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It also means that the worry of a near term capital raise is taken off the table. I think the stock price shows that everyone knows there will be a raise and that is priced in. I'm not saying there won't be a drop but i don't think it will be as severe as past raises. CYDY is moving forward no matter what and unfortunately it has been at our expense. the end game is the same and the multiples are still there. i hope.
one would think that the definition of combo would mean that pro 140 is used with at least one other treatment to be considered combo, not mono. not sure if that is possible given the negotiated protocol with the fda seems to be focused on the reduction from 300 to 30 patients and not the qualifications of the patients. seems like a little better detail into what they needed to do in 2016 would have been very beneficial to CYDY enrolling for the combo trial.
Thanks to misiu and z_smith for taking the time to educate me on the details of the combo market and the specific use - i better understand the differences. I agree there is a market for both and that it really looks like pro 140 is needed in the combo market as does IV.
I totally agree, makes me wonder why the time and resources have been wasted in the combo trial. It is great that the # of patients was reduced to 30 from 300 but that may have showed that the market is much smaller than what CYDY thought. It is troubling that CYDY continued down this path and has not acknowledged the facts of this combo trial. I hate to say it but if CYDY would have dropped it a year ago and focused on mono at that time we might be much further along. It feels like Nader's decision making has really created delays and dilution beyond what was required. I do hope the data from primary endpoint in the combo trial does change the SP trajectory so we can raise capital at a higher SP, this seems to be the primary reason for continuing the combo trial.
Also, because Taimed got ODD, we know that this means the FDA feels this market is small and needs ODD. The FDA did not give ODD to pro 140 because it has a large population market, beyond the market ODD is meant to benefit. My take away is that Taimed focused on a small market and is a long way from starting to go after the market that Pro 140 is now in P3 with.
I also wonder if the 100 patients they need for the safety part of the trial will be mentioned. didn't Tony state that the expect to have the 100 patients for the mono/safety trial by the end of Q2?
You should send an email to Cytodyn and let them know. They are aware that us investors are pissed about the stock price but we should be keeping the flames to their feet.
Good point - daily, weekly and monthly moves in the +/- $.50 analysis really is pointless when we are talking dollar multiples when data is presented.
I like your theory, I had one of my own that is purely a guess. Is it possible that now that the stock price is solidly below the warrant exercise and what the paulson investors paid that CYDY could go to paulson and ask for much better terms? My thinking is now that the investors are a little desperate and don't want CYDY to drop further or fail, they may want to double down to put a floor in the SP and protect the original investment? I'm thinking this is the inverse of what happens when you have traders buy at lows and sell on every up tick to take small wins and keeping the SP from running much higher. totally a crazy theory but curious about everyone's thoughts.
Finally they are talking to the people that need pro 140 and can also support the company. I think that once the HIV community realizes that the drug they want, pro 140, needs financial support to happen there will be a new crowd of investors.
Thanks for the post, it just does not get more obvious than that! GILD appears very interested in a combo treatment, pro 140 in the p3 combo (which is a salvage trial) appears to be very important.
you are wrong. Pro 140, as stated by many here and with actual trial participants does work on its own. it works better than the SOC and is safe with no side effects. the fact that "N=10" well, CYDY is in the process of completing N=300. the money available to get that complete seems to be readily available from those that have many other options to invest in. If pro 140 had N=300, or 100 today, the stock price would be dramatically higher. So, as we move forward with the trial one can assume that the SP will be higher in the future after trial results are in, not lower. false scare tactics may work on other investments but unfortunately for you, others here know far more than you and base their opinions of the future on facts.
Well, Its one thing to loose on cytodyn but i can see your point of view on knowing you missed out on another trade that would have worked while holding a loser. If it was easy we all would be millionares!
I have to be honest, watching Shane buy in so confidently with a large position based largely in this Sheikh recommendation and now unloading is a great example of emotional trading. I apologize for using Shane as an example, He seems to be a great guy and It is absolutely his call what to do with his money. But realize than way too much faith was into a third party to tell you what will make millions in the near future. Now that seems to be not as in focus or in the near future, Shane is getting out. I was concerned a few months ago when Shane started posting the size of his position and how he came to the decision to get in. The volume of selling at all time lows could very well be mostly Shane unloading because the Sheikh changed his timeline on CYDY.
