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.
That is a good one , entered into an agreement but no money has changed hands ect because the deal hasn't beened inked. So their is no reason why they couldn't file other than it is the normal.
Hey what did everyone keep saying , if we don't like what is happening email them. I think alot of us have tried , maybe the ones that want to blame SAGA now should write and express their concerns. As a stockholder they don't want this deal or do they ?
Dyno funny when we posted about the issues about SAGA and the corncerns with facts we were thrown in the basher list. All we all were saying was that their was big reds flags from SAGA and the fact showed it then as it does todsy , filing , one move from being removed from NASDAQ and a deal that has to be approved by SEC. We all just want the same thing the TRUTH and an end to puff PR's.
Now we all just wait to see what will come of all this BS of which none of us know at this point.
GLTA
Maybe the ones who follow GF should ask what is his take on it? Think about the amount of ENZC they could have bought and wait for the dividend period to be up. I agree with your take on a dump by them. GLTA
I guess our guy couldn't move ENZC today
I agree with you there.
The other thing I find interesting is people talking about volume on SAGA being good for two days , why would you buy SAGA when you can spend 2.6k here and get a dividend of we will just say 1000 shares for 100k of Enzc.1000 shares of SAG will cost 11K. Strange thinking IMO
Hopefully we hear something by Thanksgiving one way or the other GLTA
Yes it is a better tier and the reason it didn't help the two you mentioned is due to both being a pump jobs nothing more. Just like INND just to name a few.
Nice read with time lines from 2021, so are we not to believe what they said in 2021, but believe what they say now? That is why alot have questions that no one can exactly answer we can only go by what they have said and what they are saying now. Please read the part about ITV-1 anti-HIV Therapeutics not a word on that. Lets not forget Enzolytics ipf immune that was the replacement for Tamiflu where are they with that? GLTA
3rd Milestone: Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California
Time to completion: 6 months following in vitro testing in process.
https://www.nasdaq.com/press-release/enzolytics-reports-progress-on-its-multiple-therapeutics-platforms-and-initiatives
Clone 7 has been around https://pubmed.ncbi.nlm.nih.gov/20674577/
I have sent that post to the following emails bkostiner@fintecham.com; info@enzolytics.com; csc@bioclonetics.com inquiries@biogenysis.com
not expecting anytype of response, nothing has been replied on in the past. If they even read it atlease they will see that people are seeing thru the falsehoods they have stated over the past years. GLTA
I would like to see what happen to the ITV-1 being fully funded for EMA , does anyone know what changes. That deal was announces in 2021 . so why now are they stating they will use funding for ITV-1 trials. The below links are over the past few years , but shows alot of the claims of ENZOLYTICS and where they are in trials and plans. Today alot of the PR appears to lead us that they are just starting with some of the same things they said were well into testing.
Enzolytics, Inc. has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutic to clinical trials and distribution throughout Europe. The company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners. IMPL is owned equally by the Company and its partners and has the licenses to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medical Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania. The clinical trials will be funded fully by the Company’s European partners in IMPL. None of the clinical trials costs will be borne by the Company1.
1 finance.yahoo.com
2 investorshub.advfn.com
https://finance.yahoo.com/news/enzolytics-finalizes-documentation-international-medical-130000414.html
https://www.nasdaq.com/press-release/enzolytics-announces-its-progress-toward-completion-of-clinical-trials-for-its-anti
https://www.wane.com/business/press-releases/accesswire/726257/enzolytics-inc-announces-expansion-of-production-of-its-monoclonal-antibody-therapeutics-and-marketing-of-ipf-immunetm/
Yes, the deal for ITV-1 being fully funded for EMA is still in effect for Enzolytics. The company has made significant progress towards the completion of clinical trials for its Anti-HIV ITV-1 Therapeutic and plans for its distribution throughout Europe1.
The company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners. IMPL is owned equally by the company and its partners and has the licenses to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medical Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia, and Lithuania1.
The clinical trials will be fully funded by the company’s European partners in IMPL1. None of the clinical trials costs will be borne by the company1. The company will fund the initial production of the ITV-1 therapeutic and the company’s partners in IMBL will fund the cost of the clinical trials and cost of EMA permitting2.
