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I was told by Jody that the extra patients are just in case they need them. the trial is for 30 so the trial data is for that #.
RDHL is at a an all time low so i don't think that proves anything. I have said this before - meeting dates on a calendar is not as important as achieving key steps in development. every one of these steps checks a box in the buy out goal. mgmt does not have a lot of control over enrollment pace, trial sites, location of patients, etc. so there is a lot of range in the estimated dates given. I agree that they should not guess and fail achieving these dates but that does not mean the focus should be on a calender.
Amature, Kobe and Fred - I agree that PR needs to be read closely but all of you have taken the opportunity to draw negative impressions. These are purely speculation and can just as easily be replaced with positive possibilities. We don't know beyond what is written. All of you keep focusing on a calender and not on the forward movement in the development of pro 140. I don't care what year pro 140 will be on the market, I care about when BP decides to buy it. That can be very soon, but I don't know. Data from trial is what matters.
Nothing has changed - the results should be stellar. I think we are just discussing "what if" scenarios.
Thanks for the post Tonysd57, but i must ask if the worst case scenario is that the trial fails and the SP goes to $.70 and some pharma buys it out for cheap, then why is the SP at $.70 now? We have the potential of a major win in trials and it is priced at failure levels? Is this just because we are on the OTC? is it all just waiting for risk to be alleviated after the data? I'm not saying your wrong but this is the baffling thing to me - why is the no real accumulation on the potential growing this SP?
I agree 100%. I must say that if it was mgmt's goal to put themselves in the position to grab pro 140 for them selves after a company failure is just crazy. If they wanted to do that they would have a long list of actions they could do that they are not doing.
Also the issue of a large and or frequent dilutive raises, how the hell would you think there wouldn't be? We invested in a tiny biotech with no profit and one product that is depending on the FDA for approval. It's the same as any silicon valley startup - a lottery ticket. To think there is some way to make this happen without dilution is just crazy. If you think the dilution is more than the multiple then don't invest. I have read many posts on what this will sell for and the estimates keep creeping lower mostly because we are getting fatigue over the wait. There is no change in the market value for pro 140, the multiples are the same. if it takes $20-50 million more to get to an FDA approved drug that is approximatly $.20-.50/share - a lot in today's stock price but nothing in a multi billion market share where the SP would be in the $10-20/share with FDA approval.
Time is money but results will win!
I can't figure out why they changed there mind about PR'ing the enrollment. I doubt it was a stock price issue because as far as i remember there ability to get or know what the SP will do has been terrible. Why would they think they know what the SP would do or not do based on enrollment PR? I can only guess that there might be an outside discussion with a second party that advised against PR'ing?
At the end of the day the data is what matters and would rather just get that PR anyway.
Most of the insiders already have 500,000 shares and up so I doubt this is an attempt to let CYDY fail in order to re-boot with more ownership. Even if they wanted to go at it as a private company it does not make sense. The only bad thing i can theorize about the pulling of the open funding is maybe the remaining $9 mil of the $15 mil has no takers and they need to offer better terms. I seriously doubt this and strongly feel they know they will be able to raise capitol under better terms in the near future. As for running short of funds between now and then i think there has been internal discussion to provide the cash from insiders until data PR is released. We are watching ducks being put in a row.
Besides the RS issue, the only other thing I would like to see is Nader to exercise some warrants and/or buy some stock. The fact that the SP is right where it was 6 years ago when he got involved in CYDY is not great. I know he did step in when the company was in a lights out situation and has moved the development of pro 140 greatly but his stock options and salary at this point is a little excessive given his not putting his money where his mouth is. The few people that make money on CYDY should not be just mgmt. I will vote to keep him because he is passionate about the company and it would be too disruptive to vote him out but he really should throw us long term investors a bone.
I'm really torn over this RS situation. I want to give all the tools necessary to mgmt to get to the goal line but i also am concerned about the increased risk. Let's be honest, mgmt has not really been the most confidence inspiring in controlling and understanding the SP. Too many times good news does not move the SP up and dilution and delayed milestones have damaged the SP. The cost to uplist and increased risk of not holding a SP because of a big raise makes me want them to focus on partnering or even better get bought out.
I have a hard time understanding how the SP is where it is given where pro 140 is in development, what ever is holding it back is not resolved and i'm not so sure being on the OTC has been proven to be the reason.
On the other hand if being on the OTC is capping any SP growth then great, we have a solution. If an uplist does correctly value this company and put CYDY on the radar then that would be great. I would like it if mgmt would do a better job of showing us what and why of this to show some confidence in there understanding of a publicly traded company.
