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Broker57. I know you came in through a Paulson raise 3-4 years back. That means your shares and warrant rights are at .65 or .75. With your highly negative level of confidence in management why don't you sell in the 70's, make yourself whole, keep your warrants and move on. IMO it is highly unlikely we will see a new management team replace Nader. Why put yourself through the angst of being invested knowing Pro-140 will never make it to the finish line.
Buckysherm, you answered your question. Not enough time to be of any significant value in 2017. Look at the time it has taken to get Pro-140 where it is today with two P3's in play and we still have no takers because more data is needed. The value of the indications mentioned are not what BP will be paying for. They want what they perceive as sufficient data to insure FDA Approval. P3's are the acid test and even as effective as Pro-140 appears in the previous trials we are not home yet.
I'm in for 450k shares and my DD tells me Pro-140 is going to shine in both Adjunct and Mono. Nader and people like Dr. Paul Maddon are absolutely convinced on the efficacy and safety. I just really believe this is the real deal and has a very high probability of disrupting the current SOC. At the very least it will be approved for Adjunct. As we all know Mono single agent is the prize and Nader has a pathway that first requires a successful Adjunct P3. I think they believe that is a slam dunk.
Nader and the major shareholders will take the money and run at anything close to the 4 Billion $ number - $15 per share. To have a chance of getting that number it's going to take stellar Adjunct P3 data combined with strong interim P3 Mono data and AA. Bigger numbers than this have us deeper into 2018 - This all IMO.
The primary investors that raised the money to buy Pro-140 from Progenics in 2012 and put Nader in the power seat showed me the story four years ago - they will jump at 4 Billion / $15. That's a long ways from .70. Let's not get too greedy. I mean with all that has transpired over the last four years and all the hidden land mines even $10 per share sounds really good.
I hope you dreamers are right but I just can't see anything North of $15 unless we are willing to go down the development trail deep into 2018 needing everything go our way. I personally don't want to add an additional year of uncertainty hoping management can get it done - especially in that uncharted territory.
So my question to you is what is an acceptable bid for Pro-140 given the P3 Adjunct data is compelling? Lets go a step further and say interim P3 Mono data is clean. I know nobody knows but we all have our valuations. Just wondering what you are thinking.
pearsby09,
Thank you for your insight - I couldn't agree more.
You are right on with the Rolling BLA and the advantages over an NDA. Nader is without question focused on creating the scenario you outlined. And yes interim Mono data is going to push the envelope hard in Gilead's face as it will be clear that Pro-140 is threatening SOC and dangerously close to FDA Approval. IMO BP generally doesn't move until they have to - when that tipping point will come to fruition is the Billion $ question.
Welcome to the board and keep your opinions coming.
Jboatswain, You clearly understand the complexity of the double edged sword an OTC Biotech faces to make it to the finish line- the FDA gauntlet and SP manipulation. Did you flush HTBX and move on? What is your investment strategy with CYDY?
5TOP, Sticky if you'd like. Agree on all fronts. There will be selling pressure from warrant holders all the way up.
To convert warrants to shares you have to notify Cytodyn and pay them. Then they will issue the shares. Can take up to two weeks to complete process from start to finish. And you are right the lag time discourages exercising with tight margins because the SP could drop significantly.
I do think warrant holders will be a little more greedy in terms of exercising because they have the ability to wait until they expire. Obviously when you get down to the last year the greed will disappear and your scenario will play out. Personally I'm going the distance - buyout. That is unless the story changes.
I like what I see and I'm careful what I post. The delay in 2016 hurt but it was for good reason. Reduction from 300 to 30 for Adjunct was worth it. It's time to get the Adjunct fully enrolled and fast track enrollment in the Monotherapy. The data will deliver the SP we all know is Lurking. Many, like you have been here a long time. I'm pushing four years - what's one more year.
I'm not sure. My first private investment was Oct 2013. So they expire Oct 2018. I'm sure there are some out there that expire in 2017.
