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The way I see it, our collective group of minds does have value even if most of us aren't statisticians. We are all on the same team here trying to figure out if CVM is worth investing into. It is very valuable to have multiple people fact checking and checking each others math on our spreadsheets. My success date is mid February as well like a few other people. The fact that we are mid January without any news is reassuring to me. No news is good news.
I currently have a small long position open for CVM just as a precautionary measure for myself so I don't get FOMO and start chasing the random pumps. I'm more than happy to average up if needs be once end of February/March hit. Until then I keep just reading everyone's posts and CVM news to see if there is any other useful information I can use.
I guess you're right.
It's my turn to eat crow. I've been following CVM on Stocktwits a lot as well. (I prefer this thread more though because it has more thoughtful relevant information). Anyway I've seen a lot of articles mentioned on there. But when I did a google search I haven't found anything relevant in the last 6 months besides like you said from CVM's website. So I guess it isn't getting mentioned much at all. Besides the shitty websites like "seeking alpha".
That does give me pause, but with that said, the only thing that would worry me is if the study ends within the next two months.
On the positive side, we should be becoming compliant again officially on the 14th if I'm correct.
Hit and miss. It's a case-by-case basis. And also let's not pretend that CVM isn't getting mentioned at all. It is still talked and written about. Maybe just not as much as we would like.
I guess. But I've heard of Bio companies before that were mentioned a lot and then failed altogether.
I personally think CVM isn't going to be mentioned until the 298 events occur. Everyone is just waiting. I wouldn't read too much into the fact that they weren't mentioned.
That's a good point. I do remember the CEO of another company being very positive about his company before it completely failed. So it is is smart to not completely trust them.
It's kind of a win-win for me. If it goes up I'm happy. If it goes down I can buy more cheap shares. I honestly would be fine if it dipped under $2 even. This is a long term hold for me
Most of these bio companies that are being bought out are already worth over $50 a share though. I guess I'm just more pessimistic in terms of this. I'm holding shares so obviously I'd love a buyout I just am trying to be realistic.
I agree with your analysis of Geert. But the whole market is horrible right now. VERY FEW stocks are even green today. I'm not surprised this is down so much.
Informed biotech investors still don't know much more than us since it is a blinded study.
So as much as I'd love someone to buy out CVM. How common is this honestly? Every single board I see people talking about buyouts. It's the golden egg. But I doubt it's common at all. Probably 1 in 10,000. Anyone have thoughts on this?
No he isn't saying that. He is saying that if Standard of care increases naturally over time, we would be smart to expect that the study patients would naturally live longer overall because the standard of care is better in both parts of the study.
As to Geert, I've heard that he is fairly bad at predicting when events will occur. Which is a good thing for us because if he is predicting that it will happen early but it takes more time for it to end that only can benefit us.
Thank you! I completely spaced that part. That's a very good and promising point. Does anyone know what the completion date would be if BOTH of the two (out of three) control arms had a 55% survival rate after 3 years? At least that way we could compare where we are now to when that had transpired. I'm assuming we are already a few months past that date at least.
Also, going along with your correction. I would assume that we should still be months out at the very least if SOC is improving overall.
Thanks for your thoughtful feedback. Good to hear from you again! You're one of the only people on this board that I trust to provide smart, thought out feedback in relation to CVM. If we could make it to April I'd feel very good about CVMs chances of being successful. But seeing as I'm currently holding shares, if news comes out that the events have occurred before then I will most likely sell my shares and mitigate my risk.
Your point about CVM battling against an increasingly better standard of care is very good. It also makes it hard to say that even if we got to April is that because CVM was effective in prolonging life? Or is that because the standard of care has increased and prolonged patients lives more than the 55% that was initially proposed.
I'm glad you're a voice of reason. I see way too many people on message boards fully believing that CVM will be effective. I'm completely on the fence. There are too many variables. The one thing I do know is that the more months that pass without any news makes me feel better about success.