I don't think it really means anything. They just omitted a sentence that was opinion and not factual information. Their opinion may be valid but it does not necessarily belong in a 10k. I don't think there is an attempt to dis-credit ibalizumab, just to inform of the differences for investor benefit. It would be strange to not mention the competition and its significance to pro 140 development. Sounds like their lawyer re-read it and felt it was a little too much. There have been far more significant news in the past related to CYDY and pro 140 that don't move the SP.
I am not trding - we are two different posters.
Not sure what you mean by this but they did say they would have full enrollment at the end of q2 in combo. I called IR and was told they are within 1-2 patients and it is more of a logistics issue to first inject them. They also said they will continue to recruit extra patients. Saltz has informed us all that the decision to PR the full enrollment or wait to PR the PE data is undecided as far as we know. They are very likely gathering data and are very close to PR PE data.
I don't understand your questioning the trust for mgmt - do you think pro 140 is a hoax? Is mgmt covering up serious issues just to keep the paychecks going? Why would members of the board and Tony invest millions of their own money to keep a company that is destined to fail going? If you really don't trust them then don't invest. If you are simply questioning there ability to deliver on their calender predictions then i ask how important is it to predict the future to the day vs developing a product that can deliver multiples on your investment?
i guess no PR on enrollment, just another 8K. When are they going to throw us investors a bone?
ok, great. I'll keep focusing on accomplishments for there significance in moving pro 140 to fda approval or a partnership/buyout and you can keep looking at a calender.
very true, we have waited for full enrollment / data in a p3 trial for a long time - to get out now or to be shorting literally days in front of this major PR would be crazy.
I was under the impression that they have all 30 and then some. they just have not injected the last couple yet due to logistics. They also said they will continue to recruit others in case there are drop outs. this is only vaguely told to me by IR - exact #s are not known. The reason there has not been PR about recruitment is that they want to have all of the patients injected first so they can start the primary endpoint data timeline.
true, but we are also talking about a 1 year lag between combo approval and mono approval. long term once mono is approved this is not a situation that exists.
Nice post - thanks for the summary for all the new viewers.
based on what! give at least some evidence that would make that happen. do you think pro 140 does not work? all of the trial participants are in on it and faking there dramatically low viral levels after taking one shot? seriously - what changed?
thanks, there certainly are a few here that have very small minded motives. I guess i don't understand how someone considers it a living by deceiving others.
See what? seriously - how can you predict doom for others with no explanation? You have posted here for a long time and been a valuable asset to us and now you just feel the SP is going th $.0001 with no explanation?
I just don't understand the change in tune, what has changed in CYDY to make you go from optimistic to so negative? pro140 is the same and progressing forward and the mgmt has not changed at all. Is it that we have not gotten PR about the enrollment?
What does that mean? who are "they"? i'm not criticizing your post - just want to understand.
Thanks for the post - I changed my mind about Nader mostly because it is of no purpose to punish when the future is so close. I have always been a supporter but it has been difficult given the paycheck and lack of insider buying. But the truth is where we are now is largely due to Nader's hard work.
For the annual meeting I'm looking at each of the items and in the past i have always voted with the board recommendations. However i am a little torn over re-electing Nader - i have been a supporter of what he has done to get us here but in the last year he has really shown the limits of his ability. I find it difficult to see his compensation and the # of shares he has with no real buying of shares with his own money. Maybe his usefulness to the company is done? Or, is it just disruptive to replace him at this point? It would really be great if he put his money where his mouth is. I'm also curious about this item:
5. Approval of a proposal to amend the Company’s Certificate of Incorporation to eliminate a provision that permits the removal of the Company’s directors only with cause;
What is this about? I really don't understand some of these items that portray this is a long term employment for the CYDY mgmt - they should be planning a short career involving the company being sold!
I don't think so - it is just an approval for the board to continue to have that as an option. I have never heard much desire by CYDY to do a RS, they have always stressed an organic uplist.
I don't think the word "desperate" is really how you should look at it. the whole reason they are doing raises is because they have bills to pay - such as clinical trials. we are in the midst of spending the money they said they would need to conduct the trials. this is good because if they were not raising funds they would presumably not have many patients enrolled and therefore less cost. Of course it would be nice if the raises were at a higher SP!
Thanks for your post, this is a difficult process and path. Pro 140 will get there but the risk in small biotechs always keeps the lid on stock price until the risk of failure is alleviated.
I'm not saying your wrong, however things are moving forward. I'm not to interested in judging management as much as I'm interested in pro140 getting to the point of getting this bought out.
so, what is important to you is keeping score of exact deadline dates and ability to read into what a lack of PR means? I would rather focus on pro140 moving forward and achieving development milestones. At the end of the day we want pro 140 to be worth as much as possible as soon as possible, we are moving in the right direction and getting worked up over days and wording is really unimportant. It also shows that multiple posts about what is meant in a lack of information is easily solved by making one phone call.
