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@tarius, The big plan was having to wait for full data, wasn't it? And then we did not get full data as promised. When have you ever had an investment where lack of disclosure was used so as to reward the true believers for hanging in there for the conspiracy to play out in grand fashion? So, I assume they already disclosed whatever they felt was positive.
I mean really. Is it possible? Sure, almost anything is possible. But when has it ever worked that way? When a small company has something great to say, IMO they say it as soon as they can and they use whatever ammo they've got so that the market embraces their stock.
@TheQ, Not very old, and certainly important. That's not to say that something fantastic couldn't happen sometime soon, though, who's to know?
But to me it's obvious that the market sees some potential on the 1 arm's data that they did release, hence the price holding $300-400M market cap so far. But it's also obvious that the market is leary about what they didn't share; the secondary endpoints & the overall (all arms), hence the big % price crash. It's not all about the longs vs shorts narrative. Some things are just obvious. IMO, especially with small struggling companies, what they don't disclose can sometimes be just as important as what they did disclose. Set the timer, back to binary mode due to selective disclosure. Doesn't mean something great won't happen, but that's just how it is and the company has made it that way by choice IMO.
@Xena, Until it happens it's only a possibility. It'll be realized if and when it actually happens. I still think a BO would make lots of people a lot of $$. And to your point, exactly... you weren't following this prior, and to my point a BO now would likely be less than what most of us were hoping for as the overall primary endpoint whopper/beat. That was pie in the sky, sure, but that's what we were hoping for at the time.
We'll know in time. Binary events are pending. We're accustomed to that by now.
@Xena, It's not a conclusion, it's a possibility based on context. Although kind of an obvious one, since we were all hoping for an overall primary endpoint beat. It's nearly a no-brainer IMO that if they get bought out now it'll be less than what most were initially hoping for. The beauty of this is, in time we'll know for sure.
@flute, I wonder too, and have no idea. I know one thing, the 'unknown' factor has everyone waiting for yet another binary event. I assume BP is waiting for the full data. Unless they're in talks with Cel-Sci already based on this data? Who knows. As usual, there are as many questions as answers with this company due to how they choose to handle things. A BO would make a lot of true believers very happy, I assume. Even if it was a fraction of the previously hoped for $ amount.
@Xena, Maybe, but you also have to factor in history and what IMO it's meant in the past when the company chose the selective disclosure path. IMO it's created distrust, right or wrong. The market agrees, but also agrees with there being some potential. Plus insiders haven't been selling, either.
Quite the scenario. In light of all that I'm not surprised big shop analysts might be holding off for a while.
I don't agree that holding off on summary data for all arms was a good choice. We'll know in time once all the data comes out whether it was a genius maneuver or just a can-kick.
@TheQ, My only guess as to why lots of analysts from big credible shops aren't addressing CVM is because the company chose not to give summary data for all trial arms. Despite what appears to be exciting info provided for 1 legit pre-defined trial arm.
I would have thought analysts from big shops would finally address CVM after data dropped, but maybe the decision to selectively share has the market at large unwilling or uneasy about adressing this thing until data for all arms can be reviewed? I doubt sharing summary #s for the other trial arms would prevent journal publication, so that is likely hurting the cause right now IMO, but that seems to be the route the head honcho wants to go. I'm only guessing. It's just my attempt to put 2 and 2 together about why the malaise.
I mean the above aside from buy ratings based only on chart technicals that could come out.
@sab, Ok thanks. Appreciate it (trickle & Xena too). I've been wondering about that for a while, even before data. I'm glad to hear that.
@trickle, Are you saying the fact that ANY beneficiary is a company insider means the Trust has to report ALL transactions, no matter which person executes? Is that it? Or are you saying he's the only beneficiary?
@Xena, That's not my question. Although I admit, I don't know if my question makes full sense either. But what if the person who performs the sale of shares from the Trust is a beneficiary but not a company insider?
Or is the Trust, in and of itself as an entity, considered an insider for any actions it executes regardless of which beneficiary (person) performs it?
