CEL-SCI Investor Call to Discuss Phase 3 Results - July 1, 2021
"Success is not final, failure is not fatal: it is the courage to continue that counts." - Winston Churchill
The Starry Night, 1889 - Vincent van Gogh
On July 1, 2021, CEL-SCI held an investor call to discuss Phase 3 results. The audio link is here. This article provides the full transcript of this call.
Geert Kersten – CEO
0:00 - Good morning ladies and gentlemen, as it’s now 10:10, and we will start the presentation. The main speakers will be Dr. Talor who’s the head of research and the developer of Multikine, and John Cipriano. I will give a quick introduction and I will answer some questions later on. But let me give the introduction.
0:25 - First of all, I would like to thank you for attending. This is a very fascinating time for our company. We have said from the beginning that we believe that boosting the patient’s immune system while it’s still intact, that means before surgery, radiation, chemo should have the greatest impact on survival when it comes to cancer immunotherapy. Initially we got ridiculed, then immunotherapy became hot, and then people became more interested.
0:50 - So, we also said that it appeared to be taking longer than the Phase 3 study than we thought to reach the required number of events. And in fact, and that we figured that it must suggest a benefit or survival benefit, right?
1:10 – Hm, in fact, we just announced Phase 3 clinical data that showed that we were correct. There was a clear survival benefit.
1:25 – The successful treatment arm involving Multikine plus surgery and radiotherapy met and even exceeded the primary endpoint of increased overall survival by 10%. So what happens in Head & Neck cancer and Dr. Talor will give you much more here: you’re randomized you get surgery, and then you’re not randomized but then you get either radiation or radio-chemotherapy.
1:45 – So the chemotherapy arm didn’t work. The radiotherapy arm worked very, very well. Hm, so we even exceeded the goal for the study of 10%. The survival benefit was not only statistically significant, it was also robust and durable. The benefit at 5 years was 14.5% , which is the way FDA likes to see it. It’s an absolute number which translates into approximate 29% improvement from 48.6% to 62.7% of survival.
2:30 – This is a great success. Not only we are helping a lot of people and by the way, we have not seen any safety issue but no one has been able to do this before.
2:45 - Now I wrote something here but I think it’s too complicated because what I’ve heard essentially is people don’t understand. They said this is really good data but they don’t understand so therefore there’s a lot of confusion.
3:00 – It’s very simple here. You get surgery, and then either you get radiation or radio-chemotherapy. The arm that got the radiation with Multikine but not the chemo right? So the radiation arm had fantastic survival benefits, met all of the statistical considerations and exceeded all of the stated objectives.
3:20 – The arm where the patients got radiotherapy plus chemotherapy, somehow in that arm, the chemotherapy appeared to have negated the survival benefit, which is not illogical.
3.40 – So then the question is: ok, you showed great success in one part of the study, but not in the other part, are you allowed to use that data? And the answer is YES. Because Dr. Talor and his team thought ahead. If you think about it, this is something that has never ever been done.
4:00 – So you can only have 1 primary endpoint, that was 10% overall survival benefit for the combined patient population.
4:15 – But Dr. Talor said “What if the survival benefit actually occurs in the radiotherapy group, or the chemo-radiotherapy group?” So, all of that is in fact in the protocol, meaning you’re allowed to analyze those groups. And they are not really groups, they are actually treatment arms, right? Because they are all part of the standard of care.
4:35 - And then, following the guidance, this analysis was actually done after database lock, before unblinding, so it should meet all of the FDA regulations.
4:50 - So if Multikine receives regulatory approval in this patient population, this patient population represents about 40% of all newly diagnosed primary Head & Neck cancer patients. That’s about 155,000, and if you take a 29% improvement in survival from the 48 to 62% number, essentially 5 years later, you would have saved approximately 21,000 lives, that’s a big deal. And it has a huge impact on the life of patients and their loved ones.
5:30 – But perhaps even more encouraging is that the data showed that the survival benefit not only continued, but also maintained its advantage over control of over time, after the end of the follow-up period of 7 years and in some cases it’s even longer. And now comes the key thing. There was no safety issue. How many cancer drugs do you know that have no safety issues?
