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.
Something interesting I found while trying to find number of fast track approvals in the last 10-20 years. This wording is directly from the fda.gov website. Link below.
“Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.”
CVM has to request a fast track. The IDMC can’t do it for them. Maybe CVM is waiting until June to do so?
Thoughts?
Source is second to last paragraph on page.
https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
Lifghtrock, So if we hit June we have 100% of success?
Also off the news at TDAmeritrade, don’t know if you saw this but exact wording says “Cel-Sci’s Cancer Therapy Study Needs More Time, Committee Says”
Looks like you may be right on them needing more data until June to get the good separation and feedback on numbers :)
Does anyone have an idea or number on how many trials have been halted and fast tracked for approval in the last 10-20 years?
Sushi has a good point.
I hate to be the voice of reason here, but did anyone take this IDMC news as the numbers are very close? If the survival was above and beyond 10% wouldn’t they halt this? I assume it’s a lot closer and it’s going to come down to the wire. Anyone else have thoughts on this?
Lightrock, I know you said you wanted to get to June for good data separation between March and June. Maybe you’ll get your wish :)
Lightrock
You always provide very thoughtful feedback. Also, this is Foscos spreadsheet just so everyone knows. Not trying to take credit here.
I do agree that the thing that worries me the most is the SOC survival rates. I did read the article Sushi linked to about the low survival rates. But I'm still skeptical.
If you go to cancer.net and look at all the rates, some are very high. There is a link from a seattle hospital that boasts VERY high survival rates, even for Stage 3 & 4.
So I'm torn, the patients that were enrolled are Stage 3 & 4, multiple tumors, multiple lymph nodes infected. But even so, I need more verifiable information.
With that said, when I talked to Gavin about the IDMC meeting a couple weeks ago it sounded like they had just barely met or were just about to. And then it would take a little time to present the results of that meeting. So we still could have very positive information from that meeting :)
Here are the two links I was referencing.
Seattle Survival Rates for Head and Neck:
https://www.seattlecca.org/diseases/head-neck-cancers/head-neck-cancers-overview/survival-rates
Cancer.net:
https://www.cancer.net/cancer-types/head-and-neck-cancer/introduction
P.S. I think what would be most helpful is if someone took these survival rates and discussed them with an oncologist to see how realistic certain rates are.
Fosco,
How are your spreadsheets looking? I saw that you updated the realistic survival to 15% survival for Multikine. And you also updated the "optimistic" spreadsheet back to middle of May for 10% success.
My target date is April 16th. All my technical analysis points to that day specifically for a big move.
Link for anyone interested:
https://docs.google.com/spreadsheets/d/1qW36sMXgKvx2_76GPF3fjmXFYApgsOUq0vU1qlumz6w/edit#gid=1323197717
I feel really good about CVM, I want to say that up front. The only thing I’m worried about that I can’t find good sources or data on is the standard of care survival. I’ve seen a lot of varying statistics for survival ranging from 40%-75% mainly for 3-5 years.
And for HPV related cancers the survival is 90-100%
Does anyone know any doctors, oncologists, or any good sources to even semi verify what a realistic standard of care survival is for head and neck cancer after 3-5 years? I think if we can nail that down, that will solidly things for the Longs. The more we know the better we can predict this.
I vaguely remember lightrock talking to cotton farmer about asking a doctor he knew. Any progress there?
Also here are the countries this trial is going on in for anyone interested:
23 Countries in Total (13 in Europe, 2 in America’s, 8 in Asia depending where you put Russia)
-Austria
-Belarus
-Bosnia and Herzegovina
-Canada
-Croatia
-France
-Hungary
-India
-Israel
-Italy
-Malaysia
-Poland
-Romania
-Russian Federation
-Serbia
-Spain
-Sri Lanka
-Taiwan
-Thailand
-Turkey
-Ukraine
-United Kingdom
-United States
I hope this is helpful in some way for some one.
Fosco, I completely agree with your post. I wouldn’t say a halt and fast track is not an option at this point. This drug has to do with saving lives. If it works, and they can see that it is working well without a doubt, it would be unethical for them to continue to the trial when lives are on the line that could be helped.
I think end of March, beginning of April, things get VERY interesting very quickly.
Finli
I spoke to Gavin directly this week. I discussed a bunch of things with him which made me feel much better about holding. I didn’t speak on some of them because it was more speculation and not hard facts. I don’t like to spread false information or things that could be misinterpreted.
I will say that I specifically asked him about the IDMC meeting. I said historically they meet about every 6 months. He told me I was correct. I asked if we would get updated numbers or news of the meeting. At this point he was vague (in a good way imo) he said they would release news of the meeting when the meeting occurred. It sounded like they would need a couple weeks to format everything. I’m assuming the IDMC met very recently. Maybe even this week or last week. I would look for news on that meeting towards the end of March/beginning of April. Again, he was very vague about this. The only thing I know for sure is that they do meet on average every 6 months. And that they most likely will release news of the meeting. There was nothing in the way he talked that gave me pause or worried me. I’m waiting for news on that meeting in the next few weeks here.
