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Hope you feel better 123. Not knowing what’s going on is what I would liken to solitary confinement. Our minds create scenarios that are not reality. I like what I hear and I trust the man in charge. As Lawman said Tony is in and so is most of his family. He isn’t doing this for a paycheck as I don’t think he is even drawing a salary.
This is about winning with a drug that he is certain works, is safe, and has a market. The most important factor to be determined this year is how broad the label will be which will determine the buyout price.
Hang in there.
No low blow intended 123. Just felt your posts were a bit sloppy and out of character.
So we can disagree on Tony’s experience and ability to get up listed and to a buy out. I believe he will get both accomplished once Combo PE is met and you are not so sure. Fair enough.
Understand the implications of locking the data prematurely before getting the FDA’s consent in terms of having the correct subset of patients or some other minor detail that could create a bigger delay. The procedure is complex and that is why Nader is taking a back seat. Tony has been there and done it many times. He’s not a people pleaser he’s an operations guy that understands successfully advancing these Trials is paramount as everything is reliant on the data. There is a strategic plan in place but without successful Combo PE it’s all for not. What seems to be incompetence in the form of delays is actually the exercising of competence and experience to confirm they are on the same page as the FDA. We don’t get briefed on the details so we draw our own uninformed conclusions. There is so much going on that will not be communicated. Smart people such as Tony have solid reasons for the decisions they make and we the retail investor is not going to be informed every step of the way or as much as we think we deserve. Like it or not that’s the way it is. Either you trust and believe in Tony’s competence or you don’t. I for one could not hold a position if I did not.
As for how long? I honestly believe this is going to wrap some time in 2018. It’s game on after Combo PE is met. I expect that PR the end of February. Until then it’s a waiting game which will bring out the demons in many with skin in the game.
123, If you had this conversation relating to your last two posts with our so called incompetent, overpaid new CEO who would be serving slushie’s if not for a superstar drug you would get your head handed to you as to your incompetence and total lack of understanding. You obviously know very little about Tony’s track record, experience or reason for taking on this project. You really should understand who you are talking down to. By the way Tony C is the Executive Chairman not the CEO - that title was retained Nader.
Depends on the label. The thinking is first meet Combo PE. Then look at Interim Mono data and if strong enough meet with FDA and make the case to convert Trial from investigational to pivotal P3 and go for expanded label. This is where this investment can gain serious traction and attract multiple suitors. Not that far away.
Scoot, you are a breath of fresh air in terms of the reality of where this investment sits. Reading your post gives me no reason to post.
$12 per share. Figure 300 million shares divided by $3.6 Billion.
Tonysd57, we all have our agenda in terms of what we would like management to focus on in terms of closing this out. The reality is it’s not about any individual investor. My opinion is Tony will maximize ROI for the shareholder by drawing on his knowledge and experience with Gilead and play the poker game in the wisest way possible. He understands the HIV space both from a product standpoint as well as how BP is analyzing the strength of Pro-140. Im sure the pressure he gets from major investors to take $2-$3 a share and call it a day is overwhelmIng. Management knows what they have and it’s game on. The data will dictate how strong the hand is played. We are in a waiting game for the moment but strategy has to be in place depending on the strength of the data- in my mind that’s exactly where we are.
There is much to speculate on Gestalt. Bottom line is getting to the data. Institutions want to see the meat and then have the ability to pull the trigger. That is not a possibility on the OTC. That’s the way management sees it. If a suitor is waiting in the wings none of this matters. Management is moving in a direction that indicates they currently don’t have a reasonable suitor and it will take Mono data to maximize shareholder ROI. Many heavy investors want to see a deal now because they are fatigued like many here. IMHO Tony is going to push this hard and I for one am not interested in going cheaply after five years of being in the game. AIMHO.
IMO the warrants that are at $1 and above are likely to be converted if the SP moves above $1 on Combo PE PR.
The key is for the company to keep the tender offer at .50 open through this milestone. The fact is the majority of warrants are at .75 and that’s only a .25 savings or gain. I know personally I will convert my $1.35 warrants on this scenario but not my .75 warrants.
