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H2R, thanks for posting that chart. I agree that this rapid resubmission is indicative of the trial results finally being close to approval for future FDA submission. That was my take-away, at least, and my hope - I've been burned a few times by CVM over the past decade, so nothing would surprise me here, lol.
Despite all of the noise surrounding the trial results, I can't imagine how complex the trial data must be, given length of run-time, number of patients involved, and the number of sites and countries where the trial was conducted. From this perspective, I think that CT sending the results back for more editing several times is reasonable, if frustrating. I'm sure there are MANY T's to cross and I's to dot. I try to keep this in mind while I wait for things to start moving a little faster...
Best of luck to you, as well.
It looks like CVM was quick to fix whatever the problem was. They resubmitted the same day!
Nice, Robot! Good luck with the trifecta! I'm too invested in CVM to get into NWBO now. The price is nice, but I"m only peripherally aware of the NWBO story, and the large float is of concern to me - I've been burned a few times by reverse splits and such. I don't know anything about the other stock you mentioned, but I'm going to read up on it.
Wow... we haven't seen $5 in a long while!
I'm not sure where Mr. Feurstein's expertise in matters of immunotherapy are derived. Several here and in other spaces have reported that he has a B.S. in Political Science. I've read a few of his pieces, and have never been impressed. His conclusions tend to be poorly formed, with large holes in his logic. In fact, I've never read anything by him, or heard of any piece he's written, that has ever painted any target of his work in a positive light.
I thought he did a fine job, as well. He seems very relaxed and confident. Also, I saw that tidbit that that 5 patients had a complete tumor response to MK, which I haven't seen before with other discussions of the P3 data. That's not as high of a percentage as in the last P2 trial, but still is great news. Looking forward to learning what percentage of the ITT group had some level of tumor response.
Geert is presenting today at the LD Micro Invitational. 4:30 ET.
https://feeds.issuerdirect.com/news-release.html?newsid=5812484283987525
Lightrock! Great to see you post here again!
Great to see you again, Sab!
Excellent post!
Thanks so much for posting this!
Best of luck, Robot. I've enjoyed your posts, sorry to see you go. I would love to buy into NWBO, but I've got too much tied up in CVM.
Dr. Kaz, the letter to shareholders was included in the DEFA14A filing. I found it here:
https://cel-sci.com/sec-filings/
I agree. Geert is the best man for the job. He has been in this for 30 years. It's his life work. He's the largest single shareholder. As much as I've hated seeing the value of my shares going down, no one investor has lost more value that Geert. None of the others have sold either, except for Cipriano's annual sale of 10K shares. I'm buying more at these levels to average down and holding firm.
Well, Henkel raised a good point- Geert has said that publication and peer-review will happen simultaneously. So I stand corrected there. However, CVM is not the entity with the power here – they can’t very well tell a publication when to publish, or tell the FDA when to have a pre-BLA meeting, unless the FDA has given its blessing to proceed with a pre-BLA meeting once CVM is ready, meaning once CVM knows it’s trial data is about to be published. This is, as you say, how the game is played, and the FDA knows the company wants a guarantee that the trial data has been accepted for publication prior to a meeting that they’ll have to tell investors about. They may be able to arrange for the two to happen at or about the same time, but it’s not publication in a peer-reviewed journal that determines whether or not they can get MK approved. They want the publication at, or just before, the pre-BLA meeting for a number of reasons: having a publication in a peer-reviewed journal adds tremendous credit to their work; their scientists win acclaim for their efforts from the science community; publication in such a journal guarantees that the trial data has heavily and objectively scrutinized by other experts who are not associated with CVM; doctors who will want to consider prescribing the treatment will look for such a publication in their research before deciding to recommend it to their patients; publication will make MK a more-attractive target for acquisition; etc., etc. Given the apparent hoops CVM must jump through in the publication process [see quote in my previous comment] it’s likely that they are simply waiting for word that they’re getting published before moving forward with pre-BLA.
Unless I'm mistaken, Cel-Sci's strategy is to first have the full results of the P3 trial published in a scholarly, peer-reviewed journal, and then to seek a pre-BLA meeting with the FDA to discuss the path forward for approval of MK. To that end, here is a quote from a scientist employed by a different biotech company, that I found to be rather insightful regarding the process of earning publication in a prestigious journal (this company just concluded a P2b trial in which they met their primary and secondary endpoints):
"However, due to the strict disclosure policies of the prestigious clinical journals, which only permit limited data to be released at closed scientific meetings, the Company is unable at this time to release the entire data set with information that it believes would provide greater clarity around the results. Any further disclosures of the clinical data may disqualify the trial from publication, a situation the Company wishes to avoid. Although publication may be several months away as the peer review process typically involves several iterations of questions and clarifications, publication in a peer-reviewed journal will lend significant credence to the work and represent significant progress in the field of..."