5:50 – So, therefore the basic question is what is your plan moving forward? Very simple. We believe that what we’ve done allows us to use that group, Multikine plus surgery plus radiotherapy and we plan to rapidly go forward with FDA approval so the next goal is to get a pre-BLA meeting with FDA.
6:30 – The goal after that or concurrent with that is to publish the data in peer-reviewed scientific journals. Some people have asked me for the data. No, you don’t give the data to shareholders. You submit it to peer review. That is the accepted way of doing it, and that’s how we will be doing it.
6:45 – There hasn’t been a new treatment approved for this indication in decades. We do not know of anything in development on the horizon that could help these patients in the next few years.
6:55 – Multikine has a very favorable benefit risk profile for these patients. We believe the study data warrant approval for patients who are slated for treatment with only surgery and radiation. We are hopeful that MK will become available to the tens of thousands of these Head & Neck cancer patients whose lives could be extended with no apparent safety issues.
7:20 - So I will now turn the call over to Dr. Talor, not only our chief scientific officer but the developer of Multikine, who will give us more detailed information on the study design and the results that have been released. Dr. Talor please go.
Dr. Talor – Chief Scientific Officer
7:35 - Thank you Geert. I’d appreciate to help and hope everybody can hear me. What I would like to do is I would like to go over the study design and the results to allow for a better understanding and an appreciation of these truly momentous results. That once considered by the regulator, and the drug is approved, would really truly positively impact many many patients.
8:05 - So let me take you through the study design and treatment, and then what the protocol treatment is, because I’m trying to put it in segments so it’s can be better understandable. What is the standard of care consists of? What the results were? And then move on to another topic.
8:25 – So first, the study protocol design and treatments. The study was designed as an intent to treat, or ITT, open label, randomized control study for the effects of Multikine as a neoadjuvant treatment, meaning it was given first right after diagnosis before anything else was given to these patients, plus the standard of care. And the standard of care in these patients, for advanced primary, diagnosed but not yet treated, slated for surgery, and then other therapies in the oral squamous cell carcinoma, meaning cancer of the Head & Neck. An that was pitted against standard of care alone.
9:15 - So the protocol treatment, what was the protocol treatment? I’ll make it simple. The protocol treatment was based on the NCCN which stands for the National Comprehensive Cancer Network, basically the main guidelines to all physicians around the world as to how to treat these patients that have squamous cell carcinoma of the head and neck, all regions including the regions that we have treated in our study.
9:45 – So patients who met the entry criteria for the study were randomized into 1 of 3 study groups.
9:50 - First group was Multikine plus CIZ or cyclophosphamide, indomethacin; zinc- multivitamins, plus the standard of care. The second group was Multikine plus standard of care without CIZ. The CIZ was there to improve the ability of Multikine to do its work from what we understand from the mechanism of action. Alone, it doesn’t do anything. The third group is standard of care only.
10:25 - And how were the patients randomized? From every 7 patients that were randomized in the study, each of the patients get randomized one in the time obviously, 3 of those patients were assigned to go to Group 1, meaning the Multikine + CIZ + standard of care, 1 patient to Group 2 which is the non-comparator group in the study, but was there in order to see what if any toxicity would be given just by Multikine alone, and if the CIZ actually makes a difference.
11:10 - So for every 7 patients, 3 were randomized to Group 1, 1 was randomized to Group 2, and 3 patients were randomized to Group 3. So the 2 comparators arms of the study were Group 1 and Group 3, meaning Multikine + CIZ + standard of care versus the standard of care only.
11:30 - And so and what is the business of the standard of care? So what is the standard of care for this particular patient population. The standard of care consists of surgery, meaning the removal of the tumors and any clinically involved lymph nodes. Then after surgery [?], pathology then determines if patients following surgery are considered as low risk for recurrence in which case they receive only locally directed radiotherapy as pre-prescribed dose for a radiation treatment for this one arm of this group, or they are considered as higher risk of recurrence at which point they will receive the same pre-determined dose of radiation in the radiation treatment but also concurrent chemotherapy. The chemotherapy is cisplatin and the dose is pre-prescribed for that as well in the protocol. They receive the chemotherapy on day 1 of week 1, day 1 of week 4, and day 1 of week 7 on the radiotherapy. That would be the second arm of that same group.