@Xena, What if the person who sells isn't an insider? Or would his wife be considered an insider despite not being part of the company? See what I mean? Is the reporting requirement determined by which individual executes the transaction from within the Trust? Can they operate such that they will report buys but not sells? If it was GK's personal account then the answer would be a clear yes, but since it's a trust with possibly multiple beneficiaries (is that the case?) then I don't know if the rules are the same. Maybe they are, just thought it was an interesting facet to discuss.
@sab, If there are other beneficiaries, who are not company insiders, aside from GK as a beneficiary... does the de Clara Trust have to report sales? We saw that GK reported a buy this week into the Trust.
Does he HAVE to report that, or could it be a PR maneuver, wherein it's not required since he's not the only beneficiary (or is he? what about spouse?) which could mean the sales aren't required to be reported? Or are those required no matter what, regardless of 'who' does the sale from the Trust?
I can't remember if this was discussed years ago. It's an interesting caveat though and I don't know those kind of ins & outs. I thought maybe you'd know.
@Henkel, Right. You'd probably have to ask the company but what's the point? I'm not sure it really matters. When paid promotion starts, it can be hard to figure out who's really behind it.
@Henkel: "DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks provides and Zacks receives quarterly payments totaling a maximum fee of $40,000 annually for these services"
@sab, Or anyone, does the de Clara Trust have to report when it sells shares? This is probably an old topic that I've forgotten. Just wondering. Since he reported the buy today, does that mean he/they (who else is a beneficiary?) has to report sells via the Trust just the same?
Or is it some odd thing wherein GK has to report the purchase because it's "his money" used to make the purchase... but share sales from the Trust don't require a filing because he's a beneficiary but it's not solely his personal trust? Excuse my lack of savvy with those things. Seems like a fair question though and would be nice to understand it.
I didn't notice the first time I looked at the Form 4 today that GK's 25,000 share purchase was actually to the de Clara Trust. It says they're restricted common shares, also.
Anyone remember, were his past purchases to the Trust also?
"Form 4 hits today, he bought shares" That's all I said about him buying shares. lol
I was pointing out that some have been giving him a hard time about NOT buying shares as proof he believes in the data, and then today we see a Form 4 that shows he DID buy shares. 25,000 shares at $8/share if I recall correctly.
Didn't you see it? Then later in the day, an 8K for this morning's shareholder letter.
@tarius, I think you misread. I noted that he did exactly what some folks were on him about recently: 1) buying shares on the open market 2) filing an 8K
I didn't say anything about not buying even more shares, nor that he should buy more.
8K filed today for the shareholder letter.
Seems they're attempting to knock a couple points of contention off the list. Why doesn't the CEO buy shares to prove he believes? Form 4 hits today, he bought shares. Why no 8K filed for material disclosure? 8K hits today for the shareholder letter discussion of results.
@flute, So true, CEO buying shares is about the strongest signal to the market possible, when other goals are a ways off such as BLA submission or approval, or journal publication.
People have been needling him about why he's not buying more shares if he knows the data is approval, and so on. Well, he just did! I think that's his figurative mic drop. The plot thickens!
Just saw an alert, GK purchased 25K shares around $8. Sorry, can't find the link.
That'll be music to the ears of many, I know that much!
@flute, Same for me. I wasn't looking to be fancy with this thing. I was looking for the homerun, and it simply didn't happen. That's on me, that's what can happen when you play for the boom or bust. Although it didn't actually bust. Seems more like the air came out of the price, back into prove-it mode.
I feel like I ignored a tactical pattern of opacity, too, to your point. It doesn't matter if anyone else feels that way. Same for me, I still hope MK hits the market and can help some patients. Would be nice to see some long timers make some $$, too. I still have a few straggler calls, so if something happens any time soon maybe I'll make a little also. If not, oh well.
@hogg, It's very simple; summary #s for all arms not just the successful comparison (which does sound very good). Seems I've got a lot of company in the concern that what isn't being disclosed can also be important, not just what is being disclosed. I liked the letter. It's not enough for me, and I'm sure many others if you watch how the market receives this. But like I said, I think this WILL help. It was much more clear than the initial PR and should give some confidence IMO.
Go all in, knock yourself out. I hope you make a fortune (i really do).
PR: Letter to Shareholders
This part is interesting, little of the rest of it seems new although it's good to see the reaffirmations versus shrinking away.