I primarily trade options, always selling premium on both the call side and the put side. I am a non directional trader. This is because i don't know the future and I am confident in my ability to manage what DOES happen. All the technicals, fundamentals and gurus DO NOT KNOW THE FUTURE, no matter what the past performance has been. Relying on rumor or some cherry picked methodology from someone you may or may not know is just crazy to me. I have studied chart reading and historical methods of trading and have found most to be just curve fitting methods.
CYDY absolutely made claims that they failed to deliver on but the story of why this is an investment is exactly the same as it was a year ago. there is an increasing population of HIV positive people, the current care is ok for some, but will be not ok for all eventually. Pro 140 is safe, it works and it will work for a long time in those people. The market is still there, CYDY still must go through the challenging trials/FDA process and that costs time and massive amounts of money. I can't illustrate this better than to say CYDY is a $80 million company with a $10-20 billion dollar product. these things don't come along often and they don't come without risk.
I made my investment 12+ years ago based on Cytolin, and i have to be honest that learning options trading has changed my philosophy on trading. I would never make this investment today. The thought of being in a position for this long with so few choices to manage it is against what i would ever do today. despite this, I have only added to my position and can't see closing until after the catalysts are done. The catalysts are still there, CYDY has the access to funding to get there and the end result will be what it is.
Again, sorry Shane if this is too personal And i am not a better investor/person than you but i needed to remind everyone here that we need to look beyond Sheikhs and the MACD, bollenger bands etc. I make no predictions of what the multiples might be or when things will happen but i am confident this will not fail.
TD Ameritrade seems to be taking orders on CYDY. It could be your brokerage has a policy change on OTC stocks? I know my tastyworks account does not even show CYDY in my balances because they consider it a penny stock.
I just got off the phone with Jody Cain, the IR person. She obviously could not comment on any specifics but she did say the last CC was meant to be a re-set of timelines and to bring things back to reality. She did say they have been getting a lot of calls/emails about the stock price and that they are well aware of the disappointment from us investors about missing timelines. I told her that being off a quarter really is nothing however to be told confidently that great things are right around the corner and do not materialize is just creating more doubt and risk for no reason. I asked about the nature of the next capital raise and she could not comment but hat the terms are looked at very closely. She did stress that the results from the combo trial are what they are planning to move the SP to a more appropriate level - I agree and it seems to me the dilution in what ever form will be at a higher SP. All i could really stress to her is that it will take multiples to get us to even at this SP and that that is not ok in a high risk biotech investment. My statement was how can pro140 be a potentially multi billion dollar annual product, cost roughly 100-200 mil to develop and the SP is at $.50? She said my comments will be given to Tony and Nader and that we are welcome to call anyone at CYDY to ask questions. I Do feel they are on our side and this will work out - I just have a hard time understanding why we need to walk the coals to get there!
If they are seeking funds from an investment bank would than not be a loan? I would think the interest would be an expense and there would not be any stock dilution? am i correct in this?
Thanks for the info!
Well, it looks like CMC was bought out the end of last year but it also looks like they are not a publicly traded company so i doubt the CT has to do with something CMC wants privacy about.
I tried to read the whole paper and find info that seems relevant to CYDY's situation and it seems that many CTOs are for very specific information. Listed companies obviously can't keep the basic SEC filings a secret, but specific names, #s and terms sometimes are requested to be confidential mostly to protect ether the company requesting the CTO or the company on the other side of the pertinent transaction/relationship. It sure does look like the potential for bad news being confidential is unlikely for CYDY, the SEC simply does not allow companies to with hold that kind of info with a CTO. for example, if a patient dies in a trial - a CTO would not be able to be used to hide that. Typically they are to hide specific details from some deal that is ongoing. It is a way to fulfill SEC filing requirements without disclosing information that could potentially damage the ongoing negotiations.
I am just learning about what a CTO is so i could be wrong in some of these assumptions but it sure looks like something is going on at CYDY headquarters!
