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I mean this in the best possible way, but we have heard this many times from Nader. At this point Nader must show us before we believe him. As much as I want to back him up, the two major jobs of the CEO is to not mis-lead and to keep focus on the path. Nader has been lacking in both. It is easy to get excited about all of the indications but trying to do everything can cost a lot, sometimes the original goal. The great thing abut GvHD is that it was cheap and quick to get to approval. It was Berger's project and now that he is gone it is on a shelf. The Cancer indications will be a blockbuster but Oncology is a very steep expensive mountain to climb. I think Dr. Pestell has the experience and drive to take it on but we are early in a long process.
It still makes me so angry at the FDA for not allowing the protocol for the mono trial originally - this whole combo trial and the mono being investigational is on the FDA for slowing everything and costing us millions. The fact that the FDA created the BTD treatment is purely to speed up their in-efficient process. To hold it back to the point where it's benefit is practically nothing is a joke. What drug/disease do they think is more important to give BTD and make this a top priority?
I guess given the history, maybe Nader's enthusiasm is what we need the most. To be honest - if I had to listen to the FDA and their beurocracy the sailor language would be flying and I would have thrown in the towel likely.
I was going to call in but you asked the question o was going to, thanks for doing so. My impression is that mgmt does not understand just how bad the financing has damaged the stock price. I think they see cash raises as a necessary activity to fund what matters -trials and operations. I think they really assume great data will do magical things and don’t understand why it has not. They might even be blaming the shareholders for trading at this level keeping the stock price here. If you keep doing the same thing thinking it will be different this time then you get exactly what we have. I really hope Klump can bring fresh energy to the funding of this, Nader really did not give me confidence that he has anything but Paulson as a source of funds.
I agree with you, Nader did not prove himself yesterday. He did give us a very strong feeling the investigational would be converted to a pivotal trial and that was way off from reality. He also gave us the impression that we are done with Paulson, but that was very untrue. These are the things that kill trust in a CEO, We all know he does not know the future but to mis-lead about these very significant events is irresponsible. I fear that if there is continued pressure on the BOD to do something about Nader the end result will be Nader just not saying much at all and we will be stuck with guessing what is going on. The devil you know is better than the one you don't? Not sure where this issue is headed but I think we are stuck with him.
I think the RS chances are as close to zero as they ever have been. I counted 3 times Nader said "buyout" and Dr. Pestell said it once also. There is no way this company is a company on its own in the foreseeable future. The how and when I have no idea but they are on the path of a buyout - Nader even said the cost of up listing is not appealing at all.
I like your thinking - seems very logical. The details of the pivotal trial were rather, detailed. This makes me agree with you that this is in part already the path, with the FDA in full knowledge. The really good thing is that the worry that the investigational trial will lead to an entirely clean sheet of paper/bigger pivotal trial is essentially eliminated. I hope that it is recognized that that risk is gone and lowering risk to me is far more important than increasing potential. We have enough potential, risk is what holds these type of investments down. the financing risk is still very much there but we do have the cash to file the BLA for combo so at least the pace of progress is in tact. The dilution cost of this financing I am not a fan of but biotech is ugly until it is very attractive all of a sudden.
Good point, I think many here including myself kind of ignored the potential for the test revenue. The "pre-revenue" biotech title very soon will be a thing of the past. Also, the process of getting a licensing deal done with Quest is a path of how they can do future licensing deals - a relationship is being developed.
I was totally wrong about my prediction on that one - I really thought this would be converted to pivotal. sorry to those that insisted a new trial will be needed - you were right.
I commented on this article, basically I think the author is missing the fact that cytodyn negotiated the protocol for each trial and the design is agreed on. I also don't think it is remotely possible to have a true placebo arm in this because these are HIV positive people, no doctor would ever let their patient in a trial where they are on a placebo. cytodyn has and continues to prove the effectiveness and safety of pro140, FDA approval may or may not be elusive but the value of this drug is in the data. Cytodyn has no way to fake the data. It would be good for Nader to bput together an very detailed trial data report so these questions can be answered.
your right, I have no idea. could be the best path but at this point I really want some major institution to like what they see and have it not be us long term investors all alone (from a funding standpoint)
they are, actually they are the same as the original Paulson raises from over a year ago. the terms got worse and now they got better. The problem is that this is a cash raise from investors to pay the bills, not an institution focused on getting the value of pro140 to a much higher level and getting it through FDA approval. I have said this in the past, they need funding that is foundational so that the science of pro140 can create the value. right now the science is all we have to support this company and it's future. This Mgmt team better have some very compelling news tomorrow.