So the question is how much cash will realistically be raised through this tender offer if left open through the Combo PE PR? It would seem it will be dependent on the impact this PR has on SP. IMO the SP will have to be significantly North of $1 to put the .75 warrants in play. It would be a huge boost financially if the SP rises high enough to flush all the warrants - $25 million. I think this is wishful thinking.
My gut tells me we have a big raise coming the end of Q1- I hope I’m wrong.
I’m with you Tony. Not a fan of R/S.
The fact is management feels the best way to maximize shareholder ROI is to attract institutional investment. The OTC in their mind isn’t going to get the job done. They were hoping to uplist organically but that appears unlikely regardless of the immediate milestones - ie meeting Combo PE, Mono investigational Data, and GVHD update.
It’s time to fish or cut bait. I believe management is going to move with a R/S, major raise, and uplist to Nasdaq on the upcoming Combo PE PR.
AIMHO if course.
All IMHO
Delays are the nature of this investment. Would one prefer that Tony get wreckless and prematurely lock the CD02 Combo Trial? How would you like to find out management missed crossing a "t" or dotting an "i" and another six months has been added to the trial. There is by the way the future of our investment riding on meeting Combo PE. This is why Tony is calling the shots - he has been there on the operational side and understands the many pitfalls and details.
FWIW this is the way I see 2018 playing out:
By the end of January Combo enrollment completion PR'd. Keep in mind they need a cushion of at least five patients before locking the trial. That means 55 patients.
By the end of February Combo PE PR'd.
The Jan. 26 tender offer on converting warrants at .50 will be extended through the Combo PE PR. They need to clean the Cap table up as much as possible to uplist.
By the end of March R/S, major raise, uplist to Nasdaq.
March/April meeting with FDA to discuss Mono trial investigational data. There are two arms in this investigational trial. 350ml dosing and 525ml dosing. If 70% plus efficacy can be shown then CYDY KOL's will make the case for converting the investigational trial to a pivotal P3 trial. In addition discuss expanding combo label. This is where the reality of Pro-140's value will be defined. Will Pro-140 be one of many combo alternatives or threaten SOC in the mono space? Is this a $500 million dollar drug or a multi billion $ drug?
Rumor has it the 10th patient has been enrolled in GVHD. That may not sound like a big deal however it is a milestone in terms of reviewing the efficacy and safety data and another plus for PR-140.
From what I can understand this is managements strategy. Most likely game over by the end of 2018. If PE is met no one is going to be a bag holder. Meeting PE insure value at some level. So what is a month or two this way or that when we are in the final stages. IMO it's all going to conclude very soon.
I have been in for five years and am tired of waiting...just want to move on with this investment. I for one am going to enjoy the last chapter and look forward to personally meeting the many posters that have contributed so much valuable perspective and insight. I think it's going to all be worth it.
Couldn’t agree more Lawman. You got it right.
Absolutely. Getting to 70% efficacy is the major focus. Increasing dose is hopefully going to get us the necessary cushion. Also identifying common ground of those patients that rebound. 70% efficacy and this is a grand slam.
Positive N=50 PE may not attract an immediate suitor however positive Mono Interim at a 70% clip combined with Combo sure as hell will. The bottom line Pears is Pro-140 is much more valuable within the Combo space then you argue. Pro-140 will be acquired at some valuation and you are at the complete opposite end of the spectrum compared to the majority. Yes you are entitled to your opinion, the disconnect is how redundant and overstated your opinion is. But hey keep on posting so we can all keep clarifying the obvious.
Yes hey need $. Combo PE is the first event to get the ball rolling. Wait and then wait some more - nothing happens until Combo PE is completed and PR’d.
IMO you are correct in terms of your interpretation of the IDMC PR.
As for a buyer waiting in the wings contingent on meeting Combo PE that is possible. Personally I think they are preparing for a R/S, uplist to Nasdaq, and a major raise once N=50 Combo PE is completed. I would hope we get the Combo PR the later half of January to get the ball rolling for the final stretch.
That is a fact wshaw14. The company will do what it must to raise funds. All I care about is getting this to the finish line with the least amount of expensive diluting as possible.
Have a great Christmas!