I just talked with IR at CYDY about the enrollment in the combo trial and Jody told me that they are very close and there will be a PR when it is fully enrolled. It sounds to me they have everyone and will continue to enroll more just in-case they need more. I guess they do not want to PR until everyone is actually injected and the clock can start ticking on getting the primary endpoint data, which should be PR'd in july as well. Jody mentioned that it just takes a little time to for patient's schedules to get them to the testing sites to be injected. So, we are meeting this milestone and everything is on track!
interesting article:
https://www.yahoo.com/news/threat-hiv-business-spooks-glaxosmithkline-shares-091910034--finance.html
i Like the last sentence:
"Antiretroviral therapy has turned HIV from a death sentence into a manageable condition but patients need to stay on the treatment for life, so there is a growing focus on making medication as convenient and well-tolerated as possible."
I agree, Nader has been a positive over the years but in the situation we are in it seems odd that the biggest cheerleader has the largest paycheck and has not bought shares in any large way with their own money. Given he was the one to create the "golden quarter" which resulted in a sell off and new lows in SP one would think a PR about how he cut or eliminated his paycheck and bought shares in support of CYDY would be appropriate. It would show how close we are to a major move upwards in SP and that a salary at this point is not where the money is for himself. It would help in the monthly burn rate and show some respect to us investors about reducing the dilution needed to fund trials. On the other hand Nader's salary is not a major cost and is not going to really affect the multiple CYDY has in the near future. It may also be more disruptive to see a shake up in upper mgmt with not much explanation. the focus is and should be on trial results, not saving nickels at he cost of dollars
why do you put "both trials" in quotes? are you inferring something else? As for time lines i will say that it will take what it takes, predicting the future is just a game of maybe guessing right and likely being wrong to some degree. I am an active options trader and generally i start my day by saying "I don't know the future and neither does anyone else". It really cuts out the distracting opinions in my own head that really are based on a guess or a "feeling".
We do know patients are being injected in both trials, there are no bad results and only good news so far. We also know there really are no other HIV treatments in phase 3 and that there is a growing # of HIV patients in the world. We know it is a multi billion dollar market and CYDY is a less than $100mil company, the multiples with all the dilution is a tremendous opportunity no matter what your cost basis is.
your just plain flat wrong. pro 140 works all by itself, it has been all along. the criteria of finding patients that have failing haart so they can test pro140 along with SOC that are also ccr5 is a narrow criteria. Finding patients that have no failure but want to try pro140 alone is a large population. Also, before you start thinking because the combo trial is difficult to find patients that that means the market is tiny - that is not true. Once approved the patient and doctor decide if pro140 is added in replacement for one of the haart drugs for what ever reason. You keep commenting that the current haart is effective and there is no reason to need pro140 is really missing the point. current haart WILL fail in every patient in the future. current haart does have profound side effects. pro 140 solves both of those issues. If you think for one second that a better product will never succeed in its market you are simply lacking any understanding of basic business.
I have confidence that it will be shortly after q2 that we will get data from a fully enrolled combo trial. cydy just can't afford to put made up deadlines and blow through them as was done for the "golden" quarter. I have heard nothing but confirmation that they are on track. The difference between Nader and Tony is simply that Tony has a much more realistic and conservative personality. In the conf call there was no selling us on a rainbows and unicorn future. It was much more "here is where we are and what we are doing" attitude. I think Nader's golden quarter comment was the last straw in a string of over-selling the possibilities. I do support Nader for stepping in when the company was basically lights out but getting him focused on a specific job role was the best thing for his talents. Either way, I did not invest to be a cheerleader for any employee, I invested in the treatment and the potential multiple achievable in this multi billion market.
I agree, there is some milestone agreed on between CYDY and a partner that is penciled in. It will be in ink once that criteria is met. I don't doubt that it is before an actual data announcement, but since the primary endpoint is blinded i would think that when CYDY mgmt has the data from the 30 patients and a few of the mono trial that will get this done. the confidence by everyone at CYDY is obvious - they don't doubt the data and they are not worried about getting a deal done in the near future, like in the next 4-6 weeks.
I don't think anyone would spend over $1 mil of their personal money just to create a "insider buying" news event. Tony i'm sure wants to make money on this and the fact he paid a premium over the current SP and the fact he knows more than we do tells me all is good.
Wow, i guess Tony is putting his money where his mouth is. no doubts now! The fact he paid $.75 for a $.58 stock and warrents @ $1.35 says it all.