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BlackDoggie, You have read my mind...thank you. Spot on, on every point!
Grading Current Valuation of CYDY
Scientific Strength of Pro-14 "A"
Delays "F"
Raising Capital "D-"
Overall grade "D+" equals current SP .55
Future valuation of CYDY will be based on Tony C's ability to shift the momentum by completing enrollment and producing data.
It makes me want to puke to be invested in a disruptive, safe, and efficacious HIV Mono SOC solution that is stuck in a 30 patient Combo Trial - what a travesty to those that have this disease - what a road block this Combo Trial has been. I mean seriously go out and find the sickest patients you can find that are failing current standard of care which is 96% effective. It is no secret why FDA reduced from 300 to 150 to 30. It would have been impossible to enroll before going bankrupt.
How much was Nader's fault? I don't think he initially understood how difficult the protocol was to enroll. At any rate this has cost us valuable time. Get the Combo Trial enrolled and get to the main course.
If Mono enrollment is as fast as expected CYDY valuation will fly also. Like Charlie Sheen or not he is campaigning and awareness will continue to spread through the HIV community and beyond. There is no question as to the safety and effectiveness of Pro -140 as a Mono therapy in CCR5.
I hope Tony and his team are working 24/7 - it's time to kick some butts.
Great news to see Charlie going strong. Pro-140 works as a Mono therapy period. If it works for years with no side effects on 50% of the CCR5 population it will as Charlie says revolutionize SOC. Tony C and Dr. Berger know what they have. They also know there will be resistance. When this is said and done and they get Pro-140 to the finish line it will make for a great motion picture. Gilead will be forced to jump in at some point. Tipping point will come. In between now and then-challenges and bumps in the road but the data will reveal the truth. Many have jumped ship, but that is the nature of an ROI of these proportions. It will test everything a person has between the ears. I'm betting on Tony C and the data.
Hopefully Tony is seeing first hand how damaging missing the 30 patient enrollment in Q1 is. I have to believe he has a new urgency to get the 30 patients. That is the only catalyst combined with strong data that's going to change this pitiful SP. Hindsight is 20-20, would love to use this valuation as an entry point- I'm loaded up and under water and I have invested only in private raises- go figure. Boom or Bust - not selling here. I have faith in the science and Tony amping execution up.
Hyperbolic1, Ask Tony what his plan is for raising money with a falling SP. As Chump said "when are you going to have the 30 patients for Adjunct?". Science is great but meaningless if you can't enroll. What can we expect in terms of positive news in this quarter to shift the momentum? Current SP is a reflection of management's lack of execution - what is the difference now? Detailed answers - not the macro difference but examples of the changes he has made and is planning on making that will get Pro-140 back on track. Is he focusing on a partnership to solve the capital raises we are facing? Would have attended - bad timing as I have a business trip to Japan - leaving early tomorrow. Hopefully you will give us a recap on your take. Most of all I wish I was there to look into these guys eyes and get a read. Next time.
Spot on Tony. Good to read a post that clearly represents the facts.
I spoke with my broker at Paulson about the invitation only meeting with Cytodyn. It is April 26 in Portland, Oregon. If you have participated in private raises with Paulson you can call your broker and get an invite. I would have attended as I live in SF and it Is a short flight, however I am traveling to Japan on business that week. It would be an excellent opportunity to get more pointed questions and concerns addressed and look into Tony's eyes as well as his supporting cast. They are planning a similar meeting in NY but the date has not been set. Hopefully somebody on this board will attend and gain some additional insight.
We could certainly use some intelligent dialogue here.
Gestalt, that I s a clear picture of where we are. Hopefully Tony can get a much needed touch down by coming through with Adjunct PE and the 100 patients needed for the safety data in the next couple of months. Good data and Tony will have a shot at a partner and more lucrative capital raise options. The ability to divorce Paulson for more favorable diluting opportunities will signal the ship has changed course.
Absolutely gestalt. I feel very confident that Tony is going to achieve two milestones by June/July.
- Complete enrollment Adjunct P3 and hit PE.
- Deliver the needed safety data of 100 patients
If I read Tony correctly he believes those two milestones will change the valuation of Pro-140 substantially. Raising capital and further diluting is what is applying pressure to the SP right now, not the viability or likelihood of approval. Tony knows that these next two milestones can create a completely different environment in terms of options and value concerning raising the needed capital. He's believes he has a very legitimate shot at a value driven partnership that will rid us of Paulson and create more shareholder value. That is the key to uplisting. A R/S is out but this pathway with a partner creates real value. Tony's expertise is twofold; navigate the FDA and negotiate a partnership that keeps as much value for the shareholder as possible.