I just can't figure out how Nader does this. I would think that going to Paulson again is the quickest/easiest way to get cash but the lack of any ability to build any other financing based on where pro140 is at is just crazy. Nader better have great things to say tomorrow. Unfortunately the one thing I wanted to hear wont be it, which is announcing a great supportive partnership. If they had that there would not be this Paulson raise. I am assuming the SP will fall back down and we will get some update on trials and that "everything is great" speech from Nader.
I’m not sure I understand your post, but just so you know the 600million shares would need to be owned by a shareholder at $1.50 share price to be a billion (actually 900 million) market cap. The problem is that there is no way each and every share will be owned, if there is half of the total shares os owned and the other half is float then the share price would be $3. It really does not mean much because what matters is what the market values the company at, whether it is $150 million (value now) or potentially billions. # of shares in the float is only important in how diluted the shares owned is if the value does not change. I think everyone here is more focused on the multiples from today’s valuation being a lot greater than the dilution to get there.
good one!
thanks Bucky! I am going to send Jody disgruntled emails whenever I want the SP to go up because that apparently works also. Sometimes I think trying to figure this out is a complete waste of time.
I have to disagree, past CC's always seem to get us theorizing of bad news prior and then the CC turns out to be quite positive. They have PR'd good news and then had a CC to explain but the last CC was nothing but good news and there was no PR prior. Lets not read too much into this. Significant good or bad news must be PR'd and the fact that there is no PR makes me feel this is just an update and to calm the troops. Not sure how well Nader will be able to do that but I'm sure he got a sense that all is not good with the investors. Could very well be details of this better financing are in the works and Nader is not able to give details, how much we are to believe him is the real issue.
Nader did say their will be more frequent CC’s so it is likely an update. I the past Nader did have CC’s every 4-6 months and now we have a lot of news to potentially talk about. It think it was either Tony or the FDA combo trial that put a level of silence last year. So I don’t think this should be read into other than an update meeting.
However, myself and I’m sure others have expressed great concern regarding Nader’s ability to run things and he might be trying to get in front the issue. Could be he realized that the Paulson raises are not to popular in our opinion. I wrote a long email to the BOD and Jody is forwarding it. Basically I stated that pro140 is way to important to risk in-experience on. I did include that I do not know what potentially is brewing and my concerns might be of no concern. Maybe information to shed some light on the future financing to calm the troops?
This really points out how much they need to get these warrants in the money. Pursuing financing and having to show how many warrants are out of the money is a real tough sell. All the more reason a financial partnership built on the success of pro140 must be achieved. The Paulson type raises are just financial positions, a new backer that needs the drug is crucial. Sorry if I’m being capt. obvious!
I agree totally, I have tried to be supportive to Mgmt mostly because I don't know what I would do different in the past. But the last straw was the last CC (which was all great news) when the future financing was presented as there are many more options with much better terms now. Raising cash with Paulson again, even under better terms, to me shows there is no other funding on much better terms. To me, the funding going forward should not be simply money - it needs to come from a source that is in this for the science and the buyout. For me the Paulson raises are like mgmt. walking around with a tip jar. It is crazy at this point that this drug is being handled like it is a pipe dream. We are months away from a BLA that won't get filed until they get real funding. Mgmt must stop holding this carrot in front of us and they must stop patting themselves on the back as if they did a great job. Any company that is given a product like pro140 would easily be able to create value - this mgmt. team somehow can't. I will not vote to keep Nader as CEO and I need to get as you ask for, a plan of what they need the increase of 600k shares for. Mgmt has more than they can ask for in being able to get this done and I have very low confidence that they can.
Also - I have nothing against Paulson and the Paulson investors - they are doing their part to support this also an I don't blame them for being risk managers. The open market investors such as myself have lost money and held risk that the employees and Paulson investors have not. Mgmt must only do things that benefit us now.
Why did the employees all modify their warrants from $1 to $.75 excersize price?
