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July 12, 2021 - Brand new website dedicated to understanding CVM's P3 results and FDA approval chances. Trust us, you want to sign up for their alerts.
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July 6, 2021 - Geert R. Kersten Radio Interview - New Treatment Challenges the Old Approach to Head & Neck Cancer
July 1, 2021 CVM Investor call to discuss Phase 3 Results
Geert Kersten – CEO
1:10 – We just announced P3 clinical data that showed a clear survival benefit.
1:20 – The successful treatment arm involving MK + surgery + Radiotherapy (RT) met and even exceeded the primary endpoint of increased overall survival by 10%.
1:45 – Chemo arm didn’t work, RT arm worked very, very well.
1.55 – We even exceeded the goal for the study of 10%.
2:05 – The survival benefit was not only statistically significant, it was also robust and durable.
2:35 – No one has done this before (proved boosting the immune system before surgery works).
3:05 – The arm that got the radiation with multikine had fantastic survival benefits, met all the statistical consideration and exceeded all of the stated objectives.
3:25 – The chemo arm appears to have negated the Multikine, which is not illogical.
3.40 – You showed great success in one part of the study, but not the other part, are you allowed to use the data. The answer is YES. B/c Dr. Talor and his team thought ahead.
4:00 – You can only have 1 primary endpoint – 10% overall survival (OS) benefit for the combined patient population.
4:15 – Dr. Talor said ‘What if the survival benefit actually occurs in the RT (only) group, or the chemo-RT group?’ So all of that is in the protocol meaning your are allowed to analysis on those groups or treatment arms.
5:30 – The data showed that the survival benefit not only continued, but also maintained its advantage over control over time.
5:40 – We have no safety issues – how many cancer drugs have no safety issues?
6:05 – We plant rapidly go forward with the FDA approval so he next goal is to get a pre-BLA meeting with the FDA.
6:30 – The concurrent goal is to publish the data in peer-reviewed scientific journals.
6:35 – You submit the data to peer review – that is the accepted way of doing it.
6:45 – There hasn’t been a new treatment approved for this indication in decades. We don’t know of anything in development on the horizon that can help these patients in the next few years.
6:55 – MK 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 hope that MK will become available to the tens of thousands whose lives can be extended with no apparent safety issues.
Dr. Talor – Chief Scientific Officer (starts at 7:35)
8:28 – The study was designed with an intent to treat (ITT) open label randomized control study for the effects of multikine as a neoadjuvant (first given) treatment + SOC.
9:20 – Protocol treatment was based on the NCCN (National Comprehensive Cancer Network) guidelines – main guidelines for all physicians around the world for all patients who have HNSCC (Head and neck squamous cell carcinoma).
9:45 – Patients were randomized into 1 of 3 study groups.
13:50 – The ones who received surgery followed by radiation only represent 40% of all advanced primary H&N cancer patients.
14:05 – The ones who received surgery followed by radiation & chemo represent ~ 60% of all advanced primary H&N cancer patients.
14:55 – The question the the study was designed to determine was who would benefit from the multikine with standard of care?
15:15 – There were 3 possible outcomes of the study. Will MK help 1) all the patients in both arms?, 2) only those who get concurrent chemotherapy will benefit?, or 3) only those who get RT as part of the SOC will benefit?
15:50 – The study clearly demonstrates a statistically significant, robust and durable overall survival advantage only for patients who received Multikine + CIZ + SOC, but only in the patients that received only RT as part of their standard of care.
16:30 – For the first 3 years, the follow-up for the patients was very extensive. They returned for follow-up visits every 2 months for the first year, every 3 months in the 2nd year, and every 4 months in the 3rd year.
17:35 – The study was powered at 80% (5% 2-sided confidence interval) to be able to determine an absolute 10% OSI over SOC.
18:10 – The expected Hazard Ratio for this advantage was 0.721, and the p-value had to be less than 0.05, per the protocol.
18:35 – The study had randomized 928 patients of which which 5 were randomized, but never treated. That yielded an ITT population of 923 representing 99.5% of all randomized patients.
19:05 – The significant advantage of OS results were obtained with the following. In ITT the n-number 380 representing 41.2% representing the lower-risk for recurrence for the NCCN guideline group.
