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I agree with most of what you say as a possibility. However i don't see the extra 200 patients needed for safety as extra cost because they already factored those patients in to the cost for the mono trial. We also don't know how many patients are in the mono already, could be 100, could be 299.
The second point that must be made is that looking at the timeline until pro 140 is approved and a revenue generating product is not why most investors are in this. Its for the buy out. that time like is absolutely unknown and I will be asking Tony next week what the threshold he sees as the point where a buy out is in the near future.
I am just wondering how this all came about with the FDA wanting a face to face meeting. I don't think they just felt like changing the # of patients out of the blue. Possibly, prior to enrollment both CYDY and the FDA agreed on the qualifications for the 30 patients without really knowing if the actual population for pro 140 treatment match those qualifications. The difficulty in finding the 30 patients might show that they saw a large # of applicants being turned away due to some criteria they don't meet for the trial. It could be that the FDA saw that it would be better to loosen the criteria to include these patients to get better data that reflects the patient profile that would be prescribed pro 140 once approved for use. It is possible that CYDY has a list of applicants that are ready to get injected today to fill the extra 10 spots. The extra safety requirement is baffling to me given there has been no indication of any safety issues in the past. However it sort of does not matter because they needed to recruit 300 for the mono anyway. I look forward to the investors call next week for clarification.
As a poster who has been optimistic about this FDA meeting i have to acknowledge that this was not the great news I was fairly confident we would get. It angers me that the FDA can do these things, It is irresponsible of them to not recognize the difficulty in meeting there ever changing mood. I hope the FDA sees too much positive data and wants to see some level of failure to make sure the trial give a wide range picture of where pro 140 fits in with the HIV treatment world. The FDA owes CYDY more than letting them unblind the 40 patient data, they owe CYDY and the HIV community BTD. BTD is meant to help in situations just like this. The FDA lengthened the timeline for more data, they should shorten the timeline for there review/BLA process in return.
I can't blame mgmt one bit because they did recruit extra patients in anticipation of the FDA possibly doing this. They really are trying to make this go as fast and smoothly as possible. It is hard to see that when the FDA is set on making things difficult.
I have to be honest that the data is what will motivate BP to buy this and the more data the better. I also think the certainty of getting FDA approval is important to get a buy out also, but unfortunately the FDA is difficult to predict.
Oh well, not selling a single share, just waiting.
That is not what was said, they said there COULD be an increase in costs. They do not know what the FDA will do until the meeting occurs, today.
So you are predicting with great certainty a dim future for CYDY based on no reasonable scenario other than your past personal experience. Gloating about your trading success in the face of others is quite rude. I have to ask, how much profits come from shorting vs going long? Know body knows what will come out of the FDA meeting or over the next month, this includes you and me. Small biotechs have the strong pattern of either being heroes or zeros, judging a biotech based on the period preceding the catalyst that decides this is a waste of time. Mgmt is pushing pro 140 to a stage of development that makes it valuable to BP, I have a hard time seeing how this is the wrong direction. Anyone who has such a strong opinion of the mgmt of a company should be able to offer what they would do differently.
Are you really hoping that others loose money? do you think that pro 140 is all smoke and mirrors, the whole thing is a scam? please provide support for your opinion.
You are right, the motives in some posts are likely to grab what ever factual statement and piggyback on a very negative interpretation and declaring it as fact. I can't argue with someone's opinion or factual info, but i sure can see through opinion displayed as fact and simply finding the worse case scenario within factual info. I, like you, choose to sit and wait. pro 140 has been around for many years, injected in many patients with no safety issues and proven effectiveness. Mgmt might have made mistakes and may in the future but as far as i can tell they are raising capital as little as is needed and pushing pro 140 through the FDA process as quickly as possible. Those are the 2 things they have control of, they can't control the SP much, they can't control the FDA and they can't make BP buy them out.
It's funny how some here keep bringing up missed milestone dates and then when mgmt goes conservative on future dates the same people complain about the long timelines. I think they just like complaining.
