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does anyone know what was presented at the rodman & renshaw conference? they were to present on 9/11.
Well, it looks like the rumored $15 mil is now a $2.5 mil raise. I have wondered the same thing - why uplist if a buyout is the plan? I can guess that it is better to look like you are not interested in getting bought out in order to get a better offer? Maybe it is better to let the larger market set a price so the buyout offer is better?
I do think a raise before PR might be better, to many past good news PR's are muted from impending raises immediately after the PR.
I feel the same way, no real bad news and if there was something significantly bad it would have to be PR'd. I don't think anyone thinks that getting trough an FDA trial does not have some difficulties along the way. It is unfortunate that CYDY is not really in a position to be making any mistakes but it looks like they are controlling the situation as best as possible. In my opinion the more data the better, but it would be nice to know what specifically is going on in an update meeting. It is nice that the SP is holding up and there is virtually no volume so the market seems to not think this is a big deal.
You have failed to present any information to suggest there is any red flag. I have to ask a second time, would you not PR a planned meeting with the FDA to discuss the PE data? Would you not have a meeting at all to discuss PE data? It would be insane to do that, to simply ignore the FDA in a p3 trial?
I really don't understand why you think something is wrong. They PR that they have the PE data and are meeting with the FDA. Nothing in that says something is wrong, you are working way too hard trying to find something bad.
Be honest, would you feel better if cytodyn had no meeting planned with the FDA to discuss the PE data on there P3 combo trial? That would make me worried!
Of course there is risk - it's a small biotech company with one product in clinical trial! Bitcoin looks conservative in comparison! This is a known thing from day one - Do you think that some how there is a way to make an investment like this with very little risk? My opinion is that there is nothing to give me concern about the trial or the company. Cytodyn has access to millions to keep going with the trials. Pro 140 is being injected in patients in phase 3 trials. there have been no safety concerns in the many years of different trials. the viral loads of patients have been shown to drop dramatically with no real side effects.
Keep in mind, typical biotech drug trials are full of failures and treatments that only work slightly better than existing drugs. The FDA's job is to make sure drugs don't get on the market that will kill the patient or not do anything that they claim they will do. Many drugs have a long list of side effects but are still FDA approved. Pro 140 has not show any of these issues.
HIV is a huge market, it is growing and the existing treatments will fail. Pro 140 is clearly a marketable product even with competition.
Why would they not go to the FDA to discuss their P3 trial data? You seem so concerned about this meeting but i just can't figure out why? Do you really think the best policy is to ignore the FDA and keep them in the dark about PE results?
Ibalizumab, Fostemsavir and Pro 140 all are good for the HIV infected patients, from an investment point of view Ibaliumab is owned by tai med and already has a deal for distribution rights. Fostemsavir was bought by GSK (ViiV) from BMS. That deal is already done. Pro 140 is owned by a tiny biotech and GILD does not have an entry inhibitor that will compete with Fostemsavir. I think you can guess where i'm headed with this.
I don't think your math is wrong - you could be right on with your combo market estimate. It is hard to know but your estimate seems to be the worse case scenario and it's not a bad market given CYDY is a $100 mil valuation right now.
As for your assumptions that the FDA meeting is bad - there is nothing supporting that, it has a better chance of being great. You have been deaf to other posters here explaining that the FDA meeting is a step in the process and has nothing out of the ordinary to it. Do you really think that once a company gets to PE in a P3 trial and they don't meet with the FDA? That sounds crazy, meeting with them to discuss the data is to be expected.
As For the financing, insiders may not have or want to get heavier in investing in CYDY and the fact they get convertable notes is not out of the ordinary. The deal with paulson has been done before and has been the method to raise money to keep trials going. mgmt does not control why traders buy/sell the stock on the OTC so having to raise at these levels is just the way it is. It would be nice to raise at higher SP but they must keep going. Traditional financing is not typically into speculation in small biotechs so it is likely that is not an option. The good thing is that once they raise the funds, there isn't a future major dilution holding back the SP when PR does come out.