19:25 – The ITT n-number for the higher risk recurrence group was 50.6% in our study as determine by NCCN guidelines.
19:50 – There were a total number of 76 exclusions representing 8.2% that did not receive either RT or chemotherapy in the study. The exclusions reflect investigator exclusions – if patients are unable to tolerate treatment, or family or patient decisions. Saying “Thank you very much, I will be done after my surgery.”
20:25 – Patients have the right to leave the study at any given time for any reason.
20:40 – All study data analysis were done by 3rd party, not by Cel-Sci, following the Statistical Analysis Plan (SAP) that was completed prior to the database lock.
21:00 – All analyses were done prior to the sponsor (Cel-Sci) being unblinded. So while all of the analysis was going on, we were completely, completely blinded to the study and study results until the statistical group finished everything, and presented some of those results to us.
21:25 – In the lower risk for recurrent group, MK + CIZ + SOC, in the arm that received RT only, exhibited an absolute 14.1% OS benefit at 5-years, over the SOC group.
22:10 – This was statistically significant OS for the ITT group with a p-value of 0.0236 with a Hazard Ratio of 0.68 advantage over SOC alone, but not for those who received concurrent chemotherapy with RT as part of their SOC.
22:50 – The 3-year survival advantage for the MK-treated group over SOC was 4.9% (72.4% for MK vs. 67.5% for SOC).
23.15 – The 5-year survival advantage was 14.1% (62.7 vs. 48.6% SOC alone).
23:35 – The study protocol required a 10% or better absolute advantage with a p-value of less than 0.05 with HR of 0.721.
23:55 – Clearly, clearly Multikine treatment in this particular group met and exceeded expectations and limits set by the protocol.
24:40 – The SOC arm exhibited 67.5% OS at 3 year and 48.6% OS at 5 years but only for the SOC with RT only.
25:10 – No safety issues were found with MK in the treated populations. This is clearly an excellent benefit risk advantage particular for an anti-cancer therapy and immunotherapy.
25:40 – The study results for Group 1 bested their required prospectively set criteria for success in the protocol and SAP over that which was required over SOC alone, leading to a win and the data will support a claim for approval in this patient in our opinion, and others as well.
26:50 – Finally I would like to add one more thing, some concern has been raised that the study data was derived by “data mining”. That could not be further from the truth, and 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 best answer this accusation.
27:35 – This is what they said to us and we are summarizing it:
- Cel-Sci developed MK to treat HNSCC of the head and neck
- It has been greater than 30 since any new therapy has been approved.
- Cel-Sci protocol and the SAP were designed with a primary efficacy endpoint (OS) to be studied in 3 predefined populations.
- 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 for cancer mortality (these include tumor state, tumor location, surgical margin, risk group, and disease directed therapy).
- This is the largest Phase 3 study every conducted in HNSCC.
- 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 HR for the entire population
- The analysis methods are robust. That means the stat sig was reached with the prespecified log-rank test primary analysis for the key ITT population and supported by the other population 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 SAP, which was completed before database lock.
- Additionally SS was supported for the low risk subgroup using the Cox Proportional-Hazard model containing pre-specified same covariance.
- Every one of the above analysis were previously defined in a SAP 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 that Cel-Sci press released.
31.55 – We hope by now all of these matters have been made very clear.
32:05 – We want all to understand why 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.
33:30 Geert Introduces John Cipriano VP of Regulatory Compliance
- 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 drugs at the FDA
- At FDA reviewed and evaluated ~2,000 IND applications and served on a number of licensing committees during his 17 year tenure
John Cipriano – Sr. VP of Regulatory Affairs
34:05 – Eyal has presented a lot of detail and the conclusion is that it is a momentous finding.
34:25 – I would like to point out I was involved with the study and we shepherded it through the FDA. We included everything the FDA wanted in the 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.
35:00 – I am in full accord with the agreement to submit the results of the trial to the FDA. I would also add the statistical input we had in the study is from experts in statistics who have shepherded many applications, and they are in accord with what we feel the results of the study are what they are.
35:30 – I have already contacted FDA, both the division of oncology products, which is the division 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 US. For that purpose sometimes it is advantageous to the review process, sometimes it will speed it up and help us along.
36:10 – I have contacted those groups and told them of our findings briefly, and 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.
