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Thank you for posting the published LDN patent issued to IMUN effective October 30, 2018. The patent is very broad and general in its coverage and is potentially highly significant. Depending on how others interpret the overall impact and how defensible the claims will be, it could position IMUN in a very favorable light.
As usual, your postings have great insight and provide the most appropriate background(s) for fruitful, sensible discussion about the status of IMUN.
Just one aside note--I would respectfully disagree with your opinion regarding the statins--but that is for another discussion.
Your summary is exactly correct re: IMUN's successful attainment of just one FDA approval to market for LDN. It would have been/still would be the initial "Bingo" for the company following the path just as you described. I have been indicating that in many of my postings here for well over a year!
Your posting is the most cogent in quite some time, particularly your last paragraph. Although until clearly competent scientific clinical studies demonstrate, calling LDN a miracle drug is premature. Absolutely definite potential as an efficacious primary and/or adjunctive therapy in perhaps several disease states, but the studies must be completed appropriately. IMUN had and has that potential. But, just as you stated, "..the leadership of this company is not equipped to get it done." The horrifically unqualified CEO was never, is never, and will never be able to competently accomplish the necessary aspects to complete these studies. This goes back to over 5 and 1/2 years. Just one FDA approval to market for just one indication for LDN would definitely had launched IMUN into a highly successful trajectory. But, here the company sits in the same despicable situation and no changes. Not even after the appointment of the heralded Dr. Moore as Chairman of the Board-no changes.
As you know there is a new Chairman of the Board of Directors of Immune Therapeutics, Inc.-Roscoe M. Moore, D.V.M., Ph.D. No doubt your excellent question should be addressed exactly as you stated directly to him. He apparently can be reached by e-mail through the website of a company for which he is listed as a Founder and President-PH RockWood Corporation or through the following telephone number given for that company in Silver Springs , Maryland-301-871-1134, unless of course others have a direct e-mail or telephone number for the new Chairman that can be shared.
If you go to the actual full publication itself you will note on the first page that the work was supported by the Foundation for Research Support of Bahia State(FAPESB-grant 3538/2013). That is in Brazil. The study from the Department of Anatomy, Pathology and Veterinary Clinics, Federal University of Bahia, Salvador, Bahia, Brazil. Nothing to do with Immune Therapeutics, Inc.
Correction: Roscoe Moore does not hold an M.D.(Medical Doctor) degree but holds a D.V.M. (Doctor of Veterinary Medicine ) degree and a Ph.D.(Doctor of Philosophy) degree in Epidemiology.
Excellent response and link! It IS the OFFICIAL U.S. Government listing for appropriately submitted clinical trials.
Have to read at the top of the link's announcement page "This Trial is Withdrawn". Either way, it was a Santa Barbara College Sponsorship, not IMUN.
Totally wrong on your statement that IMUN's parent company is Cytocom--the reverse is and has been true for close to four years.
And most egregious, is your misleading statement that either company (IMUN or Cytocom, Inc.).. "are through many clinical trials with the FDA on our home shores.." There have been NO clinical trials started, yet even completed, under the direct auspices/sponsorship of either company with the FDA.
I believe that you are providing the most intelligent and no doubt precise focus in your endeavors into the continuing significant issues underlying and eroding the long time potential of IMUN/Cytocom.
The two outside/purportedly independent Directors are responsible for maintaining the unqualified Griffin even though a change was announced months ago, therefore, absolutely yes the full pressure on them to effect a change that could be made very quickly needs to be ramped up immediately. Watch what will happen when an obviously qualified individual is appointed and competent planning and function occurs within IMUN/Cytocom!
Using your own choice of words what you should be saying, and seemingly never do, is--"Current IMUN execs do not know a lick about the science and management of a developing biotechnology company with significant, but through gross incompetence, stymied potential." That is what needs focus-the PR rap is tangential to the real underlying serious issues!
The unqualified Griffin must be replaced as promised from IMUN/Cytocom and the two outside/purported independent Directors are responsible.
Great summary! Only comment-2 people that have degrees?? No doubt Ms. Austin has degrees, but NO DOUBT the unqualified Griffin does not!
Answer to your second of two excellent and appropriately probing questions--I do not have the definitive answer and hopefully someone does.
The attempt at a non-definitive answer to your first question is No, I do not believe it is even possible to have revenues out of the purported Fidson distribution contract without government grants OR any other supportive sources of revenue.