For the record NOBODY is exercising warrants at the current SP. The warrants are in the red and have 5 year expiration from the date of the private raise. Nobody in their right mind would pay .75 to convert warrants to shares until they are profitable. What is happening is the shares that were purchased to gain the rights to the warrants are being dumped even at a slight loss and the warrants are being retained. Not everyone chooses to dump their shares. I for one have been through three private raises and have kept all my shares in addition to the warrants.
Example:
Purchase 100k shares at .75 in private raise. For that investment you are awarded 50k warrants that can be converted to shares at a cost of .75 per share within a 5 year window. So it's simple for the Warrant players. They find deals where they can pile up warrants at no cost or even a gain by selling their shares to recover their investment.
For the moment the open market investors are eating the Warrant players zero risk play. The good news is when approval and commercialization becomes more certain the game will flip flop and there will many more buyers than sellers. In addition warrant convertion will ramp up because of the positive gap between warrant price and SP. At that point CYDY will be reaping .75 (or $1.00 for some of the warrants) for every warrant converted. I don't know exactly how many warrants are out there but it is in excess of 50 million.
I find it very hard to believe that with what is in the pipeline that we will not see this cycle change in 2017.
123boom, all I can tell you is Nader was more pissed about that raise than any investor. They needed the money and the timing was horrible. If we were to sit in on the discussions and alternatives that were being considered we would have done the same thing. Nader said they will never do a raise at that price again. That being said, talk is cheap - you have work to do and timelines to meet. GET IT DONE.
Broker57,
You make it all sound so simple. Get rid of Nader and we are off to the races with an increase in SP and FDA approval. The fact is none of us are privy to the changing demands the FDA presents. The protocol for the Adjunct is quite restrictive. If it wasn't for Nader negotiating from 300 patients to 30 we'd most likely would have run out of time and $'s before fully enrolling the Trial.
"As we are enrolling people into the Cytodyn PRO140 study, one has experienced resistance in 2 of the 5 classes of current available HIV medications. And one MUST have at least 2 remaining medications that are still fully active".
For all the details relating to the protocol check out: https://clinicaltrials.gov/ct2/show/NCT02483078
Instead of being hung out to dry we will hit primary endpoint Q1 2017 for Adjunct and begin Mono this month - and the Mono trial will enroll in a flash because the protocol is much less restrictive and Charlie is talking it up creating a waiting list. That calls for his head???
My point is the current SP is independent of what is taking place with the advancement of Pro-140. If we fail to make that distinction, angst gets the better of our judgement and perception because everybody is under water with the current SP. Warrant backed raises apply short term downward pressure but are the best alternative to raise $'s. Unfortunately the shares that are purchased to obtain the warrant rights are dumped by most participants that are strictly limiting their exposure to very little or zero. That is why Nader will not do a reverse split. The SP would be devoured by the warrant holders still holding shares and will ultimately screw the investor that has real skin in the game.
Nader is not going to focus on short term SP - his primary goal is to get Pro-140 approved and challenge SOC within the BP HIV space creating leverage for a major multi-billion $ buyout. The fact is Nader is quite competent and will not be distracted from the task at hand.
He understands Adjunct approval is a stepping stone, a gateway to the big dance. Monotherapy is where Pro-140 can turn the HIV space upside down. I'm not interested in going backwards for a short term attempt to increase SP.
Maxim is a Computer driven Bottom Feeder. Like a raccoon once they find food they are relentless even when there is no food to be found.
Lol Energy. Need to break this out over a buck and make good on timelines that de-risk Pro-140. Hanging under a buck is like an endless hangover.
Execution is the juice needed here. Adjunct enrollment completed and Mono Trial1st patient injected are at the top of the list. Should likely get Mono news before 2017. Bottom line is Pro-140 will not be taken seriously by BP or institutions until approval appears to be a given. There is No question as to the efficacy and safety of Pro-140. Regardless the FDA is the gatekeeper that decides how many hoops to jump through and they seem to be supportive. 2017 will answer those questions. Not that long to wait after being in for nearly four years.