I don't want to sound negative towards Nader in a bashing way - I just can't keep thinking that maybe the next round will be better. Where pro140 is now is not reflected in the SP - not even close. At some point we need to admit that what the mgmt. team has control of has not gone the way it should. They can't be blamed for enrollment delays or FDA protocol changes. They also can't be credited with the trial results - pro140 did that on its own. What is left is creating value that represents what pro140 is worth now and what it will be worth. The SP shows there is way too much risk of failure priced into this - mgmt. has not been able to alleviate this. Loyalty to a CEO because he was here from the beginning of pro140 is nice, but when it really starts costing progress we need to really put our priorities toward pro140, not the CEO. In the past I have been a supporter of Nader and a big part of that support is that I was afraid that replacing him would be so disruptive that it would cause more trouble than benefit. I just can't keep having this carrot held in front of me. Nader has has the data to get the financing to move to a much better position and he ended up going back to Paulson. No matter how better the terms are, It is hard for me to not see the failure to get the funding and partnerships that they should be getting.
I think it is time to email each board member and express the concern about Nader. I don’t think he is awful but I do think we are at the point where someone with better experience is needed. Pro 140 is too important to make mgmt mistakes with. The SP being where it is, the funding uncertainty and lack of confidence don’t jive with where pro140 is in development. There is too much risk now that Nader is at the limits of his abilities. It could really cost everyone if he fails to realize that this financing is killing the value of the company.
That is interesting, The reason Progenics sold pro140 was so they could focus on there cancer pipeline, if I remember correctly. I have not followed progenics much so I don't know the status of their pipeline. It in a way would be nice if CYDY was folded back into progenics some how.
Great article, why pro140 is not already in some BP portfolio is beyond my comprehension.
Ah, got it. For me when I hear squirrels in the attic that means you have a big problem - that was why I asked!
Huh?
It is ok to have a negative view of mgmt., I agree to some degree. there is little explanation as to why this drug is at this SP, mgmt. is accountable for that but what would you do differently? being negative is one thing but solving problems is another.
Being right about your negative predictions for a couple years suggests that you know the future based on the past - I never believe this method of future expectations. Sacrificing for a couple years might just be the key to great success. I also don't give a crap about 15 months to get to approval - CYDY will not be the company with pro140 at approval time. Which means us investors will likely be on to other things - in a very good way.
I do not think you have a sense of probability with this. I think anyone would pursue the greatest success rate in the mono trial, not seeing what the 700 dose will do is leaving a lot on the table.
You don't know if or how many patients have been injected with the 700 dose. It could already be at PE for this dose and The FDA is looking at it already. I don't think they are but there is no reason why they are not. You are the one who insists that the results of this data must lead to a larger or additional trial at the 700 dose. That has not been confirmed other than you thinking it is. I will go back to my many past posts with my opinion that the FDA is planning on converting to pivotal once the data showing 70% response rate and the effect of different doses. I could be wrong but Your in-ability to accept this as possible for no reason makes me think you just prefer being negative above all else. Why an additional 100 patients? you made that up out of thin air - why not 105 or 80? Just throwing #s around with no support makes then in valid to me.
BTD - this is a weak response, I think cytodyn knows they need to ask for BTD and they will when they are confident that they should get it. What would give then confidence? well likely the fact that the FDA told them that they want to see the PE data from the mono trial and then consider it. cytodyn is going to meet with the FDA at some point to convert the investigational to pivotal, why not ask for BTD?
We do not know what the FDA will do, but as in my last post - not accepting any chance that things could go well and the only things that will happen are all bad is just being negative. It really does not educate anyone about the possibilities when you have such a dismal outlook with not much to support it. You might end up being right, but that is only because you bet on failure and quite honestly failure does happen some times not because you are some sort of genius.
All 3 scenarios could happen, but why do you limit the list to only these 3? Why is there no possibility of other scenarios? It could also be that the FDA sees the 700 dose and converts the trial to pivotal using only the patients and data they already have. It could also be that the FDA does that and awards BTD also because they have now seen enough data to give it. Both of these are just as possible and have been the direction pro140's trial has been headed. The FDA did just cut the safety arm from 300 to 150 patients - this is a very big signal that they like what they see. Additionally, the fact that this investigational trial meets the requirements as a pivotal trial from the start suggests to me that the FDA expected to make it a pivotal all along. The only reason it was not was purely to investigate the response to different doses - which is an investigative step. The pivotal trial is to prove what is found in the investigational. The data we already have is directly applicable to a pivotal trial - patient responds to 325, fine, other patient does not, increase to 525 or 700 and the effectiveness of pro140 can be measured. There would be no change to the protocol in a new trial - why re-do the same trial?