35:35 – In my opinion we should be successful in that. An application will be accepted by the FDA and the product will be approvable.
37:00 – All drugs are approved on the basis of a benefit/risk analysis. The benefit/risk ratio for MK is very high. Large and durable overall survival benefit.
37:35 – The survival in that group (non-chemo group) satisfied and actually exceeded the primary endpoint.
37:50 – There has been a lot of criticism in the late press, but none of it was true. As was already pointed out, all analysis was prospectively, after data lock and the statistical analysis was complete and approved prior to data lock. The study sponsor was unblinded after the data was analyzed.
38:45 – Multikine also does not add any toxicity to the SOC treatment. Also MK after 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 patient populations.
39:25 – There are other factors, which will be considered in the benefit risk assessment of MK, which will add further support, in my opinion, to the request to a submitted application and ultimately approve MK. MK is an orphan drug for a severe unmet medical need. The last FDA approval for the indication we seek was many decades ago for this H&N cancer (in the 1950s).
39:55 – We don’t know of any drugs currently in Phase 3 trials for our patients populations, and don’t know of any plans for studies to provide a benefit to patients for the next 5 or even more years.
40:15 – Regarding cancer approvals in the news, many of the approved products have received Accelerated Approval. They have been put on the market based on biomarkers and they failed subsequent studies. Regardless of all that, they are still on the market. The reason for that is it is very difficult to treat cancer patients. That is why our results are so momentous. Especially in light of lack of toxicity b/c many of the approved products are extremely toxic to patients and many patients have expensive and serious side effects, and some even die.
41:15 – So from that perspective MK is a product that many physicians would welcome to the marketplace.
41:35 – We’ve been contacted by a number of experts in the field and even one regulatory expert, who believes our P3 data is very compelling, and that an application should be accepted and the product will be ultimately approved.
42:10 – Back to Geert for Questions
42:40 – If you have to do surgery (at this stage) to know what type of SOC to vie the patient, how do you determine in advance which cancer patients can get MK, if MK must be given before surgery?
42:45 – That was the first thing our team thought of, and they have determined a clear way to ascertain which patients would end up receiving only RT following surgery.
43:05 – What are the next steps?
43:30 – The binary risk is no longer. We have extremely strong data on 40% of the patients on an analysis permitted per the protocol with no safety issues. We move forward at full speed. We have plenty of money – $47M in the bank.
44:55 – What population of patients for approval?
45:00 – We are looking at the population that gets surgery plus radiation. Chemo appears to negate the MK effect so we don’t use it with chemo. By the way, people might have to look at all kinds of immunotherapy protocols in the future. B/c I am sure it’s not just the MK case that chemo screws around with the immune response.
45:30 – How large is the patient population?
45:32 – 155,000
45:40 – How much drug can you make in the next few years?
45:50 – We think we will start with 12-13,000 patients a year. And then we can increase it over time, and then we have extra space so we can increase the capacity 2-3x.
Final Comments from Geert
49:20 – The data will determine EVERYTHING – the data is good and the data is admissible b/c we followed the rules.
50:25 – We will drive this thing forward full power – 100 mph
Again, check out this response by Duduza5 on iHub.
The following is a copied from Duduza5 on iHub – Posted at 5:35 ET on July 1, 2021 (~7 hours after the CVM investor call)
Look past the noise.
I am a physician with a biochem/molecular biology undergrad degree who also has a business background. I am in active practice. I manage about 33% of my own investments split between blue chips, tech and speculative investments like CVM, all my holdings are long term. From my standpoint these stock fluctuations bother me very little. What does bother me is seeing small investors getting rattled and abused by MMs because their technical background does not align with their investments.
Hopefully the below increases knowledge in Cel-Sci’s case:
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.
When evaluating young biotech stocks for speculation I ask several questions.
1. Does the study address a medical issue that is highly impactful using a creative approach?
I do not invest in Plavix imitators, keytruda imitators etc. I like unique, aggressive, scientifically based studies which address true needs. CVM checks this box.
2. Is the study design appropriate for the problem and ethically built in a manner consistent with current physician practice?
