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Misiu, common sense is my montra. I'm well informed and stay grounded. If the story changes I will be heart broken. At this point other than the normal expanding time line of a biotech, I'm extremely confidant because the science continues to warrant crossing the goal line. I look forward to discussing this journey in person.
The next news will be:
August: Combo PE Data. Hopefully strong with many going on to extension that have completed the trial.
September: Face to face with FDA either granting or denying BTD. BLA pathway will also be defined.
Other positives to come from FDA face to face could be expanded label to increase patient population beyond Combo. This is enormous as it would increase immediate market value.
After face to face with FDA the pathway to approval and monetization will be defined. If everything goes right we could see an organic rise in SP to avoid a R/S.
Management believes after those events is the most opportune time to go for a major raise. The positive driving Pro-140 is the absence of ANY bad news. As long as the trials continue to reflect strong efficacy and a stellar safety record we will cross the goal line. The FDA will control the timeline with their decision regarding BTD which will impact the speed at which we proceed.
The next couple of months are going to tell the story.
Take it or leave it. Believe it or not. All IMHO. I hope I covered the disclaimers.
IMO Combo enrollment over enrolled and more than 30 injected. Combo enrollment completion will not be PR'd. Company has their reasons. If we were in their shoes we would agree.
IMO Every effort will be made to PR Combo PE data prior to August 25 meeting. That is in everyone's best interests.
IMO Company expects meeting PE and no safety issues. Key will be how many patients continue on extension study.
IMO Face to face with FDA coming up in September to discuss BLA submission and granting of BTD. Other topic on the table is to open consideration for expanding Combo label to increase patient population. This will dictate how rapidly Pro-140 will move down the approval pathway. Ultimately the likelihood of approval and market value will be more clearly defined.
IMO This sets the stage for attracting a partnership or buy-out and either organic uplist or R/S. The bottom line is CYDY is going to do everything possible to uplist Q4. The OTC is depressing SP and with where Pro-140 is in development it's time to go all in.
Because of all that is in the pipeline and that we as shareholders are not privy to I will vote yes on all items including R/S. Either we trust Tony C and his team or you don't. If you don't it makes little sense to be invested at this point in the game.
Well said trding.
I expressed the same opinion and was not alone as many shareholders felt a PR on completed enrollment would be a positive for all the reasons you stated.
Some at the company view enrollment completion as a non event. IMO there is only upside with this type of PR. In the big picture end game it will not matter.
6-8 $'s pre R/S. I am no fan of a R/S however getting off the OTC is something the company views as a must by the end of this year. I'm just communicating what I believe the company is thinking and also their current valuation barometer. All this is obviously subject to change as we move forward.
For example if Pro-140 goes all the way through FDA approval as a single agent the valuation will be much higher. The company does not see that happening meaning a buy out much earlier in the process.
There are many moving parts here but once again it's all about completing enrollment and letting the empirical data decide Pro-140's fate. It really is that simple. We are going to get there and yes there will be more dilution, we just don't know how much and what the cost will be at this point in time.
All this adds up to those that want in are already in. Those that are in a wait and see are doing just that...we are all waiting on the news.
Seems we are always on the same page BH.
Grip, I appreciate the respect and your demeanor on this board.
Management is concerned with one thing only right now. Complete enrollment in both Combo and Mono and let the empirical data decide Pro-140's fate. This Combo Trial has been a bitch to enroll as these patients are very sick and need a lot of hand holding. Mono is a completely different animal - enrollment is a slam dunk by years end at latest.
They are very confident as to the strength of the data in both Combo and Mono - why wouldn't they be? Unless you listen to Pears which I give zero credibility.
They know the holy grail is riding on Mono. It's pedal to the medal to enroll when Mono when Combo enrollment is completed.
They are not concerned with raising the $'s needed to complete both trials. There is plenty of interest as this investment continues to be de-risked.
BTD will be viable once Combo PE and safety data is made available to FDA. The pathway to approval will then be clear.
The trials will soon be on a time clock because once enrollment is complete the clock starts. That defines dates on when data will be available.
Tony C and Dr. Burger are well seasoned with the landscape that we are traversing. Speaking of Dr. Burger he thinks we have an ace in the hole with GVHD. We could see a deal in this space this year.
They are going to R/S if we don't get an organic uplist this year. They feel we have to get off the OTC and open the gates to institutions. They feel that there is enough good news to support an R/S if that is the case.