I'm not saying its a sure thing but I think you have a negative bias and your deep desire is to see some sort of bad news so you can give us all "I told you so" comments. I don't know why you would feel this is how you must skew everything. Why not be objective of all the possibilities, even if some of them are just plain positive?
I don't know but I would think leaked info by either cydy or the company doing the acquisition would be it. I think there are market watchers that have inside sources in BP - they are just too big to not have someone with loose lips. Sometimes the buying company purposely lets it slip so they can get investors to put pressure on the BOD to take the offer. either way, us investors likely will be the last to know!
The more I think about it, the more excited I am. BP industry is unique because they rarely develop their own drugs - they partner and buy out small biotechs that do the risky early development. They rather pay up for something that shows real potential than be cheap and by junk that ends up not working. the problem with pro140's HIV indication is that it is almost too developed - The best price we can get is selling potential - not reality. As we get further along with these HIV trials the potential becomes reality and the price will be based on actual market share and not a potential market that is bigger. The cancer indications I feel does a huge amount of showing the potential is giant. HIV is the foundation of "this drug/technology works" and the cancer indication is the "it will cost you more than just the HIV market to get this". I don't think pro140 will be in a p3 cancer trial and be owned by CYDY, As soon as we get preliminary results in a cancer trial there will be a deal done. If anyone posts a timeline based on when CYDY will be getting FDA approval for cancer expect an eye roll from me.
true, I am not sure if VIIV is a separate company from GSK - I think it is a partial merger between PFE and GSK but also an independent company? Either way, there money is green also!
This is actually great news, there are 4 major BP in the HIV market - GSK, GILD, J&J and Merck. GSK has been on the record as aggressively pursuing taking market share from GILD, this is there move to do so. We all were hoping that GSK's move would be to buy pro140, but they don't seem to be. GILD has stated in the past that they do not have anything in their pipeline other than combining existing drugs into 1-2 pill options. Saltz long ago described the process of getting BP to act as being similar to the Voice TV show. Once one judge turns their chair around the other judges also do not because they like what they hear, but because they do not want to miss out. GSK is jumping into the long acting injectable HIV treatment world so the other BP might be compelled to have their own product. All the other BP will do a simple "what is out there now" investigation to be in this new direction of treatment or defend there revenue. Pro140 is likely the only other competition and could be superior. The other indications only add more frosting on the cake. BP typically buys what is developed to a high degree, not what might work. Phase 3 is for drugs that have already proven themselves.
The pressure is on and GILD can't afford to let 44% of there revenue dwindle lower as this new avenue develops. The problem is that GILD is in a process of replacing the CEO and then building a team around that new CEO which takes time, I doubt the decision to make a multi billion purchase won't happen until there is someone in charge that says they must do this. I don't know the specifics behind the shake up at GILD but the thought that their largest revenue stream is stagnant and under attack would suggest that they know they need to make a move. If I were at GSK I would also think buying pro140 would really ruin GILD's HIV dominance severely. The pressure is on and to think that CYDY is missing the train is the opposite of what this means - they are the solution to building and preserving market share for the other 3 BP players.
Pro140 does not need to be the only and greatest HIV drug, they just need to be part of the future treatment direction. GSK has done the heavy lifting for us by pushing a long acting injectable as a treatment, CYDY is in the right place now. They have a p3 HIV long acting injectable. It will not generate a bad PR for the purchasing company from a side effect or safety problem. It will generate future great PR's as other indications show trial results. CYDY just needs to let the buying company have this. CYDY has not been great at benefitting from positive PR's, The new owner will be if we let them.
I don’t thing the sequence of events supports the “hiv is going nowhere so let’s push cancer” theory. Even if there was only GvHD there is tremendous upside. The hiv trials have paved the way for all other trials and are very much of great value, just because it has not paid off yet does not mean it will never. Given what is going on with GILD, there will be some time until they possibly show interest and that means other BP have time to act. This is simply a case of the more cydy develops pro140, the more it is worth.
Sounds like the drugs are not much better than what is out already and they show resistance developing. looks like there are a lot of bad drug interactions also - requires close monitoring.
