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I agree ahab333. The FDA is in our corner and the proof is the FDA's willingness to reduce patients in the combo trial twice from 300 to 150 to 30. Nader and his team are to be commended for that. This is all about enrollment. The best news we can get right now is last patient injected in the Combo and first patient injected in the investigational Mono trial. IMO we already know the results will easily clear the bar the FDA has set. Unless some unknown issue pops up with the safety of Pro-140 there is nothing preventing FDA Approval. The barrier right now is enrollment. Speedy enrollment builds confidence and makes timelines clear while delays kill the SP and confidence. I'm sure Nader is doing everything he can to expedite enrollment.
Yes Misiu, Agreed, we are in good position on all three points- thank you for reminding us all of what the bottom line is regarding FDA approval.
Obviously the void that must be filled is the quantitative data regarding your three points. How LONG it will take to produce such data and fill this void is the wild card that continues to apply downward pressure on the SP. I am hopeful Nader and team can stay on track with the timelines that have been committed to on the CC's.
At times the saying "Big Hat, No Cattle" haunts me. I'm patient but I need to see progress in terms of enrollment to validate that big hat.
I have warrants from three private raises dating back over three years ago. They are all at .75. No one would exercise here. It also makes no sense to be selling any of the private raise shares because any recent raise is at .75 or higher. The first raise I got in on was .65 over three years ago with the warrants at .75. What has hurt the stock is the past is all the Paulson guy's dumping all there shares and keeping there warrants for a zero risk position. Now we are at a point where there is no logic in selling below .75. Can't explain it. Can't wait to see the data turn the tide.
The longer Charlie experiences game changing results the more chance of a viral event. He is very visible however his credibility is not the best - question is do people trust and believe him. We need another star power celebrity to jump on board and God knows there are plenty that could benefit. I think it's only a matter of time - the results can't be denied forever. Patiently waiting for the data to create a tipping point.
Great Post Chump. The science and results are stellar and just need to be validated through the clinical trials. The waiting game - cross your t's dot your i's then double check it all again with the FDA to see what additional hoops will need to be jumped through. It is a grueling process. But we got the goods to go the distance.
Precisely. Couldn't agree more.
Thank you for sharing your story Misiu. I now better understand your interest and belief in Pro-140. Many people here are invested as much for the cause as the money. Initially it was all about the money but now it is also about the cause. Pro-140 can help many people - I pray it is given the opportunity.
Yes, Misiu you are optimistic and that is a good thing as long as it is tempered with reality. Your knowledge as a medical professional and your positivity are a welcomed asset to this board-Many Thanks!
Lets pray that Nader can continue to navigate the FDA process and make steady progress. I really believe the data will take care of everything- The question is can he deliver the efficacy and safety data without delays that continue to push timelines out. You say Yes and I want to say Yes, but I need results to back up his projected timelines. We will know soon.
I agree Misiu, it's not easy to find patients. Seen it many times when Bio's get to Phase 3 and protocol is approved and then enrollment stalls out. With the efficacy and safety established to date I think we will have an easier time of it. Another barrier is many have an issue with needles however if I was faced with the choices I would choose Pro-140 in a flash (and I have an issue with needles). Regardless we should be able to rapidly enroll 30 patients with 38 sites to work with.
I too am very optimistic given the success Nader has had working with the FDA. I have built a significant position and followed Nader and company closely for going on four years so my patience and confidence can be tested at times. I think we are six months away from data that can push us past the tipping point. Just nervous about progress getting bogged down in the FDA process. 2017 is going to tell the story.
COULD is the operative word when referring to first Q 2017. To me that means best case scenario not worst case scenario. Nader is going to communicate best case and we need to be prepared for Q2. This is the nature of this investment. Missing or delaying timelines kill SP while exceeding expectations will create urgency as the approval and monetizing of Pro-140 are derisked. Put a couple of exceeding expectations milestones together and the SP will run away. We as shareholders are longing for that point in time. My attention is on speed of enrollment for both Adjunct and Mono. If Pro-140 is everything we as shareholders believe it is enrollment should be like a dam breaking-flooded with patients. 38 sites and revised protocol - EXECUTE and exceed timeline expectations.
