Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
High compliments to you on two fronts. First is your original post with the video from Fidson Healthcare which provided a very good opportunity to see some of their operations and hear directly from what seems to be an astute CEO espousing Fidson's business considerations, etc.
Second, this follow-on post defines what is most likely very true and significant. Your call for the low dose naltrexone white paper is most important.
Thank you!
OK. Since I responded to you in your request to provide any information about an FDA meeting in 2013, I would like to request from you a return in helpful information in kind. Since I do not clearly recall the reasons that you have stated that you understand as to why management did not move forward into LDN Phase 3 clinical studies in early 2014, as they so indicated on Page 20 of the 2013 3rd Quarter SEC filing, a short summary of the understanding you have would be appreciated.
Would also be informative to others who are more recent shareholders as well. Thank you.
I am going to correct you since you are wrong. I refer you and others to my post # 4245 of 1/25/18 which was, interestingly, in response to Herold. Please read and note that INDEED there was a meeting held at the FDA on June 26, 2013 to discuss the Phase 3 clinical development program for a proposed 505(b)(2) application for LDN in the treatment of adult and pediatric patients with Crohn's disease. Then, IMUN received the minutes from the meeting on July 17, 2013. As I stated in post # 4245-"where does that historical info come from?" Page 20 of the IMUN 3rd Quarter 2013 10Q filing with the SEC.
So IMUN, 4 and 1/2 years later is only repeating that which already occurred. Lost time and lost money to its shareholders.
Yes, definitely observed the incorrect use of "biologists" instead of, as you point out, what should be "biologics". Adjunctive therapy use could be major potential for both LDN and methionine enkephalin in other disease entities as well.
Yes, I agree the FDA is probably taking an initial(at least) conservative/"political" approach in defining the first study to be as adjunctive therapy.
Thank you for the most knowledgeable and on target post responding to today's announcement. Much appreciated!
Where in today's announcement does it say that there is an accelerated program? Where? What are you saying??
Once again need to remind you that a very similar meeting was held with the FDA on the very same subject of LDN in the potential treatment of adult and pediatric Crohn's disease in July, 2013 with follow up minutes exactly as inferred in today's announcement. That was four and 1/2 years ago. A huge loss of time!
Absolutely no doubt your post IS the most significant post and meaningful request in a long, long time! I sincerely hope you obtain an excellent response!
Once again you are spot on in your conclusion regarding obtaining FDA approval. You may want to check Post # 3574 that I placed back in early September, 2017 summarizing a portion of my DD review of the company. But please note it is now approaching five years since the LDN Crohn's disease meeting (June 26, 2013) with the FDA.
Interesting post! If not holding a annual shareholder meeting so shareholders can vote on the Board (and other pertinent matters) is illegal, what are the remedies for the ignored shareholders? Definitely appears there are many longtime and recent very large quantity shareholders participating on this posting site that should be most troubled by the continuing lack of an annual shareholder meeting.
Excellent post! As you indicated, the November 30, 2017 Shareholder Update Letter indicates " The FDA Meeting has confirmed a meeting (note redundancy) for January of 2018 to discuss final Phase 2b/3 protocols for both pediatric and adult Crohn's Disease."
As you so correctly state, at least the company at this point should minimally acknowledge that such a confirmed meeting did indeed occur and more information to follow. Even though not definitive, such an important progress milestone input would be most beneficial to shareholders and the investment community as you described.
Could very well be a typo regarding the correct year. However, if so and it should read "..end of 2018" that is preposterous. This company should have all the data, etc. required to put a solid LDN White Paper together-and NOT take an entire year to do so-after all the company should be one of the world's expert organizations on all aspects of the actual and potential therapeutic efficacies of LDN at this point in time!
Also, once again you are on target with all of your comments regarding Cytocom, Inc. Not only typos, but other significant
inaccuracies.
Like to point out to you and others to revisit the November 30, 2017 Shareholder Update Letter wherein it is stated that the company is to "Complete a Scientific White Paper on Lodonal by the end of 2017 which will highlight its development history, approvals and clinical data that can be used with the regulators in low and middle-income countries. The company believes this paper will allow it to fast track the approval processes for various indications using the regional rules for drug harmonization."