True, the current Board of Directors, being the two outside Directors and the unqualified Griffin as the third could vote 2-1 immediately to replace Griffin, and absolutely should ASAP, however what I certainly believe is that what the unqualified Griffin has "over the Board" is the large shareholder investment combine anchored by RJ Dailey. Therein is the significant problem for the two current outside/purportedly "independent" Board members and therefore a MAJOR problem for all of the remaining shareholders such as the ones that post on this site.
Thank you very much for supplying the very interesting link! I believe it is extremely important for the followers/shareholders of this IMUN posting site to click on the link to the RedHill Biopharma Press Release and then to look more into the company as well. It will provide a significant insight into how immensely different from IMUN in many, many ways. Just look at the management and review the overall function and focus of the company.
Just remember, that IMUN was in progress with LDN for Crohn's Disease and at the FDA over five years ago. If that and much, much beyond doesn't cry out to fully replace Griffin I do not know what more does!
The entire IMUN and Cytocom, Inc. relationship, from inception to the present, begs for a detailed forensic financial audit. I would easily bet that the current two outside IMUN Directors have no clear understanding of the IMUN/Cytocom, Inc. history, functionality and questionable financial mechanics.
Long, long overdue! Thank you very much for your lead and I am sure you will be helped. This is a company with squandered significant potential for over five years by obvious grossly dysfunctional management and additionally also crippled by certain factors in the background that are puzzling and disturbing.
No doubt, you will be fully supported! So glad also that you have highlighted the urgency.
AN SEC violation or not? Maybe some one can provide the correct answer.
P.S. Sorry for the interrupted and continued posting.
Yes, exactly! For starters, and I have brought this up before, there has been NO true annual shareholders meeting since fall of 2014-coming up to 4 years-where voting for members of the Board of Directors is supposed to occur. Now why as shareholders is this allowed to occur??
I do not have the accurate answer to the question as to whether this is an S
NOW, NOW you are speaking logically and directly to what needs to be done!! And I believe the very sooner the better! There are many shareholders, both long time and short time holders, that need to initiate some action. I have posted in the past that the two outside Directors should be held significantly accountable for their collective lack of responsibility for allowing Griffin to continue in her positions. They have the legal responsibility on behalf of the shareholders.
What international exposure?? Attendance at a meeting-along with thousands of others from all around the world?? Or is there any, just any participation in any symposium, poster or platform presentation, round table discussion, open press discussion--anything indicating the actual participation of IMUN. Please answer that.
I can provide the answer to what I believe you are referring to when you noted on the bottom of the Pubmed abstract page:
DOI: 10:1016/intimp.2018.05.020
DOI is the Digital Object Indentifier and 10.1016 is not a date. Most all articles will have a 10. followed by a sequence number in this case 1016--that is not a date. What is a date follows after intimp. which is 5/20/18 which is the indication that the article was electronically published ahead of the actual journal print date. If you look at the first line of the abstract page and note the journal name and volume and date and pages in the journal you will note the intimp.of 2018.05.020 and in brackets the notation Epub ahead of print.
Since you probably do not have a copy of the actual journal publication it indicates that the paper was originally received on March 21, 2018 by the journal for consideration to be published. Hence, a timely submission.
Definitely agree. I have been concerned for a long time that a major reason for the obvious lack of professional investment funding over the many years into IMUN (as there easily should have been) is related to Griffin's background to which you are referring and her clear lack of qualification evident to professional investors.
Yes, Griffin's involvement in that case was several years ago-and to some it is "water over the dam"-but that is not the point. Whether she was involved in that situation or any other it does not change the significant fact that she was and is completely unqualified for a CEO position in IMUN or any other Biotechnology company. The "proof is in the pudding" as the old saying goes and IMUN must obtain the right personnel ASAP. AND for sure not CEO of Cytocom, Inc. either.
The usual and professionally accepted course to gain attention and interest in the potential of a new therapy is to either have a full publication on the findings submitted to a peer reviewed journal or presentation of the findings at a well attended and widely known scientific/medical society's annual meeting or special conference. Much publicity can be garnered from these appropriate routes. As just one example, there is immense scientific, investment and general news organizations' reporting personnel that eagerly await and attend the annual American Society for Cinical Oncology (ASCO) meeting held each year the first week of June. Much full coverage is garnered from that meeting.