So, the deal is indeed still in effect and progressing as planned.
1
finance.yahoo.com
2
accesswire.com
3
finance.yahoo.com
4
accesswire.com
5
Yes I would love to meet him at the club one day. GLTA Enjoy the day and thank you to the VETS
Okay , so I don't recall you posting about you making it move but that is here or there at this point . How about this next Tuesday you make the SP go up , it is at a low so you have loaded up so please make it happen. I am sure a few here would love to see an increase and maybe even help you run it up. I will even help you out once you get it at a 10% increase I will sell off a million to help the cause to keep the upward push , I am sure 29 would help out too. GLTA
2020 if 50k will make it move , why haven't you made it move. Better yet show us you can move it . You claim to have a program and you just stated if you have 50k u can, please show us. We all would like to see it rise. GLTA
I hope so , it is funny that when you start looking up what they have posted , compared to the PRs today it seems to be a big circle. They were either in trials back then or they were not and are starting over , they stated they had complete funding for trials in EU so if that is the fact why the need for testing in Africa that was to forward results for use in the EU trials. Is just one example of the circle I mentioned above. They have talked as Enzolytics and all the things they were doing , now PRs have changed to the two subs , yet when looking back they say they are licensee's. Then they state they are building a portfolio , well that is the same thing Enzolytics was telling us 3 years ago an extensive portfolio to lease out. So what has changed other than the past lawsuits keep coming up. The lawsuits are all over shares it seems so if it doesn't lay claim to the portfolio why worry who makes money from it. Are they taking this to personal ?
Very vague and or silence when it comes to what they say and are doing. I still would like to hear about Montana and the primate study they were pumping and still nothing for 2 years. Where is Samsung , Intel , I can't image that CC share such great news on their claims a few years ago and then could not go back to them ( present time ) and say can we do a deal like we formatted with SAGA with your help and not a one offered to do that, or the very least finance a 450m venture that would accomplish the samething they want to do. Again if the lawsuits are about shares at this point who cares who owns what aslong as they dont have a claim to the portfolio Enzolytics would be fine.
Hopefully it is a good thing they didn't mention a sub they wrote Enzolytics . GLTA
No problem we are all or most are trying to connect the dots with facts , here is a link from June 2021 here is everything they claimed and working on back then. They mention the herps in it. No telling what will go to SAGA but the base is in the trust. Enzolytics is the go between form the trust holdings and licensee. So with how vague the PRs lately maybe they are correct that Enzolytics won't have assets because it is in the trust and they are basically the broker for licensee. The big tell will be if the management team starts converting their holdings in Enzolytics if not their is a reason for them to hold thoses prefer shares GLTA
https://www.nasdaq.com/press-release/enzolytics-announces-a-comprehensive-therapeutic-protocol-for-production-of
Herpes Zoster is shingles I dont think anyone owns it , but to your point it is hard to pin down exactly what the two subs actually own, in a PR awhile back by Enzolytics it stated the two subs were exclusive licensee. The newer things maybe under the subs but what was done 2 years back is what I am recalling and alot of thoses claims about what they have the cure for was part of that. copied from a PR Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently being employed to produce monoclonal antibody therapeutics for other infectious diseases including the Coronavirus (SARS-CoV-2).
this link shows them as the licnesee as stated above and it also show ITV-1 so not sure how it would go to SAGA unless they transfered owner ship from the trust.
https://www.accesswire.com/756044/Virogentics-and-Enzolytics-Refute-Misleading-Information-Being-Circulated-on-Social-Media-and-Other-Internet-Outlets-Biogenesis-to-be-Featured-in-June-Issue-of-Life-Science-Review
For the ones that want more links , you can look it up. GLTA
Nice find , also that it is listed as Enzolytics not the subs. Thanks again for a positive find. GLTA
I think it might go back to the suit in 2022 that was dismissed.Peter is refiling in another district.
Before me is Defendant's motion to dismiss pursuant to Rule 12(b)(6) (D.I. 7) and Plaintiffs cross-motion for the court to set bond and compel Defendant to reissue shares pursuant to Plaintiff posting bond. (D.I. 17). I have reviewed the parties' briefing. (D.I. 8, 17, 20). For the reasons set forth below, Defendant's motion is GRANTED and Plaintiffs cross-motion is DENIED.