I think you are mistaken that there is a strong pool of buyers at .50 on another placement without a breakout in SP. Keep in mind the last few placements were flops in terms of interest and were therefore terminated long before fully subscribing. There. Another placement with 50% warrants is also stacking up more warrants that further dilute...much more than raising funds through the tender offer. Perhaps the company is thinking as you are but the ability to raise funds with the Paulson gig is drying up and they know it.
“The offer will be terminated just before the news is announced IMHO”
I don’t see how your above statement is going to happen. The news is needed to spring the SP to entice warrant holders to convert. The Tender Offer is a non event without news.
On another note IMO the company thought the last PR regarding Interim analysis by the IDMC would have provided a nice bump in SP. Obviously it did not because very few read the news as definitive in terms of meeting Combo PE. So an extension on the Tender Offer to Jan. 26. My thinking is they will keep the door open and see what happens regarding SP with N=50 Combo PE announcement and pull the offer if/when the SP breaks $1.
Personally, the company’s decision to close or keep the door open on the Tender Offer is not at the top of my list even though I own warrants from three different placements. Seeing the SP breakout on positive Combo PE news is. The tough part of this investment is the warrants that seem to put a lid on the SP regardless of news. That is why I think they would be foolish not flush them all if given the opportunity. JMO of course.
IMO the company is going to make the warrant tender offer available on a day to day basis and will quite likely terminate if SP rises to over $1.
I have made my opinion known to the company that I think they would be foolish not to keep the offer on the table regardless of how high the SP goes. Flushing ALL of the warrants at .50 would be the healthiest financial event for both shareholders and the company as we move towards an uplist to the Nasdaq.
The Jan. 26 deadline may or may not have any significance. It would make logical sense that they intend to PR N=50 Combo PE prior to that date. It also may be a date that is used because they have to have an expiration date if for no other reason than to have one.
Pears, you are nuts. Tweaking???? Seriously. You’ve lost all credibility. The trial is blinded. How and why in the #%^# would the company be tweaking the data. I’ll translate what the IDMC is saying, complete the study and it’s a done deal.
Excellent. Thanks for posting. ART will not be SOC forever.
AIMHO Pears. That is my deduction from the IDMC PR.
Because that would be violating the FDA’s power as the final say. The obvious is not finality...it’s not over until it’s over, but in all logic it is done. The real news is the obvious was not interpreted by the market so we shall wait for the final N=50 Combo PR.
Melt it down and the company knows Pro-140 works and is safe. What is it worth in the Combo space? That is where our investment lies until Mono efficacy is revealed.
That is exactly the status Pennies.
Warrant holders are looking for a SP and volume that makes economic sense to convert. Maybe N=50 Combo PE. I’m sure the .50 warrant convert opportunity will be available when that news is PR’d.
That is exactly the situation. Interim was the catalyst but the company was unable to state the obvious in the Interim PR. Meeting Combo PE is all but a foregone conclusion, however investors didn’t interpret the PR that way.
Pears, we were not an experienced company. That is why Tony was asked to step in with his high level experience at Gilead. Nader was making statements about timelines he couldn’t back up because he was in uncharted waters. The trial itself was/is in uncharted waters for both Pro-140 and the FDA. Both sides learned and made adjustments as the glitches in the protocol were revealed as the trial progressed - hence 300 to 150 to 30 and back to 50 patients. BP would have completed this Trial six months ago because of resources and experience. Gilead is playing their poker hand saying you got nothing - come back later and maybe we will throw you a bone - hoping Pro-140 drys up and goes away. Tony C is the reason why I’m in - he knows Milligan’s agenda and style and that he will not moved unless forced. Tony’s job is to derisk Pro-140 through the clinical process and proceed with the BLA checklist to create shareholder value and apply the heat to attract the first suitor.
On another front the protocol for the Combo Trial has nothing to do with the patient population Pro-140 will have access to. Seriously Pears you know better if you have all the experience you say you have in this space. Pro-140 is going to have its day with an established company that will utilize it as it should be - a much better alternative than the current cocktail.
The big picture is first get through the Combo Trial because the FDA says you want a shot at Mono first things first. So here we are on the cusp of clearing that hurdle to get to the meat which is a successful Mono Trial that gets a green light at 70% efficacy.