12:55 - Now each of the 3 groups eventually after surgery get divided into either receiving just radiotherapy or receiving concurrent radio-chemotherapy following surgery.
13:15 - It should be noted that the same patient population, it’s deemed for this patient population unethical to have a placebo injection of control. The FDA has agreed and 23 regulators around the world have accepted that the current standard of care is a comparator arm in this clinical study.
13:35 - It also was discussed that the current standard of care includes surgery, radiation, and chemotherapy. The ones who received surgery plus radiation only, this particular arm, represents about 40% of all advanced squamous cell carcinoma of the head and neck, and those who receive surgery and concurrent radio-chemotherapy arm, in that arm, represents about 60% of all the advanced primary patients that have squamous cell carcinoma of the head and neck.
14:25 – Therefore, since Multikine is given first in this study as a neoadjuvant therapy, it had to be given to all patients who were randomized to the Multikine groups in this study. And only then, after surgery, the actual arm in the standard of care for which the patient is determined to receive radiation alone or concurrent chemo-therapy.
14:55 – The question of this study was designed to determine was who within the patient population will exhibit a benefit from Multikine neoadjuvant given first after diagnosis and before the standard of care to these patients?
15:15 – Therefore, there were 3 possible outcomes for this study. (1) Mutikine helps all the patients, irrespective of the administration of radiotherapy only or concurrent chemotherapy as part of their standard of care after the Multikine treatment; (2) only those who get concurrent chemotherapy will benefit; or (3) only those who get the radiotherapy as part of the standard of care will benefit.
15:50 – The study clearly demonstrated a statistically significant, robust and durable overall survival advantage only for the patients who received Multikine + CIZ as neoadjuvant therapy plus standard of care, but only in the patients that received only radiotherapy as part of their standard of care. I hope that makes it a little bit clearer by now.
16:20 – The follow-up per the protocol, for all the patients, for all the patients in the study who were still there. For the first 3 years, the follow-up for the patients was very extensive. They returned for follow-up visits every 2 months in the first year per the protocol, every 3 months in the second year, and every 4 months in the third year for their follow-up.
16:55 - Beyond that time, patients were followed for progression and survival. Safety of course is followed up, from the informed consent to death, or to the end of the study for patients who are still alive at the time, for all randomized patients in the study.
17:15 - The study therefore was designed as an event-driven study, meaning we had to wait until a certain number of deaths had occurred to be able to have the power to discern the difference prescribed by the study.
17:30 – So what was the study power and the end-point and primary endpoint for the study? The study was powered at 80%, 5% 2-sided confidence interval to be able to determine an absolute, and I think Geert was already discussing what that was, 10%, overall survival of Group 1, the Multikine + CIZ + SOC, SOC stands for standard of care, over the Group 3 who got standard of care only, otherwise got the exact same treatment in the different arms.
18:15 – The expected Hazard Ratio for this advantage was 0.721, and the p-value had to be less than 0.05, per the protocol.
18:25 – What was the rough group size, just to let you understand that there was a large number in order to be able to obtain statistical significance? The study had randomized 928 patients of which 5 were randomized, but never treated. That yielded an intent to treat population with the size of of 923 representing 99.5% of all randomized patients. No any issue.
19:00 – The significant advantage of overall survival results were obtained with the following. In the intent to treat the n-number was 380 representing 41.2% representing the lower-risk for recurrence for the NCCN guideline group.
19:25 – The ITT or the intent to treat n-number for the higher risk to recurrence group, the two of those make everybody, was 50.6% in our study, again as determined by the high risk for recurrence / low risk for recurrence by the NCCN guidelines.
19:50 – There were a total number of 76 exclusions representing 8.2% that did not receive either radiotherapy or chemotherapy in the study. The exclusions reflect investigator exclusions, if patients are unable to tolerate treatment, first do no harm you’re not supposed to give them treatments that might kill them, or family or patient’s decision, saying “Listen, thank you very much, I’ll be done after my surgery. I do not wish to have anything else”. And of course, patients have the right not to receive treatment or the right to leave the study at any given time for any reason.
