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BTD would seem to be a certainty and we could have that before CROI. It seems the majority on this board are in agreement that the P3 Adjunct Combo Trial results are going to garner FDA Approval for our first label. Most of the debate has surrounded the probability of a successful P3 Mono Trial. The consensus is we don't make that far before a buyout and P3 Mono approval is a long shot-I don't agree. The people in the know tell me BP does not move until they have to. So the question is, is Adjunct Combo approval enough to move BP and what is the price tag with the P3 Mono in process. That seems to be the poker game that is in the making.
Sip it your on the short list.
The insatiable need to be right has many tells. Some people are starving to be understood, some are seeking to understand. We all have a scale on how we weigh the opinions that are posted by the different participants. No opinion here is going to change the destiny of Pro-140 no matter how smart somebody thinks they are. I for one am looking forward to one helluva party this year and I know who is on my guest list.
D, are you sure we have an extra 3 million over the Q report that runs through Nov. 30? I thought the 3 million was raised in Sept. I guess I was mistaken. If your right that would take us into May which is big. An extra 1.5 months of burn at this stage in the game is very important info.
You heard it straight from the horses mouth. "Little Birdies are Absolute". Would love to close the book on this investment this year with a buyout- been a long haul. Keep speculating Sip it. It is my hope you and Wallstreet are prophets.
Thanks for your transparency Sip it. I'm always open to logical speculation. There are so many ways to connect the dots. I have participated in three private raises - the guys that brought in Nader and financed the transition from Progenics showed me the story four years ago. They are whales compared to my 450k shares. I know Nader has not been happy having to raise at .75 and said that would be the last raise under $2. With the burn rate at $2M per month, CROI or a major catalyst needs to kick in soon… or your speculated handshake deal needs to happen- otherwise they will need to do another raise at a sub $2 offering.
So maybe you are right, they may not even plan on raising anymore $'s because of what you say. They also are able to raise $'s almost overnight with consistency and they do it in small increments. To me that translates to a major tipping point that could come any day. Also WallStreetSTTA is talking up his absolute birdies and proclaiming a major move in the near term. At first I gave him zero credibility but I have to say he has a ton of experience and followers and been spot on consistently. If the data from the P3 Adjunct is clean and I mean every patient continuing on the extension study it would seem a buyout would happen at this juncture and perhaps sooner. Can't imagine GILD waiting through the P3 Mono because the price tag will be crazy big if it were to receive FDA approval.
Pro-140 is gaining traction with the high probability of BTD and Adjunct Approval- thus positioning Pro-140 for the major prize – Mono Therapy. Keep your speculation coming. IMO we shall all soon know our fate as the conclusion to this compelling story is upon us in 2017.
Grip it, how is GILD supporting Nader financially? I am well aware of CYDY's BOD's connection with GILD. The SP has been hovering at the warrant and private raise purchase price because that's the way the game works. BTD and a clean Adjunct P3 will create urgency for GILD because they don't want to get stuck paying the Mono price tag. Is your theory based on prior experience,factual information or just pure speculation?
Exactly- Fortunately Pro-140 has performed exactly as we would have hoped. Holding my breath that his Viral Load stays in check for a very, very, very long time.
Yes, I agree with your take on the demographics of those that comment. My personal opinion in reference to Charlie is you were out of control and made some hefty mistakes...and your paying for those mistakes more than the public realizes. I don't need my pound of flesh. If Pro-140 works I'm not going to discount it because I don't like the individual that is benefiting. The issue here is do I (the public) trust or believe Charlie after all his poor choices in addition to his recent goat milk escapade in Mexico. The exposure is a plus-just not what it could be as we would benefit at a much higher level from another highly visible celeb with a more respectful and trustworthy image- hence Magic Johnson.
If you want to get a picture of the public's perception of Charlie Sheen read the comments on the Yahoo coverage - it would be a big boost if a Magic Johnson or another respected high visibility celebrity came on board. The only thing good about Charlie is that everybody knows who he is...and that's also the bad news because everybody knows what kind of life he has led. Regardless the fact that there were over 150 comments tells you the exposure Pro-140 received from this interview. Interesting the comments were all in reference to the viewers disdain for Charlie's lifestyle - not one comment on his life changing treatment. Most made it clear they would be pleased if he were 10 feet under. Not being negative here...it all adds up to exposure and that is a really good thing.
Charlie cranked it up on Pro-140. Pro-140 has saved my life and it is very close to approval. Basically said that HAART and all the toxic pills is no way to live. I am part of something very big and I'm going to be around in 10 years. He made it sound like Pro-140 is going to transform SOC. Very positive because he opened the interview with the emphasis on Pro-140.
