Below is a timeline of ENZC’s progress since April 2020. The timeline clearly shows ENZC is making progress in moving their technology through the necessary protocols to get their products to the market place, upgrade to the OTCQB and increase the value of the company. What has happen thus far has not happen quickly and to get to the end game (the marketplace) will not happen quickly either. There have been setbacks and probably be others in the future. ENZC has made significant use of Artificial Intelligence (AI), its proprietary technologies and collaborations to assist in the further producing of monoclonal antibodies.
How do they get these antibodies to the market?
1. Make the monoclonal antibodies
2. Have the monoclonal antibodies tested on animals
3. Have Toxicology tests done
4. Manufacturing Information
5. Clinical Protocols and Investigator Information
Has ENZC done of the above or is it just a SCAM company stringing INVESTORS along?
ENZC may BECOME the BEST EVER PIECE of SCIENCE (POS) known to MANKIND>
ENZC TIMELINE:
April 16, 2020 Regain Current Status with OTC Markets
April 16, 2020 Open operation in the Dallas, Tx area where the company has relocated
September 16, 2020 Enzolytics, Inc. today announced the execution of a non-binding letter of intent (the "LOI") to merge with BioClonetics Immunotherapeutics, Inc. ("BCLS" or "BioClonetics") a biotech company located in Dallas Texas.
September 16, 2020 The Companies plan to conduct binding studies combining the therapeutics produced by both companies to evaluate the beneficial effects and increased binding capability of the BioClonetics Clone 3 antibodies to multiple HIV isolates.
September 16, 2020 Thereafter, PBMC based in-vitro neutralization studies will be conducted with the Enzolytics ITV-1 peptide in combination with the BioClonetics Clone 3 antibodies. Based on the results, the best combination with be tested in primate studies at the California National Primate Research Center University of California, Davis, California.
October 1, 2020 BioClonetics is in the final stage of development of a parent monoclonal antibody ("mAb") (designated as Clone 3), which is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested.
October 1, 2020 In anticipation of ENZC bringing current its OTC filings the Company has made application to OTC Markets for membership. Once the Membership Application is approved by OTC Markets, the Company will begin filing its delinquent quarters.
October 14, 2020 Enzolytics, Inc. today announced the execution of a binding letter of intent (the "LOI") to merge with BioClonetics Immunotherapeutics, Inc. ("BCLS" or "BioClonetics") a biotech company located in Dallas Texas, replacing the earlier non-binding letter signed on September 12, 2020.
October 14, 2020 BioClonetics is in the final stage of development of a parent monoclonal antibody ("mAbs") (designated as Clone 3), which is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested.
October 14, 2020 ENZC is in the process of compiling the information to bring current its OTC filings. The company has begun the process of identifying a clinical research organization for the preparation of pre-IND protocols for submission to the FDA and is also in the final interviews with several pharmaceutical manufacturing companies to produce the validation order.
October 19, 2020 Additionally, we will use AI (artificial intelligence) to analyze the 16,000 known sequences of different SARS-Cov-2 viruses that have now been catalogued in the Los Alamos National Laboratory, with multiple different strains identified. By using computer analysis, several conserved (expectedly immutable and neutralizable) sites on the virus can be identified and additional monoclonal antibodies produced against these- to be used in a monoclonal antibody "cocktail".
October 19, 2020 All of our steps are taken with two objectives in mind. First our focus is on creating successful therapeutics against infectious diseases, including HIV and now our focus on the Coronavirus. Secondly, our efforts are also intended to increase the value of our technology and the value of our company - which directly translates into value for our investors. Please know that these are our two guiding objectives with every effort we make.
October 22, 2020 Enzolytics, Inc. announced the appointment, by the Board of Directors of the Company, on October 20 of Charles Cotropia to the position of CEO of Enzolytics. Mr. Cotropia also serves as CEO of ENZC's Merger target BioClonetics Immunotherapeutics, Inc. ("BCLS" or "BioClonetics"), Harry Zhabilov the former CEO of ENZC has taken the position of CSO. Charles Cotropia was appointed to the ENZC Board of Directors on October 1, 2020. Simultaneously, Harry Zhabilov was appointed to the BCLS board.