I wish I could provide you more useful insight at the moment but I think we are about on the same page here. The one thing I would add is that I followed HSGX (histogenics) and learned a few things from their downfall. I don't know if you heard about them but they were also a Bio stock company trying to get a product FDA approved. They claimed over and over again that they felt very good about their chances but ultimately failed. Which goes to show that no matter how overwhelmingly positive a company may claim they are, it doesn't mean it's a sure thing. Ultimately I think it's best to trust your gut instincts. When I do that I usually come out on top. My gut on CVM for now says to hold and wait to see what bits of news updates come out. I agree that there is still plenty of time to jump in or out before major news is released. The next update I would expect is that the 298 events have occurred but they would then have to take time to measure all the numbers which would give us time to deliberate and see if it's smart to be holding shares.
Best of luck to you. I'd love to hear your updates personally if you come across any. I'll try and do the same. Happy New Year.
Thanks for your thoughts on this. I'm currently holding shares but very skeptical at this moment if news were to come out now. Lightrock makes a good point that the standard of care has been increasing survival rates as well so CVM isn't competing against a stagnant number. They are competing against care that is getting better. Which is honestly a good thing overall, but harder for CVM to be successful.
Have you read lightrocks response? He is the person I trust most on this board.
Lightrock. I know we discussed our math on the potential success date for CVM/Multikine. I was wondering if you had any updated thoughts/numbers on it?
I keep hearing people quote the same incorrect May 2018 article (that you corrected) saying 10% success was already met by then. I am much more cautious. My numbers put me at mid February for phase 3 success. While as I remember your numbers said August 2019 for phase 3 success.
But CVM is saying they may have the 298 events by January 2019. That sounds very dangerous to me. I don't want to get caught up in the craze and lose a bunch of money if they are going to fail. My numbers still say at least mid February for good news. But you're one of the most sane people on here who has actually run the numbers so I thought I'd ask for your thoughts one more time and see if there is any more info I may have missed.
I agree. The more I follow this stock the more I feel that HSGX is leaving investors in the dark on things. I feel there is information we should be aware of that they are hiding from us. I'm out for now, I will check back in at the end of December, maybe buy in around .30 cents.
Best of luck with this shady stock
Isn't anyone else concerned about the wording in their report about the FDA meeting? It sounds to me like the FDA is on the fence about approving them filing a BLA application OR making them do more research/trials before approving them. If it's the latter, HSGX is going to have to do a R/S and another offering which would kill the stock price.
Again, the only thing I was pointing out was that you shouldn't mislead people by telling them it could be fast tracked. Even if this gets filed, NeoCart won't be on the market until 2020. This still has a long way to go. But I don't think you're understanding me. That's fine.
Not being pedantic here. That difference in terminology is actually super important. Fast tracking a drug can be the difference between months and years.
The FDA could easily say, "yeah we might accept this, BUT we need a little more data first, can you give us some more statistics from patients in 6 months first please" and then like that HSGX has to reverse split to keep from being delisted, do another offering and dilute to raise more money. I mean it could get really ugly real quick.
The news for now is still fairly neutral. Just trying to be honest and explain for everyone reading this that this is far from a sure thing. Could still totally get approved for a BLA filing, but maybe in 6 months. Thing is, no one knows for sure for another month now.
Just to clarify, the FDA cannot "fast track" a drug like this. Fast track is reserved for life saving medications like cancer drugs. Just thought you might like to know
That's a fair point. This stock has just been pummeled down for so long... I still expect info to leak before officially leaking
So if that's true, wouldn't you expect to see more big buying if the results were positive?
Yes there is a meeting today. But don't expect news today. Most likely next week. Some people are saying the end of November, but that's for the entire meeting notes, we will get a news update way before then. Somewhere between November 1st and November 8th.
Holding my shares through the meeting on Tuesday. Wish me luck!