Hope that helps
Fosco,
I can help with your first question actually. I did talk to Gavin about that issue. I asked him about evaluable patients, i.e. did we lose a lot over time due to unrelated causes. This was a little more on the speculation side, not hard facts, so take it for what you will.
But he said in December 2017 when the fully enrolled announcement was made by the IDMC they said, "CVM has enough patients to complete primary endpoint" Gavin said "based on that, the assumption is that we haven't lost that many patients to unrelated causes."
I took that as maybe a handful of patients have been disqualified for whatever reason. But not a large number.
Hope that helps.
The standard of care percentage is the golden egg question here.
Had a very productive and promising phone conversation with Gavin this morning at CVM investor relations.
We talked about a bunch of my questions/concerns which he answered quite well.
The two biggest things I'd like to point out that we talked about are these:
1. I specifically asked about the patients that were enrolled in 2011 by Inventiv. Yes, they are still being counted towards the study endpoint. And more importantly "no, the study protocol was not changed at all, patient 1 was given same protocol as patient 928"
2. I've read a lot of misinformation about how and when the 298 events will be announced. I asked him about that. For anyone reading, yes like some have said, the 298 events WILL be a material finding. They will want to announce that as quickly as they can. He did say that they will have to talk to the SEC and their team about the best way to present that information to investors and the public. But basically the gist I got is that they won't be sitting on that information for too long. He stated multiple times that they do need to announce this since it is a "material finding".
Hope this was helpful to some of you.
Fosco, on page 20 you said it confirms there are 800 patients in the two arms. Just to be clear is that evaluable patients or the number they began with?
I already saw Foscos point. And just fyi Geert is 59. Just clarifying. Still old enough to want to be done for sure though.
Updated Price Target by Analyst Oppenheimer. $7
Fosco, Good point! I just saw some people on other boards claiming he would sell it for 500 million before news came out which I scoffed at. A lump sum of $5-10 Billion is much more realistic.
Fosco Great Find!
Also, let's say that Multikine is a success. Do you really think that Geert, after building this company and product for well over 20 years. Going through all the lawsuits and mocking and doubt from everyone. Do you think he wouldn't have a bit of stubbornness and pride in making sure he sells Multikine for all it's worth?
I know if I was in that position I wouldn't take the first, second, or even third offer. IF this works I would wait for one of the absolute best offers. I just personally can't believe that he wouldn't be a bit stubborn about selling it for something under what it is potentially worth.
Just my two cents. Best of luck to the longs.
Shorts, if you're reading this, the longer this trial goes on, the worse this is looking for you.
Why doesn’t Cel-Sci do more press releases for investors? Couldn’t they mention more things to keep investors in the know and create interest increasing their stock price? For example, couldn’t they mention they have a meeting with the IDMC coming up? I just don’t understand why they don’t release more news to keep their shareholders updated? I see pump and dump companies coming up with any excuse to release more news. Why isn’t a legit company like Cel-Sci saying more? Is there something I’m completely unaware of here? Genuinely curious here
Fosco. That makes a lot more sense now. Would it be worth emailing them on it? Or would we not get an answer.
So Fosco asked a good question on StockTwits.
Does anyone have an idea how many of the 928 enrolled patients are still evaluable? Because that would make a big difference in event numbers if we lost a bunch.
I would assume someone dying from an unrelated cause like a car crash would disqualify them from being counted towards either arm of the study since their death had nothing to do with cancer. I also assume there are other factors that could make some unevaluable.
Can anyone shed some light on this?
As far as I see it, if we are still close to 928 patients that can be evaluated we are still looking very good.
Lightrock,
Thank you so much for the update. This is all very informative and interesting to me. So if I'm reading this correctly, if we can make it past February not only is that a good sign, but according to your simulations, that's when the numbers start to clearly separate and explain how effective things are in the study aka it will be very clear if Multikine works or not.
The one thing I didn't quite understand was you mentioning something interesting happening from July 9th to August 27th?
Lightrock, I mightve been in the minority but I was loving your spreadsheet analysis and monte carlo. Have you run any more simulations? If so have they told you any other interesting tidbits?
Thanks in advance
If $14 is too low and $75 too high where would you put your price target?
While I appreciate that Zacks gave CVM more exposure the price target they gave is way too low. It's frustrating.
Finviz just updated the target price on CVM to $14 instead of $75. Is this because of the Zacks article? Link below
https://finviz.com/quote.ashx?t=cvm&ty=c&ta=1&p=d
That's a valid point. But if Geert doesn't know the numbers, how can they? The best numbers on here I've seen from Lightrock and Fosco1.
Sounds like it could maybe be a pretty epic short squeeze at some point.
Okay those clarifications helped me understand this much better and the misinformation this author is spreading.
Why would they want to short this or keep stock price down though? If they want to make money, wouldn't they just buy shares as well and go long if they knew the news had a probability of being good?
Thanks again for taking the time to answer my questions and help me understand better.
Thanks for all the helpful responses! This helps me feel better about what I'm holding. The FDA thing is the biggest positive signal to me.