I think the combo trial was always meant to be a quicker and cheaper trial to show how close they can get to FDA approval while doing the mono trial. the combo is creating binary event PRs while the mono trial is on going. The fact that combo has taken longer does not mean much because we are on the brink of getting PE data while the mono trial is still enrolling. In the eyes of the FDA they are seeing data from pro 140 in the combo and will have a good idea of what the data might look like for the mono. If the appetizers are great, the main course is likely great also. This is what i mean by the combo paving the way. I don't know of a specific statement from the FDA but asked Jody specifically why CYDY is bothering with the combo trial, she answered by saying combo is a very important step to mono.
I must also repeat - any talk of the marketing and sales plan for pro 140 is the future BP's issue. CYDY is not going to exist at that point, in my opinion.
I agree with you Tony, thanks for adding detail to the pharmasette deal. also I must add that the HEP C and the HIV markets are both about $12 billion/year, so using this deal as an analog holds some water.
I think you proved my point, the MDR market is small. that is why tai med got orphan drug status. even though they cover both tropisms it is a small market. CYDY is doing the combo trial in response to the FDA wanting to see how pro 140 performs in comparison to existing treatments. it is a very important step in the mono trial and paves the way for the mono trial process and results in the eyes of the FDA. Data presented in the combo trial is very significant because it shows pro 140's effectiveness in the most sick patients who don't have many options left. If it works as well in those patients then the relatively healthy patients will have a drug that will greatly benefit them for a long time safely.
I hope you see that when ever I talk about cytodyn as an investment I very specifically talk about buy out and when a buy out happens. I don't think for one second that cydy will market, sell and distribute pro140. they are meant to be bought out. The thought that profits will be maximized the further pro 140 gets down the road of development might be true but in reality cydy is in the process of proving pro 140 works, it is safe and it works in the market size they claim it does. PE data will show that and going beyond that will only cost time and further dilution. This process is not linear, it is a sequence of binary events and the largest and most significant is PE on the mono trial. I am confident that any company looking at buying cydy is waiting to show the data and will pay the money required to get a drug that show it does what it says it does and can get FDA approval. BP picks up the ball at that point in most small biotech developed drugs. I obviously would like to have that happen ASAP, but there obviously is a threshold that must be crossed before it does, FDA approval is not it, data is.
no problem! i hope you understand i'm not attacking you - i just feel compelled to point out how pears creates bold false statements that are purely made up to scare everyone. I don't know how pears can have a clear conscious when actively trying to destroy a treatment that can so dramatically change the lives for HIV positive people for the better.
well, lets do a google search, this is what i found in a study testing pro140 back in 2010:
The first HIV trial of PRO 140 was a randomized, double-blind, placebo-controlled study in 39 individuals with early-stage disease. Cohorts were randomized 3:10 to receive a single infusion of placebo or PRO 140 at doses of 0.5, 2 or 5 mg/kg. PRO 140 was generally well tolerated, and no dose-limiting toxicity or pattern of toxicity was observed. There was no requirement to pre-medicate with antihistamines. There were no remarkable laboratory or electrocardiogram findings.
Rapid, dose-dependent and highly significant reductions in HIV-1 RNA were observed (Figure 2). Mean maximum (nadir) viral load reductions of 0.39±0.20, 0.58±0.30, 1.20±0.63 (p=0.0002) and 1.83±0.41 log10 (p<0.0001) were observed for the placebo, 0.5 mg/kg, 2 mg/kg and 5 mg/kg groups, respectively. At day 10, the mean log10 declines in viral load were 0.13±0.24, 0.37±0.54, 1.04±0.45 (p=0.0001) and 1.70±0.49 (p<0.0001) for the placebo and ascending dose groups. Mean viral load reductions of >1 log10 persisted for 2–3 weeks post-treatment in the 5 mg/kg group. All 5 mg/kg subjects had an antiviral response of ≥1.0 log10 reduction in HIV-1 RNA (Figure 2). These single-dose antiviral effects are the largest reported for any HIV-1 drug and compare favorably with those observed following 10 to 14 days of treatment with small-molecule CCR5 antagonists
The area under the PRO 140 concentration-time curve from time zero to infinity (AUC8) values increased more than proportionally with dose, averaging 11.1, 74.3 and 278 mg × day/L for the ascending dose groups. Mean terminal serum half-lives were 3.9 and 3.5 days for the 2 and 5 mg/kg dose groups, respectively. All tests for anti-PRO 140 antibodies were negative with the exception of a single low-titer result at Day 59 for a 5 mg/kg subject. The antibodies had no obvious effect on PK metrics or antiviral response. At 5 mg/kg PRO 140, there was a trend (p=0.055) towards increased CD4+ cells over baseline. There was no depletion of CCR5+ cells following treatment; however, significant receptor occupancy (p<0.05) was observed for 2–4 weeks in all PRO 140 groups. This study established PRO 140 as a potent antiretroviral agent with prolonged activity.