20:35 – So with that in mind, let get to the results. I would like to emphasize that all study data analysis were done by third party, statistical expert, outside statistical group, not by CEL-SCI, following the study statistical analysis plan that was completed prior to the database lock. And all analysis were done prior to the study sponsor, meaning CEL-SCI, being unblinded. So while all of this was going on, we were completely, completely blinded to the study and the study results until the statistical group finished everything, and presented some of those results to us.
21:25 – In the lower risk for recurrence group, Multikine + CIZ + standard of care, in the arm that received radiotherapy only, as part of their standard of care, exhibited an absolute 14.1% overall survival benefit at 5-years, over the Group 3 which was the SOC alone, or the standard of care alone. Again the standard of care alone group which received only radiotherapy as part of their standard of care, plus surgery plus radiotherapy of course, in both of these groups as part of the SOC.
22:10 – This was statistically significant overall survival for the ITT or intent to treat group with a p-value of 0.0236 with a Hazard Ratio of 0.68 advantage over standard of care alone, receiving surgery and radiotherapy only but not for those who received concurrent chemo-radiotherapy as part of their standard of care.
22:50 – The 3-year survival advantage for the Multikine-treated group over standard of care was 4.9%, or 72.4% for the Multikine plus standard of care radio only versus 67.5% for the same type of group in the standard of care alone.
23.15 – The 5-year survival advantage was 14.1%, 62.7% for Multikine plus standard of care with radiotherapy alone versus 48.6% for the same group in the SOC or standard of care alone.
23:35 – Please note the study protocol required a 10% or better absolute advantage with a p-value of less than 0.05 with hazard ratio of 0.721.
23:55 – Clearly, clearly Multikine treatment in this particular group met and exceeded the expectations and the limits, minimum requirements, set by the protocol.
24:15 - Multikine with no CIZ plus standard of care with no chemo, only radiotherapy after surgery, which was Group 2, had a 78.8% overall survival at 3 years, and 55.5% overall survival at 5 years. But remember this was a non-comparator arm or group in the study.
24:40 – And the other comparator arm, the standard of care alone, exhibited 67.5% overall survival at 3 years and 48.6% overall survival at 5 years for the patients that received no chemotherapy but only radiotherapy only as part of their standard of care of course after the surgery. That is the other comparator arm of the study.
25:10 – Well what’s about safety? I think Mr. Kersten already told us about but I would like to emphasize that no safety issues were found for Multikine in the treated populations. This is clearly an excellent benefit risk advantage particularly for an anti-cancer therapy and immunotherapy.
25:35 – So what was the conclusion from the study and the results? The study results for Group 1 that was the Multikine + CIZ + standard of care which received surgery but only radiotherapy after the surgery bested their required prospectively set criteria for success in the protocol and the statistical analysis plan, over that which was required over, if you will, standard of care alone, leading to a win and the data will support a claim for approval in this patient population in our opinion, and others as well. This population amounts to about 40% of the all the advanced primary squamous cell carcinoma head & neck patients or about 155,000 patients annually worldwide. This is a very very large population.
26:50 – Finally, I would like to add one more thing. Mr. Kersten told me that some concern has been raised by some individuals that the study data presented by CEL-SCI was derived by quote on quote “data mining”. That could not be further from the truth, and in fact was not based on fact whatsoever.
27:20 – But we can do better. Instead of just us saying it, we asked an independent statistical group and statistician to prepare how to best answer this accusation.
27:35 – That’s what they said to us, that’s what they told us, and we are summarizing it:
CEL-SCI developed Multikine to treat locally advanced squamous cell carcinoma of the head & neck.
It has been greater than 30 (I’m just reading what they wrote) since any new therapy has been approved to treat the stage 3 and 4 squamous cell carcinoma of the head & neck.
CEL-SCI protocol and the statistical analysis plan were designed with a primary efficacy endpoint overall survival to be studied in 3 predefined populations. (We just discussed those)
With 2 clinically relevant starting points (1) being from randomization to the end of the study, and (2) being from surgery to the end of the study.
The protocol predefined subgroup analysis consistent with the literature and the SEER database (this is cancer data base in the U.S., CDC runs database for cancer mortality). These include tumor state, tumor location, surgical margin, risk group (which is exactly what we found the information to be in), and disease directed therapy.