Would you rather cytodyn be out of funding options and not sure if they can raise the needed capital? The history of CYDY is that they get the funds as they need it to continue the development of pro 140 to a point where the fear that it will get through the FDA approval process diminishes. CYDY is extremely close to dropping a big chunk of that fear. BP is not eager to buy something that fails, they are eager to pay up for a relatively sure thing.
I can see the FDA looking at the profile of each of the patients and questioning the other treatments the patients have been on and the results of pro 140 in comparison to those treatments. That is my worst case scenario because finding more patients that may meet an even narrower criteria wold be very difficult. Hopefully the extra patients beyond the 30 will provide the needed data to not require a "go back to the drawing board" scenario. I do think this is also very unlikely. I honestly feel the FDA is looking at very complex data relative to each patient and just needs clarification to make sure the data reflects the effectiveness of pro140 and will for the duration of the 25 weeks of the trial.
The FDA looks at each trial as a separate file - GvHD is on a different timeline and has very little to do with the combo and mono trials. I don't think the FDA sits there and thinks about holding a decision because they have a meeting about something else in a couple weeks.
the "desperate" need for cash is a little "welcome to the middle of the movie" statement. there has not been a time when CYDY has stated that they will not need money to get pro 140 through the trials. they need money, that has always been true and to say it is a desperate situation is not really a true statement. they have a shelf capital source for $100 mil, they have used about $22 mil. of this and if you add up the amounts they need to get through all trials it is under the remaining $78 mil.
I think you are looking at the earnings based way of being listed. there are 4 different standards to be listed, each with different rules for getting listed. I don't remember exactly the pre-revenue requirements but CYDY met all except for the $4 share price.
The writing on the wall for me is that the FDA sees that pro 140 is safe and works and they want to see it get to market. The mechanism of pro 140 for GvHD and HIV is the same (protects the CCR5 cell) and in the FDA's eyes is showing effectiveness. This is preview to the data for the combo in my opinion.
Maybe you are right, the OTC is where it is at, THERF is doing great. Can you confidently say it is because they are on the otc? Where would they be if they were on the nasdaq? Do you think all biotechs should be on the otc? My point is that this stock appreciation shown in THERF has not happened with CYDY despite the development in pro 140 - to assume something is wrong with pro 140 is unfounded so therefore being on the otc is a logical explanation for the poor stock performance. I absolutely could be wrong and there might have been some poor decisions by management but i really can't see what i would do different in this situation. Some here have made the claim that mgmt is at fault but they don't seem to stick there neck out with what they would do. As far as i can tell mgmt is moving the development of pro 140 forward as fast as possible with as little dilution as possible. Is it a mistake to waste the effort to get on the nasdaq? Is it worth the risk of not getting a broader set of investors on a large market?
Why must everything be motivated by "there must be something bad" comments? In the past CYDY PR's good news and progress the stock does nothing/fall somewhat. Is that because the market does not like good news? No, it's because we are on the OTC with a very small audience which means stock manipulation is relatively easy. optimism by the few is met with shorts profiting by the fall that usually occurs after a news event. I'm not saying the nasdaq is going to solve this 100% but to sit here on the otc wasting good news and progress is crazy. It makes me angry to see where pro 140 is, what it is capable of and the otc prices this in at these levels? There is no evidence that there is anything wrong with trial results, to jump to that conclusion is as valid as me saying the phone is about to ring with a buyout offer.
I am far more interested in the outcome from the FDA meeting in 2 weeks. the RS I wish was not needed but given where pro 140 is and it's market potential it is obvious that the otc market is not doing us any favors. Which would you rather have, good news wasted on a market that has not built any value over these past 2 years or a RS to a market that could?
That is a perfect example of why shorting anything especially a binary lottery ticket type stock is a bad idea. If you really want to make money off a stock going lower the options market is the way to do it. There are no options on CYDY, if there was this would be a very different investment.
it actually is easy, you just choose to short and your broker does all of the technical steps to make it happen and when you want to close the position you just tell your broker to do so. in reality shorting is no different than going long, you are just selling and then buying the stock rather than buying and then selling as is typical. however, it is easy to grasp that you can loose money you invest where as with shorting you can loose money you don't have!