Some studies are designed with bias and I will never invest in those companies. One example of a poorly designed study is Pacira which compared their liposomal bupivicaine to saline instead of plain Bupivicaine. CVM’s study completely utilizes SOC and the descriptions of its design sound very appropriate. It is important to know that poorly designed studies do get drugs approved occasionally but I do not believe Cel-Sci’s study was poorly designed. We will know more when the journal article is released.
3. Is the benefit meaningful?
There are drugs which get approved, cost tens of thousands of dollars and only extend life a month or two. These costs do not make sense to me. In contrast with Multikine, an extra 14 people out of 100 will be alive after 5 years….
4. How adaptable is the drug?
Physicians love adaptable platforms. The devinci robot by intuitive surgical is a great example of a highly adaptable platform. Early on acceptance was slow but as physicians became more creative and facile with it, doors to new indications rapidly opened up. Cel-Sci is highly adaptable and can be easily researched by Cel-Sci or by hospitals independently. Think about case reports for unresectable H/N cancers as one example. CVM checks this box
5. Is there a clear biological signal?
Definitely for CVM. What is more exciting is we have added to the knowledge of historical controls and established statistical significance with only one product. Multikine is a 14% improvement in lower risk H/N. Cisplatin is 13% in higher risk. It is very easy to infer from this that a new study with a checkpoint inhibitor and Multikine compared to Cisplatin (chemo) could possibly breakthrough the current chemo SOC 13% 5 yr survival and replace it. I think this could be ethically researched in a small phase II and potentially ethically researched in a larger study.
Partnerships are a definite possibility but the possibilities of a buyout are also very high because of the clear biological signal and the adaptability of the platform.
There is currently a checkpoint inhibitor arms race going on with many of the big players elbowing each other out to get the first indication for each cancer. Pairing this drug with a checkpoint inhibitor gives the potential to leapfrog other inhibitors and differentiate a checkpoint inhibitor product with a greater likelihood of success (statistical significance). If there is a buyout whisper this stock becomes game on.
I am not suggesting or recommending this stock, just giving the pathway I use to evaluate biotech. I prefer to invest in ways which have the potential to make society better. Does the fact that the primary outcome was missed? Unfortunately this stretches the roadmap a bit and delays approval for all H/N but the FDA will look at the whole picture in regard to the subgroup. That is why it takes months to years to go through the process. There is always the possibility this limps along for years and we all pay the price. Hence the word speculation…
Good luck to everyone!
The following is a copied from Duduza5 on iHub – Posted July 5, 2021
Unfortunately for Cel-Sci their hands were tied at the beginning because they could not ethically design a study without chemo. The decision for +/- chemo can be made at any point, pre-surgery, pre-radiation, post surgery, post radiation. The factors weighing in to this decision are many but include staging and tumor genetic risk factors and tumor morphology. Cel-Sci had zero control over this aspect of the decision-making process.
The FDA knows and understands the whole story. Fortunately for Cel-Sci as part of SOC there is a low risk subgroup which does not receive chemo because the risk of chemo toxicity outweighs its benefit in this subgroup. This subgroup then sent out a strong signal of efficacy that was statistical significant using the primary outcome measure the study was designed to capture.
Anyone who tells you with confidence that the FDA is going to spike this is lying to you or clueless.
People should definitely make their own decisions and know the facts because this remains a risky investment, but I do not believe it is a dumb investment like many want you to believe.
I will probably stop posting soon but thought I could leave you with the below interesting info:
Cliff notes: Cisplatin prematurely ages a testicular cancer patient 7.5 years.
For CVM Bulls, this isn't over...not by a long shot
June 28, 2021
Well the data is finally out. And CVM longs must face reality. There is no sugar-coating it. Cel-Sci’s P3 trial missed the large primary endpoint of 10% OSI over SOC for the entire study population.
For us that were expecting this grand slam, it feels like we’ve been hit by a truck. Our dreams of becoming retirees in one day didn’t materialize.
In addition the market didn’t like it as it ended ~47% down for the day. But this is an over-reaction and I will explain why below.
Does this mean Multikine failed? No. Not at all as I will also explain below.
So now what?
We 1) focus on the facts at hand, and 2) make a plan.
Step 1 – Focusing on the facts at hand
When one looks closely at the results in the PR and the study design, Cel-Sci did hit the primary endpoints for 1 of the 2 groups represented. Granted, it was the smaller of the 2, but they did crush it.