Your story about your son is powerful. As a father of 2 sons and 2 grand children your post makes me realize the weight that can be lifted from the hearts of families that are haunted with HIV. Thank you for making my day:))
How long has your son been on Pro-140?
This is just the start we needed for 2017 Misiu. It is quite possible we will be grated BTD prior to CROI. What other developments will be unveiled at CROI? I believe we are nearing the tipping point.
Peasby09 you are walking a thin line by calling Misiu out. Keep up your know it all posturing and you will have everybody on this board placing you on ignore. I for one invite opinion. There was nothing respectful about your post. Clean it up.
Pearsby09 you are so caught up in the details you are unable to see the forest through the trees. Over analyzing is going to talk you right out of the best investment you ever made. You are very knowledgeable but that may not be an advantage here. We have a saying in business that when a person knows too much they have a propensity to become ineffective because they sit on the fence unable to commit. It's not that your insights are invalid it's the persuit of what you are missing or we are missing. It's all there...your not missing anything except an extraordinary opportunity.
Pearsby09- NOT a low probability. This is a self fulfilling prophecy- I understand Murphy's law but you can't dwell there. You did your DD now trust it.
Not talking seven years. CYDY story and strategy is different than PCYC. Point is the SP can change rapidly with news that solidifies real value. We have major catalysts and milestones on the table this year. As we clear the hurdles the SP will move and a buyout is not going to be offered with our SP sitting at .70. A buyout will occur when the SP is moving. We could see CYDY move from .70 to $5 over the course of a couple of months and then the buyout that corresponds with a 150-200% offer meaning $7.5-$10 per share. This is a REAL possibility. Problem is many feel this is where we should be today. I'm making the case that we are exactly where the real risk and value is of Pro-140 measured by the so called experts. Do they understand the story at my level or yours or many others here on this borad -- I think NOT.
Thank You Misiu. I view you as a visionary too:)))
CYDY is not going to run from .70 to $5-$10 in one move. Look at PCYC. March 24, 2008 closed at .65. Today $257 – who had the courage or instinct to hold all the way up to today or even until it hit $100 per share? Not me as I would have been happy or convinced that $20-$30 was too much to pass up or at least sell the majority of my position.
There are catalysts and events that have to be achieved one step at a time. The fact that there are several of these events that have to fall in favor of Pro-140 adds up to a risk factor that is viewed by the investment community and BP as a long shot. As the barriers are removed and the pathway for FDA approval becomes increasingly tangible the SP will move upwards because the risk factors are now perceived as manageable and de-risked to a probable level that favors successful completion- we have more road to travel. CYDY will organically up-list when the data forces a shift in perception or what I call the tipping point. A R/S at this moment would not deliver the intended result because there is not enough belief in the data to foundationally support the SP- the market wants more proof that Pro-140 is the real deal.
All this focus on SP is a disconnect between the perception on this board and investors that understand the story at an in-depth level versus the rest of the investment community that views CYDY through a completely different lens. It seems most of us (myself included) are trying to make sense of the current SP and our perceived value- it doesn't compute. In reality it does compute and it's not because of Nader's lack of business degrees or business experience. This is a function of supply and demand, pure economics that represent the broad statistical risk level of where we are right now as a biotech penny stock. We (posters and followers on this board) are part of the small minority in terms of perceived value at this juncture but that doesn't mean we are wrong in our value assessment or diminish the story and likelihood of Pro-140 making it to the finish line.
I signed up for a 10-20 bagger- to many that means I am a dreamer; to me it means I am a visionary. My key to success as an entrepreneur and business owner is to trust my vision and not get distracted by all the external noise being made by the herd. Pearsby09 you are at times part of that noise.
My feeling is that Nader is shifting from over promising to allowing some breathing room to possibly beat some timelines. Maybe this will be a case in point. Regardless very positive events right around the corner.
Very possible...my guess is that we are a buyout at $8-$10 range. Not the number many are looking for on this board but I think realistically that is where we are unless we hold on deep into 2018 and final data from Mono P3. That values Pro-140 at $2-2.5 Billion. I hope I'm wrong and it is much higher. Speculation is what it is- speculation.
Great move by Nader to clear up any confusion as to what the strategy is for 2017. My take is this isn't going to move until Adjunct Primary endpoint is completed. At that juncture BTD approval would be instrumental in expediting the BLA process and significantly moving the SP.