"In the DELSTRIGO and PIFELTRO treatment arms of the DRIVE-AHEAD and DRIVE-FORWARD trials (n=747), a total of 11 participants showed the emergence of doravirine-associated resistance substitutions"
"In the EFV/FTC/TDF treatment arm of the DRIVE-AHEAD trial (n=364), 12 participants showed the emergence of efavirenz-associated resistance"
I have a theory, I'm thinking the current and future financing must be on much better terms. We will find out at some point but the large blocks of selling don't seem to be there. The upward trajectory is under light volume so there is not much to read into but the lack of 10-50k blocks is mildly interesting. It could be that warrant holders know there are no future raises that include warrants, or at least 1:1 stock to warrant ratios. They might be more compelled to hold their stock and are happy with their position size now.
It could also be that the Paulson roadshow was more of a meet/greet to explain that selling off shares might not be a great idea. Could be that the info discussed at these meet/greets was to build a relationship and explain/convince the warrant holders that they should hold their stock? I am sure mgmt. has gotten quite an earful and is very aware of the warrant holder share sell-offs over the past year and they decided to try and do something about it. Maybe these meetings were not about raising funds at all, maybe it was to build a relationship and tell the story to those that might have been looking at this as a quick flip investment.
There is no way this can be worth more than the ink it is written with, the volume does not tell much of a story, but the lack of large selling blocks is interesting. It could also be that we are in-between price levels and that if we get to $.75 the selling starts up again.
I think asking someone who has signed an NDA to reveal inside info is what is not proper. If you want to know more than what is publicly disclosed you can call cytodyn, sign an NDA and find out what you want. To think that someone under an NDA would respond online with inside info that might alter the SP and drive buying or selling prior to public disclosure is ridiculous. The SEC does check this kind of stuff and you know better than to expect a response.
I would assume this sentence does mean we are getting the patent owned by Dr. Pestell personally, however it is not specific. I remember when Nader and Dr. Pestell were asked directly about this in the CC, they did say the patent was part of the deal.
"CytoDyn will acquire substantially all of the assets of ProstaGene, including the transfer or assignment of certain intellectual property rights held by ProstaGene and Dr. Pestell."
mildly interesting article:
https://seekingalpha.com/article/4201183-gilead-debate-focused-threat-gsk-hiv-management-departures
thanks for posting this interview. I have a hard time understanding that the only thing you got out of it is that you think there will be a new trial needed. Nothing in the wording suggests that a new trial is coming any more than the existing trial will be converted. Nader says specifically "for that population" and "get a pivotal trial for that", to me those sentences can easily suggest that the already collected trial data is enough "to get a pivotal". We don't know until the FDA says so but you are really reaching to think that this is any confirmation that a new trial will be needed.
The other interesting things in the interview is that Dr. Pestell approached cytodyn - not the other way around and that Klump heard of cytodyn a few years ago and after the cancer news decided he wanted to get more actively involved. Again, he approached cytodyn for the opportunity, not because he was fearful of his investment. These are all from Nader so who knows but it does show things are optimistic from there perspective. Trying to read between the lines might be just looking to hard for something bad that likely does not exist. Sometimes what is right there is all there is and the pessimism has no facts to support the theory.
I know your thesis and how you generated your numbers and generally agree, however there is a big difference in the 15mil for BLA and the 70-100 million needed for the next year in total. The nature of how, who and when funds are raised are very different than just throwing around 100mill as if anything less means all is lost. You seem to be overly specific to support your theory but go with assumptions and generalizations when it matters most. recognizing facts matter and a lack of them is just as important. Did you at any point predict that cytodyn would be buying dr. Pestell’s company? I agree the road show does not make sense but it might make perfect sense. We don’t know. Attacking others that seem to be very open about there opinions are just opinions just makes your rigid financial model kind of thin.
Finesand, I appreciate the work you have done building a financial analysis but the 70-100 million you throw out is your number, not what is actually needed to file the BLA. The BLA needs 15million, I realize more is needed for operations and trial costs but to portray this as a sinking ship that won’t survive the month is not true. They can keep hobbling on as they have, delay the BLA, etc and just keep going. The story has not changed and to somehow link the science as questionable because of the finance situation makes no sense. You wrote this in bold so I am assuming you feel there is some trouble with the science, which there is no evidence of. Please slow your roll on this, you seem to believe your model is the only one that works and any deviation is sudden death. You just have an opinion, with just as limited facts as the rest of us.
Also, I know many very wealthy individuals that know very little about their investments and don’t do DD and won’t bother with extra steps to make an investment. Stereotypes of what you assume are surprisingly not true. Rich people often are not smarter or more diligent than regular people..