No conference call tomorrow. Nader is presenting at LD Micro Main Event at 2:00pm. The question is will there be any new updates - Adjunct enrollment completed, first patient injected Mono Trial, or ODD.
Right in picking a winner was my point. $2-$3 - No. $10 minimum depending on how far down the road we are at time of buyout. I like the way 2017 is looking. With Charlie getting more vocal there's going to be an overflow of patients for enrollment in the Mono Trial.
Going to be one helluva payday. I'm in for 450k shares. Hope your Dubai guru is on target again.
How many shares are you up to now? Sounds like you surpassed 500k shares.
I agree Amateur17. It is important to meet the timelines that have been committed to. 1st patient enrolled in Mono Investigational Trial Q4 2016 is one such commitment . According to Nader this Trial will be much easier to enroll and will fill rapidly. If that's the case he damn well better enroll the first patient before the end of the year.
I have to believe that Nader realizes how important it is to hit the timelines he has committed to. If he slips and there are more delays the next raise will not be at the $2 SP he is anticipating and the SP will sink further. The feeling I get from many on this board is a lack of confidence that Nader can execute on the business side. We are going to find out in the next six months.
Yes JBEM, my mistake.
Thank you for your opinions on 2017 - I agree. BP will buy before CYDY begins monetizing. I think approval P3 Adjunct plus interim P3 Mono results will get us close to the tipping point. You are also on target with faster enrollment with P3 Mono. After a long delay on enrollment with the P3 Adjunct investors will be taken by surprise at how fast enrollment goes with Mono - Less complicated to find qualified patients.
JPG77,
I respect your opinions and the way you think. You put together a powerful DD piece when you originally got on board and many that follow you did the same leading to our 52 week high. Obviously we have had a few delays that have lengthened timelines . I will say protocol reducing patients from 300 to 30 has shortened what could have been a very long P3 Adjunct Trial.
IMO an updated DD analysis would be of great value. I know that is no small task but your the person that can pull it all together.
If nothing else your thoughts on 2017 would be appreciated??
I like your thought process 5TOP. Many questions come to mind as to our inability to complete enrollment considering Pro-140's benefits in terms of efficacy and zero side effects. IMO P3 Adjuct protocol was more complicated and restrictive than we understand as investors not privi to the facts. We may very well be on the cusp of very good news in terms of enrollment on both Adjuct and Mono P3's given the FDA's willingness to support Pro-140's approval path.
5TOP is correct. Nobody is selling warrants. The last raise was a purchase of shares at .75 with warrants at 1.00. The selling pressure is the unloading of the .75 shares even at a loss to control warrants at no risk. How many .75 shares are still out there is speculation.
Remember there are many that invested in past private raises at .65 and .75 shares with warrants priced at .75. I have participated in 3 private raises and still own all my shares and I know many investors that are in the same position . The point is not everybody unloads their shares in favor of just owning warrants. When the SP moves up its unknown how many investors may change there strategy and possibly sell their .75 shares in favor of just holding warrants.
IMO the current SP is not an accurate market cap valuation with the catalysts we have on the horizon. The math is clear - when the warrants are considerably in the black say at a $2 SP some will exercise and the company will receive the warrant price creating cash flow for the company - and future raises will be positively impacted.
Nader needs to hit the timelines he has set out. The data is going to be strong but delays are going to give us more of the same - a SP that tests our patience.
Q1-Q2 2017 going to tell the story.