Quick question for you Q. So were these two statements he made false because they didn't have enough data aka deaths to determine if it was safe for patients since they were delaying standard protocol for 21 days because the benefit was unknown at the time? But now the FDA released the hold because they had more data which was probably showing that Multikine was helping so it was no longer an unknown hold?
"Because the company was informed by independent data monitors in 2014 and again in 2016 that the Multikine study should have been shut down early."
"The FDA refused Cel-Sci’s request. Then, the agency halted the clinical trial entirely, telling the company there was an “unreasonable and significant risk of illness or injury to human subjects” participating in the study. The FDA stepped in to protect patients after learning belatedly about the independent monitors’ failed effort to stop the study. "
I mean, that sounds really bad... Is he paid by another company to write this or is there any merit to his claims? I'd honestly love any information that can dispute what he is saying since I currently am holding a decent amount of shares.
Yes that's what I'm referring to. So just to clarify. Is CIZ ALSO an option for the SOC group? And if so, it might prolong survival in that group as well?
And from what I understand from reading, CIZ is not chemotherapy, it is extra immune boosting which is thought to help Multikine work more effectively?
Page 4
http://www.annualreports.com/HostedData/AnnualReports/PDF/AMEX_CVM_2017.pdf
"The primary endpoint for the protocol for this Phase 3 head and neck cancer study required that a 10% increase in overall survival be obtained in the
Multikine group which also is administered CIZ (CIZ = low dose (non-chemotherapeutic) of cyclophosphamide, indomethacin and Zinc-multivitamins) all of which
are thought to enhance Multikine activity), plus Standard of Care (Surgery + Radiotherapy or Chemoradiotherapy) arm of the study over the Control comparator
(Standard of Care alone) arm. As the study was designed, the final determination of whether this endpoint had been successfully reached could only be
determined when 298 events (deaths) had occurred in the combined comparator arms of the study."
Fosco1 Thank you so much for your explanation! That makes a lot of sense to me. Guess that's why we have a Phase 3 then, to continue testing in depth.
One more question I want to clarify. It was mentioned that in the Phase 2 study, that when Multikine was injected into patients, it was combined with a chemotherapy drug. And because of this there was no way to know whether it was Multikine that was shrinking the tumors or the chemotherapy drug. Is this true? Or is there further information to prove that Multikine was indeed having the positive effect of shrinking tumors?
What do you mean by that? Just to be clear I am VERY bullish on CVM. But when I run across critical articles I just want to understand them. All I'm asking for is clarification. I'm not trying to scare people. I'd prefer people drive the price UP.
Can you elaborate and not be rude please. I'm not trying to push fear. If you know what this article is or if the author is bogus then please explain.
Lightrock and Fosco1. I'd also love your opinion on this as well.
I was doing some CVM searches/reading today and I stumbled across this article.
Has anyone read this article? It seems to say that CVM and Kersten embellished data and designed a poor study in phase 2. Also says that in the phase 2 study Multikine treatment was combined with a chemo drug so that might've shrunk the tumors instead of multikine. Is anyone aware of this article/claims? Can it be disproved?
Here are the links for Part 1 & 2
Part 1:
https://www.thestreet.com/story/10679292/1/cel-sci-cancer-drug-claims-crumble-part-1.html
Part 2:
https://www.thestreet.com/story/10679302/1/cel-sci-cancer-drug-claims-crumble-part-2.html
There is a cart to checkout. You may have just missed it! Here is the link to the checkout page.
https://lalpinainc.com/checkout
It's funny how people react.
Price goes up --> CVM is going to be huge! Greety is the best CEO! We may never see (x) price again.
Price goes down --> This company is sketchy. Greety is selfish and a scumbag. This could be super risky and we all might get screwed here.
Personally I agree with you. Anytime price drops I keep buying up a little more as time goes on. Either you believe or you don't. I still think we have until March or April until big news comes out. Until then price will fluctuate. But I don't want to get caught chasing this one.
That $3.08 was on 100 shares. I saw it. That's nothing. I expect it opens at 2.90 tomorrow...
That sounds like great news! That goes along with my spreadsheet saying Mid February 2019 is success. But why were you applying a 25% multikine benefit? I got a little lost as to how you arrived at that?
That makes a big difference for us. I bet you're right in thinking that optimistic survival modes include stage 1 and 2. If anything this could increase events after a few years. This makes me feel better about CVM's chances of success.
Thank you for the response. That helps clear a big thing up for me.
Quick questions that I'm sure has been answered before but I can't remember.
For the CVM study, what phase of cancer patients were allowed? I know there are 4 phases of how advanced cancer is (Phase 1 = least, Phase 4 = most advanced). This would obviously make a difference to survivorship over years as well.
1. No. The longer it goes the better it is. If in some strange world this study went on for two more years it would only be better.
2. I think day/swing traders are shorting this. They aren't expecting to hold it when news comes out is my thinking. But I've seen some people who simply like gambling and short stocks just hoping the news is bad just like some people hope the news is good.