Bingo. Simply getting their house in order.
Agreed. The Fear-mometer is running a bit high. Nobody likes to be in the red. However to make the type of returns most of us are anticipating this is what we signed up for- future looks bright but the SP is not cooperating. Maintaining a clear perspective and exercising patience are sometimes easier said than done - we are after all humans that don't operate on pure logic.
I think it is fair to say that the many posters on this board have identified the many reasons why the SP is where it is - Managements inability to hit timelines was clearly stated by Broker57; investors don't believe management can get this across the finish line, and other posts regarding the OTC MM manipulation, shorting etc. Raising money and diluting is a known factor in order for the company to continue - So yes diluting is part of the reason but IMO not the core of the issue. What hurt on the last raise is having to do so at .75. And we don’t want to do that again. I think Nader is convinced the next raise will be over $2.00. He obviously has some work to do to make that happen.
When you look at the progress that has been made it is impressive in terms of Nader's ability to communicate with the FDA. Reducing patients in the Adjunct PIII from 300 to 150 to 30 is miraculous and speaks volumes in terms of the FDA’s opinion on the efficacy of Pro-140. Negotiating safety data to be inclusive for PIIb and Adjunct PIII also represents a positive relationship with the FDA and further reduces economic cost and timelines. It appears the FDA is in our camp and likes the data in terms of efficacy up to this point and the Adjunct PIII will put the efficacy issue to bed. The remaining wild cards are the safety data and why the drug is effective in some patients and ineffective in others. It appears our screening and qualifying process for the PIIb was not 100% effective in identifying qualified patients. I am sure Nader is making adjustments here to insure we have qualified patients with the correct strain of HIV that will respond positively.
Where Nader and his team have yet to perform and execute is ENROLLMENT. With the effectiveness of Pro-140 it has been irritating to witness enrollment stagnation regardless of protocol. The PIII Adjunct has been idle for basically a year as enrollment sputtered leading to the time consuming process of negotiating with the FDA the number of patients required and protocol. While the outcome was positive with the FDA we made no real progress with the PIII Adjunct – a huge loss of time and $’s and investor confidence. Completing enrollment in PIII Adjunct is the first milestone that we are long overdue in achieving. When that is achieved and we are moving with rapid enrollment of the Mono Trial to satisfy safety data and BLA submission is a given, investors and BP will view Cytodyn and Pro-140 much more seriously. The reality is at this moment we are not disrupting anything and until disruption in the HIV market appears to be much more certain the SP is not going to move significantly.
I believe Nader and his team are focused on; completing enrollment for Adjunct, get Mono protocol completed and enrollment ramped up, stay connected to the FDA to satisfy safety requirements, and then submit BLA and let the power of Pro-140 disrupt the current SOC. If he can execute enrollment ON TIME and continue to develop transparency and clear communication with the FDA, timelines can finally be achieved on time. Until Nader and his team string some hits together and score some runs we are going to get what we have been getting – a depressed SP and what we as investors view as a seriously devalued company. He understands the urgency here better than any of us and as investors we are trusting him to execute. Not everyone believes he can get it done. I for one do.
The good news is – the stage is set, the pathway is clear and attainable, and Pro-140 works. Just get enrollment completed and change the current pattern of delays into producing the powerful clinical data that we know is there waiting to be unveiled.
Gonna have to buy a few more shares to own that title.
Mike really went large with 11k shares. Would've like to have seen 100k shares plus. You would think of all the insiders someone would step up and buy a chunk at his price.
Misiu you are always a delight. Positive, vulnerable, and knowledgeable. Thank you for your contribution.
When fear is highest so is opportunity. That I believe is where we are right now. I just simply don't need more shares as my position was built some time ago and even at this price my average would move very little. When we look back I'm sure many will kick themselves for not buying here. Time will tell.
Sleep peacefully my friend.
Great dialogue today from this board - thanks to all for taking the time to share there logic and opinions.