Looks to me like pro 140 has no problem binding to the CCR5 at all. Pears is really just making this stuff up.
here is the link:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2760828/
I think it is hilarious that you criticize cytodyn for the combo trial being delayed and a small market but praise tai med for their getting approved for a iv version that is for a small part of the market be cause it is a fast way of getting in the market. Why is it smart for tai med and bad for cytodyn? Also, the fact that tai med has more employees and a large sales staff says they will likely not be bought out yet cytodyn is not wasting time or money building infrastructure because they know they will be bought out. I'll take a buyout offer in the near future any day.
Thanks Misiu, I feel crazy for looking at it this way but there must be some source of the mgmt's confidence. They are not in this just for the paycheck.
I have just done a little analysis of the GILD buyout of KITE to see if there is some insight into what might happen with CYDY.
GILD paid $12 billion for a company that is in phase 2 and will be in phase 3 later this year for ZUMA, it's CAR-T treatment witch is a $2 billion/yr market.
Also, back in 2011 GILD paid $11 billion for Pharmasette, the hep c market is $16 billion/year and at he time there PSI 7977 drug was in phase 3.
So, CYDY has pro 140 which in phase 3 in 2 trials and is in a $12 billion HIV market. right now CYDY is a $100 million company.
In looking at this I can only conclude that CYDY should not be at this share price and a buyout # should be somewhere around $11 billion. That works out to roughly $40/share - way beyond any estimates given here and I have a hard time seeing this actually happening. But, pro 140 is at the stage of development and in the size market to have this happen.
The big difference is that GILD bought both KITE and Pharmasette to get into those markets, for HIV GILD is already in the market.
I'm sure this is a very superficial look at things but just because we a weary of the time this is taking does not mean our price tag should suffer.
Exactly, this is not your typical publicly traded company. I think of it as I'm an investor in a small business. The daily SP fluctuations really are meaningless and the milestone developments in pro 140 are everything.
Fred, It seems like if your argument about SC vs IM injections does not hold water then you jump right into timeline estimates for pro 140 getting on the market. I think you are very strongly in the opinion that pro 140 and cytodyn is going to fail some way and you will be right and we will be wrong. there is very little facts behind your statements and they are purely guesses with a bias. I personally don't think anyone is that concerned as to when pro 140 is actually on the market - CYDY will be sold by then. getting a drug through the FDA process is very time and capital consuming - we know that!
Maybe tai med should buy cytodyn!
You again are really working hard to find fault with pro 140. even if your argument turns out to be true you are looking at just the MDR market. it is splitting hairs and there is plenty more market for pro 140 than ibalizumab. Tai-med is not pursuing ibalizumab as a mono treatment at all. Also, I don't think most of us are really thinking about the value of pro 140 when it is on the market - we are thinking more about the value of cydy stock when it gets bought out.
just for fun, here is a sequence of headline milestones for ibalizumab over the past couple years. align the dates with the chart and we can see what the SP might do as we achieve these milestones. P3 data results for them was in early feb - that is when the SP was at $3.5/share, now at $7.75/share.
•May 3, 2017
Theratechnologies Partner Submits Biologics License Application for HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab
•March 6, 2017
Theratechnologies Acquires Commercial Rights to Ibalizumab in the European Union and Four Additional Territories
•February 14, 2017
Theratechnologies Announces New Data from the Pivotal Phase III Trial of HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab
•January 17, 2017
Theratechnologies Inc.: Ibalizumab 24-Week Pivotal Phase III Study Results Accepted as a Late Breaker Will Be Presented at CROI 2017
•August 18, 2016
Ibalizumab Phase III Study Primary End-Point Results to Be Presented at IDWeek 2016
•May 24, 2016
Theratechnologies Announces that 82.5% of Patients Achieved the Primary Endpoint in the Phase III Ibalizumab Trial
•April 27, 2016
Theratechnologies Announces Completion of Enrollment for Phase III Ibalizumab Trial
•March 18, 2016
Theratechnologies and TaiMed Biologics Sign Exclusive Marketing and Distribution Agreement for Ibalizumab
I might have a naive view of this but the FDA's job is to evaluate if a drug does what the developer says it does and is safe. there are many treatments that have a long list of side effects, possible safety issues, may only work for a very limited # of people and only improve their health only slightly that are FDA approved. The drugs that fail to get FDA approval have patients who die and or drop out due to side effects in trials and/or the drug ends up not working in its intended benefit. We don't have those problems at this point, to think that The FDA is some sort of gatekeeper that just decides to limit the application of a drug or not approve without good reason does not seem to be true. If anything the FDA looks to me to want the trials to go well and approve without any issues. I don't know if the FDA will just widen the label but i surely don't think they are holding pro 140 back in any way. The FDA does not care about a stock price or the competition to a drug - they are not doing market analysis as a determining factor on FDA approval.
