Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I know we have had light volume days in the past but only one trade for 500 shares? does that mean something?
I agree with you, it is a publicly traded stock and the SP is our relationship with CYDY. However, CYDY has very little control over the enrollment sites and the FDA. It is better if Nader considered the fact that he can't make patients walk into an enrollment site and can't hold anything over the FDA to get them to deliver on their own timelines. But, Pro 140 works and the market is in the many billions so what more can you ask for?
My attitude about timeline is that it is just a measuring stick for judging Nader's optimism. At the end of the day the enrollment for both trials will take the time it takes. the data from the trials i am confident will meet the FDA's requirements and get approved. Deciding weather not the enrollment sites get all of the patients by a certain date is just a speculative hope that has very little to do with whether CYDY gets bought. I would like for things to move fast but i would rather things go as planned and take the time they require. I've been in this for over a decade and to focus on a few weeks really does not matter to me.
Insider Transaction Type Value Date Shares
POURHASSAN NADER
Officer Purchase at $0.66 - $0.66 per share. Indirect 9,900 Oct 20, 2016 15,000
MULHOLLAND MICHAEL D.
Officer Purchase at $0.66 - $0.66 per share. Direct 7,260 Oct 16, 2016 11,000
NAYDENOV JORDAN G
Director Acquisition (Non Open Market) Direct May 9, 2016 1,000,000
I like your tempered tone but i must add this for the requirements of BTD:
First, this designation can be applied only within the context of a “serious or life-threatening disease or condition.” Second, it must be predicated on “preliminary clinical evidence indicat[ing] that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints.” The FDA has interpreted the second criterion to mean that data from studies in animals or conducted in vitro showing that a drug has promise are not sufficient to justify this designation; data from clinical trials in humans are needed.
this is from a new England journal of medicine article. In my opinion pro140 meets this criteria more than most other treatments and this designation is designed for a drug like pro140. for the FDA to not grant BTD would be more of a what the hell does a drug need to be to get this designation in the eyes of the FDA? I think the only reason pro140 did not get BTD earlier was because there was not enough data in human trial for the specific indication they were requesting BTD. when the application was submitted Nader also said they needed 5 patients data and they already have 7 patients. So i will be shocked if they do not get it.
my favorite quotes from the article you posted:
If or when PRO 140 goes to market, the company likely would partner with a larger pharmaceutical company.
“We don’t believe that we’ll be selling this product,” he said. “We are going to get the partners.”
“We’re talking about $60 million the last three years we have spent on this product,” Pourhassan said. “We are probably going to spend another $50 or $100 million even. But if you can come out and sell even $1 billion, that’s huge.”
also, keep in mind the 2018 on the market prediction is likely for mono therapy, the adjunct should be much sooner than that.
looks like the 10k+ sell blocks are gone. that's a nice feeling!
maybe i'm missing something but i don't see your scree name on the list. do you have multiple screen names?
I agree with the 100% statement from wallstreet - mostly because i know that wallstreet is just very confident and does not need to explain why he feels that way. You must admit the possibility that the results will be much closer to 100% than your 0% fear mongering statements. why in the world would you put a dollar behind a company when you do nothing but post about complete failure?
i don't think you understand - adjunct has a very small chance of failure. your comments are on the same level as "if the plane's wings fall off the plan will crash". We know that over a hundred patients have been injected with pro 140 and zero have died from it, all have seen a VR drop and i think if you ask them they would prefer pro140 over any other HIV drug.
good question for the next conf. call - ask them! i'm all in favor of CYDY getting bought for $2/share or up (i don't think for a second they will get bought for $2/share). the thing you have to remember that even if the worst is true, there are a certain percent of re bounders, pro140 does work in a much larger percent of patients. it has value and even as a combo it is the best part of the combo against all other treatments. also, the criteria in the trials does not require 100% perfection, the VL suppression is set higher that what pro140 has shown already. you do not need pro140 to work in all patients. Many drugs are FDA approved that have horrible side effects and only work in a small # of patients. To say that pro140 will fail is just a sky is falling statement.