I have been in for nearly four years and 90% of my position is through multiple private raises. Could have sold all my shares and just kept the warrants and made money and taken all of the risk out of the investment. Instead I have never sold a share and in no way am I pulling out - the science is just too disruptive and the multi Billion $ HIV market is in need of Pro-140. Seems the FDA is doing everything they can to green light the approval process.
So I agree, it is both frustrating and unclear to make sense of why the SP is in the mid .60's given the news and point in time Pro-140 is positioned in the approval process. Any of the opinions voiced here could be correct. IMO the current SP is a result of the delays over the last 12 months and Nader's inability to hit any of his timelines. As JPG77 mentioned investors may be taking money off the table and investing elsewhere because timelines to hit milestones are consistently being stretched - consequently a huge lack of urgency exists. Past performance has shaken investors confidence and belief that Nader can execute on time. The SP will surge when the PIII Adjunct is completed and most importantly the safety data is sufficient to satisfy the FDA. The million $ question is how long will all this actually take. The longer it takes the more diluting we will have to endure at a low SP. A very experienced investor told me that BP generally doesn't move until it has to. If that's the case we need FDA approval, and be down the road in the BLA process to get BP's attention. Nader's interaction and results with the FDA are to be commended. Now it's time to put his business hat on and get this moving. I for one don't want to wait another 2-3 years to see this pan out. I'm looking forward to seeing green on a daily basis when the fear of loss sets in. When it turns and I strongly believe it will it's going to be a helluva ride. I'm betting on it.
I'll state the obvious. Very positive recent FDA news and what appears to be very disruptive technology in Pro-140. One would conclude enrollment would be a slam dunk. The question, as everyone knows on today's CC is why haven't we enrolled 30 patients and how long is it going to take???? A little nerve racking when we are looking at 300 patients in the Mono PIII. I hope we get some answers that make sense and a clear plan that gets things moving. The SP reflects lack of confidence in managements ability to execute. IMO there had to be issues with the protocol that made enrollment a lengthy process with the Adjunct PIII. The FDA said ok then we will reduce to 30 patients but the protocol remains unchanged. I have a feeling the Mono PIII will be much easier to enroll. Shareholders need assurance that management can execute. For the last year it has been a long list of delays and that needs to change.
It is quite possible that the Face to Face with the FDA was requested because the protocol with the PIII Adjunct was making it unreasonably difficult to enroll patients. The FDA's response was a huge reduction in the number of patients required from 150 to 30. The question now is how many have actually been enrolled and how long will it take to enroll the required 30. In addition is there some easing on the protocol as well. Just thinking out loud. Overall the future seems quite positive in the face of a very lathargic SP. I'm looking forward to getting some perspective on Tuesday's CC.
5TOP, I totally agree. With the incredibly positive news today it is over my head to identify with certainty what particular manipulation tactic was in play to halt a rally. The only thing that is certain is that manipulation is at work. The Paulson Idiot post was also filled with its own manipulation agenda. We need answers because the SP is completely out of balance with the data that has been presented. I welcome a reply from Paulson Idiot with facts that support his accusations.
I agree. Hard to believe the SP didn't move today but nothing surprises me. Just know this will move once the dust settles - the positioning is just too good on all fronts.
I don't think people realize how big this is. FDA paving the way. In Pro-140's corner. That doesn't happen very often when dealing with the FDA. Pro-140 is the real deal and the FDA is saying if the data continues we're going to shorten the runway. Good to have you back JPG77 - that means things are happening!
Buy-Out, Yes. But when would it be best for the shareholder? Are we looking for a 5 bagger or 20 bagger?
Personally I'd like to see a Buy-Out after end points on both PIII's. We are talking night and day between a Buy-Out In the next couple of months and 1 year from now - the difference is $Billions. I also think BP isn't going to move until we are closer to BLA approval and it is a given that Pro-140 will be taking a chunk of the HIV space. Gilead isn't going to bite yet. Best thing that could happen is interest from another BP other than Gilead to create fear of loss. Also don't be surprised if Nader and team push towards monetizing on there own ion 2017 to push the value of Pro-140. This all means we wait longer but the return is much greater.