They would not take $5 per share at this moment in time. Tony C's goal is to maximize shareholder value and sell this company within the next 12 months.
What the SP does day to day is meaningless until Combo PE data is released. That is the defining moment that will start the momentum.
I believe the data is going to be strong in both trials and CYDY will be purchased no later than this time next year in the $6-$8 range.
I've waited for this point in time for Four years. I'm ready for the last chapter. I'm not a day trader I'm an investor that stays close to the story. I like this board because I like to know what people are thinking. My main observation is speculation is just that.
Either you believe in the science and Tony C' competence or you don't. I do.
All IMHO.
Grip, you are playing with fire if you want to increase your position and you are waiting on a possibility of such a minimal correction.
Here is the wild card. My discussions with the company have revealed a noncommittal position regarding if they will PR when enrollment has been completed for Combo. What we do know is the compiling of the data will take up to four weeks before it will be PR'd. So what we do not know is where we are in this process. It could be that they are condensing data right now or it could be that enrollment is not quite complete.
My point is if they do not PR completion of enrollment you are going to get the Combo results without warning and if PE is accomplished the SP is moving forward period and you are going to kick yourself over a greedy strategy.
How much the SP will move is the million $ question.
Fred, the $5 million in debt can also be converted to shares at .75 plus 50% warrants @ $1. Is that not case? That would seem to be the more likely scenario as the SP in January should make that more attractive then recovering the $5 million plus 7%.
Agreed they do have some security in their investment if things don't work out favorably. I do know the consensus at this moment is the company would not take $5 per share buy out at this moment. I think these investors are planning on converting and making a very nice return within the next year.
Thoughts?
There will be no volume or movement in SP until news is released. The question is how will the market react to successful PE data combined with positive safety data. Will the FDA then grant BTD?
Does CYDY get a mild round of applause or a standing ovation or somewhere in between.
It may take completing Mono enrollment and then interim data to get the standing ovation.
GVHD is the other sleeper that may trigger a partnership.
While it is oh so very quiet many milestones are at our finger tips that will tell the story. IMHO CYDY will be purchased within the next 12 months.
The debate inside the company is do they PR both last patient injected and PE data or just PE data. The thinking is PE is a significant milestone and last patient injected is not. I have not heard a commitment to PR last patient injected other than michelinvests post per Jody's email.
Many shareholders have strongly encouraged a PR for both milestones directly to management. I think they understand the pros and cons better than we do so I trust they will make the right call. IMO, in the long run it will make no difference. Short term however it will establish a time line and confidence with momentum leading up to PE Data.
If we don't get a PR soon I will assume they have opted for PR'ing PE Data only.
Fred, you are on the money with your comments.
The strategy is to see how the market reacts to Combo PE results and if the FDA based on those results will grant BTD. If that goes favorably along with expected rapid enrollment of the P3 Mono we may have an organic uplist. All of these variables will dictate the timing and size of the next major raise.
I don't expect Combo PE results until August. As of last week they were in the process of injecting the last two patients.
IMO the fate of Pro-140 is fast approaching and the end game is in sight.
Very accurate post tonysd57. Agree with all you stated.
Tony C has the experience to get a deal done. It's going to happen- the only question is how much. IMHO $5-$8 per share buyout within 3-10 months
Your information is meaningless Pears. Your simply uninformed. Spin it any way you want. Your uninformed and that is a fact.
BD, the pipeline of info will begin to be released this summer and Pears is going to be left sucking his thumb. By years end he will be in a mental institution.
Been paying attention but nothing of value to contribute.
I trust my relationships and am confident of where we are at this moment. All this noise about missing the Q2 timeline and how management is incompetent is nonsense. I have more confidence than ever in Tony and his team which stretches far further than five employees. Things are going to get quite interesting in the coming weeks and moths.
They are hoping to get a big bump in SP over the next couple of months by hitting milestones and releasing strong data. Also may be looking at a GVHD partnership. They want to uplist on the Nasdaq which means a $4 SP. They feel they have to get this opened up to institutions sooner than later. They believe with where they are in terms of a positive pipeline of news the SP will hold if they go ahead with a R/S.
Personally a R/S makes me nervous. On the other hand if I knew all the cards they are holding I might see it differently.
Yes, Lawman I like the way things are going. Tony is confident, experienced, capable, and looking at the end game. We are fortunate to have him at the controls to negotiate. He's familiar and well seasoned with the landscape. I'm ready to see this come to fruition in the next 12 months.