I am not concerned because all of the issues you bring up have a rational explanation. BTD was not approved months ago because the FDA wanted to see more data, cytodyn now has more data and is going back the the FDA to see if they can get BTD. I have already explained the cash issue - they want to raise at a higher SP, they feel the data from combo will do that. The reason the trial enrollment stays open is because patients sometimes drop out of trials - remember this trial has 15 patients on pro 140 and 15 not on it as a control. They want to have extras to make sure they can keep the trial going without delays due to patients not making it through the whole trial. Remember - these are very sick patients where current SOC may not be working. Having extra patients is a no brainer. Cytodyn is very aware of how pro140 benefits HIV positive people - they have created a way for past trial participants to stay on pro140 in extension studies because it is so important to them.
You are reading way too much into this and failing to simply read the words as they are. I know this is a risky investment and anything can happen, but there simply is no evidence that anything is wrong. You might think i'm blind but to bail out when the clinical trial results for a drug that has no side effects, no safety issues and has show such a dramatic benefit to HIV patients would be dumb.
This is the only investment i have in my portfolio that is so dependent on binary events. I will never invest in another situation like CYDY because my philosophy is very different now. I trade options and futures with the rest of my portfolio and know as a rule that trying to predict the future is foolish and it is best to trade what does happen, no speculation necessary.
I'm not sure where you keep getting this "alterations to the protocal" idea. The meeting is to discuss the results of the PE and see if they can get BTD and AA along with the BLA steps. This is a step in the process and has not changed. Mgmt must feel confident about the trial if they are asking for BTD and AA. I'm not saying that it's a sure thing that everything is great until we know it is but i have a hard time seeing anything that suggests anything is wrong.
They need to go through the FDA because it is an FDA trial. These trials are to get FDA approval and that means the companies direct communication is with them, we are along for the ride. The cash they have is enough to get them past this meeting and it looks obvious that they expect good news and a higher SP with which to raise funds that will be less dilutive. There is nothing that looks out of place here Fred.
Fred, I'm sorry but your points in theory are possible but just because you are not getting the information now does not mean "the chances it is very bad are increasing sharply"
There has been no news that there is any problems raising money. the closing of the funding round has a better explanation that they want to raise cash at a higher SP after the combo PE data is PR'd. Any other reason does not have much supporting evidence.
As for going to the FDA with "hat in hand", i don't think there is any news that that is the case either. The FDA lowered the patient count from 300 to 30 simply by asking them, that tells me they are confident in the results and that 30 patients should show sufficient data.
I really don't see where you get any supporting evidence making this statement: "prioritize the funding to complete the combo trial which now looks to be in some sort of trouble" What trouble are you talking about? the fact that Tony hasn't called you weeks ago with a full update? have you talked with the 33 patients and they told you pro140 doesn't work? would you rather they do funding raises at this SP?
I think this is a risky investment but jumping to conclusions that must be negative is not as easy as conclusions that patients are being injected, pro 140 works, non are diying from it etc.. CYDY is collecting a lot of data and it takes time to collate it and present it with the FDA. We have to wait and see.
I'm not sure how you draw the conclusion that they are trying to alter the protocol. just because they are having a meeting in which the data from the combo trial, the safety from the 100 in mono trial and the status of BTD has anything to do with altering protocol.