This is the largest Phase 3 study every conducted in locally advanced squamous cell carcinoma of the head & neck.
The study randomized patients at 78 sites on 3 continents.
The decision to pursue a claim for a predefined subgroup is supported by the following considerations:
The primary efficacy endpoint remained overall survival per the protocol.
The efficacy target was met, meaning the 0.68 hazard ratio for the low risk subgroup was consistent with the previously targeted 0.721 hazard ratio for the entire population.
The analysis methods are robust. That means the statistical significance was reached with the prespecified log-rank test primary analysis for the key ITT population and supported by the other populations of the study.
Survival outcomes are robust. That means statistical significance was supported whether by measuring it from time of randomization, or from surgery.
Model results are robust. Statistical significance was supported for the treatment of a lower risk interaction using the Cox Proportional-Hazard model containing pre-specified covariance. (Not something that was done before. Everything was pre-specified in a statistical analysis plan, which was completed before database lock.)
Additionally statistical significance was supported for the low risk subgroup using the Cox Proportional-Hazard model containing the pre-specified same covariance.
Every one of the above analysis was previously defined in a statistical analysis plan for the study.
The study did not encounter any overall safety issues.
31:40 – The conclusion by the statistician was: There was no data-mining that took place to support the information in that CEL-SCI’s press release.
31:55 – We hope by now all of these matters are made very clear. That’s just me saying it at the end, and all understand why it is that the data are so momentous, and why we intend to submit the data for review in order to seek FDA approval for this study population. I thank you for your attention. I know it was long. I tried to do it as quickly and as thoroughly and as simplistically as I could. Appreciate it. Geert.
Geert Kersten - CEO
32:35 - Yeah, this is the best part, as simplistically right? I have so many discussion with shareholders. Oh this shouldn’t take you months, it is so easy. Guys, just listen to Dr. Talor, listen to the last part. We achieved something that has never been achieved. It took 10 years. It was gruelling years. This is a tremendous thing. We’ve done it the route Dr. Talor thought ahead. He spelled it out. All of that statistical stuffs are way above my head but I can tell you the brain power that’s gone into it leaves me impressed and I’m not easily impressed. So but I want to take you to our next brain power, John Cipriano who is the senior VP of Regulatory Affairs.
33:30: So John has had several decades in the industry but probably the most relevant here are 17 years at NIH and FDA, 20 years as US Public Health Service Commission Corps officer. He was the deputy director of the division of biological investigational new drugs at the FDA. At FDA, he reviewed and evaluated ~2,000 IND applications and served on a number of licensing committees during his 17 year tenure. Please John, tell us what you think about how’s the study.
John Cipriano – Sr. VP of Regulatory Affairs
34:05 – Well I think Eyal has really presented a lot of detail and I don’t know if everybody absorbed it all, but I think, you know, the conclusion is that it is a momentous finding that we come up with this study.
34:25 – I would like to point out that the study, I was involved with the study way back then and we shepherded it through FDA. We included everything the FDA wanted in that protocol and we implemented the protocol exactly as it should have been implemented in accordance with all regulatory requirements of good clinical practice and anything else. It is truly a momentous decision.
35:00 – I am in full accord with the agreement to submit the results of the trial to the FDA. I would also add that the statistical input that we had on the study is from real experts in statistics. They have been around many years and have shepherded many applications to the FDA, and they are in accord with what we feel the results of the study are.
35:30 – I would like to let you know that I have already contacted FDA, both the Division of Oncology Products, which is the group that will manage any application that comes forward, and the Division of Orphan Drug Products. Our product is an orphan drug, which means it affects under a certain population of patients in the United States. For that purpose sometimes it is advantageous to the review process, sometimes it will speed it up and helps us along.
36:10 – I have contacted those groups and I told them of our data, our findings briefly, and indicated to them that we will be in contact to line up a pre-BLA meeting at which we will present all the data and seek their approval to submit an application.
36:35 – And in my opinion, we should be successful in that. I think an application will be successful, that will be accepted by the FDA and the product will be approvable, for all of the reasons that Eyal outlined.