I pointed out recently on this posting site the availability of what I believe is the "white paper" on LDN therapy. I gave the link to the Pubmed website to view the abstract. Here it is again: www.ncbi.nlm.nih.gov/pubmed/29885638. Since there is cost ($37.95) to obtain the full article fro the journal publisher, not sure who has a full copy.
Please note the authors on the publication-it IS an IMUN article. There is only minimal discussion in the entire article contained in a very short paragraph titled LDN and AIDS. Only two references are indicated, one to a 23 year old article by the late Bernard Bihari, M.D. and a reference to a Fengping Shan group article covering effects of LDN on macrophage function that contains only a notation that "In Nigeria, LDN has been approved for the treatment of AIDS." There is absolutely no reference to the actual results of the bridging study of LDN in Nigeria completed well over two years ago.
Why?-easy answer-nothing was published or presented at a conference covering this, and I quote you, "huge" piece of knowledge. If you want to pursue the PR failings of IMUN you should be pressing to know why no presentation or publication on the results.
You stated that the unqualified Griffin has done a great job as a private company CEO/COO, but apparently you were discerning between a COO and CEO position. Quite muddled. However, and it would be best for you to start to seriously consider as an apparent investor in IMUN, whether COO or CEO, whether a private or public Biotechnology company Griffin is completely unqualified and proven incapable to be involved as such in either.
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Perhaps also for you to consider--a little more detailed Due Diligence on your part regarding the Nigerian activity, including the purported Fidson interaction, might disclose to you that it actually involved the sole or for sure the concurrent efforts and connections of other people representing IMUN.
Big time kudos to you dwarren for posting this information!!
We need clarification-what private company CEO/COO position did the unqualified Griffin do a great job? Please provide-thank you.
Good question! If you look back at the 8-K coverage of the announcement of the receipt of the purported follow up minutes/guidance from the purported FDA Meeting in January, 2018, the framing was IMUN/Cytocom--there was wording, as I recall, that stated that IMUN was attending the purported Meeting on "behalf of Cytocom" and hence the IMUN/Cytocom framing. I am just guessing here, but since the original IND with the FDA most probably still sits with IMUN, it was probably that situation leading to a joint IMUN/Cytocom purported presentation at the FDA. Thus if any Phase 2/3 studies are to start with the FDA I believe IMUN would be absolutely obliged to announce such to the public.
I have been and will continue to be resolute about pounding home to all posters who are shareholders the absolute necessity to have FDA sanctioned clinical studies done. If anything,the HIV Plus Magazine article serves to underline the unfortunate fact that LDN studies for therapy in Crohn's Disease at the FDA under the IND of IMUN should have been completed long ago. Now, as of January of 2018 another purported FDA Meeting was held and follow up minutes/guidance purportedly received by the FDA. Now what? Have the study protocols even been designed-let alone the studies started? How could they be-no Chief Medical Officer (CMO) and a continuing unqualified CEO.
Need to have the funding in place- and not a few hundred thousand here and a few hundred thousand there sold at literally pennies on the dollar and diluting the blazes out of the OS. That is not how a competent Biotechnology company with significant potential operates. And why has this continued??
Good point-yes, I do believe a new law is now in effect allowing patients to elect to receive an experimental drug if all other therapeutic avenues are no longer effective and illness is terminal. However, no doubt, the experimental drug will have to be at the FDA under an IND (Investigational New Drug) application. Not sure about Lodonal re: terminal life issues BUT definitely methionine enkephalin (MENK) could qualify as there is an IMUN sponsored IND at FDA on file for use in pancreatic cancer. The company had meeting at FDA on this in mid-2013.
Interesting information, BUT the most obvious aspect is how does this benefit IMUN. You and all other stockholders must know that in order to benefit from use of LDN as a therapy, IMUN, like all other Biotech/Biopharma companies MUST receive FDA New Drug Application (NDA) approval to market the drug. NO IF, ANDS OR BUTS about it. And to do that clinical trials approved and monitored by the FDA need to be done!
No, I have not confirmed with management. Perhaps one of the other posters that seem to call management frequently could pose the question. What happened to Dr, Abeles at Cytocom, Inc.??