Do you think buying a biotech is an ebay action? cytodyn presents at a conference and Gilead cracks open their wallet on the spot and buys it? Do you think that any company in the HIV market is unaware of pro140 and needed CROi to enlighten them? GILD knows about pro140 - it's there business. we have discussed the why CYDY has not been bought yet and the general consensus is that they want more data. I think you even made that statement. has there been any new data presented?
thanks trding! as for the selling there are 2 reasons i can think of. one is the agreed upon reason is warrant holders are selling off shares and holding just warrants to reduce there risk. i can't understand why they would sell at such a low but, it might be just a rule. the second reason might be some large holder of shares just decided to unload there position because they changed there attitude about the future of the company, found another investment or is in some sort of pickle and needs the cash?
sorry, i'll be the first to admit i'm a terrible speller and often don't bother with spell check - my bad.
they have cash - they just did a capitol raise.
Nader is a mechanical engineer, we have known that for a long time - thanks for bringing it up again for no reason.
why did you not bring up the low "N" and re bounders in your last post? seems just as repetitive as any of your other statements.
did you figure out how you ended up being a moderator? is it just because you post a lot? i don't think anyone here thought it would be a good idea for you to be a moderator, even yourself.
There are more articles about what GILD might buy than Gild has dollars. the most articles i see are for oncology companies. however the HIV market is growing and a huge chunk of their business. big companies don't tend to just shut down major parts of their business just for the hell of it. I'm sure GILD is looking for the next market to dominate but they are in a desperate situation in there HIV business.
I remember the conf. call when the announcement for the denial of BTD last time. It was because they were using the data from p2b trials which are mono trials and the BTD was for adjunct use. It was stated that the data needed was only i think 5 patients, and we have at least 7 that we are certain of in adjunct p3, i would think that is why the re-application for BTD was done. It would be very surprising if the FDA did not give BTD this time. I also remember that Nader did not think BTD was that important because they were already getting preferential treatment from the FDA to a degree equivalent to having BTD. all the more reason to beleive the FDA wants cytodyn to apply and get BTD just to justify the preferential treatment they are getting.
Just a thought, maybe its another motivation to buy up CYDY just because they have pro140 so far along the process with the fda. BP i think considers the flow of new patents and expiring patents as part of doing business and CYDY is the closest new thing in the process. as if CYDY needs yet another reason to be bought out!
I would agree saltz on the FDA wanting to see p3 adjunct data to be sure there BTD is appropreate. If there is a PR about BTD with out an update on enrollement/PE for adjunct i would assume the FDA has seen enough of the adjunct data to confidently award the designation. So, i don't think both need to be PR'd at the same time to have the effect we want on the SP.
I bought a little more - just too cheap not to
I have to admit that there are too many times i anticipate logical expectations for this SP and i am 180 degrees wrong - i've chosen to sit on my position and just watch what happens. nothing is different about the market and pro140 so why worry. just wait until what will happen happens.
Can someone explain why the selling volume today? it seems so odd to me that it has been building for the past 2 weeks despite the near future catalysts. is it as i guessed just sell before the news risk off attitude? curious of your theories.
did not think of that - thanks for pointing that out chump! interesting how these little bread crumbs will make sense in the near future.
I hope that this raise is enough to last until some SP appreciation provides an better negotiating position. I do strongly believe we are on the cusp of that happening.
Why would CYDY do that? i would think the terms would be more strict given how damaged the SP got after past raises? When is CYDY going to do something to benefit us long time share holders?
and your solution to the fact that clinical trials cost money is.... Why do you always paint a picture of some sort of perfect world where stocks just go up, people involved have perfect backgrounds, cost of development is free, no competition and it can all get done in days?
Nader explained why they use capitol raises - time savings. the time it takes to maybe get some sort of grant money is why these type of trials take many years to happen. it sucks but i'd rather move forward than sit around waiting at a low cost.
also, I seem to remember that the reason the FDA lowered the # of patients for the adjunct trial to 30 because Taimed only had to have 30 patients for their trial. Since Taimed got BTD i would think CYDY would also get it.
You really think it has to do with the SP? you posted direct insults to other posters and they responded by blocking you and then giving up on this board. are you really not taking responsibility for your past posts? I guess i have a thicker skin and try and find the good in your posts but even I find it difficult to read your mood swings.
If you look at the purpose and criteria for BTD, it would be difficult to understand how pro140 would not get it. I would be on Cydy's side in saying the FDA really is off base by not giving it. I do have to agree that the when is completely out of our control so why worry about it.
here is the info i found on GILD's TAF, my opinion (i'm not a medical or scientific person) is that this is just GILD trying to come up with something for later this year when their current patents expire. not a new form of treatment. also, PRO140 is really a mono therapy and being approved as an adjunct just to speed up the approval process.