I. BACKGROUND
Plaintiff Peter Mergenthaler filed suit against Defendant Enzolytics, Inc. (“ENZC”) on August 11, 2021, asserting, “[Defendant] should be ordered to reissue to [Plaintiff] 10,000,000 of its shares” pursuant to 6 Del. C. § 8-405. (D.I. 1 at ¶¶35-51, 51).
Plaintiff states that he owns 10,000,000 shares of ENZC, but that James W. Zimbler engaged in a scheme to fraudulently convert Plaintiffs shares to his and others' ownership. (Id. at ¶¶9-26). Specifically, Plaintiff states that, beginning in 2015, Zimbler orchestrated the fraudulent transfer of Plaintiff s shares in ECOP, which is a predecessor corporation of ENCZ, to Sage Market Advisors (2,500,000 shares), OMS Consulting, Inc. (1,500,000 shares), M. Lamar Outz (1,000,000 shares), and American Asset Management Services Corporation (5,000,000 shares). (Id. at ¶¶3,22-26,40). Zimbler owns American Asset Management Services Corporation, to which 5,000,000 of Plaintiffs shares were transferred. (Id. at ¶¶26, 41). At the time of this transfer, Zimbler was the vice president of ECOP. (Id. at¶37). Zimbler resigned from his position at ECOP on July 6, 2015, after the conversion of Plaintiff s shares. (Id. at 38.)
Defendant requests that this court dismiss Plaintiffs suit pursuant to Rule 12(b)(6) for Plaintiffs failure to comply with 6 Del C. § 8-405. (D.I. 8). In a cross-motion, Plaintiff requests that this court set a sufficient indemnity bond compliant with 6 Del. C. § 8-405(a)(2) and order Defendant to reissue 10,000,000 ENCZ shares to Plaintiff. (D.I. 17 at 1, 7-8).
Thanks was looking for a seperate filing for that .
Sorry must have missed that since the SEC doesnt show anything. I see a section that has the 50m shares mentioned for voting rights just didnt see a filing for it.GLTA
https://www.sec.gov/edgar/browse/?CIK=0001855351
Maybe I shouldn't have used cash influx ( but something has to be able to support the added shares to keep the SP @ 10.00 that would be the PIPE money that would hold the value at 450m) , This was the point I was trying to point out.They have to report
Yes, a company listed on NASDAQ has to report an increase in outstanding shares. According to the Nasdaq Listing Center, companies applying to list and listed on Nasdaq must meet the qualitative requirements outlined in the Rule 5600 Series1. In addition to meeting the quantitative requirements in the Rule 5200, 5300, 5400 and 5500 Series1, companies must meet all of the criteria under a particular set of standards2. Each listing firm must adhere to U.S. Securities and Exchange Commission (SEC) Marketplace Rules for Nasdaq listings, including corporate governance rules 4350, 4351, and 43602. The regular bid price of shares of the company’s stock at the time of listing must be at least $4.00; however, a company may qualify under a closing price alternative of $3.00 or $2.00 if the company meets varying requirements2. Companies must have a minimum of 1,250,000 publicly traded shares outstanding upon listing, excluding those held by officers, directors, or any beneficial owners of more than 10% of the company2. To stay listed on the Nasdaq, a company must continue to meet the minimum listing requirements or risk being delisted and removed from the Nasdaq exchange2.
Learn more:
1. listingcenter.nasdaq.com
2. investopedia.com
3. listingcenter.nasdaq.com
4. sec.gov
https://securities-law-blog.com/2021/12/14/nasdaq-updated-las-form/
Just trying to connect dots from the past and what we are seeing currently. The facts not wishful thinking or misleading items being showed as fact but can't be proven by the poster. We all are here to make money and support a company that has cutting edge technology from their own posting, now it is down to a countdown to see if SAGA can file paperwork that the SEC and NASDAQ will accept after a vote of the shareholders to keep the SPAC alive.