Right on. You called it Misiu. Timelines have just been shortened and most importantly the FDA is i agreement with safety and value in expediting the process. Been on so many where it's snag after snag - not here. This is a game changer that will save the company time and money and will have a dramatic impact on the duration and protocol for the Mono PIII. Here we go!
Misiu that is news in itself. "No response from the company".
To me that means they have information that they can't disclose until it is made public or they are in the process of getting on the same page with the FDA. PRO-140's safety and ability to suppress viral load is unparalleled and SP is completely unrelated to the data. Delays and silence translates to uncertainty and that's where we are in terms of SP. I'm siding with your opinion on the PIII Adjunct. If your right things are going to heat up in a big way:)
Not a medical professional. However if your invested in Biotech it makes sense one should understand a bit about how the FDA operates. Amateur seems to knows more than most about the process and is a strong asset. He is spot on when he talks about timelines. Almost always much longer than investors perception. So many snags in the process. I'm with you on your optimistic outlook because I think Pro-140 is special. It's up to Nader and his team to navigate the FDA Gauntlet. We are going to find out how the next chapter is going to unfold very soon.
Your comments on the hold on enrollment for the PIII Adjunct makes sense and it is a high probability that we have enough patients or are very close. On the other hand there is the possibility that they stopped enrollment when they requested the Face to Face with the FDA because it was to make a case for relaxing the protocol. Odds are you are right. That will be very good news and BTD will be icing on the cake.
That is correct.
All I know is it was all institutional. Went in a blink.
Agree 100% Misiu.
Once again BLA Approval for Pro-140 must meet the following criteria and IMO it's only a matter of time. The debate is not over if it will be approved but HOW LONG IT WIL TAKE.
Approval of such therapies would likely depend on several factors, such as:
- the safety of the therapy
? the target population of HIV-infected people that the therapy is intended to TREAT
? the magnitude and duration of viral suppression, and
? the potential for re-treatment.
It's all relative. For me yes. Compared to some of the people that showed me the deal four years ago no.
I get it Amatuer. There are plenty of hold ups with the FDA in terms of BLA Approval. Yes my timeline on milestones are optimistic and aggressive however I think the safety and results of Pro-140 are at a level that the FDA is going to work closely to expedite the process. Maybe I'm wrong but I think this Face to Face will reveal the answers and this could be a huge turning point. We shall see. I have a tendency to think the negative having a father as an attorney - if something can go wrong it will - Murphy's law has saved me much money and grief. In this case when I weigh all of the facts I just see it differently. I've been in this for close to four years and participated in three private raises and have done my DD. As you said the path through FDA approval is littered with corpses. This one is a different animal IMO. You are a clear thinker that obviously knows the turf. Thank you for sharing your insight.
Lots of speculation going on here. I'll add my two cents and go out on a limb.
News coming soon, hopefully this week. Company has been very quiet since last conference call on Aug. 19. Going to be very positive news from the FDA face to face - as Misiu says "FDA loves Pro-140" and no reason not to - safety is always the catch - not here. Timelines to reach milestones will shift from the distant unknown future to clarity in the near term.
Saltz top 10 timelines and milestones:
1- Face to Face with FDA regarding PIII Adjunct: Further reduction in the current 150 patients and less demanding protocol. Also possible BTD.
2- First patient injected PIII Mono Q4 2016
3- Completion PIII Adjunct Q1 2017
4- Submit BLA Q1 2017
5- Organic Up-list Q1 2017
6- Partnership Q1 2017
7- Approval BLA Q2 2017
8- Monetization begins Q3 2017
9- Completion PIII Mono Q4 2017
10- Buy-Out Q4 2017 $3-$6 Billion / $12-$24 per Share
For those interested here is how the BLA process works: http://www.avac.org/sites/default/files/u16/RegulatoryIssuesModule_November.pptx
IMO this is where Nader and team are focused. The BLA process is a roadmap of what has to be navigated to get to the promised land. Lots of hoops to jump through but we have already jumped through many of them.