With price so low I honestly don't have much to lose here. I'd rather take the small risk the meeting goes poorly because if the meeting goes well I expect a big price jump since price hasn't moved. Usually after these types of meetings people sell since price has been pumped up so much, but price has nowhere else to fall to. Anyway, just saying I'm going for it on Tuesday and don't care. Hopefully I'll see you guys at $3
They won't do a R/S if price is above $1 in a week. Stop creating fear unless you can back it up with a source
They have 180 days to become compliant. This is just fear mongering.
Can you post the link to the filing so I know this is real?
One of these days it's going to gap up overnight
Licenses are super important. But I'm not going to argue that with you.
I think we agree though that the price will run up to the 30th after the offering closes on Wednesday. I'm still more bullish thinking it will gap fill back up to $2.50 before the offering. But to each our own own.
It just would make a ton of sense to me for it to hit the price it was at before the Phase 3 fail since it has a great chance of getting back to that development wise. The next 3 weeks will show us what's true here, not too long to wait.
Yep, glad to help. Hope you can read this information and decide for yourself. Again, I'm not saying there isn't risk here. But unlike the other poster who said I did poor research lol I do believe this will run up way earlier than he does. It's your call and your money at the end of the day. I have recently found a lot of people who are in on HSGX are very bitter now because they bought in high on Thursday before they dumped the price and are down quite a bit of money and are salty because of it. I'm still sitting pretty since I bought in so low. Again, research it yourself and see if I'm right. I'm confident in what I'm saying and am not trying to blatantly pump this stock. Usually big moves are made by the hedge fund companies anyway so little people like us buying in the thousands aren't even a drop in the bucket so "pumping" it to a few people would do nothing anyway. Good luck to you.
Haha actually no I didn't. I emailed them directly as well to confirm some of this. If the meeting goes well and the FDA approves them moving forward they will be filing a BLA. The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. Or in layman terms, introduce a drug to the market. Yes, it may take a bit before the drug is officially launched, but people would be piling on way before that. Buy the hype sell the news. Pretty simple stuff here honestly. This is how you make money.
Also if the meeting goes well this price still WILL skyrocket. Also I really don't care if you buy this stock or sell it or whatever your goal is. I'm just trying to provide honest, non-jaded information on this stock.
For anyone reading this, do your DD, check if I'm right yourself. Pretty easy to look this stuff up.
I think $10 personally, maybe even $15 for a few days before it came back down with a lot of hype the few days after. Yeah I've been researching everything I can on it.
I posted it to another forum here is my DD if you care to read all of it. Short explanation, I'm very bullish on it.
First to be up front. I’m holding 1,300 shares currently. My price average for these is .61 cents because I got a good entry (which is crucial for stocks so you don’t emotionally overreact when there are price swings).
Background: HSGX is a bio company coming off of a recent failed Phase 3 trial for a product called NeoCart. This in layman terms is a simple, fairly non-invasive alternative to knee surgery for cartilage repair, they are basically implanting synthetic cartilage into your knee to repair the damage instead of heavy surgery.
They failed their Phase 3 trial by a measurement of 2 single patients. This is tiny. If those patients results would have been positive they would have had a successful trial and HSGX price would have jumped way beyond the $3 price it was at before the failed results.
But here’s the catch, when HSGX designed this study, they designed it with much more stringent criteria than the FDA needed. Don’t ask me why, HSGX just likes to be very anal about their results. The FDA criteria is much less demanding than this, if HSGX would have submitted their results under the current FDA guidelines they would have passed.
In the study, NeoCart actually had better results in EVERY SINGLE measurement than the standard of care. This is insane. They were seeing positive feedback from patients after only 6 months as opposed to surgery which is invasive and takes up to 1 year. Other drugs similar to NeoCart, took even longer. Doctors have been raving about NeoCart and how simple the procedure is. Not only that, but also how it could be used for more than just kneed. Think other areas like shoulders or elbows.
Under the current administration I’ve read that the FDA has been approving drugs about 80% of the time now. HSGX has a type C meeting set for October 30th (don’t get me started on the differences between A and C, I talked to HSGX via email and the main one was timing which they got accelerated so they didn’t mind) with the FDA. They have a fantastic shot of their meeting going well and their drug being approved for marketing.