October 22, 2020 Enzolytics' application with OTC Markets was approved and ENZC has begun the process of bringing its filings current having filed the September 30, 2018 report.
October 22, 2020 In addition, management of ENZC is scheduling a meeting with a GMP manufacturer anticipated to take place before the end of the month.
October 22, 2020 The Company has also procured a commitment for funding of $500,000.00 to be used for implementation of the planned combined operations and the initial steps of the merged business strategy of creating successful therapeutics against infectious diseases thereby increasing the value of the Company's technology and the value of the Company through the combination the Enzolytics ITV-1 peptide in conjunction with BioClonetics' anti-HIV monoclonal antibodies. As part of this initial $500,000.00 funding, the Company and certain of its current convertible debt holders have agreed to a standstill on the issuance of any additional shares from conversions of debt.
November 10, 2020 Enzolytics, Inc. announced the appointment of Ronald Moss, M.D., to the Medical Advisory Board of the Company.
Dr. Moss has an extensive 25-year background as an executive with numerous Biotechnology companies including direct clinical experience. He has a respected history of leveraging leadership, analytical analysis and clinical experience to assist companies through the complexity of drug development. He has extensive clinical and regulatory management expertise in guiding programs through Phase I, II, and III clinical trials, including IND and NDA experience. He is skilled at forging innovative partnerships with regulatory agencies, the NIH and large pharmaceutical entities.
November 13, 2020 We are making great progress on our plans to further develop additional anti-HIV monoclonal antibodies and to now begin the production of fully human monoclonal antibodies targeting the CoronaVirus. On December 1, we are expanding our lab to the campus of Texas A&M University at its Institute for Preclinical Studies. This expansion will allow us to complete production of monoclonal antibodies against both the HIV virus and the CoronaVirus and collaborate with the biopharma experts on the campus. Although we have NIH grant applications pending for the production of anti-HIV and anti-CoronaVirus monoclonal antibodies, we have secured funding that allows us to proceed without delay.
November 13, 2020 Here is why we are confident in our technology:
It will be imperative that produced antibodies target a conserved and immutable site on the virus - otherwise the antibody (over time) will be rendered ineffective due to mutation - known as "virus escape". Our anti-HIV monoclonal antibody targets an immutable virus site on the HIV virus - one that is constant within virtually all 6000 now known different HIV isolates (strains) of the virus. The CoronaVirus has structure correlative to that of the HIV virus. Because our primary anti-HIV monoclonal antibody has been proven to neutralize numerous different strains of the HIV virus in tests in 5 international labs, and knowing the binding site on the HIV virus to which our antibody binds resulting in neutralization, this knowledge provides insight necessary to identifying corresponding structure (amino acid sequences) on the CoronaVirus that should be targeted to effectively neutralize the CoronaVirus. Moreover, we have proprietary methodology needed to produce anti-CoronaVirus monoclonal antibodies targeting such known - to us - sites.
November 13, 2020 Additionally, our antibodies retain the original natural antibody affinity and specificity and have lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, and, in the recombinant form, will have accessibility to the virus epitopes (binding sites) not accessible with a whole antibody. We are actively moving forward in our production and testing of such antibodies.
December 1, 2020 Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") announced the execution of the definitive business combination agreement successfully merging the biotech companies Enzolytics, Inc. and BioClonetics Immunotherapeutics, Inc. on World AIDS Day.
December 1, 2020 The Company has recently confirmed plans to test its monoclonal antibodies at the University of Strasbourg, France, under the direction of Dr. Christiane Moog, Ph.D., Research Director at INSERM, University of Strasbourg, a leading specialist in conducting the preferred PBMC based in vitro neutralization assays protocol for anti-HIV monoclonal antibodies. Additional testing of the Company's antibodies is also being planned at San Raffaele Scientific Institute, Milan, Italy, under the direction of a further expert in the field, Dr. Gabriella Scarlatti, M.D., Ph.D., Head of Viral Evolution and Transmission Unit at San Raffaele Scientific Institute.
December 1, 2020 The therapies of Enzolytics' two technologies, that produced by Enzolytics and that created by BioClonetics will be tested in combination and are expected to be synergistic.