The thing to really watch as many have been posting that SAGA increased in market cap if so at some point that value will have to be justified or it will drop due to it. Would SAGA been required to file a 8k to disclose the influx of cash for such an increase in the market cap? If the management of ENZC been issued shares ( which I don't think has happened ) would the date of said transaction of shares being issued to them be the date of record for dividends since that would be part of the deal that would invole ENZC shareholders? Again the post from GFand others showing they have their shares I believe is a mockup of what SAGA structure would look like if deal goes thru. If they do have the shares issued to them then why would they need more time and the SPAC to be extendend because the ink would be dry at this point. You don't give someone something ahead of time hoping that the deal will be extended if so that is just another case that SAGA isn't the right company to deal with. Kinda the samething ENZC did in the past gave shares ahead of time and then didn't get what they thought would be provided.
The latest data for Sagaliam Acquisition Corp (SAGA) on NASDAQ is as follows1:
Price: $11.06
Price Change: -$0.04
Price Change Percent: -0.3604%
Market Cap: $545,770,500
Accumulated Volume: 21,959
Average Volume: 850
Last Traded: October 27, 04:00 PM EDT
Please note that this information is subject to change as the market fluctuates.
Learn more:
1. bing.com
2. nasdaq.com
3. finance.yahoo.com
4. wise.com
5. google.com
+1 more
https://finance.yahoo.com/quote/saga/
Thanks I hadn't heard anything about the funding from the past either. So my question of the involvement of another company that maybe is still providing funding would want something in return for the funding they have provided to date noone is talking about. Just another piece of the puzzle that would need addressing. GLTA
I am asking about the funding from 2021 has nothing to do with NASDAQ or this deal that we have been told , if the sell goes thru for the two sub companies and ENZC will have nothing as many have stated. Then ITV-1 would go with the sale. This taking from links I provided earlier today
The clinical trials will be funded fully by the Company's European partners in IMPL. None of the clinical trials costs will be borne by the Company.
No I am not referncing the PIPE , I am talking about the business deal that was made to fund the EU ITV-1 in 2021 , where did they go or are they still funding it. If so I would say the will be asking some questions especially if the ITV-1 goes to another company by way of sale as it has been implied.
Question I don't think anyone has brought up. What do you think the business partnership that was promoted by Enzolytics that would fund the EU trials 100%, no money from Enzolytics will be needed is thinking at this point. What do they get out of this deal SAGA is proposing? If they are still funding the trials in EU would there have to be sometype of compensation to them / what will that be? Posting is old , but haven't seen that that deal went away for the funding and Enzolytics hasn't said they have been covering the cost. The reads imply that trials would be completed soon date of PRs 2021. GLTA
https://www.biospace.com/article/releases/enzolytics-announces-its-progress-toward-completion-of-clinical-trials-for-its-anti-hiv-itv-1-therapeutic-and-plans-for-its-distribution-throughout-europe/#:~:text=The%20clinical%20trials%20will%20be%20funded%20fully%20by,trials%20costs%20will%20be%20borne%20by%20the%20Company.
https://finance.yahoo.com/news/enzolytics-reports-engagement-scendea-usa-123000633.html.
https://www.biospace.com/article/releases/enzolytics-announces-its-progress-toward-completion-of-clinical-trials-for-its-anti-hiv-itv-1-therapeutic-and-plans-for-its-distribution-throughout-europe/#:~:text=The%20clinical%20trials%20will%20be%20funded%20fully%20by,trials%20costs%20will%20be%20borne%20by%20the%20Company.
All good don't argue with people throwout facts and if they can show a difference with facts always open and welcome. What should be looked at is the statement CC said if we don't put out a PR ourselves then don't count it as truth. So for all think about that , SAGA a company that is not current with anything puts out PR's but nothing from Enzolytics. So if you follow CC statement nothing is facts yet. GLTA
No you have been saying 9k shares for every 100k shares , I am saying 9k dollars worth for every 100k shares. Big difference . Have you found your example to show what you remember GLTA
Enjoy your weekend everyone , nothing is going to change over the next two days atleast .