"We have determined that it is possible to select the population that would receive the Multikine benefit at their time of diagnosis. We have vetted this with a number of expert physicians in the field and they agreed with the feasibility of the proposed pre-selection methodology". HOW? And who are the experts?
Also, who is the statistician they referenced? Maybe that doesn't matter. Anyway, it's a good read. Still no data from the other arms. What if there's a negative effect in the chemo arm? I feel strongly that they should have given that #, plus the overall. Yet they choose not to. I think this will help the stock at least some (even if only for flippers), but won't get me to re-invest. I'll hold onto my out-in-time nearly worthless calls though, since why not? What if something great happens? Never say never.
https://ih.advfn.com/stock-market/AMEX/cel-sci-CVM/stock-news/85534273/cel-sci-corporation-issues-letter-to-shareholders
July 07 2021 - 08:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
Dear CEL-SCI shareholders:
The purpose of this letter today is to address some confusion regarding the Phase 3 study results we announced last week. In the world’s largest Phase 3 study in newly diagnosed advanced primary head and neck cancer, our Multikine® (Leukocyte Interleukin, Injection)* immunotherapy produced a statistically significant 14.1% 5-year survival benefit in patients receiving surgery plus radiotherapy, representing 40% of the study population and an estimated 155,000 patients annually. The confusion appears to lie in whether the data, which shows benefit in 1 of the 2 potential treatment arms for our patients can be used for approval. As we will explain here, the analysis for the successful treatment arm was pre-specified in the protocol and conducted before unblinding. This means the data from the successful treatment arm can be used in seeking FDA approval. To be clear: we now have excellent 5-year survival data with no safety issues and we know the use of this data is permitted in seeking FDA approval.
Very Successful Pivotal Clinical Trial Results in Newly Diagnosed Advanced Primary Head and Neck Cancer Patients
On June 28, 2021 we announced results from our Phase 3 cancer study that proved that Multikine met all of the protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies. Based on this we will be filing for and seeking FDA approval for the use of Multikine in the treatment of advanced primary head and neck cancer in this patient population.
Our Phase 3 results showed a long-term 5-year overall survival (OS) benefit in this treatment arm that was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), which is about a 29% improvement, control arm 48.6%, Multikine arm 62.7% survival.
That means an additional 21,000 patients would be alive at 5-years if all 155,000 eligible patients received Multikine plus surgery and radiation compared to the current standard of care (SOC). This is extremely significant because the survival benefit is large and the last approval for this indication was many decades ago. This is a serious disease with an unmet medical need, something very important when you apply for FDA approval.
The Study Design is Based on National Comprehensive Cancer Network (NCCN) Treatment Guidelines with 2 Different Treatment Arms, One of which was Very Successful
Let me give you some details about the study design so that you can understand what happened. The NCCN Treatment Guidelines recommend to all physicians that the treatment for advanced primary head and neck cancer cases should be surgery first. Following the surgery there are two different treatment arms. The first treatment arm for the SOC is surgery plus radiation (about 40% of the patients) and the second treatment arm is surgery and concurrent radiochemotherapy (chemotherapy and radiation at the same time, about 60% of the patients). The toxicities in that radiochemotherapy arm can be very harsh, debilitating, and even fatal. In our protocol, the study endpoint was a 10% absolute improvement in OS when comparing the Multikine treatment regimen plus SOC vs SOC alone.
Patients receiving Multikine followed by surgery and radiation showed excellent 5-year survival benefit and met and exceeded all the designated parameters set for the protocol for the study to be deemed successful. Per the protocol, these determinations could only be done after at least 298 events (patient deaths) had been reached in the combined comparator arms of the study. If you look at the study protocol you will see that we thought that it might take us about 3 years of follow-up to achieve 298 events, but the significantly slower accumulation of events extended that time frame allowing us to see over 5 years of survival data, which is even better. The 5-year OS benefit was 14.1% in absolute terms exceeding the protocol required 10% or better. The study result’s p-value was 0.0236 exceeding the protocol required p-value of <0.05. The study result’s Hazard Ratio was 0.68 exceeding the protocol required 0.721.