December 1, 2020 Additionally, the Company has identified correlative structure between the HIV virus and the CoronaVirus and, with its capability to produce targeted monoclonal antibodies, is moving forward to produce monoclonal antibodies targeting the CoronaVirus. The Company is extending its lab capabilities on the Texas A&M University campus at the Institute for Pre-clinical Studies, where it will be producing both addition monoclonal antibodies against HIV and the against the CoronaVirus.
December 1, 2020 The Company's addition of Dr. Ronald Moss, MD, to its Medical Advisory Board has provided experienced guidance for its strategies and in its planned testing and validation of its therapeutics in animal and clinical trials.
December 10, 2020 Enzolytics, Inc. (OTC PINK:ENZC or the "Company") today announced the filing of a provisional patent with the U.S. Patent Office on December 9, 2020 for a treatment of Multiple Sclerosis developed by Harry Zhabilov, titled NUCLEAR PROTEINS ISOLATED FROM MAMALIAN SPINAL CORD (SCNP) IMMUNE FACTOR, Ser. No. 62/123341. The Company received confirmation of filing from the U.S. Patent Office today.
December 10, 2020 Charles Cotropia, CEO stated, "The management team at ENZC is focused on the development of its proprietary technologies and this is a continuation of what is expected to be an expanding pipeline of products for treating serious illnesses."
December 14, 2020 Enzolytics, Inc has engaged SAMM SOLUTIONS, INC. (DBA BTS Research), through a Master Service Agreement ("MSA"), to conduct a toxicity study on the Company's Flagship compound ITV-1. The Company has previously tested the compound in successful Clinical Trials in Bulgaria, but FDA regulations require separate Toxicity tests before an Investigational New Drug process may begin in the United States. SEE NOTE 1
December 30, 2020 Both management teams were committed to this mission, and even before the completion of the combination documentation, transition of our organizations began by my appointment to the Enzolytics' Board as a Director and CEO and appointment of Harry Zhabilov to the BCLS Board. This allowed us to share information for assimilating our proprietary information for research and development purposes and for streamlining the administrative function to accelerate future growth.
December 30, 2020 Currently, the Company has requested proposals from several PCAOB accounting firms to provide quotes for Audits of the Company's current and prior year Financial Statements in order to become fully reporting. Bids were requested to be provided by mid-January, and the Company anticipates making a decision by the end of January 2021.
December 30, 2020 Our new lab is being opened on the campus of Texas A&M University in the University's Institute for Preclinical Studies. Here we will expand our development capabilities for the production of additional monoclonal antibodies targeting immutable sites on the HIV and SARS-CoV-2 viruses. In addition to those primary targets on these viruses already known to us, we have engaged an artificial intelligence (AI) and genetics and molecular biology data science team to curate the thousands of isolates (strains) now known as existing in both the HIV virus and the SARS-CoV-2 virus. This process will allow us to identify conserved, immutable targets against which monoclonal antibodies are to be produced.
December 30, 2020 Testing of the newly produced monoclonal antibodies is also being arranged. This includes testing of our now being produced recombinant anti-HIV monoclonal antibodies created from the parent antibody. Such testing is now scheduled for early 2021 at the University of Strasbourg in Strasbourg, France.
December 30, 2020 In addition to these successes, we have been very successful in raising necessary funding to execute our plans. Our initial $500,000 raise is being followed with $1 million being funded in the next 30 days, and additional investment is being made into the Company by officers of the Company, bringing the total raised since the signing of the non-binding letter of intent to $1.7 million.
December 30, 2020 The Company has also negotiated a debt exchange whereby most of the existing convertible debt has been exchanged for equity instruments that have a two-year conversion clause to postpone conversions for the next two years. We believe this step, along with the reorganization under Section 251 G that was initiated prior to the closing of the combination agreement, will significantly enhance the equity position of the Company.
December 30, 2020 The Company acknowledges the enthusiasm of our investor base, and in response to their desire for up-to-date information, we are updating our website and will be launching it in the New Year.
January 11, 2021 Enzolytics, Inc today, announced it has accepted a proposal from a Houston based PCAOB Audit firm to Audit the Company's year-end financial statements, subject to the receipt and acceptance of the engagement letter. The proposal covers the 2019 and 2020 calendar years for filing with the OTC Markets.