In hindsight I have to totally agree with Lawman. This was a defining moment for Pro-140. We finally have an experienced, been there, done that professional at the helm. My gut feeling on our pathway and getting to the goal line has never been higher.
2016 was a year spent negotiating with the FDA to reduce patients from 300 to 150 to 30. If we were stuck with enrolling 300 patients with the complexity of the Adjunct protocol we would never make it to the finish line. FDA realized that 300 and even 150 patients was unreasonable. So was it a lost year? Yes in terms of our expectations at the time. In hindsight I think not. I'll take a lost year and in exchange for an adjustment of 270 patients. Thats the difference in being able to complete enrollment and being out of business. FDA wants to give little Cytodyn a fair shot because the science warrants that type of consideration.
The takeaway today was the reality of where we are and what we can expect in terms of timelines and $'s to get there. We just went from the minor league to the majors in terms of experience and execution. I really believe this message boards opinions had an impact on the promotion of Tony C. No defensiveness. All questions were addressed in a professional way. I feel like we are under a new administration. Tony has more resources than meet the eye and as a successful executive he knows how to utilize the different skill sets and grow the team. I'm more bullish than I have ever been.
Did you not hear what Tony and Dr. Burger stated. FDA said come back after P3 Adjunct PE and provide safety data. Tony says we will have that June/July. Dr. Burger is asked directly what the odds are of getting BTD then. He says point blank there is no question we will get BTD. These guys have been there and done it. This isn't Nader talking.
I was the one who asked that question about the P3 Mono. My take is that the enrollment resources are being utilized to enroll the Adjunct Trial. Tony is going to make sure the priorities are getting the proper attention. I think we have been scattered in our approach. No more.
Tony C is the man in charge period and Lawman should be a happy camper. I too feel much more confident about the future of my investment with Tony C running the show.
Can't believe all the negative posts about this call. Obviously many looking for a quick buck. IMHO the outlook is quite favorable. Tony is proven, capable, and direct about what it is going to take. The FDA likes Pro-140 because the data up to this point is quite disruptive. Tony has two priorities. Enroll the trials and deliver the data to the FDA... and find a partner so we can discontinue the suicide raises with Paulson. I think he believes the game is going to change when we deliver Adjunct P3 PE and safety data. He felt that could be achieved simultaneously by the end of Q2. Dr. Burger stated that BTD for Adjunct would be pretty much a done deal at that point. Missing by one quarter does not signal that we are about to capsize. If the drug appeared to be headed for the ditch I'd be out. This negativity is all about having to wait another couple months for what we expected now.
P3 Mono will enroll rapidly once they complete enrollment in the P3 Adjunct. BLA submission this year.
To call this company an OTC scam is ridiculous with the reputation of Tony C and Burger alone. These guys are not going to put their name on any type of scam. Bottom line is Tony would not have taken this on if he didn't believe he could get it to the goal line.
Well said Misiu. Everybody has an opinion. I for one have missed yours.
Wallstreet, I totally agree with your thoughts on tomorrows CC.
In addition BTD is a big deal IMO. ODD was meaningless but BTD is a clear vote of confidence in Pro-140 from the FDA. The likelihood of approval and shortening of process are big advantages that will be very helpful if we get a thumbs up. I'm interested to hear what the status is...what is it the FDA needs to grant BTD. What is it that is holding the decision up.
Other big questions are obvious:
When will Adjunct P3 complete enrollment and why is it taking so long to get 30 patients?
Where are we in terms of enrollment with the P3 Mono? Can we actually count on enrolling 100 patients by the end of June - 1H 2017.
How much and when will the next raise be? Are there any other options besides the warrant backed Paulson raises that erode SP?
Bottom line is what news can we expect to change this dynamic. Seems to me we have been hearing for over a year that we will never have to raise money at these discounted prices again. Here we are again. Show me the money Nader. What's the plan? Finely packaged rhetoric justifying delays is not a plan.
Would love to be ecstatically surprised with news that signals a shift in the pattern of delays and a shortening of the pathway.
Updatedslide deck projects 100 patients enrolled Mono P3 1H 2017. That means they expect to meet safety data requirements at the same time as they complete Adjunct P3 PE. Glass can be half full or half empty. What matters is the data from these studies. Pro-140 is highly effective and safe and I believe the data will continue to support that. Everyone wants the process to run faster including management. Tuesday will tell the story.
I too have invested in three raises with Paulson and received no invitation. I sent my broker at Paulson an email and he knows nothing about such meeting at Morton's. He is looking into it. Won't know anything until Monday.