It seems that the FDA is doing everything they can to expedite the approval process of Pro-140 -the data just needs to continue to support efficacy and safety. IMO the Adjunct Combo is a slam dunk. With all of the players in the same room at CROI it would be huge if the Adjunct Primary Endpoint was breaking news to turn some heads. That may be wishful thinking but not impossible.
There is a reason why the Shiek owns 9M shares- Gilead will have to pony up at some point. My guess is they may well make there move when they see that the Adjunct Combo pathway is a done deal. I don't think they want to wait and pay the Mono price tag. Nader gets it- Complete enrollment in both P3's and let the main event begin. I'd not sleep well going in and out of this stock. The flippers and shorts are going to get burned at some point. Can't wait for the day this opens huge- Ka-Ching. Makes me tremble just thinking about it. Our day is coming my friends!
Wallstreet hope your birdies are as absolute as they were when they called the SP dropping to .65 - they come through again on the retirement call and I'm gonna be following these birdies everywhere they go.
When Nader is quiet and off the grid it generally means good news. We shall see very soon. And yes what is it about the first time posters that post doubt--it's all part of the BIG game. Fear & Greed makes the world go round.
That is true. However past data shows that the chances of that are close to zero.
I agree with much of your perspective Amatuer17.
2016 brought up many question marks regarding Nader’s ability to execute. Starting with what appeared to be a major stumble on the enrollment of the Adjunct P3. It would seem ridiculous that Nader couldn't enroll 30 patients long ago. Is it as simple as that or is there more variables that we are not considering.
Think it through – It became clear to Nader and the board early on that the P3 Adjunct protocol was quite restrictive and the timeline to enroll 300 qualified patients was less than ideal. So, Nader had a choice; spend valuable time renegotiating the protocol with the FDA or go ahead with recruiting 300 patients. Nader along with the consensus of the board opted for a meeting with the FDA. At that juncture recruitment was halted because the Face to Face meetings with the FDA was a review of the entire protocol not just number of patients. I honestly think that Nader and his board, i.e. Maddon and Burger viewed the existing protocol and 300 patient requirements as a deal breaker. What appears to be a lack of execution on Nader’s watch may have been a very wise decision.
So here we are and all eyes are on Nader because 2016 is viewed by many investors as a lost year filled with delays and no progress. The monetary and emotional cost - $25 million in burn and a SP that reflects a year of no new data. Data is what will move the needle and we are now on the cusp of producing such data. Some want Nader out, some have him on a very short leash, others on the inside have total trust because they have all the cards on the table.
To me it is not about Nader’s credentials, it’s do I think he can deliver. One of the most critical factors that will determine the strength of the P3 Adjunct and Mono data is accurate selection and screening to insure enrollment of qualified patients. If we race to the finish line compromising this process it will cost much more than a delay it will cost us our investment. My conversations with Nader indicate unequivocally he has his life invested in Pro-140 and is utilizing the board and KOL’s to make the tough decisions. Reasoning that a person’s credentials are such or because a person hasn’t done it before is a poor reason to assume a person can’t. Character and drive are equally important and Nader has those qualities.
My eyes are on enrollment status and enrollment completion for both P3’s. The science has never been a question mark for me- so produce the data. This is Nader’s complete focus and he will be judged critically in the coming months as to the progress. Let’s not lose sight of how far we have come and how close we are.
Thanks to all for the contributions - your opinions and knowledge are for the most part invaluable. It is my hope that 2017 be one of accelerated progress that clears the path for Pro-140 to improve the lives of those that struggle with HIV.
Happy New Year!
For all the "know it all posters" slamming Nader's experience and qualifications tell me;
What are your qualifications and experience? Are your opinions really based on experience and real knowledge or emotional attachment to the current SP of just plain emotion. All I here is a lot of panic and noise related to SP. The majority of the talk calling for Nader's head is coming from our new posters that are now the experts looking for traction. Objective awareness is imperative. That is not what is going on here. It's called the blame game.
I'm not buying it-- at this point there is NO focus by the board to replace Nader and there won't be unless he fails to hit timelines in the first half of 2017--then that conversation may have relevance. For now it's negative energy trying to find a home.
Broker57. You are entitled to your opinions. Redundancy of the same opinion is called a broker record. I mean a broken record. Take your opinion to the board but don't use this forum as that platform.
Do us all a favor and take a brake until you have something new to contribute.
Couldn't agree with Wallstreet more.
Lawman, just wondering how long you have been invested in CYDY and how much skin you have in the game? I would presume it is large with the size of your opinions.
