think mgmt had many other options but it's effect on the SP is obvious. Getting the warrants to exercise helps remove this ceiling on SP appreciation.
and 3. the delays and missed deadlines were mostly due to outside factors such as the FDA protocol approval, the FDA increasing the # of patients and the slow recruitment due to a very specific patient criteria. mgmt, i believe, has very little control of these delays. the timeline to get the 40 patient combo trial PE data out is a much more defined process and i think mgmt can deliver this on time - they do not need to wait for elements that are out of their control.
These 3 observations to me say this was a planned way for warrant holders to benefit greatly right before positive news, for the SP to rise on this news without being held back by warrant holder stock selling and a sign that the data is compiled, positive and ready to be released. We will find out if that is the case and this is just my opinion but it is based on a very different and unexplained event. these things are confusing at the time but sometimes become obvious moves in hindsight.
So you guarantee your opinion is right and all others are wrong, despite the fact you nothing more than anyone else? How can you say that they will be side effects when you flat out don’t know and claim that others are uninformed if they think there will be no side effects despite all past trials have shown that there are none?
If a company puts something on paper it has to be presented to the board and shareholders. This is how other companies will know. this is a publicly traded company so mgmt and the board are required to share this with the public. The key is that it is a formal, on paper offer of some type. Random conversations do not warrant disclosure. I am sure the M&A folks know way more than i do but it is the board's interest as representatives of the shareholders to review all offers. I find it interesting that Dr Berger was so open about the conversations of partnership with multiple parties over the GvHD indication. The BP world is very aware of pro 140.
At some point years ago the HAART treatments were N=50 also, comparing a drug in development to drugs that have been on the market for years is a pointless observation. I agree, mgmt is partly responsible for the timeline but what would you do differently? I can only think that they could have been more transparent about the steps and potential delays in more detail to provide an insight to what their timelines are based on. Other than that the delays are due to the FDA and patients slow to enroll, even that really is not in anyway mgmt's fault because they got as many sites open as possible to enroll quickly. Everyone must recognize that many FDA approved drugs do not show perfection in their trials, Pro 140 is far beyond what is typical in showing safety and efficacy from past data. Many drugs that get FDA approval have side effects, safety issues and a marginal effectiveness. Holding pro 140 to a perfect standard otherwise it is a terrible failure is ridiculous. I'm not saying it is a sure thing, but my concerns are very different than yours. I only worry about the cost of financing and when/if something triggers a partnership or buy out. The science, the market need and the likelihood of FDA approval in the future do not worry me.
There are many articles about the future generation of HIV treatment, and it is long term injectables. The combo pills are the last development of the current phase of care. To think that all current and potential BP companies take a pass on pro 140 is crazy. Here is a link to an article from earlier this year that paints a picture of where we are at and what will be next.
https://www.cnbc.com/2017/02/14/the-new-hiv-challenge-treating-the-disease-as-a-geriatric-condition.html
The delays in the HIV trials is mostly (if not entirely) due to the FDA. The timelines given in the past can only be guidelines because the FDA has ultimate ability to change things at any time, which they have. The second reason there have been delays is the rate of recruitment, which again CYDY can't control and is mainly due to the FDA setting a very specific profile for approved applicants. If you know of an example of a biotech that got a trial protocol approved, recruited and conducted with the FDA right on schedule let us all know - i don't think that has ever happened.
As for the value and development time of the GvHD, they are going through the process and the preliminary results are great. To think that it is a waste of time and not worth the effort is just ridiculous. GvHD indication is not simply created out of thin air solely because the HIV indication is not going to make it, to think that is beyond crazy. The fact that CYDY has stated that there are interested parties already is significant, the long way off timeline for this is not long at all.
typically SA is a little late to the party, however in this case it looks like the author is jumping in right before the big catalyst. I find it nice to see that the author recognized the possible dilution that likely will occur yet feels the potential to be strong enough. It is as if the author read the comments from this board over the past year and sees what we see. This is re-assuring and the very blunt comment about GILD could not be more clear about their point of view, they can't afford to let pro 140 slip by.
Thanks for clarifying the situation, I just did not fully realize the reason behind increasing the RS range. I don't doubt the PE data, i am worried that the investment world may not react the way it needs to. I wonder what could have been done to not put us in this situation. Part of me knows that you need to deal with reality rather than have 20/20 hindsight.
Also, the FDA really should give out the BTD, it was created for this very situation and holding as a carrot in front of pro 140 is very irresponsible.
I really wish the general public across the worlds would understand that this is now what it takes to develop these treatments. The thought that a tiny company could fail for finance reasons at this stage and the HIV population will be out of luck is just crazy. I'm staying put but it would be nice if some insiders (i don't mean Tony) put some money where their mouth is right now.
Sorry, should have been more clear, that is my understanding as well. In past conversations with the CFO he stated that the have no problems with access to funds because of this shelf offering. It was my impression that the investors willing to put up the cash were available whenever they needed it. What you are stating is that there are not investors willing to put up the cash to the extent that CYDY wants. This is troubling as it makes this combo PE data and RS more of a must catalyst, rather than a "it would be nice but not necessary" situation. I really don't like the over-confidence of timelines to be part of the SP expectations post PE data. Missing timelines can't also mean missed SP performance from PE data. That would suggest that further development of pro 140 might run out of steam. Mgmt does not have room to create this increase risk in this investment, The SP suggests a zero to hero situation and success is now a narrow window (in terms of money, not science).
That is interesting, I was given the impression that they have no problem raising funds because of a shelf offering. Is that not true?
interesting, however why would they raise any capital if there was a pending deal? I suppose if it was a partnership in the GvHD indication they would still need funds for the HIV trials? Could also just be a boilerplate thing to say based on no actual pending news.
oops, i should read better!