I found this interesting study about CT filing results:
"There are 2,436 common stocks granted for confidential treatment from 1998 to the end of 2008. 268 out of 2,436 of them were delisted within one month after having been filed for confidential treatment. 922 out of 2,436 of them were delisted within three months after having been filed for confidential treatment. And about half (1,109 out of 2,436) were delisted within one year after having been filed for confidential
treatment. The dominant reason for delisting was due to merger and acquisition. About 1/3 (883 out of 2,436) of these stocks were delisted due to M&A within three months after having been filed for confidential treatment. One quarter (3 months) is relatively short compared with
the time it takes to complete any merger and acquisition, especially if you count the time that there were just rumors about potential M&A toward a target firm."
http://www1.villanova.edu/content/dam/villanova/VSB/assets/marc/marc2011/Why%20Do%20Firms%20File%20for%20Confidential%20Treatment_.pdf
ah, got it. I guess I'm thinking that combo opens the door to something much bigger. I am likely too optomistic. either way the data from the 100 mono patients needed for the combo's safety part should really tell a good story. I still believe BP is looking at how effective pro140 is in a larger patient set to decide the value. It seems obvious to me that FDA approval may take time and money but if you know it will get there. BP will step in some way. I don't think CYDY will be raising the $60mil all alone. $60mil to BP is close to walking around money!
Totally - i don't think CYDY HQ is dumb, there might be a very good reason. As i guessed - the combo trial might be closer to fully enrolled than we think. Tony did say it takes 4-5 weeks to screen patients so the fact that we are only 10 weeks to the end of Q2 would mean quite a few patients are screened and getting screened.
But even if it is used as a combo, as labeled, the # of HAART patient that will want it is huge. I'm not suggesting that doctors will prescribe pro140 as mono even though it is a combo drug. when pro140 gets mono approval the HAART patients will then be able to eliminate all other drugs and only take pro140. My idea is that the # of combo patients is just as big as the # of mono patients.
I just wanted to run a potential scenario past everyone, basically what happens when pro140 gets FDA approval for combo use. When that occurs, HIV positive individuals who are on HAART will want pro140 in the mix because of the lack of side effects and to not worry about the current HAART drugs loosing effectiveness. This is all CCR5 patients in my opinion - not just the patients that now have failure of one or more drugs. My thought is that once on pro140 - those patients and their DR. will start weening patients off HAART because it is not necessary and Pro140 is in trials for mono. Combo trial will lead to a large market that will directly replace current HAART drugs the day it is approved and on market. This will be as important as Mono indication's approval. The # of CCR5 HIV patients is the same and if they are taking pro140 in combo or mono does not really matter because they are on pro140 either way. Am i missing something?
I think the reason originally for the combo trial was that it would be the quickest trial to get through and achieve the first of many FDA approvals. However while listening to the CC, I was thinking if the 30 patient recruitment is slow and holding back the Mono trial as far as recruitment, it would seem to make sense to flip the priorities. I did not ask this during the CC because i felt there might be a very good reason - the combo trial is very close to fully enrolled and the enrolling sites will already be shifted to gathering mono patients soon. I do think there is going to be an acceleration in enrollment in the near future. Tony indicated they are getting many requests for both trials and that many patients just aren't in bad enough condition to get into the combo trial. I must stress this does not mean the market is smaller - i think many HIV individuals want pro140 very badly even though their current treatments are working. the quality of life is the motivation, pro140 is not just for salvage patients that have no options. Once pro140 gets FDA approval the Dr. and patient decide whether to add it to there treatment regimen or to replace all other treatments with pro140. This is the reason to not get down about the market size, it is as big as it always has been - the trials are just a very narrow window.
Keep in mind that just because the requirements to be in the combo trial are tight does not mean the market is small. Once approved for combo it is up to the dr. To decide if pro140 should be added to a patients treatment, most likely it will to many patients. In fact the dr may see the results and eliminate other drugs because pro140 is doing its job.
I am confident that things are moving forward with the trials, a slower pace than we would like but it's not like they are getting no candidates. I am also confident CYDY has access to funding to keep moving forward, again i'm not happy with the dilution that comes with it or the low stock price it is done at. I am confident that Tony know what he is doing and that the task is the same as what it always has been - develop pro140 and sell it. The thing that i am not happy about this the stock price being completely dis-connected with the potential. I feel dumb for holding this for the many years while shorts make money, Nader makes money and investment firms create low risk positions that have a much greater multiple than i will ever have. Sell at this SP? that would be even more dumb. There are just no signs of failing financially or clinically. This will get there - it's just going to take the time and money it needs. Do you really think CYDY will close shop? Be sold for less than $1/share? Spend 10 years getting through clinical trials? no on all of them. If it was a simple road Progenics would have kept Pro140.