36:55 – You heard from both Geert and Eyal about the benefit/risk analysis. And all drugs are approved on the basis of a benefit/risk analysis. The benefit/risk ratio for Multikine is very high. As you heard it shows a large and durable overall survival benefit in our Phase 3 study.
37:25 – Radiotherapy arm, patients live significantly longer than the comparable standard of care population. The survival in that group satisfied and actually exceeded the requirement of the primary endpoint after patients received Multikine.
37:45 – Again, all Eyal pointed out because there has been a lot of criticism in the late press, but none of it is true, huh. As was already pointed out, all analysis was performed prospectively, after data lock and the statistical analysis was completed and approved prior to database lock. The study sponsor, we were unblinded only after the data was analyzed. And as Eyal pointed out, our statisticians indicate there was certainly no data mining.
38:35 – Multikine also did not add any toxicity to the SOC treatment, and the risk from administrating Multikine seems to be very low. Also Multikine over many years of research has been shown to have a favorable safety profile over a wide range of dosages and routes of administration in a number of different patient populations. That’s important. And the radiotherapy arm represents about 40% of the entire squamous cell carcinoma of the head and neck population as Dr. Talor pointed out. That’s a significant number of patients to be helped.
39:20 – Now beyond the positive data that were outlined and described, there are other factors, which will be considered in the benefit/risk assessment of Multikine, which will add further support, in my opinion, to the request to a submitted application and ultimately approve Multikine. Again, Multikine is an orphan drug for a severe unmet medical need. The last FDA approval for the indication we seek, that squamous cell carcinoma of the head and neck, was many decades ago. I believe it was in the 1950s. We don’t know of any drugs currently in Phase 3 trials for the advanced primary squamous cell carcinoma of the head and neck patient population, and do not know of any plans for studies that could provide a benefit to patients for the next 5 or even more years.
40:15 – If you’ve caught up with any of these press with regard to cancer approvals lately, you’ll see many of the approved products have received Accelerated Approval. They have been put on the market based on markers and they failed study that was done subsequently. Regardless of all of that, they’re still on the market, many remain on the market. The reason for that is it’s very difficult to treat cancer patients. That’s why our results are so momentous. Especially in light of the lack of toxicity because many of these products that have been approved, targeted therapy or others, are extremely toxic to patients and many patients have expensive and serious side effects, and some even die. So I think from that perspective, Multikine is a product that many physicians would welcome to the marketplace.
41:35 – In fact, we are not the only one who believe in our data. We’ve been contacted, the company has been contacted, by a number of experts in the field and even one regulatory expert, who believes our Phase 3 data is very compelling, and that an application should be accepted and the product will ultimately be approved.
42:05 - I think those are the major points that I would like to make and I’ll pass it back to Geert.
Geert Kersten - CEO
42:10 - Well thank you. It is all just part and parcel of the interesting CEL-SCI’s history. And then again you go to Amgen or Biogen, they all went through the same stuffs. It’s just that people forget. So then I said I would answer to some shareholders’ questions. I hope that we’ve answered most of them. But yeah we do have a few here. Some of them are fairly lengthy so I’m gonna make them short or shorter alright.
42:35 – One question here is. Ok, after surgery, it is determined that whether you to radiotherapy or radio-chemotherapy. Well how do you give Multikine, how do you determine that in advance?
42:45 – And obviously, that was the first thing our team thought of, and our team has determined a way, a clear way to ascertain which patients would end up receiving only radiotherapy following surgery. So we have that and so therefore you can easily prescribe for that patient indication.
43:05 – Then another question here is: what are the next steps after the announcement of this week? Change of business plan?
43:15 – No. It’s called “doubling down”. You know, 2 weeks ago, we could still have failed completely. The risk / benefit ratio on CEL-SCI is completely different. The binary risk is no longer. We have extremely strong data on 40% of the patients from an analysis that’s permitted per the protocol, right? With no safety issues. You know the way I look at it, from my own investment and as you know guys, I haven’t sold 20 shares in 21 years, I kept on buying more. Obviously I believe. I feel better off. So the stock’s lower. Fine. Next week, 2 weeks, it might be higher again. Our stock has been a yoyo since the beginning of the year. $11.70 to $41, down to $15, down to $27. It’s all over the place. The only thing that matters here is can we get it to market, can we bring a benefit to patients. And the stock price is not the indicator. The only indicator that you need to look at is: What’s the data? What’s the p-value? What’s the hazard ratio? You know. What’s the patient population? What is the benefit? Et cetera. And now you have the data to make that decision. You can say yes, you can can say no whatever, but now you have the data, you don’t to worry about the complete flop anymore. Big deal. We’ll move forward full speed. We have plenty of money. Our thanks to folks for having helped us raise this money. We have $47 million in the bank and we’re in a very good shape.