I agree - the FDA i doubt will shorten the trial. I'm not counting on that, just pointing out that details of an ongoing trial can change and the meeting with them is very important for the future. As for the mono trial results taking time - i don't think this is true, it is not a blind trial and over 100 patients are in it already. If a BP wants to sign an NDA they can see what is going on with that trial now. I would think it would be crazy for any BP in the HIV market would not want to know what is going on with pro140. Obviously this must be very confidential and we won't know until a deal is already done - Tony has stated this in the last CC.
The combo trial is not done - it is in process. the PE data is just from the 1 week from injection results. Meeting with the FDA is really important to show where they are at and what the FDA is thinking as far as the entire trial. The FDA can change their requirements based on these PE results. They might even say they have seen enough to approve without the trial being complete. Assuming this is bad is working harder to find a negative vs the data is good.
As far as mono being more important - i agree but it really does not matter which trial they are in. it just matters to have a large data set of good results to show that pro 140 works, works better and there is no safety concerns. Cytodyn just has to show they have the best mousetrap in this multi billion market and the ones with the most to loose and gain will jump in. I don't know what the threshold is but there are many biotechs that are bought out in P2, the fact we are in P3 and still no buyout tells me the stakes are high and no BP wants to get stuck with a looser and/or cytodyn is not selling for cheap. I am confident about the science and the confidence of the mgmt tells me that hey are confident of the dollar value of pro140.
i was in cytodyn back then and at the time and that was when they bought pro 140 from progenics. the big news was not just the purchase but the fact that pro140 came with i think $20 million of grant money. I might be wrong about the amount but i'm sure that was used up long ago. I remember wondering why progenics would sell it but the reason given was that they needed to focus on cancer treatments and felt pro140 would take too long and too much money to develop. cytodyn was kind of dead in the water at that time and the pro140 purchase changed that.
Can't blame you for taking profits after years of being in this. I just wonder why there is any selling given the enrollment is complete and we know in 2-3 weeks at most we will get the data that should propel the SP. hopefully you jump in again at the right time.
I'm curious, when you say management needs to do better what are you looking for? I can see sticking to timelines better and clearer communication but to be honest compared to other public companies they are very transparent. Also a lot of the future of this company depends on independent trial sites, patients and the FDA - mgmt has very little control of these for obvious reasons. what would you do if you were mgmt?
-not trying to bash you for selling - just interested.
I'm not trying to question your opinion - i was just pointing out the math behind a RS. If the end game is to be bought out then staying on the otc is fine. I*t would be silly to go through the process and spend the money to be on the NASDAQ for a few months. However to get the most money it would be better to let the market set a value and go from there, if it takes uplisting then so be it. Right now on the otc there is very little valuation going on given were pro 140 is in development. we should be in the $3-6 range but because larger investors are out of the picture there just is not enough to put a price on.
Not a good example, if a BP offers $1 billion, then the amount per share lets say is $4. If there is a 2:1 RS the $1 billion would result in $8/share. An offer to buy the company is a total dollar amount, not a per share offer. Mathematically a RS does nothing and is intended in CYDY's case to get uplisted to a real exchange to allow larger investment firms to buy in on the open market. The history of companies that do RS is that they are in trouble and trying to stay in the market and do many raises. For this to work there must be a steady string of positive PR to keep the SP up so it does not fall off the market it is uplisted to.
seriously? If cytodyn gets bought out entirely then yes, they would not be developing pro140 for another indication. If cytodyn licenses pro140 for one indication they could also develop it for other indications and licence it out for those indications. I don't know how much more clear this can be.
I agree, it is very frustrating to see no bump. In the past there have been plenty of good news that fails to move this stock. my fear is that the news we are waiting for will also fail to move this. We all assume the data will do the job but until we understand why past news didn't work then why assume anything. I would like to get more answers from mgmt about why we are stuck here. my logical assumptions seem like a waste of effort. on the other hand this PR is just that they enrolled, no results, so maybe all that matters is data?
I think you are right, but given the guessing required to know what mgmt will be doing when, your guess is as good as any. All we know is that they stated they will be meeting with the FDA in the next few weeks.
All I know is that the 100's of patients injected over the years have shown efficacy and no safety concerns so i'm not worried about the data. the only worry is what the FDA does - and know one has control of that!
Yup, we don't know when the 30th patient was injected. It could have been over a week ago and the data is being compiled now. I would think that if mgmt set up a meeting with the FDA for early sept then they must have the data now.