Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The only thought I have is that this model is good with the hiv indications because they are so close to being real revenue and fairly defined to the market size. However the breast cancer is being assumed to market size and I really believe we are not doing a p2 trial for breast cancer specifically. We are testing pro140 to see if it works with ccr5 cell cancers, which there are many. To me the way to look at it is the value will be based on the real value of hiv and the potential value of cancer. I don’t think that is easy to do and the valuation kind of falls apart because of that.
Sorry, that is not what I meant, I was asking if you think the investigational trial will convert to a pivotal without needing a new pivotal? That was the hope last summer but a couple cc ago Nader seemed pretty sure we will need to do an additional pivotal trial. There was some specifics to the trial as to the length and # of patients but we have not heard from the fda.
Do we still think there is a possibility that the fda might convert the investigational trial to pivotal trial? I thought Nader’s tone in a couple cc’s ago was that a new trial will be nessesary.
It was not meant to be an insult to your predictive abilities, I don’t even try and predict the future because so many times what makes sense is not how this goes. I think if you were on the board, personal friends with Nader etc, you still would not know what happens next week, I wouldn’t either.
With all due respect, your predictions have not been too accurate. I don’t mean that as a flaw, more to point out that we really don’t know what next week will bring. Finesand is kind of the opposite, wanting to analyze closely and jump in right before the actual catalyst that moves the sp. I really don’t care too much for either, I just want some concrete rational of how we are in this pickle. Trding’s explanation for why there is such skepticism by the BP and VC for this technology goes a long way to explaining the steepness of the hill we are climbing. Many have been burned investing in the next great thing and have it turn out to be worthless.
There must be some reason why the BOD, which is made up of a diverse set of very successful and smart people support Nader. We don’t know if behind the scenes if Nader is on thin ice or we just don’t know the genius of his plan?
There are many things about our history and current situation that we can be armchair quarterbacks on. A few times in the past I’ve supported Nader mostly because replacing him might be more disruptive that it is worth. I can say that if Nader was refusing stock options and buying stock with his own money, the support would be much greater. In reality, Nader alone is not the obstruction, he is easy to blame but the science will steamroll right over his shortcomings.
The nature of the past raises has been built on individual investors, it is hard to get tens of millions this way. there is a huge amount of sales pitch to get a $50k investment. In reality if we really only need $20 million, we are in good shape. With this last push funding, we have a BLA filed and a cancer drug. Keep in mind, there is some big money investors that are not going to let there investment fail just for a shortage of funds.
I agree, the risk is greater than my loyalty to the guy that got us here. Us investors, the BOD, dr Pestell and Nader all want the same thing and benefit for accomplishing that goal. Nader made it very clear way back in the October CC that he was in discussions for a non-dilutive finance deal. The very next day we learned of a road show to accredited Paulson investors with dr Pestell. If there were discussions back then that apparently were not as solid as portrayed and future opportunities, why would the door be so open even then to Paulson investors? I feel somewhat duped by Nader and I strongly feel a more experienced ceo had been in place since then. We have members of our board that are more qualified and I can’t figure out how they keep silent and supportive with Nader. I hope I am completely worrying about the financial future for no reason and one day I will be the idiot that didn’t have 100% faith in Nader, but right now I am scared.
Pro140, the market size, the funding climate and the status of the trials could not make this final push easier. What the F is hard to get $20-40 million when revenue in the hundreds of millions is months away! We do not need to win the ballgame in the bottom of the ninth inning, some value should be accumulated along the way.
I have a question, when others here post "label expansion" for the Mono after the combo BLA, what does that mean? Is the idea that once the FDA approves the combo, they will possibly give the approval to allow the drug to be a mono drug without any pivotal trial at all? I guess it is possible with the safety data and the investigational trial complete the FDA will do this but I thought the company made it relatively clear that a pivotal trial is going to be required.
Thanks for clarification, I guess my point is that we keep looking at this funding requirement as an expense only, and in reality those funds are used to produce and distribute product. The product cost is part of product revenue - which is a very important detail.
correct me if I'm wrong, but the $25 million for the BLA is not a cost to file - it is a requirement to have those funds on hand? In other words, the $25 mil does not get spent after raised - it is just there for the filing. I'm really not sure but after the filing I would think those funds can be used for anything. Maybe that level must be maintained throughout the BLA until approved? I just want to clarify that this need to raise is not like other raises where the funds are needed because they will be spent on trials etc..
At the end of the day, BP is interested in the drug, the patents and Dr Pestell. They could give a crap about Nader so selling because of Nader is ignoring the real value. Yesterday things were all rosy, today all is crap and tomorrow?
The science is as solid as it can be and the thought that some BP won't jump in at some point is crazy. Merck might just buy this solely to piss off gilead.
I don't know where the source of the billionare status came from - thanks for correcting that. Maybe I was assuming he was a billionaire already with the cytodyn buyout (that has not occurred yet!)