The Analysis of the 2 Different Treatments Arms is Permitted since it was Pre-Specified in the Protocol and Done Before Unblinding
The analysis for the successful treatment arm was pre-specified in the study protocol and also the study Statistical Analysis Plan (SAP). These documents specified that we would analyze and present to the FDA not only the combined results of the two treatment arms but also each individual treatment arm, such as Multikine followed by surgery and radiation (the successful group in the study) and also Multikine followed by surgery and radiochemotherapy. What we saw in the study is that patients who had been treated with Multikine followed by surgery and radiation had a robust and durable survival benefit that exceeded the parameters set for the study endpoints, but we also saw that when chemotherapy was added to radiation in the other treatment group, the survival benefit from Multikine was negated.
We have determined that it is possible to select the population that would receive the Multikine benefit at their time of diagnosis. We have vetted this with a number of expert physicians in the field and they agreed with the feasibility of the proposed pre-selection methodology.
False Assertions Addressed
Some false assertions and misrepresentations have been made and published by parties who either did not understand the protocol and statistical analysis or had ulterior motives pertaining to our stock price. The key false assertion was that CEL-SCI is not permitted to rely on the surgery plus radiation treatment arm on its own to file for FDA approval. I say it clearly: this is absolutely false and incorrect. The surgery plus radiation arm of the study was pre-specified and is in fact one of the 2 potential treatment arms per the NCCN Treatment Guidelines for this disease. Analysis of any of the treatment arms on their own was always a part of the SAP, and it was pre-specified before database lock and before anyone began analyzing the data. To summarize again, all analyses were pre-specified in the protocol and SAP and were performed only following database lock and prior to unblinding to the study data. Therefore, we are permitted to use the Multikine plus surgery and radiation data for FDA approval submission.
We intend to seek FDA approval for patients who receive Multikine followed by surgery and radiation. Why should a lack of survival benefit for the treatment arm also receiving chemotherapy have negative ramifications on the approval for the patients who only receive Multikine followed by surgery and radiation?
We are talking about a clear long term statistically significant survival benefit in one of the two treatment arms which had 380 patients. This was about 40% of the total study patient population, not some small subgroup of patients who could potentially benefit. Two different and pre-specified treatment arms were given to the patients following surgery and both follow the NCCN Standard of Care Guidelines, one worked really well, while the other one did not.
Other false assertions made were that CEL-SCI had the data in our possession for over a year and that we had been “data mining” to find a benefit and “p-value hacking”. CEL-SCI did not receive the data until just before we made the announcement and up until that time, we were blinded to it. The p-value of the study was in fact very strong.
Support From the Independent Statistician
We are confident that the decision to pursue a claim for a pre-defined treatment arm (Multikine followed by surgery and radiation) is sound and based on significant data and solid results. Here, we are being very transparent and sharing the following from our independent statistician:
(Note: When the statistician says ‘low risk’ treatment group the statistician is referring to the surgery plus radiation treatment arm.)
CEL-SCI developed Multikine to treat locally advanced SCCHN (Squamous cell carcinoma of the head and neck). It has been >30 years since any new therapy has been approved to treat the Stage 3-4 SCCHN. The CEL-SCI protocol and SAP were designed with a primary efficacy endpoint (overall survival) to be studied in three pre-defined populations with two clinically relevant starting points (randomization, surgery). The protocol pre-defined subgroup analyses are consistent with the literature and the SEER database; these include tumor stage, tumor location, surgical margin, risk group, and disease-directed therapy. This is the largest Phase 3 study ever conducted in locally advanced SCCHN. The study randomized patients at 78 sites on 3 continents.
The decision to pursue a claim for a pre-defined subgroup is supported by the following considerations:
The primary efficacy endpoint remains overall survival
Efficacy target was met: The 0.68 hazard ratio for the low-risk subgroup was consistent with the previously targeted 0.721 hazard ratio to the entire population.
Analysis methods are robust: Statistical significance was reached for the pre-specified log rank test (primary analysis) in the key intent to treat (ITT) population and supported by other populations in the study
Survival outcomes are robust: Statistical significance was supported whether measuring from the time of randomization or surgery
Model results are robust:
Statistical significance was supported for the treatment low-risk interaction using the Cox proportional hazard model containing pre-specified covariates
Statistical significance was supported for the low-risk subgroup using the Cox proportional hazard model containing pre-specified covariates
The study did not encounter any overall safety issues.