I believe the end of 2017 has occurred-where is the Scientific White Paper?? All the purported information to be included would be quite important,and hopefully compiled by knowledgeable, experienced and respected scientist(s) in the immunology field. Indeed would go a long way to develop solid credibility.
Your postings are most interesting and, in general, pragmatic. Your comment "I just hope they realize that they should go for other markets too, simultaneously" is particularly pointed. If you have checked, or have time to do so, you should find in the past SEC filings that there were two meetings schduled and held at the FDA in mid-2013, approaching five years ago, regarding the use of (1) LDN as therapy for Crohn's Disease, both pediatric and adult and (2) methionine enkephalin as potential therapy for pancreatic cancer.
Nothing has moved forward in either of these areas since then. And apparently not because the FDA indicated any roadblocks. The simultaneous and necessary strategy ceased. Only the potential use of LDN in Africa was pursued.
You have most correctly and fully summarized the situation with IMUN, a company that as you noted no doubt possesses significant potential, but with the current Board allowing an unbelievably unqualified individual to continue as CEO shows their own incompetence and duty dereliction to the shareholders lasting over a long period of wasted valuable time.
Most interesting. Once you have some time it would be helpful to know, from your pretty studied aspects of the company, what clinical trials you feel are on the cusp and where are they being or to be performed and under what regulatory agency(ies).
You are absolutely and completely right on target on everything indicated in your post!
The questions you clearly and with rightful emphasis pose about the Cytocom, Inc. issue need credibly intelligent answers!! Significant issue!
Exactly as you well stated!! There needs to be some credible answers forthcoming. Significant issue!
Thank you for the response and information.
How do you know Cytocom one day will be a Huge, Huge public company-based on what information?? Please inform!
Also, what does your due diligence inform as to why IMUN has only now a 10 % (and who knows if that percentage is correct) ownership interest when it was initially a wholly owned IMUN subsidiary??.
Yes! You are very astute and correct in your assessment!
What is the "partner" company Cytocom's product whose sales are about to kill it? Please inform.
How do you know that Cytocom is "worth a lot"?? Based on what information?? Please inform.
Emphatic yes again regarding FDA approval. Just as a matter of very pertinent company history there was an FDA meeting to discuss the Phase 3 clinical development program for a proposed 505(b)(2) application for LDN in the treatment of adult and pediatric patients with Crohn's disease.The meeting was held on June 26, 2013 and the Company received the minutes from the meeting on July 17, 2013. That was over 4 1/2 years ago!!. Where does this historical info come from? Page 20 of the 3rd Quarter 2013 10 Q filing with the SEC.
What occurred to prevent development to proceed over this long period of time?? And since that time the patent that covers the use of LDN in Crohn's Disease was licensed to Cytocom, Inc., which IMUN now has only an approximately 10 % equity interest and maybe less at this time.
Excellent point regarding an FDA meeting update! Also, I am certain your worries are shared by many others.
What do you mean by Q1 is approaching rapidly?? Already here! This is the beginning of Week 4 of Q1 2018.
What do you mean by "Continues to load people"??
Curious-in the past you have made several indications on this message board that the current CEO of IMUN was in or was about to be in serious legal troubles with the SEC. Any update(s)?
It is been my understanding that Form 8-K is a current report that must be filed with the SEC to annouince major events that shareholders should know about. Do you not agree that the initial PO under the August 22, 2017 Didtribution Agreement in Kenya is a major event that IMUN shareholders should know about? Subsequent PO's no doubt would fall under the continuing course of business and reported in the 10-Q and 10-K forms.
Not at all certain what you are talking about? If IMUN has received a purchase order from the company in Kenya ( as was supposed to happen based on the contract with such company) then IMUN is obligated to file a Form 8-K with the SEC reporting this event within four business days of the event. No waiting until March 31st!
Anyone familiar with the company-LDN Pharma, Limited (London Company).
I am not suggesting nor would I suggest that you or anyone sell their IMUN shares or buy any IMUN shares. I have just been putting forth for thought and discussion aspects of IMUN and Cytocom that I have noted in researching the company, its history, progress and current status.
As you and others are no doubt certainly aware there are some IMUN shareholders that are also Cytocom shareholders based on the stock distribution that was in effect for shareholders of record back in 2014.