Sorry but you are incorrect , Let us know what you find. Do you think people would be a little sour on a deal that would give them 90k for every 100k shares , instead it will be more like 9k for 100k shares held. GLTA
BM the example was 900-1200 for every 100k shares
It would have to be after Sept 6 2023 , I just found the delay mentioned in a Sept 6 PR saying it would be coming .GLTA
Virogentics, Inc. Receives Permit for Export to Africa of the ITV-1 Immunotherapy Solidifying the Scheduled Administration of the Treatment
ALLEN, TX / ACCESSWIRE / August 8, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/)
Virogentics, Inc. ("VIRO") a wholly owned subsidiary of Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced today the receipt of an export permit for the delivery of the treatments to be administered to the volunteer HIV/AIDS patients at the HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. The results of this African pilot clinical trial will be used in the development of the European Medicine Authority (EMA) clinical trials expected to begin in late 2023/early 2024.
so what are we missing we were told in 2021 clinical trials according to this PR
for Its ITV-1 ANTI-HIV Therapeutic and Securing Use Authorization Under the European Medicines Agency
PUBLISHED
JUL 29, 2021 7:30AM EDT
COLLEGE STATION, TX / ACCESSWIRE / July 29, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (http://enzolytics.com/) has completed arrangements and agreements with Danhson (https://danhson.bg/en/) and Clinic Design (https://clinicdesign.eu/) to advance its anti-HIV therapeutic ITV-1 to production and clinical trials. These steps are prefatory to approval by the European Medicines Agency (EMA), leading to patient use authorization.
Production of the therapeutic will be accomplished at Danhson pharmaceutical company facilities, to be followed by clinical trials conducted by Clinic Design. Production of the therapeutics is expected to be completed in the next few months followed by clinical trials to be conducted immediately thereafter. The protocol of the trials will be guided by Pharmalex (https://www.pharmalex.com/), an EU regulatory consulting company.
Earlier in the year, the Company announced the formation of International Medical Partners ("IMPL"), a Bulgarian Limited Liability Company, of which the Company is 50% owner. Pursuant to that formation, the Company will fund the initial production of the ITV-1 therapeutic and the Company's partners in IMBL will fund the cost of the clinical trials and cost of EMA permitting.
IMBL will be the exclusive distributor of the ITV-1 therapeutic in the European Medicines Agency member countries (namely all 27 European Union member states and Iceland, Liechtenstein and Norway) as well as the countries of Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania. IMBL may distribute the ITV-1 therapeutic outside of its exclusive territory where an exclusive license does not otherwise exist.
All documentation for registration of IMPL has been filed with the Registry Office in Sofia. The initial funding of IMBL, by Enzolytics and its partners, has been provided by the partners.
The Company's two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as completed. The audit is proceeding as planned without any unanswered issues.
Harry Zhabilov, CSO of Enzolytics, stated, "We are excited about the progress we have made with the assistance of our IMBL partners. Contracting with Danhson, Clinic Design and PharmaLex is integral to the success of the EMA permitting process. As this is the second time our ITV-1 therapeutic has progressed through clinical trials and the first trials were successful, we are fully confident that we will succeed in the permitting process. With the reciprocal treaty between the EMA and FDA, we believe that the EMA approval with lead to further advancement of our ITV-1 as a successful therapy."
This is the last two updates about why Africa hasn't started
https://finance.yahoo.com/news/enzolytics-offers-virogentics-inc-itv-145500819.html
Virogentics, Inc. Receives Permit for Export to Africa of the ITV-1 Immunotherapy Solidifying the Scheduled Administration of the Treatment
ALLEN, TX / ACCESSWIRE / August 8, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/)
Virogentics, Inc. ("VIRO") a wholly owned subsidiary of Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced today the receipt of an export permit for the delivery of the treatments to be administered to the volunteer HIV/AIDS patients at the HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. The results of this African pilot clinical trial will be used in the development of the European Medicine Authority (EMA) clinical trials expected to begin in late 2023/early 2024.
Additionally, VIRO acknowledges the announcement by Sagaliam Acquisition Corp, ("NASDAQ:SAGA") that they had notified Continental Stock and Transfer Company that it was exercising the option to extend the time available to consummate a business combination agreement by an additional month to August 23, 2023. VIRO reports that substantial progress has been made on the combination agreement.
Barry Kostiner, the CEO of Sagaliam, stated "The VIRO team has done a great job of moving forward on their clinical and regulatory milestones. We are getting involved at the right time to provide the resources needed to build a platform for helping many people in Africa, Europe and globally."