Every one of the above analyses were prospectively defined in the SAP.
P-value hacking occurs when the original protocol and/or statistical analysis plan (SAP) are modified after the fact in the attempt to reach statistical significance:
Collecting additional data.
Dropping aberrant data.
Focusing on alternative measures.
Changing the analyses method.
Specifically:
We collected the data pre-specified in the protocol and eCRF.
We did not drop any data; we used the NCCN low risk definition and we used the ITT population.
We focused on the protocol-specified primary efficacy endpoint (overall survival [OS]).
We followed the pre-planned analyses to compute [Overall Survival] OS hazard ratios and p-values.
Based on all of the foregoing, NO “data mining” took place to support the (information in the CEL-SCI) press release.”
We believe this very detailed statistical data will serve to inform those who are well versed in statistics as they apply to clinical trial data.
Do Short Sellers Value Their Profits More Than the Tens of Thousands of Lives That Can Be Extended?
I believe that there are people with a large incentive to drive the stock down since CEL-SCI had a 25% short position. Before we announced our Phase 3 data, it was understandable that some people would bet against our company and our drug since the outcome was uncertain. But now, the data clearly shows that Multikine extends life in 40% of newly diagnosed advanced primary head and neck cancer patients. In fact, after we file for FDA approval, should Multikine receive marketing clearance, tens of thousands of people may live longer five years after treatment. What kind of person continues to sell short and attack a company that can make this kind of difference in the lives of cancer patients?
Uncertainty from the fact that the chemotherapy treatment arm did not work allowed attacks on the stock. It looks as if the shorting volume on our stock on the day of the announcement was 56% of the daily volume and around 40% for the next few days (www.shortstockvolume.com/Chart/CVM/). That should not be possible since there are not enough shares to borrow and brokerage firms are supposed to check if stock is available to borrow before selling short. You draw your own conclusions.
We have followed all of the rules to achieve a very significant never before seen long term survival benefit in advanced primary head and neck cancer, for which no new therapy has come to market in decades. In addition, no safety issues were identified, something not seen in other cancer drugs. The disease indication represents an unmet medical need and in fact, Multikine has received an Orphan Drug designation from the FDA for the “neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN)”.
Closing
In closing, our very successful data for the Multikine treatment regimen in patients who received surgery plus radiation treatment eliminates the data risk. Since the analyses were pre-specified in the protocol and the SAP and analyses were done after database lock and before unblinding to the study data, we are allowed to use the data showing robust and durable 5-year overall survival benefit in our FDA submission. No safety issues were identified. We have $47M in the bank. We are now preparing to meet with the FDA for a pre-Biologics License Application (BLA) meeting and seek and file for FDA approval.
In talking to experts in the field we hear only positive reactions to our study results. FDA and/or the medical community will look at the clinical impact: improved survival over SOC alone; benefit/risk of the drug; the safety profile (excellent); the statistical calculations (excellent); and also analyze and assess all the results with the knowledge that this is an unmet medical need for which no new treatments have come to market in decades. As one physician wrote: “Head and neck cancer is possibly the most horrific of all cancers. Not only does it take your life, but it takes your beauty, your voice and your dignity.”
Thank you for your support and interest as we seek to help these patients. More data will be presented in peer reviewed publications.
Sincerely,
Geert Kersten
Chief Executive Officer
@Q, I'm not sure 'who cares' is an investment thesis or FDA approval path. But to each their own, and I know what you mean about it still potentially being worth it to request the treatment even if you don't know whether it'll apply to you (re: chemo vs not). Maybe that's exactly how it'll work and maybe the medical community (and FDA) are fine with that. All the nuances, for lack of more info and context, is for the smarter experts to figure out. Definitely not me.
@lightrock, I understand and don't disagree with your logic. At the same time, that makes me feel as if this thing still has year(s) before it all gets ironed out. Who knows maybe a BP will see value, ask the needed difficult questions & demand to see all the data, then step in and take over the company with savvy for future potential. I mean, current existing value & potential but a proven experienced team to work all the politics and wedge this product into the cancer treatment field. I don't trust how it's being handled so far, big letdown but I don't know the future. I hope you make serious bank on it.