Here is the study design. Take note of the two red boxes.
These treatment groups were separated from the beginning. And they were going to be analyzed separately all along. This is not new information.
It appears the market (and many longs) expected the company to hit 10% OSI on the entire study population (i.e. RTx & CRTx).
The company beat the 10% on the RTx group only. And they beat it significantly – 40% greater than the study design!
So when people say that Multikine failed, this false. Failure would mean no survival benefit in either treated patient group.
A quite large percentage of the advanced H&N cancer population cannot tolerate, or will not be prescribed, chemo (~40%). And no wonder – chemo is essentially poison designed to destroy cancer cells. It often takes out the entire immune system in the process, leaving the person susceptible to other infections.
So what type of patient group would not be prescribed chemo? Any patients with kidney issues (which often present in elderly populations) are at increased risk of complications from chemo use. This group also includes pregnant women and women who are nursing. Below is a screenshot of Cisplatin (used in the Phase 3 trial) contraindications from rxlist.com.
In summary there are many conditions can preclude the doctor from including chemo in the treatment of H&N cancer.
Here is the primary takeaway from Cel-Sci’s PR:
1) Patients treated with the Multikine treatment regimen plus SOC vs. SOC alone had an overall survival benefit of 14.1% at 5 years which exceeded the pre-defined 10% overall survival benefit set out for the study population as a whole. This result was statistically significant (ITT; p =0.0236, HR=0.68) with a robust and durable duration effect exceeding 5 years.
The 14.5 % improvement is huge considering the FDA now approves drugs that show as little as 6.5% OSI. The p-value of 0.0236 means one can be certain the treated population is truly random.
The Hazzard Ratio of 0.68 is also significant. It means that there is a 32% (1-0.68) lower risk of death vs. the CTx SOC when treated with multikine.
But there is another nugget in the PR. See point 3 below:
3) The OS advantage increased over time and was evident from the inception of the study participation for this group of patients through the end of the follow up period with a median follow up time greater than 7 years for those still alive.
This means the OSI from Multikine continues to improve over time vs. SOC (without chemo). Each year the OSI increases slightly. It is unknown if the company is still following the patients at this time, but if they are, they can claim a greater OSI.
And of course we know that Multikine is (and always has been) safe. Safety is 1 of the 2 overarching criteria needed for the FDA to approve a cancer drug.
But what is the other criteria?
According to new guidance issued in Dec 2019 by the FDA, a drug must also show clinical benefit. Clinical benefit is any one of the following (this is not an all encompassing list):
- Improved overall survival
- Improved quality of life
- Reduction in tumor size
- Better defined tumor margins
Since the results showed a 14.1% improvement in survival (which is the gold standard for clinical trial endpoints), we can expect Multikine to get approved on this metric alone. But Multikine most likely also hit one, or more, of the remaining benefits, which are outlined as Secondaries in the clinical trial. We need to wait for published results to know this for certain.
These secondary endpoints are important for understanding the full potential of Multikine.
For example when a tumor shrinks, or has more defined edges, making it easier to cut out, it helps doctors treat the disease. For H&N cancer this potentially means cutting out less of your tongue and jaw.
BLA Submission Debate
There is some debate if this data can be used in the BLA submission. The answer is Yes.
The analysis of Multikine + SOC (without chemo) was part of the Statistical Analysis Plan before the data was locked.
Indeed, the PR states the following:
The analysis of this separate group is expected to meet regulatory requirements for FDA submission.
Geert also tweeted the following the morning of June 28 in response to shorts saying the data will not be accepted by the FDA:
He also tweeted this a few weeks back.
To repeat, Geert says any data derived before unblinding can be used for drug approval. This is key.
In addition, John Vandermosten of Zacks, who covers biotechs exclusively assumes (in his valuation calculations) that CVM will have drug approval by the FDA and in the EU in 2023. See below. If he thought there was a chance of not getting approval, his valuation calcs are absurdly high.
In conclusion the data on this group [Multikine + SOC (less chemo)] can be used in the BLA submission to the FDA. And since they showed a greater than 14% OSI, it will most likely be approved. Remember that Keytruda and Opdivo only extend life by a few months and were still approved.
What is the Multikine market size?