Harry Zhabilov, Chief Scientific Officer of VIRO, stated "Every day we move closer to the ultimate goal of administering our immunotherapy to patients who we believe will benefit greatly from our technology, as well as the funding that will be unlocked by moving to NASDAQ."
Then you have this last update
Start Date is expected by the end of 2023 / beginning of 2024.
VIRO also offers an update on Diabetic trials and Sagaliam transaction.
ALLEN, TX / ACCESSWIRE / September 6, 2023/?Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/).
Virogentics, Inc. (“VIRO”), a wholly owned subsidiary of Enzolytics, Inc. (the “Company” or “ENZC”), a drug development biotech company, announced today that based on the Bulgarian population of HIV-infected individuals that the sample size for the ITV-1 clinical trials will be 60 individuals.
R&D Services Ltd. ("R&D"), under the leadership of Aneliya Vidinlieva, Manager Clinical Trials, assisted by Dr. Ivaylo Tsonev, Chief Medical Officer of Desing and three consultants assigned by the University of Pharmacology, will be performing the clinical trials. R&D and VIRO expect the clinical trials to begin in late 2023 or early 2024.
With locations across Bulgaria, where the Clinical Trials will be conducted, R&D services will manage all the administration of the Clinical Trials of ITV-1 conducted in public, municipal, and private healthcare institutions. R&D is certified to ISO 9001:2015, ISO 27001:2013, and ISO 14001:2015 quality assurance standards for services provided
R&D Services Ltd.’s general responsibilities include but are not limited to the following:
Improving the quality of the collected data during the clinical trials.
Building up a trial site at each healthcare institution and providing all the necessary equipment for conducting clinical trials and premises for proper document and study drugs storage, in compliance with the Good Documentation Practice, Good Clinical Practice, and Good Manufacturing Practice.
Ensuring protocol compliance, compliance with the International Conference on Harmonisation – Good Clinical Practice guideline, Bulgarian legislation and specific requirements of the Sponsor/CRO.
Providing the necessary documents for the initial study submission.
Prescreening of eligible patients during the initial review/approval period so that a maximum number of patients can be enrolled in the relevant time period.
Redirecting eligible patients from trial sites that do not participate in the trial to sites that are approved; building a referral network of physicians to support the study enrollment.
Quality checking all the needed documentation concerning the proper conduct of a clinical study (eCRF, temperature logs, subject logs, study drug accountability logs).
Reporting any adverse events to the Sponsor/CRO.
Ensuring document access for audits on behalf of the Sponsor/CRO, independent auditor, and regulatory authorities.
In addition, the trials being conducted by R&D will include a review by an immunologist to evaluate any correlation of patient outcomes with a different origin of immune deficiency using cell examination.
The Company’s therapeutic developments will include participation by many established pharm entities, including the following. VETPROM AD, a division of the French company Danhson, currently headed by Stanislav Stoev, Executive Director, represents over 65 years of continuous operations in the Bulgarian economy and is one of the largest pharmaceutical manufacturers of medicinal products (for human and veterinary use), food supplements and cosmetics in Bulgaria. VETPROM manufactures products under its brand name, as well as for third parties under contract manufacture agreements operating under accepted ISO 9001:2008 System for quality of management and the integrated system for Good Manufacturing Practice, under requirements of Volume 4, Good manufacturing practice (GMP) Guidelines.
The German Cooperative Clinical Grug Research and Development (CCDRD) is a contract research organization for clinical phase I-IV trials and will be performing the pharmacokinetics study on ITV-1 under the guidance and leadership of the CEO Rossen Koytchev, MD, PhD and Petra Kowalski PhD, Director of Business Development. CCDRD was founded in 1990 and has been performing clinical trials for over 30 years. The company is headquartered in Hoppegarten near Berlin, Germany.
The Center of Phytochemistry was set up as a joint project of the Bulgarian Government, UNDP, and UNESCO for scientific and applied research and training of specialists in organic chemistry and chemistry of natural products. The organization was renamed The Institute of Organic Chemistry with Centre of Phytochemistry (IOCCP) and is the leading scientific institution in t organic and bio-organic chemistry field in Bulgaria. VIRO has engaged IOCCP, represented by Prof. DSc Pavlina Dolashka, a member of its organizing committee and scientific committee to perform the biochem analysis of ITV-1 at the Bulgarian Academy of Science.