Your entitled to your opinion jboat. Just be careful when you post a statement like that that is completely false. You are in my eyes an experienced investor that I follow because I am not a rah rah long. I'm an informed investor that draws on all resources. This board is just one source.
I stand corrected, but, but, but, no that nonsense you posted was way off base, period.
How do you arrive at that conclusion. It appears that between him, his wife, and daughters he's pushing 2M shares and rights to over 200k warrants. Where do you see that he sold any of his position. He was in on the Paulson raise a year ago at $1 a share and warrants at $1.35. Looks lie he laid down $200k on that purchase alone.
I'm with you BH. I hope you are right about simply moving golden quarter from Q1 to Q2. I studied the updated slide deck and agree with what is hopefully timelines that will be achieved on time. Biggest thing that popped out was 100 enrolled P3 Mono 1H 2017. If we enroll 100 and complete Adjunct enrollment at or near the same time in Q2 it will validate BlackDoggie's opinion. If that is indeed the outcome all will be good in Cytodyn Land.
I'm not worried about the science, just concerned about executing timely enrollment so we can get to the data. Time is money and the P3 Adjunct has been dragging. Maybe BD is right, they are waiting on the safety data from the P3 Mono. Have to admit that delays and silence can grate on me after four years of continually increasing my position thinking we are so close. I would have never thought that my warrants from my first private placement in October of 2013 could possibly expire. It's time to deliver - Nader is going to get an ear full on the CC if it appears he is not going to get it done in Q2.
LOL. "Appropriate for any outcome". I'm West coast so it's a little early for bourbon...but you have me thinking. I just hope it's celebratory drinking:))
BD, I agree on all fronts. If your speculation plays out it will be more than a nice Wednesday. It would break this wide open and Nader would break his cycle of over promise and under deliver.
Thank you BD. Well said. Silence leads to a lot of negative speculation and I am not immune to questioning managements competency. The upcoming CC is overdue and much needed.
The last two raises were small because they are raising just enough to bridge to positive news. I believe Nader believes we are close on many fronts or they would have raised substantially more. The issue is believing in Nader's ability to meet any of his timelines. The fact is Q1 has been another missed timeline. The question is how big is the miss this time? What is the reality of Nader getting these P3's enrolled? We are starving for new data that further validates Pro-140's likelihood of approval. Meanwhile with no new data time will erode SP and investor confidence as the raises become increasingly penal. This pact with Paulson is the bail out go to play right now because it is CYDY's ONLY option. We are currently in bed with the devil himself and positive data is the only way to break this continual warrant driven raising of capital.
It's time to change the sheets and move on - all we need is the data. Pro-140 is highly effective and safe and it can absolutely disrupt both the adjunct and mono HIV space. I expect some impatience on this CC if timelines are stretched and backed by empty promises and finely packaged excuses. If we are pleasantly surprised with the timelines then we will be off to the races. Personally I'm bracing for what we have been getting for the past year while optimistic that Nader has only fractionally missed the Q1 timeline and we are closing in on the end game.
Lol Chump...that was my exact thought when I read Pears post.
Not blaming the FDA. Just acknowledging the complexity of the approval process. Couldn't agree more that Nader needs to do a better job of executing enrollment.
What a laundry list is side effects. If I needed HIV meds I would beg to be on Pro-140 if I was CCR5. It just amazes me with safety and efficacy up to this point evaluated in over 200 patients we can't get these trials enrolled more rapidly. I hope this is about to change. I feel for those that have to use these dreadful drugs. The FDA gauntlet is a test in persistence and patience. It would be a travesty if Pro-140 is not approved.
The reason why the SP and valuation of CYDY is at .60 is simple. Delays in enrollment and the capital raises with Paulson. I have been through three raises with Paulson because the caveat of 50% added warrants to shares purchased make more sense than investing on the open market. The downside is they kill the SP. We are fighting a double edge sword with these raises. As long as we are held prisoner to Paulson at the current SP we are stuck in reverse in terms of valuation. Until management can expedite enrollment in these P3's and produce data we will remain where we are right now and that has nothing to do with the OTC. The trend has been raise upon raise with no new data. There is no doubt Nader was very confident that we'd be further along at the end of Q1. The question now is how far behind are we and what is the real change in management with Tony C's increased responsibilities?
This next CC will either provide some real meat or a bunch tightly packaged excuses. Direct questions need to be asked to determine the current status of Pro-140 and what the realistic timelines are. The trend of delays has to be broken.