John Abeles,M.D. is no longer CEO of Cytocom, Inc. The link you refer to on the bottom of the Home page shows the original announcement of his appointment. Just probably the usual ineptness in not removing that link. There was a large full page under the Management tab in the Cytocom, Inc site that indicated him as CEO and that has been removed several weeks ago. Now just shows Griffin as President, Aronstam as CFO and Fengping Shan as CSO (Chief Scientific Officer).
Yes, there should be an 8-K re: Abeles departure from Cytocom. I indicated that in post several weeks ago.
Here is another link to a most interesting 4 year old publication in the journal Expert Review of Anticancer Therapy. The link is to the National Library of Medicine (NLM) Pubmed site. It is an abstract of the article, however on the upper right on that page you will see View Full Text. Click that and it will take you to the publisher's site. There a link is found for .pdf copy of the article. Click that and the five page article will download free of charge.
Dr. Ian Zagon is an advisor to IMUN/Cytocom and the article is about very important therapeutic potentials for methionine enkephalin (MENK) for which, as you should know, IMUN possesses use patents. OGF (Opioid Growth Factor) is methionine enkephalin.
This article is food for thought and provides just more indication of lost opportunity for IMUN/Cytocom in progressing with the needed clinical studies for which the companies were established. Note on page 249 of article under Financial & Competing Interests Disclosure. Reminder-TNI Biotech Inc. is now IMUN.
Here is the link: www.ncbi.nlm.nih.gov/pubmed/24397732
I have not tried to contact the company to answer the questions I indiated nor many, many more that I have to ask as I do not believe the current management and the general practices of the company have any appropriate credibility. However, another investor in IMUN that I know has contacted one of the two (2) outside Directors with similar questions and the response(s) were generally expressing concern in providing information that has not yet been released officially to the public. Plus he told me the rest of the discussion(s) were vague promises of some upcoming progress.
The Shareholder's Letter from Griffin indicated as a strategic objective for 2018 a Board of Directors approval for a search for a new CEO replacing the wholly unqualified Griffin and a new CMO (Chief Medical Officer). The Company's goal was to fill both of these roles by the end of Q2 of 2018. Lo and behold we are 18 days past that goal and there is absolutely no doubt the goals are nowhere near completion. As an aside, flying under the radar is the fact that a very significant position in a Biotechnology company is the CMO. What happened to Angus G. Dalgliesh, M.D.? Remember him-he was the CMO. What happened? I know where he is and doing excellent and very meaningful research on LDN: Department of Oncology, Institute for Infection and Immunity, St. George's University of London, London, UK.
Why no longer CMO of IMUN??
Want some real news to have the stock immediately rise in value-it would be the attainment of the aforementioned goals ASAP. But the replacements must be with qualified and proven individuals. They are out there!
And finally, and once again, what happened to the highly touted John Abeles, M.D. and the proposed initiatives as a result of the January, 2018 Meeting with the FDA.?? Same question-What Happened??
Why is the article a "must" read?? Because Griffin has her name attached as "co-author"??
Your consistent indications regarding the proper PR from IMUN are, in general, on target but I firmly believe that the ongoing persistent deficiency in promulgating the company's accomplishments and positive outlines of planned future projects with valid endpoints is a matter of, alarmingly,"nothing there". Just one example to start-Here is a company that twice, not once, but twice over five years had a meeting with the FDA to consider moving forward its IND with late Phase 1/Phase 2 Clinical studies for a patented indication in a disease state still in need of relevant and effective drugs. What happened? Where is the highly touted John Abeles, M.D.? Where is the funding?When will the studies start? There can be no truthful PR until "somethings there".
With all the potential therapeutic uses for LDN and MENK--where are the true FDA clinical studies? Why have they not been started over the last five years? NOT ONE! Screaming for PR about what?? Announcements go out-but nothing of any substantive progress ensues. Why? Answer is simple-but let's see who can provide the no doubt correct one.
If one uses the Pubmed link and goes to the abstract on Pubmed there is link on that page to the journal's publisher Elsevier and there the cost for download of the paper is $ 37.95 not $ 55.00.
In either event, it seems IMUN could seek a copyright fee deal with Elsevier that would allow IMUN to place full paper on its web site for all to read and/or download and thus shareholders do not have to pay any fee to attain.
And just a note of information--it is not a "huge" deal that the paper's abstract is on the National Library of Medicine(NLM) Pubmed website--virtually all articles published have abstracts listed on Pubmed.