Documentation and correspondence that is required with the EMA as part of the permitting and application process will be performed for VIRO by Vili Topalova, MD EU QPPV Medical Director of AV Consult Pharm ("AVCP"). AVCP is a consulting company in the fields of Regulatory Affairs, Pharmacovigilance, Medical Devices vigilance, Cosmetovigilance, price and reimbursement and other consultancies for medical treatments. AVCP's expertise is based on years of experience with the Bulgarian Drug Agency (BDA) and the technical expertise of its employees – former experts and employees of the Bulgarian Drug Agency (BDA).
As a result of a delay in delivery of the Toxicity report to the African hospitals, GOMA, PRC, and Panzi Hospital, Bukavu, DRC, the administration of the ITV-1 immunotherapy initial injections into the HIV/AIDS-infected volunteers was delayed. We expect that to commence soon.
Since entering the U.S. Market six months ago, VIRO's growing nutraceutical division has resulted in the exclusive distribution licensing of + Liver Rescue™ in the North American market. This product accelerates the functions of the liver (accelerated emission of alcohol dehydrogenase), thereby reducing the harmful effects of alcohol on the body and the central nervous system. This is a new revolutionary nutritional supplement in the form of a drink, which is currently being marketed in Europe with great success. Coupled with the monthly increasing production and sales of IPF Immune™, the market potential for these products is favorable.
Currently, the Company is pursuing testing IPF Immune as an immunomodulator under EMA guidelines on patients with cirrhosis, as an after-radiation and chemotherapy treatment of cancer patients in an attempt to reduce recovery time from the effects, impact on HIV patients immune system (in addition to the ITV-1 Clinical trials), application for type 2 diabetes patients effect on blood sugar levels and glycosylated Hb (in addition to the clinical trials of ITV-1 as a treatment for type 2 diabetes scheduled for later this year), herpes, COVID, influenza and all diseases where there is an immune system decline - including autoimmune disease. With the potential of both ITV-1 and IPF Immune to participate in the aforementioned markets, capturing 1% of the 2022 autoimmune $104.21 billion market and the $84.56 2023 diabetes market, VIRO could realize over $2 billion in revenue in addition to what it captures in the HIV/AIDS $30.46 billion market where VIRO expects the most significant market penetration.
VIRO has also filed two utility patent applications covering its new developments, one covering the European Union and one for the United States.
“With the quality of our partners and our past success with ITV-1 Clinical trials, we at VIRO are expecting great success in not only the ITV-1 application to HIV but also its application to Diabetes and other areas being pursued,” stated Harry Zhabilov, CSO of VIRO.
ENZC has provided SAGA with its draft of the Business Combination Agreement and related documents and is awaiting any edits or comments in anticipation of a final version being circulated for signature by October 31, 2023.
Barry Kostiner, CEO of Sagaliam, commented, “We are continuing to make progress on the consummation of our transaction with Enzolytics. The deep bench of expertise and therapeutic solutions is impressive. In addition to our dedicated scientists, we have an outstanding team of collaborators who support all aspects of the business including regulatory, clinical and manufacturing operations. The goal is to build a pharmaceutical platform company, going beyond one-off therapies, to providing solutions for broad categories of chronic disease.”
The above was copied from Enzolytics web site .
I would say they kept us somewhat updated then nothing on Africa after thet say they got the importing clearance. If anyone has a different update please post. GLTA
Correct thanks Timing A/S .
Hopefully it is for and will be used for a good reason. Time will tell. GLTA
Not sure what you are saying , can you dumb it down for us or show what you are talking about on pacer. Thank you
Glad you are still doing well , you really haven't missed anything that would move the neddle as you can see the SP is about where it was a year ago. Stay healthy and enjoy life. Hopefully we will meet at the club soon rather than later. GLTA
Another thing to keep in mind they raised the O/S by 900m awhile back why? We were never told exactly why, but it was done for a reason. If the float is low why would they need another almost billion to work with.
All above our paygrade, it is now a wait and see what they actually can provide to the world as a treatment and cure. GLTA
Yes 1/100 on Oct 12
Totally agree