To short a stock you are basically borrowing stock from your broker, selling that borrowed stock now and hoping the stock goes lower so you can buy it back at a lower price and return it to your broker. Some brokers don't allow this on stocks like this mostly because it might be impossible to find shares that not only can be borrowed for shorting but also might be difficult to return the shares to close the position. The big huge problem is that if the stock goes up you might be given a margin call where the broker decides the stock is going against your short position and feels you might not have enough cash to buy the now higher stock to close the short. In the case of CYDY, if for some reason the SP shoots up your losses could be quite dramatic. I personally can't fathom why anyone would do this with the SP near all-time lows, you can only make money by it going lower and how much lower can it go? Given the near term catalysts that could move the SP up a short position would be frightening! Even those arounf this board that are negative on CYDY for what ever reason must recognize this risk.
good example - my neighbor was bragging to me a few weeks ago that he bought $1k of etherium and it's now worth $14k. Sometimes it feels like all this research and risk is pointless.
I share your frustration and have wondered the same thing. What keeps me going is that a majority of the board and mgmt are already successful and don't need a smoke and mirrors company to discredit their career accomplishments (maybe not Nader, but i do genuinely believe he believes in pro 140 as much as anyone.) .
To me there are 2 reasons for the SP to be at these levels: 1. it is on the OTC and 2. there is plenty of fear/risk that this won't get through the FDA process. The actions of mgmt to push the trials through as fast and detailed as possible with the FDA and to have the ability to RS to get up-listed are central to solving these problems.
This is a vaccine treatment which means it may prevent un-infected people from getting HIV but it does nothing to treat HIV positive people. To say that this will make pro 140 or any other treatment obsolete is not really true, assuming it does work. I would also wonder what the process of getting FDA approval for this will be - inject a huge number of people with the vaccine and see if any get HIV while not knowing if they even come in contact with HIV during the trial? I would think this will take a long time to get through trials. Sorry if this sounds cold hearted but Pro 140 is all about the next year, not what is happening 5-10 years from now.
Below are a few links to articles about reverse splits and uplisting in the biotech world. lots of good info and my take away is that the majority of reverse splits are to keep a company from being de-listed and typically fail. the few reverse splits used to get uplisted with catalysts to support the SP seem to be very successful. I'm sure there are many specific examples of good and bad outcomes but the nature and rational of the reverse split seems to be the main driver of the success/failure of a reverse split.
below some of the links are quotes from the article
https://www.caseyresearch.com/trading-opportunities/
https://web.b.ebscohost.com/ehost/detail/detail?vid=0&sid=46ae845f-28ce-4a5e-8694-77937415d16f%40sessionmgr4008&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#db=aqh&AN=100436189
https://www.thestreet.com/story/10725448/1/how-an-uplisting-works.html
"Using a reverse split to raise the share price and obtain an uplisting is a very positive sign for a company and is much different than companies that use a reverse split to prevent being delisted. Once again, the confusion relates to delisting as opposed to uplisting. Many people who don't focus on uplistings only encounter reverse splits in the context of companies that are trying to stave off a delisting, so in many people's eyes a reverse split is a sign of a troubled company."
https://seekingalpha.com/article/3957442-uplisting-power
http://www.thechairmansblog.com/delmar-pharmaceuticals/jeffrey-bacha/reverse-stock-splits-uplisting/
"In contrast to companies executing a reverse stock split to maintain a listing, companies that execute a reverse stock split in order to up-list often have an upward trajectory."
http://aimprogramblog.blogspot.com/2014/07/dr-krause-comments-on-local-otc-stock.html
https://www.accesswire.com/viewarticle.aspx?id=441112
"Few things can get investors' attention faster than when a company announces a reverse split. This is due to the fact that reverse splits are often associated with penny stocks which most investors assume lack a path to profitability and only want to prop up their share price in order to float more shares. The other scenario could be that a company is desperately trying to maintain its listing in the major exchanges such as NYSE or NASDAQ since these require the stock prices to be maintained at certain levels.
However, many cases of reverse splits should not be viewed as a negative event since they give an opportunity for small over the counter (OTC) stocks to join the ranks of peers at the major exchanges, increasing exposure and liquidity. This essentially means that such stocks will be able to garner much needed attention from retail brokers and institutional investors as well as increasing their access to capital."
