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Pears, thank you for your always optimistic bullish outlook. What a shocker coming from you. Have a great day...I'm sure the weather is cloudy and gray.
That's a fact BD. I'm not expecting any news to move the needle until mid July to early August. Combo enrollment complete, data for Combo PE, a possible partnership for GVHD, and BTD approval. I expect this to be a hot summer but it's not going to begin heating up for another month or so. I'm going to take your advice, sip some cold ones and enjoy the summer.
I have talked to the powers that be and Mono enrollment will fully enroll 2017.
That is exactly what is taking place. Company is more than confident to fully enroll Mono this year. All resources are on Combo at the moment. Pedal to the medal on Mono enrollment in less tha a month. Pears is wrong on the Mono-it's a slam dunk.
It's not about how polished the presentation at a micro invitational, it's about the data and the facts. When we need a polished presentation Tony C will be at the podium.
Bottom line is you need disruptive data, business savvy and experience to negotiate a deal and that is where the buck is going to stop - If you don't think Tony C has the goods to bring it home you are mistaken. Believe me this guy relishes the upcoming opportunity to push the envelope - he's quietly lining up the potentials for a helluva poker game when the data creates a tipping point. This is all about derisking Pro-140 to a level that entices one shark to bite. Blood may be in the water sooner than many expect.
My guess it is not going to be Gilead. Gilead would just like to see Pro-140 go away. A smaller player is going to take this baby and create disruption in the HIV space. IMO BP is willing to wait this out and buy it for billions more after Pro-140 is a done deal, thus taking the safe route.
You can't dispute disruptive data. Some are questioning the science. That question will be answered a step at a time as data is compiled and released.
Absolutely correct trding, they need a couple weeks after enrollment is completed to compile data so that puts us in the middle of July. I think many just stopped believing that enrollment was ever going to be completed. Nader only missed by one quarter and some felt the deal was dead.
This will be the start of a stream of data coming to fruition. The P3 Mono is absolutely going to complete enrollment before the end of the year and that is going to place Pro-140 on a very precise timeline. The HIV players will have to place their bets.
Yes, things are going to get very interesting very soon.
We are not pumpers - you especially Misiu are not a pumper. That is just how the negative naysayers paint the picture to discourage and scare investors away as they have an agenda to depress the SP.
I post the bottom line in terms of what is actually taking place. No exaggeration, no agenda, not trying to convince people to invest. Just the reality of the state of Pro-140. The nature of this type of investment is one of delays - it's the landscape of the path to approve a first in class drug. Our minds can become unclear if our emotions get the best of us. I know that you post the facts as you see them from a medical professional perspective. Most here respect that - I do. There is great value in what you contribute.
All I can say is that we are in good hands with Tony C at the controls. Nader is part of his team and a valuable asset. Many moving parts and Tony C has the experience to manage the team to get us across the goal line. That is why he was asked to step in. Quite frankly most of the negativity has been an overall attitude that we are never going to get these trials enrolled and we are going to go bankrupt. That couldn't be further from the truth. This is all going to turn as enrollment in both trial are completed and data starts to be released. Gvhd is also in the mix and a potential driver for partnership this year.
I have never been more confident about the future of Pro-140. The fun is about to begin.
I know, me too...Trust me it's coming together.
Misiu, Yes we do agree.
The trials are going to fully enroll - Combo in July and Mono before the end of the year. The data is going to have the final say very soon and Tony C and his team are very confident.
Let the concert begin.
All IMO of course.
30 patients around the corner - July 15 PE at latest. Then pedal to the medal for 300 patients enrolled in Mono by end of the year. Closing in on fun time.
Have to say I agree newmike. Lawman is a bit hard on Nader. Am I glad Tony is running the show- yes. Has Nader made the biggest contribution- yes. There is still a place for Nader and that is working with the day to day developments with the FDA and putting the full court press on enrollment. Tony will handle the big picture and getting a deal consummated.