January 19, 2021 Enzolytics, Inc. (OTC PINK:ENZC)(the "Company") today, announced it has received the official filing receipt from the U.S. Patent Office confirming the filing of its patent application for "Nuclear Proteins Isolated from Mammalian Spinal Cord Immune Factor - Pharmaceutical Composition for Treatment" and has received the third tranche of the $1.2 million dollar financing.
February 1, 2021 Enzolytics, Inc today announced it has identified seven additional conserved, expectedly immutable sites on the HIV virus against which it plans to produce targeted anti-HIV monoclonal antibodies. The Company's primary anti-HIV monoclonal antibody targets one conserved site on the HIV virus, which site is 98% conserved (either directly or by way of conservative amino acid substitutions) over all 87,336 HIV isolates which have now been curated (analyzed) by the Company using Artificial Intelligence (AI). Additional conserved target sites (some with 98% conserved sequences) have now been identified against which fully human anti-HIV monoclonal antibodies will be produced in its lab on the campus of Texas A&M University in the University's Institute for Preclinical Studies. The significance of producing multiple monoclonal antibodies targeting multiple conserved sites is recognized by experts as a critical approach to effective therapy. This allows the administration of a "cocktail" of antibodies, all targeting conserved and expectedly immutable sites.
February 1, 2021 Additionally, the Company's Genetics and Molecular Biology data science team is now screening (using computer analysis/Artificial Intelligence [AI]) more than 275,000 CoronaVirus isolates now known, to also identify conserved sites which expectedly are immutable. From this information, anti-SARS-CoV-2 (CoronaVirus) monoclonal antibodies will be produced. The significance of producing monoclonal antibodies against conserved target sites on targeted viruses is made evident by the mutant strains of the CoronaVirus currently surfacing in the U.S, South Africa, Brazil, United Kingdom and around the world. The same virus mutation exists with HIV, as well as other well-known viruses. As a virus mutates, a therapeutic becomes ineffective when it neutralizes by attacking a site that changes. By targeting an immutable site, a therapeutic is not affected by the mutation. This is well understood by the necessity to produce a new flu vaccine with each flu season, namely because the flu virus mutates. Producing therapeutics that target a conserved site on viruses makes possible the production of a therapeutic that is not rendered ineffective by virus mutation, and therefore can be applied successfully both universally around the world and durably over time.
February 1, 2021 Additionally, the Company's Genetics and Molecular Biology data science team is now screening (using computer analysis/Artificial Intelligence [AI]) more than 275,000 CoronaVirus isolates now known, to also identify conserved sites which expectedly are immutable. From this information, anti-SARS-CoV-2 (CoronaVirus) monoclonal antibodies will be produced.
February 1, 2021 The Company is also applying Artificial Intelligence [AI] to scan the hundreds of thousands of isolates that exist in 14 other prevalent viruses, ranging from influenza to Rabies to Ebola. Using the Company's proprietary technique for producing fully human monoclonal antibodies directed against these infectious diseases, the Company will produce multiple neutralizing monoclonal antibodies against these viruses. The significance of this approach is well recognized by experts in virology due to the ability of all viruses to mutate and render ineffective initially developed therapeutics.
February 1, 2021 Production of the Company's primary anti-HIV monoclonal antibodies is underway at Genscript Labs. Testing of these newly produced monoclonal antibodies is scheduled for early 2021 at the University of Strasbourg in Strasbourg France. Thereafter, Macaque trials are planned at the California National Primate Research Center, Univ. of California, Davis, CA. SEE NOTE 1
February 1, 2021 Based on this information, the Company took the following actions. On January 28th, a notice of default and termination was registered with the courts in Sofia of the Sub License Agreement issued to IMMB BG. The company has entered into negotiations with a supportive group in Bulgaria to form a new entity and enter a funding agreement to cover any new cost of clinical trials under EMA standards and permitting by the EMA. Strategically, the Company believes that the actions will be cost effective resulting in a significant advancement of the Company's therapeutic portfolio.