5TOP, I think the reason Pro-140 MAB is being held to ARV standards is because it is attempting to disrupt the SOC for HIV. This is a big market that affects millions of lives that is being challenged. As much as BP is not supposed to have influence or leverage over the FDA - they do. With $10 Billion plus in jeopardy Gilead will not go quietly. The results are so powerful they just need to be proven - especially in terms of safety. It seems we are close however the FDA makes me nervous because they have a way of continually lengthening the approval process - the bright spot is they seem to be expediting the process for the Pro-140 cause at the moment. I hope this behavior continues. 2017 will tell the story.
Let's get real here. Make no mistake there areTwo reasons why the SP languishes in the mid .60's.
1- Already been stated clearly. Private raises are keeping a lid on SP. Nearly 100% of the shares purchased at .75 are being sold and will continue to be sold until they are gone at a loss of approx. .10 per share. Owning a pile of warrants that have zero risk with huge upside at .10 per share is a bargain to those that play this game. In regards to the next raise not going to happen before the end of Q1. Nader wants end point in P3 Adjunct met before raising more money and there is enough in the bank to get us there.
2- Pro-140 has not garnered the volume of data needed to convince BP or the investment community. P2b with 40 patients no matter how good the data is, is not sufficient. The data coming in the next 4-6 months may radically change that perspective and create the tipping point we are waiting for. Hitting timelines and producing data that shortens the FDA approval runway is the SP mover. At this point the runway looks long to many investors.
With the performance of Pro-140 it is aggravating to be in a waiting game. Welcome to the FDA process. Average nearly $2 Billion and 10 years to get to the finish line. I'd say Nader is doing a pretty good job. From my perspective I hate the current SP but I'm really bullish on our prospects in 2017.
If they had an offer that made economic sense I believe they would sell. The tipping point has not arrived yet and will not until Pro-140 is further de-risked. Need to be further down the FDA path-its coming, hope you stick around for the ride.
broker57 I understand your frustration with the SP. What I don't understand is how you would push Pro-140 over the finish line differently.
What tools does Nader have to suppress the dynamics of a private raise with warrants. I have talked with Nader directly and he dislikes the low SP as much as anyone. They monitor the liquidation of the shares purchased through the private raises and clearly see the repetition every time the shares can be legally sold under rule 144.
The only way to push Pro-140 over the finish line is by completing the clinical trials that are on the table with convincing data. My focus is on Nader hitting the time lines he has laid out. A RS is the other tool and he is not willing to use it at this juncture and for good reason. Without perfectly timed breaking news to back up the RS it will cost shareholders dearly and not result in an uplist.
All IMO of course. I would like to know what I am missing from your perspective.
I for one am very impressed with Nader's ability to navigate the FDA. I think we have to understand the magnitude of Monotherapy and how big of a play that is. There is a reason why HART has controlled the SOC in the HIV space - it's complex and multi faceted which creates a significant barrier. The Monotherapy path is like taking on Goliath and Nader knows it is unattainable without first successfully completing the Combo P3.
Bottom line is there is every reason to believe that Pro-140 will continue to deliver in terms of efficacy and safety. Endpoint P3 Combo Q1 2017 is going to happen and at that juncture we will have a clear read on Mono enrollment. Word is that Mono will be a simple straight forward patient enrollment process with an abundance of eager patients.
I like Nader's priorities - focus on clear communication with the FDA to insure the path to approval and ultimately monetization. SP will take care of itself as the data becomes more concrete. Proof in this space is an arduous process and Nader is actually expediting the process. If he hadn't reduced the patient load in the Combo P3 from 300 to 30 the path would be much, much longer. The private raises create immense pressure on the SP because of the risk free warrants - it's pure economics. There is NOTHING Nader can do to offset that dynamic other than focus on exactly what he is doing.
When the consensus turns from pessimism to OMG Pro-140 is gong to make it to the finish line BP is will be scrambling to make a deal and the Longs are going to laugh all the way to the bank. We will have our day.
Let the wine age, it's going to be much more valuable and pleasing to the palate.