44:55 – Now, what population of patients are we talking about for approval?
45:00 – We’re looking at the population that gets surgery plus radiation. We found that chemotherapy appears to negate the Multikine effect so therefore we don’t use chemotherapy with Multikine. It’s very simple. By the way, people may have to look at all kinds of immunotherapy protocols in the future. Because I am sure it’s not just in the Multikine case that the subsequent chemotherapy screws around with the immune response.
45:30 – Hm, what’s the, how large is the patient population?
45:32 – 155,000. That’s a big deal. It’s a real number. I told you the benefit would be approximately 21,000 people alive after 5 years, again.
45:40 – So you have a manufacturing facility and you’ve just expanded it. So how much drug you think can you make in the next few years?
45:50 – So we think we will start up with about 12 to 13,000 patients a year. And then we can increase it over time, and then we have extra space so that we can increase the capacity about 2 to 3 times beyond that.
46:10 - So the next one. We’ve already covered that one. We have already covered that one also. Bear with me, please.
46:25 - Alright, the big one. The share. So this person said: periodically and certainly the last Monday, there seems to be coordinated effort to attack the value of the share. Would you please offer an objective explanation also consider how the company running the book of transactions for CVM explain how they’re handling the apparent frequent naked short sells which artificially retard the fair value of the share. Do the sellers have an unlimited or uncheckability of short shares they fail to deliver. All shareholders will be interested in the firm’s perspective.
47:00 - You know how that I am outspoken as a kid, not against short sellers. If you want to sell short because you think we’re gonna fail, then you have the right to do so. I have a real problem with lying and manipulation. Ok, so for example, the whole idea that we, CEL-SCI, have had the data for a long time and we’ve been data-mining. I would hope that after this call, that thesis has been destroyed. But what you’re seeing is there is a whole group of these people that work together. They work with journalists with this and that and here. And so the only reason that I think that they were able to beat us in the last week is because there was certainly uncertainties that people cannot understand. I hope this call will help it. Because now you know we’re allowed to look at this group, at this treatment arm. We did it by the book and the data is great. So then, but I have to say that the short sellers are as powerful as they look. In fact, I don’t think that the big sales of the last few days have in fact been the short sellers. They were successful in creating what you might call a panic. Because I talked with a biotech fund on Monday, that was unable to look at the data. They’re biotech fund, their job is to look at data but all they could talk about was the share price. That tells you that their brain was shut down by emotions. That’s never a good thing when you’re trading, right? So I recommended to them that they hire themselves some oncologists or specialist of head & neck guys to look at the data because their brain was not functioning. I think that has happened to a lot of people. I think what actually happened is some of our large funds sold before the end of June because there’s too much controversial around CEL-SCI and they didn’t want to be seen holding CEL-SCI stock. There are certain other indications because I’ve requested the meeting with them before the annual meeting to discuss their vote and usually they grant me a meeting. This time they didn’t get back to us. So I think we’ll find out that they sold. So fine, ok, fine, we’ve been through this before.
49:20 – The data is what will determine everything, alright. And the data is good and we’ve learnt that the data is admissible because we followed the rules. So here we are. You can now make your own analysis. We’ve presented the data to you. We have presented our analysis of it, what we think of it from regulatory perspective. We have presented to you how the data was derived of that. That was pre-specified, that the analysis was done subject to a statistical analysis plan which was signed in November with database lock occurring in December. The work was done independent of us, blinded to us. We didn’t get the work until we were unblinded at which point we quickly have notified you of the results. I hope that was helpful. I thank you for your support. We will drive this thing forward full power, 100 miles per hour. Thank you so much to everybody and have a wonderful day.
Who was the statistician that independently reviewed the data? This should be revealed to ensure authenticity.