They were planning to continue enrollment long before the PR of the enrollment reaching 33 patients. I talked with Jody the second week of July asking why there has not been full enrollment PR yet. At that point Jody told me that they are still enrolling and will continue to enroll extra patients in case they need them due to drop outs etc. At that time she could not say where they were at with the enrollment but that they were close. I don't think the decision to continue to enroll is driven by the data, it was to cover the bases in case they need it.
I can understand that but I've been hearing them talk about an organic uplift for over a year. There has been enough forward progress in pro 140 and yet we are at the same level. It's my opinion that the otc market is a problem that must be solved. I don't think to mans other companies doing RS have a drug in phase 3 in a multi billion market.
Why? A few here have claimed that a RS will dump the SP because that is was always happens. I would like to see examples of this with info about the details of the RS. I'm not saying it's not true sometimes but what would you rather management do? Stay on the otc?
I did see in the share holders meeting notice that there are 555 individual share holders, so more than the 400 needed.
Thanks Saltz for your posts also - they really put some great insight into what is going on.
I decided to do a little research on the value of a pre-revenue biotech based on historical info. I found this interesting article on Investopedia:
http://www.investopedia.com/articles/stocks/06/biotechvaluation.asp
I found this interesting related to the risk at different stages:
"As the drug moves through the development process, the risk decreases with each major milestone. The Pharmaceutical Research and Manufacturers of America reported in 2003 that drugs entering Phase I clinical trials have a 15% probability of becoming a marketable product. For those in Phase II, the odds of success rise to 30%, and for Phase III, they climb to 60%. Once clinical trials are complete and the drug enters the final FDA approval phase, it has a 90% chance of success. These improvements in the odds of success translate directly into stock value."
To use the rough math in this article and the possible revenue estimate for combo sales only of $670 mil/year. If i extend this to the 10 years patent life with a ramp up early in the 10 years, i'm assuming roughly $6 billion revenue for 10 years. If there is only $3/share per billion valuation (330 million shares / 1 billion = $3) that is $18/share. this is just combo revenue at the low estimate of market penetration. I'm very rough with the #s but this seems better than looking at the premium over a stock price or how much some other company got bought out at.
Basically, lets not lower our expectations of what is possible just because it is taking a little longer that we thought.
here is the revenue for the top combo drugs available for 2016:
struvada, gilead, $3,566,000,000
altripla, gilead, $2,605,000,000
triumeq, GSK, $2,134,000,000
stribild, gilead, $1,914,000,000
prezista, J&J, $1,851,000,000
complera/eviplera, gilead, $1,457,000,000
isentress, merck, $1,387,000,000
viread, gilead, $1,186,000,000
tivicay, GSK, $1,172,000,000
sustiva, BMS, $1,065,000,000
epzicom, GSK, $669,000,000
Non of these are used/approved for mono use. If Pro140 is only approved for combo, it will take market share from one or more of these drugs. worst case is at the bottom of this list at $670 million/year revenue. our market cap is at $100 mil. I don't need to go much further than to say the multiples in just combo are 7x, and i'm just looking a 1 year's potential revenue at the bottom of this list. We have all focused on how important mono trail is and that it is what will drive this buyout. I don't think Gilead, GSK, BMS or J&J will let there market share drop by this magnitude over a $100 mil company. I can only assume that there has not been a buyout yet only because CYDY has not shown P3 data and that an FDA approval is closer to a given than a maybe. October 12 - Nov. 1 is the time when this will be answered.
The focus on dilution is also a little out of context, if we have $50-60 mil needed over the next year to get both combo and mono trials done that means the 260 million shares that make up today's $100 mil valuation will be at 360 million shares (i'm assuming a $60 million raise at $.60/share = $100 mil). This is a drop in the bucket and i'm using the dilution to do both mono and combo trials over a year and looking at the potential revenue for only combo! guessing at the revenue from mono is difficult to estimate because there are no mono treatments to compare to.
I strongly feel the FDA required the combo trial because all past drugs were tested as combo drugs and they need to see pro 140 go through a similar trial. I think the FDA is very aware of the importance of this trial and they can't screw it up. My worry is that they will want to see more data but to honest there is many years of data and safety from pro 140 already. i guess we will know in a few weeks!