Yes
The purpose of this luncheon is to clarify where Pro-140 is from a clinical standpoint. I think there is much confusion among investors as to exactly what the current situation is. Most importantly an opportunity for investors to ask questions. I wish I could be there but unfortunately I couldn't make that happen. I am suggesting to Nader that it would be powerful to have this broadcast on FB Live. Don't know if they will use that platform or any other for that matter. My intuition tells me this will not be broadcast in any form. I do know someone that will attend. If I have further details I will post.
Nader and Mulholland will discuss clinical developments
Nov. 7
Portland, Or.
Portland Airport Embassy Suites at 11am
To attend rsvp via email at tmelchoir@cytodyn.com
Shane Chowdhury...don't feel alone I've got an equall amount of skin in the game. Opportunities like this don't come along often. You only do life one time and watching is not for me.
Haha! Lol Goldenisla.
Misiu, reduction in number of weeks would be like granting an informal approval. You are right in the sweet spot of what Nader is hoping for and anticipating. Conduct study on large patient population by enrolling rapidly on the coat tails of stellar data from the Adjunct. Disclose overwhelming positive interim Mono data. FDA says your done-that's enough proof.
You can bet BP and specifically Gilead will be watching closely after Adjunct knowing the ticking time bomb is the Mono Trial. Do they wait until the Mono Trial is complete and the FDA approves? This is the hand Nader is going to play IMO.
Once again he is 100% confident in the safety and efficacy of Pro-140. That is why he is focused on these milestones and not concerned about SP. I know many will disagree but it is also why he will not proceed with a reverse split- he doesn't have to and if he did he would run the risk of seriously watering down the shareholders ROI Unless it was timed perfectly. He's simply not willing to risk that at this point in the process. I for one agree with his logic.
Excellent observation Buckysherm. Yes it is possible but I think Adjunct completes enrollment first and Mono shortly thereafter. Once efficacy becomes clear with no safety issues to speak of enrollment for the Mono Trial is likely to enroll in a flash.
The way I see it:
Mono injects first patient this year.
Adjunct completes enrollment Q1 2017.
Adjunct results are 5-10 fold better than protocol requirements in terms of viral load suppression for meeting efficacy.
Those results are going to expedite the enrollment of the balance of patients left to filll the Mono Trial and it will close quickly.
It is quite possible both trials could be fully enrolled by April of 2017.
There has been speculation about the number of patients in the Mono Trial. My understanding is Nader wants 300 patients because he wants the numbers to hammer home the safety and effectiveness of Pro-140 to the FDA, BP, and the HIV community-a small number of patients isn't going to get it done. Mono treatment is the the big play and he understands it's not a cake walk to disrupt and replace SOC. If this goes according to plan BP will be "trying"to cut a deal Q2-Q3 2017.
Understand enrollment was halted when Nader negotiated with FDA to lower patients from 300 to 150 to 30 for the Adjunct. Enrollment is now moving and will be completed no later than Q1 2017. We can also expect first patient injected for Mono this year. There are reasons why we are where we are. I know we lost time in terms of enrollment however moving from 300 to 30 patients was worth the wait. The path is clear now and we are going to see an acceleration in terms of enrollment for both trials. I think Nader believes when the efficacy data comes in on the Adjunct in terms of suppression of viral load it's going to turn some BP heads and especially the many people that are longing for a better solution to the current SOC. Remember that is one week after last patient injected in the AdjunctvTrial. The Mono trail will have patients beating the door down to get in. Seriously they could enroll 300 patients in The Mono Trial a month or two after the Adjunct Enrollment is completed. Things are much more positive than we know right now.
I can understand the frustration and speculation here. However I believe Nader is doing a much better job than meets the eye. It's patience that is needed here.
IMO Nader will make good on his commitment for completing enrollment Q1 2017 (January, February or March, 2017) and announce primary endpoints. The data will blow away the viral load bars for efficacy that the FDA has set in this study. The game is going to be in full swing by Q2 of 2017 as the reality of Pro-140 being a threat in the Mono space is ratcheted up - hello Gilead.