How good of a CEO do you really need to be? If anyone was asked if they can make a drug like pro140 worth more than today's valuation, I think the answer would be sure - no problem. Nader is either giving the wrong pitch or pitching to the wrong people. Pro 140 is like no other drug out there and this is insane that he can't get a deal done. Nader's openness in these phone conversations lead me to think there is no huge deal in the works right now, maybe there was or might be but I don't think we would see the $1.5 million raise last week if there was. I just don't understand where the BOD is on all this - we have heard nothing from billionare Klump. I would think there must be some foundation that would support this.
I hate to say this, but I wonder if getting rid of the IR firm was a way of keeping disgruntled investors from getting opinions directly to the BOD. Maybe Nader got tired of the BOD asking him why so many investors are not happy with the situation. Our only way of direct communication goes strait to HQ and our questions and opinions never gets to the BOD. I mostly think this is not the reason but our voices do need a way of getting to the board, as they are representing us.
My question is more about why the FDA requires this, not if or what might happen if they don't. I know the FDA won't change but the rational behind this is without purpose other than to make this process way more difficult. Why would the FDA care how funded a company is to manufacture the product? I can see the importance for access to patients but that is the company's problem - the FDA is just suppose to approve drugs that do what the say they do and all side effects are documented.
Can anyone explain why the FDA requires $25 million in funds available as part of the BLA?
It is so amazing to me that Nader apparently does not get it. As long as he pursues deals appropriate for otc penny stock, we will be an otc penny stock. there is a huge difference between chasing dollars that are invested because of great terms and chasing dollars that are interested in the science and future potential. Two very different rationales and two very different sales pitches. If Nader is wasting time chasing deals based on the least worst terms - he is completely ignoring the relationships he should have been making. A partnership built on the future potential of this drug is the only discussions that should be going on and that is a very different phone call list than the one he is using. This is very depressing, I hope we are wrong but If Nader is offering private placements to whomever calls investor relations then he really is tapped out as a CEO. He is proud of the funding raised to get us here but it is becoming obvious that he can't make the transition to getting foundational partnerships. How can the BOD and Dr Pestell not see this?
The rumors and optimism for the past week is starting to smell like a lot of meetings that resulted in no dice. I really hope this is un-true, but there is absolutely money out there ready to support this, how this is not behind us is baffling.
If this is the reason for stretching the timelines possibly, I would think stating the BLA filing is delayed due to the government shutdown would be smart. Letting the current and potential trial participants know that this drug that could save lives is delayed because of a border wall would be a good side promotion to get knowledge of this drug out there. On the other hand, it might also look like thin excuses and not really part of the optimistic nature of this process we currently are in.
The thought I had was that CYDY wants financing based on valuation including the cancer indication and the potential source of funds wants to get in at a level only paying for the HIV combo valuation. Because the big funds needed are for the BLA combo filing, I would think any delay in this is because they want to get some TNBC data readout to show this is a cancer drug and get much better terms. The delay, if there is one, will be from full approval of the protocol and enrollment of the TNBC trial. As soon as we get data from that trial, the financing will appear and the BLA filing will be submitted, I think. The FDA might be partially shut down and that might be the source of this move from Q1 to 1st half?
The thing that could really solve this is any licensing for the prostrate test. Additionally, the last CC they did point out that they got a patent extension into the EU, I don't think that was without a purpose. Didn't Dr. Pestell mention the potential licensing of the prostrate test was an Israeli company? (not that Israel is in the EU, but an international exposure is possible)
I don't think warrants will get exercised until not only the SP is higher, but when they are close to expiration. Why exercise and put the cash up when you can hold he warrant even if it is in the money? I would not think funds from warrant conversion will ever be something to count on for trials etc..
I too was disappointed buy that. It was already tired to put out timelines and let them ship like this. The Q1 was the deadline mgmt. put out and repeated many times - what changed? I will assume funding is the problem that they assumed would be solved but has not. It could also be the paperwork to file BLA is more monumental than thought - but they should know that before putting out timelines. Nader is slipping timelines again instead of delivering - He must deliver now.
I seriously doubt the $50 billion # also - It was the most recent crazy # so I decided to guestimate what a deal of that magnitude might look like. I think anything in the 6-20 billion level is where it will be at - but i'm guessing.
If never heard of that, very interesting. Not sure how the mechanics of that works. It could be the royalties are for only class A shareholders? I would thing the royalty could only be distributed to individuals if they are a preferred shareholder or minority partner. I wonder how they handle a shareholder that sells the shares? Maybe it is an incentive to not just dump the shares once awarded?
How do these type of buyouts look when the buyer does not have the 50 billion cash? I have seen cash and shares of buyer company being done but I’m sure there are other ways of doing these deals. We have all looked into how much cash each BP has ready for deals, but I don’t think any BP has 50 billion ready to go. This kind of makes me feel this number is just made up.