I can't dispute your or others less optimistic opinions and do respect that I don't know any more than anyone else. I just don't feel the need to raise a red flag. It was my expectation that good PE results would have been PR'd weeks ago and the milestone of establishing that pro 140 should and will get bought out soon afterwords is not realistic now. Apparently there are more steps involved that I agree we're not part of the plan earlier this year. I do have to say that I am optimistic about the FDA meeting and will be more than a little curious what the SP reaction will be. I'm not super clear about the uplisting pros/cons but do know the otc sucks.
Why are you and others jumping on the everything is bad train? CYDY for more than a year has stated that getting uplisted is very important and a top priority. Staying on the otc is terrible for attracting new investment, providing very little liquidity and its not establishing a value for the company. Don't put the cart before the horse, doing nothing and waiting for the buyout phone to ring is not a plan. I think the plan is to see what the FDA says, hopefully that provides some stock movement and get uplisted so larger investment can be made on the open market. It likely will take a RS but staying on the otc has proven to be a wasteland. The best way to get bought out is to look like your not trying to get bought out.
I don't think that is what that means. You are jumping to a conclusion. I think they just want as much flexibility as they can get. It is a possibility that with limited trading on the otc that a manipulate effort to drive the SP down might occur and they need a 15x reverse split. It's the otc, it does not take much to do some wild things.
Because we don't know what will happen from this meeting all we can do is guess and like or dislike each other's opinion. I don't think the continuing the enrollment is a sign that there is a problem, they indicated the continued enrollment was always the plan in case someone dropped out of the trial etc...
I like Saltz's response better. He seems to have clearer info on the status. Nothing suggests there is a problem other than it's the FDA and who knows what they will do. We just have to wait.
that's what i thought also, it is also interesting that this is 2 weeks after the oct 17 FDA meeting. I guess because they have no idea what will happen to the SP after the FDA meeting they won't know how much of a reverse ratio will be needed? It's also interesting that they feel they will uplist 4th quarter this year or 1st quarter next year.
I could very well be they have more than 4 extra patients. With the dropped exclusion of prior use of maraviroc or any other CCR5 co-receptor antagonist they might have many more in the trial. just a guess however.
Thanks for posting this, I talked with the CFO last week after the $.58 dip because i was quite frustrated. He was frustrated with the SP also but did clarify the capital raise situation. Many here have been concerned that there is some $15mil raise coming soon but that is not likely. basically they have a shelf financing of $100mil, they have used $22mil of that. given the typical raise has been at a get it as they need it attitude i feel the prospect of a large capital raise is not likely. Micheal did not say this specifically but was clearly tired of explaining that access to capital is not a problem and it should come as no surprise that they need money to keep moving forward.
I also asked what the deal is with this FDA meeting and he really can't say much other than they originally were going to have a phone meeting and the FDA asked for a face to face. He indicated they are very prepared for the meeting, it is very important and that the continuing enrollment in the combo trial is to gather as much data as possible to be prepared for what ever the FDA has questions about. My impression is that the FDA has loosened the requirements for this trial so much that now that the data is rolling in they need to really see if they have enough to feel confident that this data is at the BLA level. I feel the pressure is on the FDA as much as it is on CYDY, other wise why would they need the face to face instead of a phone call.
The current SP is a reflection of the risk building heading into this meeting, unless they PR that the data looks great going into the meeting i doubt we will see anything but this SP level. I would guess PR'ing the data or something similar before the meeting would set up a "The FDA caused this bump in the road" situation/excuse if the meeting is not positive. Guessing what is going on with the FDA is impossible but i am confident that Pro 140 does do something and that it is safe. The only concern is if the protocol for the trial is not what the FDA was expecting in the data then they may want to change the trial for their comfort level. Given that this protocol has been worked on for over a year before i can only assume the FDA should be good with the protocol.
either way, i did not get much info other than this meeting is very important.
Well, I don't have "sources", I just call Jody at investor relations. This is something anyone can do when they have questions, such as yourself for example. I have bought all of my shares on the market, I have no Paulson or renshaw relationship.