I understand your Murphy’s law conundrum - If shit can go wrong it most likely will. If it is overwhelming I’m out. That’s what I don’t get about you- why do you stay in with such little hope. IMO the Pro-140 glass is half full at the very least.
What I mean is the limited resources CYDY has vs BP.
Your spot on BD. The number if patients they are having to screen would blow you away. It really is that difficult to find qualified patients. I know Pears feels regardless it should have been enrolled long ago. It really is that complex and also add into the mix the limited resources that BP would have to ramp up the screening process. This was/is a very difficult trial to enroll. Good news is IMO company already know Combo PE is done. Just need the FDA to put its stamp on it.
I think we missed the actual meaning and outcome of the IDMC Interim Combo PR.
“Independent Data Monitoring Committee Recommends Continuation of CytoDyn’s PRO 140 Pivotal Combination Therapy Trial as Planned Without Modifications to Achieve Primary Endpoint”
The fact is there were only three conclusions that could have been reached by the IDMC.
1- Discontinue Trial
2- Amend the Trial
3- Continue as is
Pro-140 got the best result that was possible and I believe N=50 Combo PE is a done deal they just can’t say so because that would be out of line with the FDA. The FDA said 50 patients so they get 50 regardless of the N=40 Interim Combo PE Data.
Terminating the trial at 40 patients was not an option regardless of how convincing the data was to the IDMC. The company was never given the green light to unblind other than to the independent Doctors. The above PR was the max the company could say without crossing the line with the FDA which gets final say.
This is a big event but it does not come across as one because of the procedure that has to be adhered to with respect to the FDA. I think the company thought this was going to be a major news event but because there hands were tied in terms of what they could say it was not.
The issue as always is time. How long until they can get 50 patients and end this charade. When they have the 50th patient enrolled it will take five more weeks to PR N=50 Combo PE.
The good news is the company now knows they have a drug that works in Combo and has had zero SAE’s to date other than a couple of site injection issues. So IMO Tony is diligently working on the BLA checklist. His expertise with Gilead was building out the manufacturing platform for new drugs. This needs to be done to increase valuation for a buy out.
I think we can expect a R/S and uplist when N=50 Combo PE is announced. The Interim Mono data will be the first news to come after the uplist. It’s bye bye OTC, hello Nasdaq some time in Q1 2018. Time to open this science up to the investment world.
The company isn’t offering to buy anything. They have reduced the convertible price on 51 million existing warrants to .50 with Dec. 22 as the deadline although they reserve the right to extend the date. This would raise approx. $25 million.
Fair enough Pears.
Pears, are you two different people? While most of the time you are predictable now and then you are predictably unpredictable.
Many here think as you do.
Mono is the big kahuna. If the Mono Trial shows a success rate North of 70% Pro-140 is going to the highest bidder before completion of the trial
Asking what the SP is anybody’s opinion. Personally if Mono Interim shows that efficacy will be met I think it’s game over and we could see as high as $15 per share. That puts the valuation at roughly $4-$5 Billion. Some here will say I’m too optimistic while others will say I’m too low.
All IMO of course.
Personally I think any PR on Mono Interim will be after Combo PE. We are once again waiting for Combo PE which I don’t expect until late January. Combo has been a knock down drag out Bitch of a trial to enroll. Closing in on the finish line...dare I say.
The strength of the news is important- more important is the movement in SP. For me to get serious SP has to be above $1 and heading North.
Yes, I am aware of that transaction and that Tony is very confident. The thinking is if Combo PE is met that will assure Pro-140 as a winner in the $2-$3 per share minimum range with Mono and GVHD results ramping up the valuation with positive data.
Grip, anything is possible. My gut says not at this moment.
IMO the tipping point is combining achieving Combo PE combined with strong Mono Interim Data and a decision by the FDA to grant further latitude with the current P2 GVHD after the 10 patient enrollment. That may be enough to get a suitor to the table and create a bidding war. We are not far off from getting this final chapter written.
Your statement below is 1000% opinion and speculation yet you state as if fact. This is why I don’t take you seriously.
This stock is now been revalued as a 2X proposition at best, with the ace card in the suitors hand.