The PR states the following for advanced H&N cancer numbers:
The group showing significant survival benefit (no chemotherapy) represents approximately 155,000 patients per year globally, or about 40% of newly diagnosed advanced primary head and neck cancer patients.
This is a significant patient group. But to be conservative, we will only focus on US & EU potential sales numbers since Cel-Sci has those rights.
In the US cancer.net states that 66.5K new cases of H&N cancer occur every year. If 40% of those are advanced and can’t tolerate chemo, ~26K US cases potentially qualify for Multikine use.
In the EU the NIH states that 151K new cases of H&N cancer will occur each year. If 40% of those are advanced and can’t tolerate chemo, ~60K EU cases potentially qualify for Multikine use.
This brings the total possible cases that can qualify for Multikine use in the US & EU to ~86,000. To be conservative, we will cut that in half to 43,000.
Keytruda and Opdivo both cost ~$175K/year, are toxic and only extend survival by an average of 3 months.
If we put the price of multikine at $100K (a very low figure), we get the following yearly sales:
43,000 cases/year x $100,000/patient = $4.3B/year.
Can multikine still be a blockbuster. Yes, it can!
But also consider this.
In Phase 2 a few patients saw significant tumor reduction and no cancer cells remaining as verified by pathology (i.e. complete response). Do you think that happened in this P3 trial? I think it did.
Remember that Phase 2 had 19 patients that received Multikine. Geert stated on a radio program that one patient (it might have been 2) had complete tumor elimination after Multikine injections, and did not want any more treatment. Who can blame them if the next step was to cut away part of their face.
This phase 3 trial had 398 patients (3/7 x 928) that received Multikine. I believe some of these patients saw the same tumor-elimination effect. Remember the patient has the ultimate say as to if they want to continue treatment. Not sure how ICON accounted for this condition, but I am quite certain it was part of the reason why data analysis took so long.
Some Confusion on the % Improvement Numbers
In an effort to be transparent, I cannot make sense of the following:
The press release states the survival benefit was 14.1%. This is the number you get when you subtract 48.6% from 62.7%.
But the phase 2 results were continuously stated as a 33.1% survival benefit on the company presentation. The only way to get this number is by subtracting (63.2 – 45.7) = 17.5. Then take 17.5/45.7 = 33.1% improvement over SOC. See Slide 26 of the Multikine Presentation.
Using this same ‘division’ method on the numbers in the PR would give us (62.7 – 48.6) = 14.1. Then take 14.1/48.6 = 29% improvement over SOC.
I can’t explain why there are 2 different ways of reporting this data. If someone has an explanation, I would like to hear it.
A summary of the facts
When we step back, here is what we observe.
- Major facility upgrades totaling $13M dollars to increase Multikine production capacity
- Continual hiring of new positions for manufacturing & quality control
- Exceeded the primary 10% CTx OSI endpoint by 40% (i.e. 40%)
- Multikine was safe and well tolerated
- CEO going on record saying the derived data was acquired before unblinding; therefore, it is not data-mining and should be acceptable to the FDA.
- Company has enough cash for next 2 years (enough to start commercialization)
- As of 6/29 an insider purchased 3,000 shares on the open market (CVM management needs to buy in BIG to show conviction, in my opinion)
Many longs were hoping for beating the 10% OSI on the entire population, as was I. But achieving 14% improvement over SOC for the CTx group is still very impressive. For this group Multikine clearly works!
There is a clear path forward and the market is still large. The contentious part to the PR is the FDA being willing to accept the data from this group. I believe they will.
It takes about 6-8 months for file for a BLA after receiving the data. With a new class of drug, as with Multikine, it may take longer since the mechanism of action is new and requires additional data. Once the FDA acknowledges receipt of the BLA it will take about 10-12 months to review. This puts us at the end of 2022 before potential approval.
For now, I believe the SP will eventually rise (although there may be some extreme dips) as the market digests what actually occurred and its significance. How far it will go is anyone’s guess. Cel-Sci still needs to report secondarys and based on Geert’s recent tweet, Dr. Talor will be publishing the results in a peer reviewed journal. The good doctor has a lot of work ahead of him.
So what about Step 2? That ball is in your court. You have more facts so its time to make your plan.
All the best.
If any facts in the above article are incorrect, please send an email to firstname.lastname@example.org . Thank you.