Agree 100%. Perspective is important. Yours is quite clear as it aligns with the way I see it. What I don't understand is why people stay in an investment when they see so many risk factors that paint a negative perspective. If I thought this was going to end badly because we have such a poor management team I would be out in a second.
I have taken the time to build a relationship with the Tony and his team to gain insight into the stability of this investment and probability for success. Without that relationship I would have many concerns. Fact is as you said "Tony and his team are more than capable and the science is strong" and that sums it up. All the micro details cloud the direction and velocity this incredible story is moving at. As Tony has said, the fun is about to begin. He knows the empirical evidence will dictate Pro-140's fate.
Couldn't agree more BH. From my perspective we are on time...we are so very close. I guess people are not able to deal with the reality of this investment.
If people sell in the next couple weeks because there is no PR that is risky to say the least. Personally it makes little difference to me, but yes there could be a buying opportunity or it could continue to run.
Amateur,
You should know last patient injected is something they cannot control to the day. I have spoken with the company about this milestone and it is a six week process after a patient agrees and can take longer. They knew they had more than enough patients six weeks ago but that it could go a week or two over the Q2 timeline. They weren't even thinking of PR'ing until they had the PE data which takes four weeks to compile. I strongly suggested that it was important to PR last patient injected and many shareholders have voiced the same opinion to the company.
Bottom line is you are premature in your finger pointing. As Grip said quarter isn't over until the end of today. At this point if you know it's a week or two into July what is the big deal. I'm sure this will fire Pears up and he will make a case along some of the other bashers that this Trial will never find 30 patients. People are just uniformed as to the reality of what is going on.
Not being negative Tony. The Gilead buy out is all speculative. On the topic of manufacturing Pro-140. It is expensive and complex.
Thanks Hyper, As I do for you and many others here.
I will say my conversations with Nader over the years indicated we would be bought out Q1 of 2017. I will believe a buy out when it is officially PR'd.
My sources tell me it may take some more de-risking before we get that long awaited PR. I have waited this long so I will remain patient with the perspective that longer means more $'s.
And for the record nobody knows for sure what Gileadis thinking. The one thing is for sure is that Gilead will not prevent Pro-140 from making it to market. When I said self the product, that would be Gilead's reason for buying at this moment. They are not going to pay in excess of a Billion $'s to shelf Pro-140. I do believe they would like to see Pro-140 go away.
BD, I totally understand your logic... that was my take.
That is until I heard it from people that have been inside. I can't name sources but this is somebody who gets it in a big way. I came back with much of the same response you did. Take it for what it's worth but it seems Gilead doesn't want to have to retool and would buy out Pro-140 to shelf rather than develop at these stages of the game. The reality of BP is it's all about money, not improving people's lives first.
Now on the other hand if Pro-140 nears the finish line and appears to be a genuine threat perhaps Gilead will be forced to change their tune. To read between the lines this is what I think the reality is. Gilead will not buy out Pro-140 on the timeline that CYDY is looking for - prior to approval. They will sit and wait and if somebody else can bring it to market they will pay more if they have to. Pro-140 is definitely going to be a buy-out target but maybe not by the obvious BP players.
This is obviously IMHO.
Delayed enrollment is what sent the SP into the toilet. The word is out that enrollment is no longer an issue consequently the pathway to data, BTD, BLA and approval is clearing.
Most that follow the science of Pro-140 are very confident on the efficacy and safety. IMO this is all about the data from this point forward. Tony C is experienced with the turf that must be negotiated to find a suitor and cut a deal - that is his primary function and without his expertise I would be concerned.
Having been in this four years and been through disappointment in delays and a SP that made me puke it appears we are coming down the home stretch and the only thing that can stop Pro-140 is negative data. I got in because of the science, many here got in because of the science, Tony C came out of retirement because of the science, Dr. Berger and many others at the company are in it for the science. They know a whole lot more than I do about the science as many here on this board. Everything including Mono will soon be on a time clock as enrollment is completed. This is going to get very interesting with a hopeful up-list late this year or early 2018.
I loaded up with shares and warrants on three occasions and purchased on the open market. I'm betting the science is going to be worth at least a Billion $ and possibly a whole lot more if we wait for Mono and GVHD. I simply can't see Pro-140 being worthless. Projecting value is all about how far CYDY takes Pro-140 and GVHD down the approval path. The other half of the equation is what BP is willing to pay. My sources tell me Gilead would like to see Pro-140 go away and they will not move unless forced to. It will be interesting to see how long it will take in the de-risking process before a bidder will step up. It will only take one for Tony C to engage in the fun he is salvating over.