Be assured the current SP is all about the liquidation of cheap shares from the last institutional private raise, and yes the institutions are dumping their shares and close to liquidating their positions. They are satisfied with their warrants even at a 5-10% loss. That is their business.
Sometimes we as human beings speculate and dream up stories and outcomes that are based on our emotions not reality. The reality is Pro-140 is disruptive and Nader and his team know it. They are also in the know and seeing real time developments that we are not privy to. Let's see where we are by the end of Q1 2017. I think we are going to feel much better about our investment in the near future.
That's the plan Amatuer17.
The fact is we all thought we would be further along at this point in time. We can ill afford more enrollment delays. Get it done so the data can move the needle. Very frustrating to be in the dark but that's where we are. Hope Nader can deliver the news we are looking for in terms of enrollment for Xmas.
So we agree on all fronts TheBioTechG.
I too have stated many times my #1 concern is completion of enrollment of the Combo Trial and injection of first patient Mono Trial. IMO the SP is indicative of investor confidence in completing enrollment. Nader's justification was the face to face with the FDA to reduce # of patients from 300 to 150 to 30. The issue is enrollment was frozen while that was negotiated. We lost over a year but could argue we now have gained it back because the decrease from 300 to 30 was hopefully worth that year when enrollment would have continued. The other hurdle is 300 patients is still required for safety data although the FDA is likely to cut that number down if interim data is really strong.
All and all this is a case of investors seeing timelines delayed. Delays are like poison with an investment like this in terms of SP. Add the cumulation of all the shares that were purchased at .75 over the last 3 years through the private offerings and shares are going to be dumped and the warrants retained. The first raise I participated in was at .65 and warrants at .75. That was oversubscribed so we all got cut back. I believe it was 14 million shares and 7 million warrants. Like you said announce the last patient injected Combo and first patient injected Mono and things will change. Things will really change if the Mono Trial enrolls rapidly. I'm not concerned about the results just getting these trials enrolled. Your right about patience...if you don't have a lot of it get out. I'm long and staying until this company is purchased.
IMO the pressure on the SP is directly related to the private raises.
If an investor can sell all their shares and recover their investment and hold the warrants with close to zero risk many will do so. As Chumppunk states "I'm protecting your account and could care less what is ahead". Just eliminate or minimize exposure for your client.
I have participated in several private raises with Paulson Investments and that strategy was discussed. It was tempting as I could have made a profit many times over the last three years and still retained the warrants with zero risk. I think that is the way most play the game. Personally I have enough confidence in this investment that I want the shares from the raises in addition to the warrants so I have retained all of my shares. The difference is this is not my day job and how I pay my bills but to many it is and that's how they play the game. Eliminate risk.
So I don't believe there is something we are missing. That is the doubt that creeps into our minds when we get nervous about our investment - we look for reasons to support the illogical SP. Most of the private money is in at .75 per share with warrants equal to 50% of the total shares purchased good for 5 years. So I do agree with Broker57 it makes little sense to be selling below .75. However selling at .65 is a loss of .10 per share while maintaining control of warrants- that may not be free but the cost is minimal in terms of the cost of your investment.
Example: You purchase 100K shares on the private raise for .75 per share at $75K. In return you get 50K warrants. If you sell the 100K shares at .65 you are negative $10k but you control 50K warrants. That is still a deal many will take. $10K in total risk for 50K warrants. If the deal blows up you loose very little compared to those that purchase on the open market. This is the game that has been going on for some time because of all the cheap shares that are available from the private raises. Most have a 6 month hold to convert to sellable shares so there is a delay on the impact of the private raises on SP. When the cheap shares dry up the equation will change.
Nader is going to do everything he can to prevent another raise below $2. He's counting on some big milestones coming to fruition in the next 6 months. Milestones that will heavily impact the likelihood of FDA Approval.