@lightrock, I agree. That's why I'm afraid they'd need further/additional studies in order to figure that out. Which is fine if they can make it that far as a company and if it holds water in the end.
With the current study, they'd need to give MK to all H&N patients. Then the patients would have to wait & see if they're deemed low-risk... at which point it might give them clinical benefit. If they aren't low risk, they'd have to be told... sorry, that $100K MK treatment is a moot point for you, no benefit. But they'd have to be told that upfront... we can give you MK at $100K but if you end up being a higher risk patient it won't help you. Maybe that's fine, maybe it's not. I don't know such things.
@TheQ, But how do you design a trial upfront where you're stating that MK has to be given to 100% of patients and then you'll deem 60% of them as dropouts? Is that a valid trial design? It sounds kind of loose. I don't know the answer though, am not savvy with how the FDA works, etc.
Seems to me like they'd need a way to identify & specify upfront how NOT to have to give MK to 100% of the patients first before determining who qualifies for the trial. That's more logical to me.
How? MK would first have to be administered to everyone, in order to end up excluding those who need chemo. Or are you saying something else?
You can't exclude anyone until after surgery, right? If so, too late, they already got MK and are therefore included. Just like the way that this study was handled.
Maybe they could specify the primary endpoint as those non-chemo patients, but would the FDA approve that design in light of that population not being identifiable until after MK + surgery, with 60% of them needing chemo which means the MK application was a waste for 60%?
@The_Q, But how they could have done that, when the need for chemo isn't determined until after surgery (correct? or no?)... yet MK is administered prior to surgery? Nobody has addressed that, not even the company aside from saying something about having a way to figure that out in advance. Really? How?
So that's the catch, isn't it? MK would have to be applied to every patient in order to end up adding a clinical benefit to 40% of them. Maybe that's fine, maybe it's not and it means more trials required in order to identify a way to determine lack of need for chemo upfront. If the company really knows how to do that, I assume they would have explained it at least a little bit because that's a hugely important caveat. It would mean NOT having to head down the path of approval to give MK to every patient. Wouldn't that idea be received more readily? Yet right now, nobody has commented on a way to determine it.
One might say, well SOME patients are obvious non-chemo patients and it's known upfront. True. But in that case, the population would be much much smaller than 40%.
@ex, Isn't the fact that they won't discuss it, and chose not to provide that info, our answer in and of itself? If they don't want investors drawing their own incorrect or negative conclusions, and had something good to say about that, then they would. No?
They chose to present the positive info in an isolated silo fashion, in a way. Very strange. No mention of secondary end-points at all?
What are we supposed to conclude? Whatever we want? Ignore the rest of the study until it 'ends up' in a journal?
@flute, Same for me. Good luck and thanks for the level headed views. From what I gather, we're still not even going to get what would amount to TLD as far as #s for all study arms for improved context to the positive data. Either way, would be nice if MK ends up helping some sick patients and investors make a bunch of money in the process.
@flute, Yeah that aspect really surprises me and is very interesting. Especially with such drastically limited data being PR'd after waiting all that time for 'full data', I would have expected some of them to lighten their load. So who knows, maybe they have an ace up their sleeve of some sort. I don't trust the boss anymore, but then again he didn't develop the product either.
@flute, Looks like shares acquired. More free money for management? Great.
@mikedel, Ok I get what you mean now. That's a logical point. I don't know how the FDA handles such things, but would they see 10% against the less severe grouping of patients as significant? A 29% improvement (14% difference) sounds significant to me, but then we're stuck with the logic circle that almost everyone would have to receive MK because so many of the patients aren't chemo candidates until after surgery. No way to delineate that ahead of time? And would these limited results be enough for the FDA to approve it on an 'everyone can get it' basis?
I wonder how Drs and patients would view it... $100K+ for a treatment that might help 40% of the total population of H&N patients but not help the others at all (or, will it? we don't know b/c the company has kept that secret so far)? Not being able to define who it would help, in advance, is what makes me think additional studies/data will be required so that it's less of a guessing game. But that's just me trying to be logical; I don't understand the science nor what truly matters to the FDA.