Histogenics presented at a conference in California and basically reaffirmed everything I just said plus more on Wednesday Oct. 3rd. HSGX has over 57% institutional ownership, that means over 50% or their totally shares that are owned are owned by hedge funds and big companies. Why would these be holding onto a simple pump and dump stock? They wouldn’t, because HSGX is legit.
So let’s talk about the news release about a new offering the other day. Price shoots up, everyone climbs aboard, massive volume, then after hours a random weird ass timing of an offering. Seems pretty shitty right? I do agree this one is weird, but let me give my two cents on it and why I’m holding and thinking of buying the dip and averaging down. In the news release they specifically state “to raise funds for NeoCart biologics license application and commercialization following approval by the U.S. Food and Drug Administration."
To me that sounds like they are planning/almost already know the FDA will approve it and because of that they need money for commercialization i.e. marketing and selling the product.
Plus on the technicals there is a gap that needs to be filled up to $2.60. I suspect that happens before the Oct 30th date.
If you’re even still reading at this point, best of luck to my true bulls. Hold this shit down tight. This stock could be potentially worth $10 by end of November imo. Get a good entry or average down. And don’t let other idiots who didn’t do proper DD confuse you and scare you into selling just because they are salty and lost money.
See you at $1.
Offering: New offering for 26 million new shares at .65 cents. The offering closes October 10th.
Just batten down the hatches and wait it out now if you’re in. Price will move up and it will move down as it trades sideways until the offering is closed. Words of advice: -don’t risk more than you’re willing to lose. -don’t get greedy or fearful, trade off fundamentals and technicals -sometimes just ignore the stock for a while and go enjoy your day/weekend instead -never average up on price, get a good entry and then hold/average down -if someone says something, go fact check it yourself, bulls and bears both make things up
Sources:
FDA Meeting Date: https://www.google.com/amp/s/seekingalpha.com/amp/news/3393245-histogenics-meet-fda-october-30-review-late-stage-neocart-data-shares-13-percent-hours
NeoCart Phase 3 Results: https://globenewswire.com/news-release/2018/09/05/1565410/0/en/Histogenics-Announces-Top-Line-Results-From-Phase-3-Clinical-Trial-of-NeoCart-in-Patients-With-Knee-Cartilage-Damage.html
Public Offering/wording of funds being used to market product: https://www.google.com/amp/s/seekingalpha.com/amp/news/3395438-histogenics-41-percent-pricing-public-offering-common-stock-warrants
Risk vs Reward of NeoCart passing FDA meeting: https://www.google.com/amp/s/seekingalpha.com/amp/article/4206368-histogenics-risky-odds-limited-payoff
Recent Presentation in California Powerpoint: http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NzAwMzY1fENoaWxkSUQ9NDExOTk2fFR5cGU9MQ==&t=1
If FDA approved, how much could HSGX be worth?
It would make more sense if this was just to get more shares. They already bought/exercised a lot of shares at .56 cents so I can't see them thinking it dips below that again. Tomorrow will hopefully shed some light on things.
You think this is manipulation? Regardless, this stock could see $2.50 by end of this month and $10 if approved
I read it the same way. The wording exactly was "...to raise funds for NeoCard biologics license application and commercialization following approval by the U.S. Food and Drug Administration."
To me that sounds like they are planning/almost already know the FDA will approve it and because of that they need money for commercialization i.e. marketing and selling the product.
I personally think they might do an offering AFTER the FDA meeting so they would be selling shares for something like $2.80 a share.
Just my two cents.
Really? What's their newest update? TD isn't showing a lot of activity..
Okay, so if I get in under that I could definitely get a few thousand for nothing. But how long are you expecting to hold this for before good news of a buyout comes, if it does at all.
How long in your mind until OTC/a buyout? I've seen it drop as low as .03 cents. What would be a good buy in price?