I have been dealing with some restricted shares with Tracie Melchior at Cytodyn. I inquired today via email as to any word on the next cc. She replied "I have heard the week of the 17th but no final date as of yet".
There has not been a PR as to the next CC. Unofficially it is to happen the third week of April. I would expect a PR very soon as to the date of the call.
None of my comments were related to conference call announcements. They are projected timelines in reference to the updated slide deck stating completion Adjunct PE and 100 patients enrolled Mono in 1H 2017. Why would they state 100 patients enrolled in Mono 1H 2017 as a projected date if they would not PR that news when it occurs? It seems to me that is a significant event that they have identified. Or are you saying it is nothing more than an expectation of the pace of enrollment?
I would anticipate a PR as to the date of the next conference call this week.
Seven weeks without a PR and we get a bottom feeding shareholder alert-not what I anticipated this morning. As common and frivolous as they are it isn't what we need to start Q2 after a non eventful Q1.
Positive data from Adjunct PE and 100 enrolled in Mono Trial are a must for Q2. Updated slide deck said 1H 2017 for both milestones, now make good on it.
Boom, I hope you are right about Tony C. All I'm saying is that there hasn't been a formal transfer of power. Tony C has a new title as Exec. Chair and Nader still has his title as CEO. In talking with the company all I have been told is "everyone is working really hard and that the addition of Tony C has been great". Also been told that "Tony C will not lead the upcoming conference call but will be on the call" - whatever that means. The next conference call should clearly define the new role Tony C will assume as EC and what impact that has on Nader's responsibilities as CEO.
I can't help but get a little excited as I look at the upside. If the data is strong from both Adjunct PE and interim data on first 100 patients, BTD would be granted shortly thereafter-probably a few months as the FDA would take the 60 days again-hence moving BTD to 2H 2017. Those events in addition to a large percentage of patients on the extension arm from Adjunct could likely trigger a buyout. Think about it, if the data is strong this could likely be the end of the road.
IMO Tony C was not brought in to replace Nader. He may be assisting and guiding with regards to FDA, however his major emphasis is on packaging a deal based on the events above having positive outcomes. We will find out on the next conference call. I for one will ask, if it is not addressed, how do Nader's and Tony's job descriptions and responsibilities differ? Are they in equal positions of authority? What has changed in Nader's responsibilities since Tony was brought on in his new role as Executive Chairman?
A tweet for a .60 to $6 move is a distinct possibility in the not so distant future.
In the slide deck BTD has been moved to 2H 2017. Primary Endpoint and first 100 patients enrolled Mono is 1H 2017. This IMO tells the story. They have been in communication with the FDA regarding BTD. The data the FDA is requesting is going to come from Primary Endpoint Adjunct and Interim data from first 100 enrolled in Mono. Those two milestones being achieved 1H 2017 are major deriskers if the data is strong. We are not far off from significant events. The Golden Quarter has been moved to Q3 2017.
BH, I caught that also and wondered if that signals a significant shift in power and responsibility. I called Traci Melchior about lifting restrictions on shares I have owned for over two years with the intent to ask her if Tony C. would be leading the next conference call. Her reply was she didn't think he would be leading the call but that he would be on the call.
Question is; Can Tony C., our new Executive Chairman, make good on the new timelines? Will he lead the next conference call? I would suspect he will as we need a new voice to assure investors that the path to approval is on track. With his experience I would expect a more insightful explanation regarding the delays and the reality of the new timelines. Are they timelines we can trust? Are they his timelines and is he taking ownership?
The question for me is WHY does it take years to find 30 patients? I understand all the reasons why; negotiating from 300 to 150 to 30 patients, complexity of protocol, and the time consuming communication with the FDA--I want a clear explanation. Enrollment completion is all that I care about at this point. I'm sure the FDA has told Cytodyn management to complete enrollment in your P3 Adjunct and hit your PE. Then let's take a peek at what's going on with your first 100 patients with the P3 Mono and we will grant BTD if it all looks favorable. This right now is all about the need for data from both P3's. Realistically the golden quarter has been moved to Q3. You can't have a golden quarter without data and you can't generate data without enrollment.
Obviously delays don't change the science. Delays bring into question managements ability to execute. Is Tony C. Going to make a difference? The next conference call will she'd much light on these questions.
That is what is going to happen to CYDY once the stock is derisked to a level that the data indicates approval is imminent. That tipping point could come at any time. Anthony C is working long hours...on what might that be?
Couldn't agree more d0lphint0m. Management understands the risks and downside of uplisting with a R/S. They are committed to an organic uplist and yes I believe they have the goods to pull it off. When that happens it will be game over.