All I know so far is it seems shady that we've only been given the positive data and nothing else. That's not what everyone waited all this time for full data analysis for. The data for the primary endpoint should have been shared no matter what IMO.
Maybe they'll be transparent and open today about the #s for those other groups. Everyone deserves it, whether they sold or held or lost money or made money.
@mikedel, I thought the 14% OS comparison was for the MK + surgery + radiation vs just surgery + radiation? I think that's what's being said, which is a correct comparison at least when talking legit pre-defined subgroups.
@sab, You aren't alone in your views of broken trust. Not because the primary endpoint failed, but because of how he deflects and remains opaque to his benefit. The whole thing culminated in a data PR with cherry picked positive data, are you kidding me? Yes, it was a defined sub-group. But it was still cherry picked because he didn't provide ANY other data in the PR.
That wasn't even topline data. It was selective disclosure. After all that time? We all had to wait for full data analysis... for that? He owes us the #s for all trial arms and overall, not just the one he likes. That needs to happen today, and maybe it will. The PR also should have included a mention of a call to discuss trial results. Not announced two days later as the stock is bleeding out and everyone confused and/or outraged at the lack of info that already should have been provided but wasn't. Gives the impression of the person in charge being asleep at the wheel.
@sab, Insiders and related parties win as always, right? That's just the usual.
This was exciting and fun to hope for a while. The tweets over the past months started to concern me because it seemed like management was too focused on creating a deflective narrative. And this week's data drop barely being something resembling even TLD data broke my trust. Maybe I'm wrong, who cares. I'll hang onto a few straggler OTM calls, just in case. Selling them now won't do any good anyway. I expected much more initial clarity after waiting for full analysis. Instead, we got a tweet to short-sellers and some other non-helpful comments.
Hopefully it booms in the future for others who are more patient or who still believe. Sometimes patience is rewarded, but like you I'm in Missouri mode now.
Thanks for all your, and others', level headed insights lately
Re: MK helping patients who end up being in the chemo treatment group, as a post-surgery decision, it stands to reason that since MK is a tissue injection it might only help to a statistically valid degree for the primary tumors.
But, since patients whose cancer has metastasized are the usually the ones who are given chemo... we can't exactly see MK as a chemo replacement even though chemo is extremely hard on patients.
It seems like apples vs oranges to me. MK helps non-metastasized cancer, but wouldn't be too effective against metastatic cancer. Therefore, you can't simply replace chemo with MK, right? That seems to be an errant conclusion by many so far? Those who have metastases will still end up being recommended for chemo.
Simply giving everyone MK could still be helpful, overall, but without this distinction being vetted further I can't see how it could logically be a replacement. What would they do with patients for whom they discover cancer has metastasized after receiving MK + SOC surgery? No chemo? More MK? Where, everywhere? Inject it all over the place to try to get at the metastases? I assume that is a big NO. So, how would chemo be replaced?
That brings us back to the utility only being in low-risk (non-metastasized) H&N cancer, but that's not known until after surgery. Darn. I could see this being extremely useful for other types of cancer also, but that would require additional/other trials, right?
You see this logic circle?
Agreed, we'll see what tomorrow brings. If they provide clarifications with summary info for all groups, that'll be a huge plus even if it's not what we want to hear. I had much higher hopes for clear communication on such a pivotal company event. That's what I get for expecting the opacity to dissolve when data dropped.
@lightrock, What does that have to do with whether they've provided any data on % OSI for the overall study? You claimed it helps to some extent for the whole trial population... well, how much? And where did you get that info? Did they provide that and I missed it, or did you avoid my question?
And while 155K may be the non-chemo population overall, we've been given no other info to support the validity of the claim as of yet. Did you miss that? And who gets it, seeing as how the need for chemo isn't known until after surgery? Again, total lack of context provided so far.
With the info we have so far, the question is... will the FDA approve this based on the concept that everyone should (or can choose) to take MK while knowing that only 40% will benefit from it. I'm not scoffing at that idea, since any benefit to anyone is great. But it's not as simplistic as that w/out being able to see the other info.