Exactly gestalt2. The fact is Nader said he was hopeful to complete enrollment as early as Q1 2017. We are going to be within a week or two of completing enrollment by Q2 2017. A miss of one quarter. I'm telling you Management is confident in fully enrolling the P3 Mono by the end of this year. You have waited longer than most - our time is coming. The empirical data will decide our fate. That's why I'm invested-let the data do the talking. That's why Tony C is in the game along with the rest of his team. They know what they have.
Yes it has taken quarters. Eyelash means a couple patients.
Amatuer17, the Combo Trial is an eyelash away from complete enrollment.
#1. SP. when 10k trade impact SP 5-10% does it matter? The major shareholders are staying put. Watching the day traders move SP is a non event.
#2. Upcoming conference. News will be positive. Enrollment for P3 Combo will be completed within next 4-6 weeks. Done deal. Data for Primary Endpoint 2-4 weeks after enrollment completed.
#3. Financing will be much more positive than the bottom feeding Pears is trying to sell.
#4. The new Sherrif is ramping the game up.
#5. Disclaimer. All IMO of course.
Raise is all but done. Just need to cross the t's and dot the i's. It's all about the P3 Combo data coming up.
Or much more.
Not much to discuss. We've got 6-8 weeks to wait for P3 Combo PE Data. Thats the first of many milestones that will shift the valuation of Pro-140. I have every confidence that we are back on track. Tony gets it.
Thank you for stating the facts Gestalt - and Fred you have some very valid points.
I have had many conversations with the company and the bottom line is the combo trial was required by the FDA to proceed with the Mono Trial. They are not in this for the narrow combo market - they are thinking Mono all the way. They firmly believe that Pro-140 will be approved in the Mono space. The million dollar question is the rate of adoption by the Doc's - as you stated Fred. The good news is Pro-140 does not compromise a patients ability to go back on the cocktail they were previously taking if they choose to do so. Once again Pro-140 is safe and efficacious and no side effects. The P3 Mono data will tell the story and Combo data will clear the way.
This is a major play that is going to meet resistance but will disrupt SOC gradually with the positive impact within the HIV space. The videos that have been shot with the current patients that are still on Pro-140 after years are supposed to be very powerful and emotional to say the least - tear jerkers. Unfortunately, until approved that tool is not allowed.
In talking with management they are confident they can complete the P3 Mono enrollment this year and come up with the needed capitol get to the data. SP will pick up momentum after July when P3 Combo PE data is released and that is when they will go for a larger raise.
I think we have a payday if we are willing to be patient - how big is uncertain.
PRO 140 - Differentiated HIV Drug With Favorable Safety vs HAART, Phase 3 Data In 2Q17: Initiating BUY/$3 TP
· We are initiating coverage of CytoDyn, Inc. with a Buy rating and 12 month target price of $3. CytoDyn’s lead candidate, PRO 140, is a fully humanized antibody in Phase 3 development as a new class of therapy against CCR5-tropic HIV. Our valuation is based entirely upon projected revenue from PRO 140 for CCR5-tropic HIV infection in the US, where CytoDyn intends to market PRO 140 itself upon potential FDA approval. We project US approval and launch in calendar 1H19, and at an annual cost of about $10,000, we project over $400M in PRO 140 net sales in FY2022.
· The next most important investment catalyst for CytoDyn is the 2Q17 release of topline data from the 30-patient Phase 2b/3 PRO 140 combination therapy trial for HIV. The Phase 2b portion of the trial will evaluate the efficacy, safety and tolerability of PRO 140 in conjunction with a highly active antiretroviral therapy (HAART) regimen that treatment-experienced patients are currently failing, and the Phase 3 portion will subsequently evaluate the same patients in conjunction with optimized background therapy. The primary endpoint is the proportion of patients with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of the 1-week double-blind Phase 2b portion, a low hurdle in our view. If positive, the data will likely increase the chance of receiving Breakthrough Therapy Designation in 2H17, and support a 2018 BLA filing. The success of this trial will serve as the first path for PRO 140 approval for HIV in patients with multi-drug resistance.