Not sure why you responded in an aggressive manner to my providing you with some facts to ponder as you stated in your post, in response to the post that indicated Cytocom is a BS spinoff, " Oh yes? Back it with some facts". I was just giving you some to ponder and I was not asking anyone to contact the company nor do I expect that. I have just provided areas and avenues to seriously consider about IMUN and Cytocom.
Also, I find it very, very interesting that you are so absolutely resolute that Cytocom is a private company. I indicated in a previous post that yes technically because of dilution of IMUN's holdings of Cytocom stock it became a minority subsidiary, and yes IMUN is technically not required to include Cytocom's financials and progress in its filings, it still has a highly significant attachment in many aspects to IMUN. Just note on IMUN's website and the related releases about the hiring of John Abeles, M.D. to be Chairman and CEO of Cytocom, his picture and all the background AND that he will also be a Senior Advisor to IMUN. Most curious.
Yes, I have previously noted the 8-K filing re: Saiid Zarrabian covering his settlement with Cytocom as an employee and received as part of that settlement 5,000.000 shares of IMUN stock-not Cytocom stock.
Back with facts re: Cytocom-easy! It appears this is a company with at least one viable patent licensed to it with very promising published peer reviewed clinical data that underlies the patent. Also, OVER FOUR YEARS ago a Phase 2 level type meeting and follow up was held with the FDA to move forward toward approval. More facts-what happened to the tenure of Graham Burton, M.D., Ph.D. with Cytocom and what happened to another competent individual that was also to develop Cytocom-Saiid Zarabian. Just make a careful review of the Cytocom website wherein no substantive or supportable information, except the newly appointed Dr. Abeles info., is available. Note the power-point slides show a May, 2015 date-approaching 2 and 1/2 years old.
I never said that I KNOW we are entitled to more information. I was specifically logically addressing the issue I promulgated as a potential investor and as a shareholder should be addressing--the question of what has been performed by management in OVER FOUR YEARS with a very valuable asset, one that could bring excellent therapy to many individuals. Remember again, this is/was an IP asset of IMUN-and if a shareholder an asset that you own/owned.
I know that you and others keep indicating that Cytocom is a private company and technically it can be considered as such. HOWEVER, this "private" company became a minority owned subsidiary instead of a majority owned subsidiary due to, as you indicate, dilution as shares in Cytocom were issued for who knows what purposes. But, here is the rub-Cytocom was given the license to the U. S. Patent No. 7,879.870 for the " Treatment of inflammatory and ulcerative diseases of the bowel with opioid antagonists". This Patent is one of 3 or 4 IMUN Patents with a reasonable life period still in existence and is/was a very valuable asset belonging to IMUN. Now, no one who is a shareholder or anyone with a miniscule amount of intelligent business acumen would not want to know at least what has happened in over FOUR years with a very valuable patent that has underlying positive clinical data in the hands of the FDA and with a Phase 2 level meeting held with the FDA in order to proceed with further clinical studies, expanding upon the clinical data and head to approval to market. This is/was a very valuable asset of the public company IMUN and the Board of Directors and management should be strongly held to account in detail. If you are a shareholder I cannot fathom how you would not want to know what has been done or is being done to further the value of this asset. What happened to the plans for Cytocom that was a majority owned Company and why such significant dilution in IMUN's holdings?
Take a look at the Cytocom website and tell me what progress has been made over FOUR years.
Any explanation from anyone regarding the lack of any progress in OVER FOUR years following two separate meetings in 2013 with the FDA seeking approval to move forward on Phase 2 studies with (a) LDN for Crohn's Disease and with (b) methionine enkephalin (MENK) in pancreatic cancer. No explanations??
Obtaining a listing on an exchange would definitely be beneficial, but that will no doubt require investment bankers to support the move and it should be readily evident to all that no invesment banking group would do so with current management-none. Perhaps that should be food for serious thought to all shareholders.
In the process of attempting to comprehend the company by reviewing as many of the various SEC filings as posssible, it appears stunningly remarkable that a company that apparently had IP rights-now apparently assigned to its minority owned subsidiary (Cytocom)- to the therapy of Crohn's disease with LDN allows over four years pass since a productive meeting with the FDA to plan Phase 2 level study(ies) and with apparent Orphan Drug Status to boot. In the meantime, based on the information in the filings, all this valuable time has passed wherein a product could have already been or very near to approval for narketing by the FDA. What is management's explanation(s) for this-does anyone know?