COMPANY videos related to testimonials cannot be released until Pro-140 is approved.
Thanks for correcting Bucky...spot on.
Grip, the bottom line there is nothing but good news, great news, and really great news on the horizon. The company knows it and it is leaking out. Delayed timelines are going to be a thing of the past as Combo is filled in the next week or so and Mono will run ahead of schedule filling the 300 patients before the end of the year. The data will speak for itself. With the PE data and safety data BTD is in sight.
CYDY is primed to run.
Pears, your going to eat your words in the very near future. You obviously have no clue as to what is going on.
I need to add to my last post that many including myself has urged the company to PR when enrollment has been completed. They company feels the only real news is the announcement of the data. I think completing enrollment is worthy of a PR for two reasons. First it all it removes the delay cloud and installs confidence in management and secondly it starts the clock ticking towards a definite date for the disclosure of data.
It's quite simple. PE Data from Combo Trial takes 4 weeks to compile. Announcing enrollment completed isn't going to move the SP much but it will start the clock ticking towards a known date in which the PE Data will be disclosed. That 4 week window will be the time for many on the sidelines and new investors to place there bets although most will wait for the news. It resembles reporting quarterly earnings and what the whisper is. The amount of $ raised makes perfect sense. They are very confident about the PE Data. They know the SP will increase. Nobody knows how much. They do know regardless they will be in a stronger position at that point to take on a larger raise.
Bucky, They are right there. Might be first week in July or even second. They may or may not PR when enrollment is complete meaning 30th patient injected. Then 4 weeks to compile data for PE which is the major PR. Many have advised management to PR both milestones.
We are all learning here. Nobody is an expert however some are wiser and more experienced than others.
Watching SP makes some more nervous than others. There are many moving parts here and nothing is an absolute given.
I like the way things are coming into form and I believe in the science and the team in place.
I can understand why you would ask that question "michelinvests". How do I know? I either get close to the know or I'm out. Boards are mostly about speculation - when the speculation is off base in relationship to the facts I feel a need to inform. I have often thought of vanishing from this board because it has no impact on the outcome of this investment. I post as a service, because I care, and for the most part gain value.
As an investor you have a choice as to who or what you want to believe. I have no agenda here other than the reality of what is transpiring. Some have referred to me as part of the cheerleader fraternity - believe me I am no cheerleader - I actually adhere to Murphy's Law - "if something can go wrong it will". As expected things have gone wrong at times. I measure the impact and significance of what has gone wrong - only stumble has been miscalculation on managements part regarding enrollment. That has been corrected and the data will soon be unveiled.
Most here have integrity, compassion, and respect for their fellow posters while adding value with their unbiased insights - that is attractive and educational. Inspiring people has been the focal point within my lifelong career. I build relationships and pursue the truth with a vengeance. That is my contribution here.
Misiu, I admire your compassion and priorities. Number one the HIV sufferers need a better solution and Pro-140 is on the cusp of offering an alternative to a cocktail that is toxic.
The word is traveling within the HIV community that Pro-140 is doing amazing things. The videos of the testimonials of patients tearfully expressing the impact on their lives can't be viewed or released but the word is getting out. The Mono Trial is going to enroll so rapidly even the most optimistic will be surprised. I am most excited about clearing enrollment as the major hurdle. Bottom line is that will be behind us very soon and it will be all about the data.
I have no doubt that Pro-140 will gain approval in the Mono space. That's a big statement but the view from the company is they have the goods. As Tony said "the data will tell the story" The ultimate value will be determined by the adoption rate of the medical community. The road is long but journey is rewarding in many ways. This investment is not for the impatient.
In my very strong opinion:
Combo Trial will completely enroll within a week of Q2 2017. PE data will be out four weeks later. Data will be clean.
P3 Mono will fully enroll all 300 patients prior to the end of the year.
GVHD in play for partnership and/or licensing deal later this year possibly sooner.
Bottom line is this is going to heat up in a big way the second half of this year.
Ask yourself...do you think the data will be strong?
Completing enrollment has been the biggest set back with CYDY. That set back is on the verge of being history.
Mark this post and ignore the naysayer(s).
It's always 5:00pm somewhere.
All I can say BH is a big thumbs up. Nice to know the majority here are of sound mind and quite informed. One bad apple ain't spoiling the bunch here.