Totally agree, the selling could be one trader who just threw in the towel because they did not double there money in a few months. Once we get a new set of data and they can stop presenting the data from P2b things will be much different. the end of Q2 is only 10 weeks away.
Ok, you are making sky falling assumptions based on nothing. CYDY will not ever raise the entire $60mil all at once. They have never indicated they would or could. The enrollment history is not great but we don't know how many they have other than it is more than 7. Tony indicated they might have the PE for combo in Q2, that would tell me they are closer to 30 than closer to 7. To say it will take to end of Q4 is just BS based on no evidence. I'm not saying that is impossible but to arbitrarily throw huge delays in out of thin air is silly. As for BP intelligence vs Nader's - who cares - Pr0140 works, HIV is a multi billon market and BP is not going to let patents run out and not have a plan. What else do you think they are going to do? This is a less than $100mil company, it would be cheaper for them to buy it than not buy it. Just because Tony did not hold a carrot in front of us like Nader has does not mean there aren't talks and key milestones for a partnership or BO deal are set. Also, I don't care what Sheik does or feels - he knows as much as we do.
Small developmental companies die from a lack of funding, not from dilution. it does not feel great to have dilution and it is a race against time/funding to hold onto our piece of the pie but not having available funds is death.
It will be nice change of pace to be pleasantly surprised by good news we weren't expecting as opposed to the disappointment of missing optimistic milestones that we know couldn't happen.
Looking at the volume of buys at .59 makes me feel good. I don't think the sell off will go beyond this level. Is great that many here look for these opportunities to load up. Also, the end of Q2 is just 10 weeks away and i think most here would agree that Tony's timeline is better than Nader's.
I agree getting the 300 patients reduced to 30 is significant, however it looks like the criteria is the problem. I don't understand how they let the protocol be such a narrow window. It sounds like there is no shortage of people who want in on the trials, unfortunately they just aren't in bad enough shape.
i was hoping for a little better news but overall nothing is really different other than Tony is clearly in charge. I do feel that 2016 is a lost year - if they had just stuck with the protocol as is they might have enrolled by now and had a larger data set. Maybe not - could be we would be getting tired of hearing the trials are not enrolled yet just like we are now. I guess the lack of a stock run up to this CC is good because the SP will likely stay here for awhile. I really do not understand why they bother with orphan and BTD - by the time you get them potentially the time consuming and expensive part is done. CYDY just needs to generate new data asap. At least know one will give a crap about ASM microbe - we know thats a waste of time!
I wonder if the whole point was to show that pro140 is a larger market than ODD is for? seems a little too forward thinking but the SP seems to be ok with it. I wonder if the manufacturing agreement is purely there to get the BTD? is this the strategy behind these FDA applications? Maybe CYDY mgmt has a deeper grasp of this than we realize. Hopefully this is the extent of the bad news and everything is good news in the CC.
I just don't understand why CYDY applied for this, seems fairly obvious that pro140 does not qualify. why create a risky bianary event out of thin air? I am also wondering why thy bothered with BTD. the last time they were rejected because their data did not match what they were specifically requesting BTD for but they stated that they were already getting the preferential treatment that BTD would provide. Why rely on the FDA for anything beyond what you have to? we need greater and new data to establish the potential market share that pro140 can take so CYDY can confidently set a price tag for it. That has nothing to do with the FDA.
I have no details, was not invited and have not been in any Paulson raises. I only know about it from other posters that are invited. I live in Chicago so I will not be able to stop by. Interesting that you were in three raises and have not been invited.
I get that Tuesday is a much needed update and that Paulson is likely just having a meet and greet with Anthony but the timing seems sloppy to me. Too much financial engineering focus and not enough putting your money where your mouth is. I really hope the update is good and that we are on track. I tend to think we are and everything is fine.
The Paulson meeting could be Cydy pressuring Paulson to let some of us longer term investors a chance at being part of the next capitol raise instead of being left in the cold. I would assume many of the emails and calls to Cydy from us have been to discuss our dilution and why these investment firms get to jump in with little risk. I am at my max investment in this and would be pissed to see so much jumping in right before a run up by individuals that have not been loyal for years I supporting this. I have not been invited to the Paulson meeting and really do not like the timing of all of this.
What will the paulson meeting cover? is it potentially another raise opportunity? some sort of coordination meeting? more detailed information based on their investors having signed a non-disclosure? just curious.