Approval of such therapies would likely depend on several factors, such as:
- the safety of the therapy
? the target population of HIV-infected people that the therapy is intended to TREAT
? the magnitude and duration of viral suppression, and
? the potential for re-treatment.
Does Pro-140 passes all the above criteria? Without question. I like Pro-140's chances.
Agree 5TOP. I think we get news on all fronts sooner than later. Hopefully a reduction in patients and last patient injected for Adjunct PIII, possible BTD for Adjunct PIII, start of enrollment for Mono PIII, BLA submission Q1 2017. If Nader said Q4 then why not the first week of Q4 as in this week. If this all goes well we could have a partner by Q1 2017 and on our way to monetizing Pro-140. Raising $ the expensive way could be a thing of the past.
Misiu, you makes some very valid points with the TaiMed example and your the medical professional so I'm on board.
With the safety and efficacy Pro-140 has demonstrated up to this point I think we are looking at some type of relaxing of the protocol for Adjunct. Just exactly what that may be is the question. Once again the more impactful the news on reducing the timeline dictates how fast the SP ramps up. FDA's number #1 responsibility is safety and that's being or already been debated in the face to face. That's where we are right now - at an intersection sitting at a red light waiting for the light to turn green and what the speed limit is. I think we are about to get traction.
You can count on it Misiu. WS is fortunate to have had an awakening. The timing of the private raise combined with delays is the reason for the oversold SP. All of this is going to turn 180 and being anything but Long here would be foolish as WS said. Nobody has a crystal ball but as I review the possible outcome(s)of the face to face with the FDA, Pro-140's future may become much more certain very soon. Timelines may be shortened considerably. News that provides a clear timeline for the completion of the PIII Adjunct is most important. It's time to get this show on the road.
My opinion is the same. The S-3 was filed because the company is preparing to release very impactful news in regards to SP. We should know very soon.
It will - no worries. Fasten your seatbelt and enjoy the ride. Negative chirping is about to be replaced with singing.
I agree. Never heard about birdies-metaphor. If negative news with the FDA face to face then yes it will look very suspicious. If a person had insider info I can't believe they would hang wide open on a message board- that's why I think it is a calculated prediction(s). We will have answers soon.
It seems to me that it was a calculated prediction. WS turned from a full on bull to a bear after delays became the norm. Predicting .65 was based on riding the delays into a private raise at .75 and thinking with no news it's going to erode. WS also knows that the SP can rise rapidly with positive news relating to completion time line associated with the Adjunct PIII. This is why he is saying .50 or 1.50. It's all a calculated opinion based on forecasting the time line. Nothing more nothing less. None of it matters unless your flipping. Sooner or later the calculated prediction is wrong. IMO of course.
IMO the reason why the stock is at this level is because there has been zero news to turn it around.
-no PR that the last private raise has been completed - that translates to silence from Nader and company which means:
-no word regarding face to face with FDA which strongly impacts Adjunct PIII completion date
-no idea where we are with enrollment with Adjunct PIII which dictates the completion date
That adds up to uncertainty for investors in the near term. The long term fundamentals have not changed, however the timeline to achieve milestones that solidify this investment is unknown. My point is the above leads to shorting. Shorting will be the Long investors best friend when the news displaces the uncertainty. Having said that all of the above will IMO be addressed shortly and and positively which will wipsaw the SP dramatically.
From a macro view all we need to know as investors is when the Adjunct PIII will be completed because the results are going to lay the foundation for a partnership and the monetizing of PRO-140. This is the most logical path to an organic up list. My gut feeling is that the focus is on how the company can best achieve this economically and in the least amount of time. Clearly a defining space in time for Cytodyn and those invested.
FYI- I do not post often because my opinions matter little in the outcome of what happens with Cytodyn. I do post occasionally because I understand the emotional roller coaster this type of investment can impart on anyone and that includes myself. This board is unique in that it is respectful, knowledgeable, and a common ground to share opinions - thanks to all that contribute. The future is bright!