· PRO 140 is also being evaluated in a Phase 2b/3 long-acting monotherapy trial with enrollment expected to complete in 2H17. The trial will assess the maintenance of viral suppression in 300 clinically stable CCR5-tropic HIV patients following substitution of HAART with 350 mg PRO 140 SC weekly for 48 weeks, and therefore evaluate PRO 140’s potential use as a single-agent maintenance therapy as well as in patients who choose to take holidays from HAART therapy. CytoDyn then plans to target the substitution benefits of PRO 140 as a label extension for maintenance monotherapy, serving the large general CCR5-tropic HIV population. The trial is actively enrolling at about 30 sites.
· PRO 140 offers competitive advantages over standard of care HAART in its once-weekly flexible dosing, as well as its far more favorable safety and tolerability profile. Compared to HAART’s strict once-daily oral regimen, PRO 140’s more flexible once-weekly SC dosing regimen provides a differentiated convenience, especially for those with difficulty adhering to a daily HAART regimen, or for patients who would like to take a break from HAART due to safety or tolerability. Most importantly, PRO 140 appears to demonstrate a safer profile with no serious side effects observed in trials and no negative impact on immune function. Also, no drug resistance has been seen in patients on monotherapy for up to 24 months, as compared to 76% of patients who experienced resistance to 1 or more of the drugs that comprise HAART.
· CytoDyn had about $7.8M in cash as of February 28, 2017 and is therefore clearly in need of additional financing to proceed with its BLA preparation after the imminent Phase 2b/3 data.
Jonathan Aschoff, Ph.D.
Managing Director
Equity Research - Biotechnology
Opus National Capital Markets
Securities Offered Through National Securities Member FINRA/SIPC
410 Park Avenue, 14th Floor New York, NY 10022
212-417-8277 Direct/ 973-985-4796 Cell
jaschoff@opnresearch.com
Well said Gestalt. Thx for saving me valuable time to express my sentiments.
Absolutely Grip. Birds of a feather flock together.
That won't be a problem. I'm sure I will be up to at least an 8 index by the time we meet so you'll be giving me 1.
Ross, Company misjudged the protocol challenges with the P3 Combo. It cost time and money. Trust me Tony C has things back on track. The data is coming. The pathway and plan is in place. They are executing and working around the clock right now. Keep your head up, SP is not what we have here. Bluehorse said it best patience will be rewarded.
Your welcome Grip. I'm a 5, so when we actually meet we can get a round in and lay some cash on the line in between the fun in Vegas. Don't want t get ahead of myself but the plan and pathway is in place. Don't measure your investment until the end of this year. I can tell you right now there is nothing coming until July except the details of the next round of financing.
R-E-L-A-X
Pure speculation. I'm dealing with people that know far more about this space than you do. Your information is based on your own flawed fear based assumptions. Like I said Pears your opinions carry zero eight with me.
Bla, Bla, Bla, Bla.
Have to wait on details. Should be available as early as today.
First warrants expire Oct. 2018. The rest are in 2019 and 2020.
All good questions Grip. I can tell you this depressed SP is going to change when the data is released. July is firm - more to end of July. The data will prompt a meeting with the FDA for BTD. GVHD is in play for a partnership.
My take is that with the delays on the P3 combo enrollment the day traders and smaller investors exited. Confidence on this board in regards to the fence sitters was diminished by one deranged poster and his fear driven personality. The fact of the matter is those with major positions are still in the game and sitting tight. It won't take much buying pressure to send this to $2. The upcoming P3 Combo data is going to derisk - the question is how much. The P3 Mono data is going to completely derisk - meaning FDA approval and for a much broader label.