Geert has repeatedly stated that, in order to ultimately succeed, things have to be done the right way the first time. I believe that is why he has been silent on Twitter, and that is why the company has been in information lockdown since July. The company's priority is to get the results of the P3 trial published, which will help them when they meet with the FDA. I am long here.
Titan Pharmaceuticals Receives Funding to Develop Combination HIV Therapeutic and Contraceptive Implant for Women in Developing Countries
7:15 am ET October 25, 2021 (PR Newswire) Print
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") today announced that it has received funding from the Bill & Melinda Gates Foundation to support the demonstration of its ability to deliver a human immunodeficiency virus ("HIV") preventative therapeutic and a contraceptive from a single implant using its proprietary ProNeura(R) technology, and ensure this technology is accessible to women and adolescent girls in low- and middle-income countries.
https://mma.prnewswire.com/media/472621/titan_logo_2016_copy_Logo.jpg
"Reducing the burden of HIV, while simultaneously increasing access to contraceptive options, could have a major impact on the health of women and adolescent girls in low- and middle-income countries," said Marc Rubin, M.D., Executive Chairman of Titan. "We believe that our ProNeura platform is uniquely suited to this program, as we have demonstrated the feasibility of long-term delivery of two pharmaceutically active ingredients from a single implant in an earlier development program. The continuous long-term delivery of a contraceptive/antiviral combination has the potential to have a greater public health impact in developing nations, compared with daily dosing of multiple compounds."
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura(R) long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
CONTACT:
Stephen Kilmer Investor Relations(650) 989-2215 skilmer@titanpharm.com
https://c212.net/c/img/favicon.png?sn=SF50375&sd=2021-10-25
View original content to download multimedia:https://www.prnewswire.com/news-releases/titan-pharmaceuticals-receives-funding-to-develop-combination-hiv-therapeutic-and-contraceptive-implant-for-women-in-developing-countries-301407256.html
SOURCE Titan Pharmaceuticals, Inc.
https://rt.prnewswire.com/rt.gif?NewsItemId=SF50375&Transmission_Id=202110250715PR_NEWS_USPR_____SF50375&DateId=20211025
Sure seems that way... :(
Just curious, but as a matter of pure speculation, and barring any positive PR's from CVM, am I silly for expecting the stock price to back off next week before August options expire next Friday? Thoughts? Not asking for advice, just a seasoned opinion; I am fully responsible for my own investing, of course.
As I understand it, the company was required to provide results for the overall endpoint for the entire test group (i.e. all patients who received Multikine prior to Standard of Care). The goal for this group was a 10% improvement in Overall Survivability (OS). The trial did NOT meet that goal for the entire test group. This is what the nay-sayers are referring to when they say the trial failed.
However, as was pre-specified in the trial design, the test group was divided into two "subgroups": a group receiving MK plus SOC which included surgery, chemo, and radiation; and a group receiving MK plus SOC which included only surgery and radiation (no chemo).
The chemo subgroup did not see a benefit from MK. The non-chemo subgroup (about 40% of the patients in the test group) saw a 14.1% improvement in OS at 5 years, which handily beat the 10% improvement endpoint.
Sab, really great to see you posting here again. And thanks for the info/insight.
I hope he does. It will do wonders for the SP!
Consider that if CVM were to conduct a new phase III trial for Mk as a treatment for HNSCC (not actually even a remote possibility), in which the treatment arm would only recruit patients who would not receive chemo as part of the SOC (the subset from the IT-MATTERS trial that showed excellent benefits of MK treatment), then that group would be a superset.
I think that the potential for MK is beyond measure here. CVM proved something - that a non-toxic agent can boost the immune system to fight HNSCC and deliver genuine benefit to thousands of people. It's absolutely extraordinary. However, MK was not designed specifically to fight this type of cancer, it was designed to help the immune system recognize and fight tumors. Once they receive approval, there's no telling how many off-label uses MK can/will be applied to. If I were BP, with deep pockets and an eye to the long-game, I would be interested in CVM. But I don't think Geert and co. want to sell. They have an independent streak as long as the PIII trial. I think they would welcome partnerships.
A bourbon from Virginia Beach...? Blasphemy!!!