M&A activity could really pick up this year:
https://seekingalpha.com/article/4231701-celgene-deal-means-biotech-sector
Merck must be really eager to get revenge with gilead:
https://www.reuters.com/article/us-usa-court-merck/merck-loses-bid-to-revive-200-million-gilead-verdict-at-us-high-court-idUSKCN1P11G5
would I take $110+ per share? - YES. If I found out the BOD turned down such an offer and did not publicly disclose they had this offer I would fly to CYDY HQ and let them know my opinion.
this is the most ridiculous rumor ever. an offer like that would absolutely go to the BOD and the thought that none of the BOD would not take it is crazy. they would take 10% of that offer seriously - maybe not agree to it but they would not just brush it off.
This is actually really good news - BP is willing to pay up for small biotechs and willing to take the risk. Also, these buyouts over the past month do not include MRK or PFE and GILD is still sitting on a lump of cash. Which in my mind mean they have yet to make their move, yet.
If this is the worst I can find - then I think we are in good shape!
To keep up my reading too much into things mentality, I would guess that that means they are talking to specific companies and that this might send a message to other companies that are not currently talking to Cytodyn that they better step up before the train leaves the station.
again - reading way too much into everything on my part!
If I had to find a negative in this, it is that the status of partnership negotiations appears to be not very far along.
" Because of the recent studies we published demonstrating synergy between CCR5 inhibitors and several other drugs used for cancer treatment , we intend to develop strategic partnerships with specific pharmaceutical companies"
" Because of the recent successful outcome of our 10 years retrospective clinical study in prostate cancer , we intend to pursue non-dilutive licensing agreements for our prostate cancer prognostic test"
These statements make me wonder why we have been told they have been and are in talks with BP, yet the wording suggests they are “intending to” start talks. I guess it is much better to actually have data from the p2 trial for tnbc when negotiating but I really thought things were further along. It could also be this is just the safest statement to make.
The process really should be modernized. I can understand the actual trials to know the safety and efficacy are necessary, but the months of review, waiting for feedback on protocols and no real direct contact that the company can contact. The very fact that the fda created orphan drug, fast track and break through status shows that the know they are inefficient. Why do we need $25million for the BLA manufacturing requirements? What is the difference between rolling submittal and just submitting everything if they only look at everything when they have it all?
I do believe there is shorting and manipulation. The question is the same however, why would anyone sell here and why would anyone short here? No matter how much control the shorts might have, the potential for a huge news event is any day. Can you imagine having a large enough short position to make it worth while, thinking you can smother any up tick, and then a partnership or buyout is announced? The losses would be huge for the short position. I can only assume the shorter must have good inside info so they can cover before the major catalyst occurs. As for anyone who is just selling, it does not take much volume the move the price when there is only a couple hundred thousand shares traded daily. I think when we see a big increase in volume the shorts will be covering and the inside info will be that something is actually happening.
If things actually pan out and this goes from $.54 to $10 in a very short time based on some major news, it will be the perfect example of how dysfunctional the otc is. We assume markets are efficient but this has to be the most distorted valuation in history.
It is interesting that the jpm biotech showcase conference is in San Francisco Jan 7-9, which we believe Nader will be at and the rumor that he is in New York this weekend. Maybe we are looking at things way to closely but it is interesting.
The volume and the sp tells me there is no big deal, yet. But it is fun to guess what is going on.
I really don’t understand the raise at all. It could be some preferred investor wanted to do a direct placement and there was none open so cytodyn made an exception for the investor? Maybe they were a little short on cash for some bills that were due now? Really odd.
The other odd thing is not renewing the contract with investor relations. Could be they are really expensive and they are signing up with another company or giving the job to someone internal?
Maybe they are getting a huge loan to take the company private?
No idea
I can’t pm it but here it is:
I attended the shareholders meeting when Dr. P 'said why would we want to accept 5-6 dollars a share when in time it could be worth 200 or 300'.
I listened to the recent Q&A posted here and I heard a similar theme. They truly believe they have much more than a HIV drug and it sounds like they are willing to take it to the market themselves if they do not get the price they think they should. I have no doubt they are in discussions with Big Pharma, but without proof of FDA approval, the interest will not match the multi-billion dollar price they must be demanding. They are broke but don't seem to be bothered by it which is curious, so something is up.
Dr.P has has done a great job but his timelines and over promise leave me concerned.
I just spoke with Jody and there contract has expired with them so she said to contact the company directly (she was very nice about it). Should we read into this as we always do? I'll speculate that they don't need investor relations anymore because they are in the process of getting bought out. (this is meant to be a sort-of joke)
My thought exactly - buy back suggests it is company money. If it is a rumor of insiders buying stock themselves then that is different. Is there such a thing as employees/board members loaning cash specifically to be used for share buyback? All of this is rumor so....
I just looked at the website and I don't see Jody as being the IR person - it does not look like there is one? just the transfer agent? anyone know anything about this?