The news is coming and the science hasn't changed. They have tweaked their screening for the P3 Mono and expectations are high. Unlike the P3 Combo enrollment P3 Mono is going to fly - they could probably enroll the entire 300 patients from their five sites in San Francisco alone. The P3 Combo has been like looking for a needle in a haystack which is why the FDA ratcheted from 300 all the way down to 30 patients - they knew what Pro-140 was up against. The FDA made the Combo trial a requirement to get to the P3 Mono trial which has been a major hurdle that was misjudged by Nader. Keep in mind going after single agent therapy (Mono) is first drug in it's class. This is a big deal and you don't just get to the goal line without putting together a balanced drive. The bashing that has gone on around managements inability to enroll 30 patients in the Combo trial has been pure ignorance as to the reality of the situation - especially by one such poster that I have zero respect for. Lack of funds also handicapped this effort. We are not BP we are a little biotech with great science and limited capitol.
There is a new level of competency and accountability taking place at Cytodyn. The pathway is clear and the goal line will be increasingly more visible as we move into the second half of this year.
In answer to your question about the SP and where to buy, ask yourself what is 5 cents per share going to mean in the next 12 months?
Details on Bank note out by end of month. 10-15 million non Paulson raise.
P3 Combe PE data out in July.
P3 Mono will fully enroll all 300 patients no later than the end of this year.
GVHD has strong possibility of generating a partner this year.
Second half of this year we are back on track and data will derisk Pro-140 for the last raise and push for the goal line.
Thank you. Makes perfect sense.
Anything else. Like who is and what is the arrangement
Broker, Where did you get your info on the raise and what are the details? I knew they were going to do a small raise in the 5-10 million area to bridge to data but nothing on the nature of the raise. My Paulson connections haven't heard a thing at this moment. What can you tell us?
I agree with you on most everything because it is all happening. The one thing I disagree with is Pears knowing as much as we do about what is actually taking place -- he doesn't.
Talk about pure speculation backed with no factual information.
Seriously Pears, your agenda is so clear. Your attacks on Misiu are predictable because her input is based on the strength of the science based on facts - that is a contradiction to your fictional rant on what is currently taking place with the P3 Combo Trial, etc. You are clearly here for one reason - to undermine the efficacy and potential of Pro-140 while saying that you are invested. Your story and opinions are a sham and bring negative value to this board.
Thank you Hyperbolic1. You are absolutely correct. The Combo Trial is close to full enrollment and will be completed and data released in next couple of months and P3 Mono will complete enrollment of all 300 patients this year. Science is more than strong and will change the landscape after releasing data on P3 Combo PE along with needed safety data. SP is an indication of a small percentage of investors fearful that there is bad news in the wind in addition to further dilution. Yes a small raise to bridge to data but no bad news-quite the contrary. If we were seeing significant volume it would be a different story. I mean really 100k shares or so daily. That's $25k being traded. Big investors are all in. Nobody likes the SP but it will be short lived. We now have experienced leadership with laser focus in charge.
Couldn't agree more with you BD.
Get closer to the people in the know and Pears assumptions become meaningless - he has created his own story and it truly is nothing more than his own nightmare. It is obvious he knows nothing about the status or events that are taking place at this juncture.
The next raise coming up will be small. Just enough to bridge to P3 Combo PE data. That means one month after enrollment has been completed because it will take one month to compile data. The value and derisking of Pro-140 at that juncture will dramatically increase options for the major raise. The timing for that tipping point is end of July-August. That is IMO a defining point in time for Pro-140.
Currently all resources and energy is on completing enrollment of the Combo. We are nearing the finish line. I believe they have the final patients in testing at this moment. We have to put into perspective the purpose of the Combo trial - a requirement by the FDA for Pro-140's Mono pathway. Mark my words the P3 Mono enrollment WILL fly once Combo enrollment is complete. They strongly believe they will enroll 300 patients by year end. Keep in mind this is on Tony's watch now and his timelines.
Once Combo PE data is PR'd the landscape changes in a big way. Many new options and possible deals will surface and that is where Tony C's experience comes in. You can bet he is licking his chops and setting the stage right now because he knows how strong the data will be. They know how disruptive the science is and know they just need to produce the data. It's coming in a few months. Only news between now and then is how they will put together the small raise to get Pro-140 to the data.