As I'm from Kentucky, I really enjoyed the bourbon banter this morning, lol. I used to bartend at a bourbon bar at a State Park, and learned lots about bourbon. I really like Buffalo Trace as a moderately-priced, drinkable bourbon - not as much bite as Woodford or Makers, and not as sweet as Four Roses. Basil Hayden is a unique bourbon, great for Old Fashions. Also, Eagle Rare is quite smooth. Love the Angel's Envy.
Well, I'd like to blame the shorts for this morning's dive, but I think it's actually my fault, since I bought some more shares shortly after open... SMH...
Cool, thanks. I always appreciate your posts and input.
Hi Lightrock. This looks as if, along the way, the company has changed their wording from year 3 to year 5. But the trial design was to show improvement at year 3. Is that the gist of what you're saying? I'm not super smart with these things, so forgive me.
Does anyone know if/when today's meeting will be posted to the Cel-Sci website? Did Geert and co. mention this? I heard the first part of the meeting, right up to where Dr. Talor began speaking, but got pulled away by work...
Am I understanding that the trial design originated prior to chemo being a part of SOC, and as such, that the effects of chemo on MK treatment were not accounted for in the trial's design?
I've been wondering - is it possible that the likelihood of lack of efficacy of MK for the patient subset receiving chemo was not foreseen simply because it couldn't have been known? Immunotherapy is still a new field, and the trial was designed a decade ago (or more). A lot has happened since then. Wasn't it just last year, or the year before, that the trend for the benefit of immunotherapies to increase (statistically) over time was being recognized for the first time?
You are correct - my apologies - the initial PR did not say that the OS for the entire experiment group was 4.9%, it only said that the endpoint of 10% improvement was not met.
Actually, there weren't "dozens" of subgroups in the trial. The 3/7th of the patients in the study who received MK + SOC were in two subgroups: those receiving chemo and radio post surgery, and those receiving only radiotherapy post surgery. Radiotherapy uses focused radiation to kill cancer cells and shrink tumors. However, chemotherapy introduces a drug (a toxin) to affect cancer cells. The drug [toxin] must ultimately be metabolized and processed by the body, and this can affect multiple areas, functions, and pathways in the body. It is entirely reasonable to see conclude that chemotherapy negates the benefits of MK. The trial results show that MK does have benefits, and is line with the recent revelations that the benefits of immunotherapy are actually greater over a longer timeframe than in a (relatively) short amount of time, and that specifically the patients receiving chemo didn't see a statistical benefit of MK is actually proof that it boosts the immune system. CVM has done something extraordinary here, and other companies will follow in their footsteps.
"But they never reported the overall data. And that is the key to understanding when companies spin subgroups."
So, the full data for the trial results wouldn't be released at this point, because that's not how it is done. The ultimate conclusions of the trial (as addresses the endpoints) is released first, while the company prepares the full data for public consumption (i.e. dumb it down for non-science types - the full data will be released in it's pure form to the scientific community). Today's PR is entirely in line with what GK said would be the company's MO regarding trial results all along. The company will release the full data later.
Looks like they're getting their chance. Some of them are just waiting for the price to go down even more so that they can really bank. Just makes me sick. The trial results are actually fantastic, but the misinformation machine is just too strong... I'm adding here and not selling a single share.
I tend to agree with you. The PR asking investors to email their questions before the ASM, to me, suggests that the data will not be released prior to ASM. The release of data, whatever it's outcome, will lead to so many new questions from interested parties that can't necessarily be pre-conceived until the trial results are made public and investors given time to digest the information. Seems to me that Geert is trying to get a handle on investors' questions before the ASM because he won't have the data by then.
I agree
Interesting perspective. Thanks for sharing that. I remember some discussion here awhile ago, probably last year, about the possibility of them slightly hitting below 10% OS improvement, and if MK could still be approved. I have seen a few interviews with Geert where he has mentioned that aside from seeing a 33% improvement in OS in the last P2 trial, that many of the patients reported improved ease of swallowing and eating, reduced pain, etc., and your comments are in line with that.
I also remember one interview with Geert that I watched, some years ago, where, while discussing the endpoints of the P3 trial, he mentioned that some cancer treatments were only able to show 3-5% improvement in OS, and were still approved by the FDA. I would hope that, if the MK P3 trial came up a percent or two short, that still showing a ~8% or so improvement in OS would be enough for it to get to market. I do fear that the stock price would take a nose dive, though, at least initially...
Anyway, glad you're still with us.
Lightrock, great to see you post. I've been wondering if you were still around. I hope all is well on your end.