Like Gestalt I know the background of Nader's story and how far we have come in the last two years- it hasn't been perfect. However, we are close to the finish line and you seem to think we are wandering aimlessly and have no chance of finishing because Nader is in uncharted territory. If you think it's easy to hire a proven replacement that can deliver Pro-140 to the finish line you are mistaken. If you were right Nader would have been replaced long ago. Arm chair quarterback's are a dime a dozen.
I agree on the importance of hitting timelines. IMO make good on full enrollment on both P3's by end of Q1 2017 - the data will determine Pro-140s destiny and value by the end of 2017.
Getting further bogged down on either P3 with delays will be a huge red flag as to Nader's competency. This is a make it or break it year for this company. Cannot afford to raise $'s with an eroding SP.
P3 Mono quick but not going to fully enroll 300 patients in 2016. Adjunct P3 not quick but only 30 patients. What I heard Nader say is full enrollment and primary endpoint as early as Q1 2017 for Adjunct. He lumps enrollment and primary endpoint together because primary endpoint is one week after enrollment is completed.
Primary endpoint is only one week after full enrollment.
I would have thought so also. The reality is the private raises that combine warrants with shares are keeping a lid on the SP. Just seems to be no end in willing sellers that own shares purchased at .75. It seems Nader is thinking positive data on the Adjunct is coming Q1 and hopefully news that the Mono has been fully enrolled. It would seem that this is his thinking because the last raise was just enough to get through Q1.
Yes. Lots of tension right now because everybody is under water. We shall see very soon if he is up to the task.
5TOP you are so right. Pro-140 was originally positioned as a drug holiday away from the current cocktail. Cytodyn was hoping for a $1 Billion BO. The P2b changed that thinking. Here we are with much higher expectations - we shall see. Great post.
BP is not going to give our Adjunct play the valuation that many CYDY investors may believe. Doesn't mean BP will dismiss Pro-140, but keep in mind it will be one piece of a multi drug cocktail. It's not like Pro-140 can lay claim as the magic bullet when it is being utilized in combination.
My sources tell me interest in Adjuct is minimal and that it's all about Mono therapy with BP. The bottom line is if Pro-140 can stand on its own as a single agent treatment and gain FDA approval for that label Gilead is forced to move. Disrupting SOC is a bold move and Nader is convinced they have the goods. Adjunct is the first piece of the puzzle that MUST fall into place - the value of Pro-140 as a combination treatment is whatever BP is willing to pay-could be zero or up to $1-$2 billion. A current .70 SP speaks volumes on the anticipated valuation of Adjunct. I hope I'm wrong but hopefully it won't matter because the P3 Mono Trial will deliver stellar results.
IMO, yes Adjuct is likely in the bag but that will result in a BO below1 Billion, in the $3 per share range. It would be nice insurance even at $3 a share if P3 Mono results are disappointing. I mean $3 is better than zero and that is the risk factor in an OTC Biotech - absolutely zero.
Going forward I have to believe Nader (not Nadar) has resolved the patient screening issues they experienced with the P2b trial. To risk inaccurate screening with the 300 patient P3 300 Mono would be a fatal mistake. If Nader has this resolved things are going to get very interesting as the data comes in. We will leave .70 and the OTC in our rear view mirrors and this chapter will be a forgotten nightmare.
Between all of the cheap shares that are acquired through the private raises that are in endless supply, OTC manipulation and trading restraints, and some unanswered questions regarding the data it's simple- we are where we are for a reason. We have not been de-risked to a level that gets BP to turn their chair around -- ever watched "The Voice". All we need is one chair to turn to validate. It's a big chair to get turned but when it turns others will follow.
Where's Wallstreet and his "little birdies"? Time for some chirping come January.
I agree pearsby09... a huge win. However IMO we need more data to move BP. The 300 patient P3 Mono trial interim data is what BP will pay attention to. That could fully enroll before P3 Adjunct Primary endpoint is achieved meaning that data could be available by the end of Q3 2017.
So far there is nothing that tells me that the data will be anything but disruptive to the HIV space. There is a tipping point in here somewhere in terms of data - wish I had a crystal ball, so instead I will hurry up and wait.
Thank you Pearsby09! You summed up the positive events nicely. Even the Partridge in a Pear Tree.
Nader is pushing hard on the FDA path and knows he just needs to let the data do the talking by completing enrollment as fast as possible. Problem is people's emotions get the best of them with the depressed SP and headhunting becomes the answer. If Nader is unable to move the SP in 2017 with clean data I will be looking to support a house cleaning. For now let it play out. I really like your scenario to clean house - a buyout...love it.
What evidence do you have that supports a real possibility of a change in management soon?