TAF was originally positioned as a potentially more potent tenofovir prodrug, but virologic and immunologic responses in trials comparing TAF with TDF have been indistinguishable. However, there are three advantages of the low milligram dose needed for TAF: 1) smaller size tablets for fix-dose combinations (FDCs), 2) lower generic equivalent production costs and prices for low-income countries, and 3) reduced kidney and bone toxicity.
Although there are no data confirming that TAF-based regimens are associated with a reduced risk of significant renal disease or frailty fractures compared with TDF, TAF is likely to be a safer drug, both over many decades of use and for those with pre-existing conditions resulting in declines in kidney function and bone mineral density. Unfortunately, however, TDF’s safety concerns have not been sufficiently pressing for Gilead to rush TAF to market: development was shelved for at least ten years, with coformulation approval timelines curiously tied to TDF’s patent expiry in December 2017.9
As the new TAF-based coformulations become available, Gilead has been undercutting the prices for its own TDF-based products. This is not generosity, but is instead likely a strategy to retain market share before TDF goes off patent, as it will be more difficult to switch patients back to a generic version of a drug that they were previously tolerating well.
People living with HIV should have better drugs. But the strategy for this particular advance threatens to tie drug purchasers and insurance providers, whether public or private, into higher cost ART for at least the next decade. This can potentially result in two-tier access to low- and high-cost treatment for people living with HIV.
I don't think anything has changed with possible competition to pro140. we have discussed every possible competitor to pro140 as they come up and the typical consensus is that the competitors are years away from where pro140 is now. the speed that pro140 is moving has not changed and we are not falling behind just because we are feeling a little starved of updates. also, if the value is only $250 mil, that's still a $4/share SP - not bad in my book!
I think the 3rd possibility is everything is fine with pro140 and CYDY and stock traders are taking a risk off attitude. there may be one or a few traders that bought months ago taking the chance that the SP would rise on anticipation of future news with the plan to sell before the news. many traders don't take binary event risk and CYDY announcing results etc is a risk that can't be predicted. The lack of enough buying pressure to drive up the SP is purely because everyone that knows about pro140 and wants to make an investment in it is already in it. mgmt probably has not done us any favors by not getting the word out as much as they should or not getting uplisted somehow to create more buying pressure. However this is where SP and actual product development operations are on different planets. I believe that pro140 is currently moving forward ant a fast pace and that some day the company will profit from it, SP is just a representation of different motivations.
I'm no expert in the small biotech investing field so i need to ask what you think of cytodyn focusing on developing pro140 as fast as possible and not really focusing on promoting the stock? It would seem a warning sign is when there is more emphasis on stock pumping while the product sits there doing nothing. I'm not that concerned at this point mostly because there are actual trial going on, actual patients praising the existence of pro140 and the FDA honestly is pushing for pro140 to make it through.
Thanks newmike for the dose of reality - the volume is actually quite good today on no news. I guess who wouldn't buy at $.69, screaming deal considering!
I doubt we can get any info until there is some official news. I talked with John in IR this morning but mostly to let them know the potential of pro140 does not seem to be represented in the stock price and us investors are getting tired of it. I think keeping pressure on them so they don't forget us is always a good idea.
That makes more sense - cytodyn is paying a contractor to do a job. as much as cytodyn needs to get this done the contractor ultimately must deliver.
I just called IR just to ask if they are aware of this selling pressure. They said there is nothing to report - no bad news etc.. Basically it looks like someone just decided to jump ship for whatever reason this week. It would be great to hear from Anthony, especially with some good news. It's just difficult for us to see so many positive catalysts in the near future and the SP is not responding in a logical (go up) way.
I hope your right and find it hard to imagine there is anything but positive new in the future. maybe the pressure is building on anticipation and its too much for some stomachs? it is certainly challenging my stomach!
I don't see a big chunk but obviously selling volume is greater than buying volume.
I woke up this morning thinking the same thing. I don't know for sure but before Nader the stock price was around $.70, and now with all of the development in pro 140, a product that can take a chunk of a $10 bil/yr market, it is about $.70. I would think if you asked any potential CEO to take the reigns of a company with a product that has this kind of potential there would be a line of qualified candidates. I have supported Nader for years because he has moved the pro 140 development at a very fast pace, however the disconnect to the SP has become an elephant in the room that he has never addressed.