February 1, 2021 As stated in the year end update, proposals were recently requested from several PCAOB accounting firms to provide quotes for Audits of the Company's current and prior year Financial Statements in order to become fully reporting. The Company has engaged MaloneBailey, LLC of Houston, Texas as its PCAOB accounting firm and has begun the audit process. It is still the Company's plan to complete the two-year audit as quickly as possible but will file the December 31, 2021 Annual Report Financial Statements pursuant to the OTC Markets Pink Basic Disclosure Guidelines immediately upon completion to allow time to complete the two-year audits and remain current with our filings.
February 16, 2021 Enzolytics, Inc. announced today the results of an in vitro study of the Company's ITV-1/IPF peptide treatment that demonstrated the broad efficacy with low toxicity. The Company's ITV-1 peptide was tested against human corona virus 229E Strain (HCoV-229E) and exhibited comparable efficacy but with a 20-fold lower toxicity than the widely used anti-influenza medicine Tamiflu®.
February 22, 2021 Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") today announced the execution of Articles of Association to form International Medical Partners ("IMPL") a Bulgarian Limited Liability Company of which the Company is 50% owner. The Company's partners in IMBL are a group of successful Bulgarian businessmen who will fund the cost of the Clinical trials under the European Medicine Agency (the "EMA") standards and the application cost for the EMA permit for the Company's ITV-1 patented therapeutics for treating HIV. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the company believes that issuance of the EMA permit for the ITV-1 compound should qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage Clinic Design to begin the clinical trials that may be required under EMA standards.
February 22, 2021 The Audits of the Company's current and prior year Financial Statements are in process and the application for OTCQB is being prepared for submission upon issuance of the Audited Statements. The Company plans to complete the two-year audit as quickly as possible but will file the December 31, 2021 Annual Report Financial Statements pursuant to the OTC Markets Pink Basic Disclosure Guidelines. The Company anticipates filing the financial statements under the Basic Disclosure Guidelines for December 31, 2020 in the coming weeks before the filing deadline of March 31, 2021.
February 22, 2021 Enzolytics, Inc. today announced it has identified eleven conserved, expectedly immutable sites (epitopes) on the Coronavirus against which it is producing targeted anti-SARS-CoV-2 monoclonal antibodies. Using computer analysis (Artificial Intelligence [AI]), the Company's genetics and molecular biology data science team has now screened more than 50,512 Coronavirus isolates currently known and has identified conserved sites which expectedly are immutable. The 11 conserved sequences identified on the virus isolates curated have been identified on the basis that they are 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed.
February 22, 2021 The Company has filed a comprehensive patent application covering these discoveries. This initial application has been filed in the U.S. and will be extended to claim international patent coverage through the International Patent Cooperation Treaty (PCT) to which 153 countries subscribe. The patent coverage sought includes patent claims on the discovered epitope/antigens, vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to the epitope/antigens.
February 22, 2021 As the Company has previously reported, it is also curating (analyzing) the amino acid sequences of other major viruses and will file patent applications claiming the identified antigens/epitopes and associated therapeutics. Using AI analysis, the Company is now identifying and will claim the conserved epitopes/antigens on the infectious diseases caused by HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV), Visna virus (VISNA) and mouse mammary tumor virus (MMTV). Patent applications will be filed claiming the inventive findings. Patent claims will cover the discovered epitope/antigens, with proposed vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to these identified epitope/antigens.
February 22, 2021 The Company has clarified the lack of significance of the prior expired Company patents covering the Company's "parent" Clone 3 anti-HIV antibody. The expired Company patents were issued on the "parent" Clone 3 antibody. As is the case with virtually all parent antibodies, the parent antibody is a "slow producer" - which means it could not produce sufficient antibody therapeutics to treat the 36 million individuals infected with HIV. Thus, a recombinant form of the antibody had to be created employing a fast-producing CHO cell line. This has been accomplished by the Company and patent applications are pending claiming the recombinant form of the antibody, the form that will be used in patient therapy. The term of issued patents will be 20 years from filings, such filings having been made in 2020.
March 8, 2021 Enzolytics, Inc. (OTC PINK:ENZC) (the "Company") today announced it has filed for patent protection on the identified 8 conserved sites on the HIV-1 virus, some with over 98% conserved sequences. These applications will be extended to international filings under the Patent Cooperation Treaty (PCT) allowing the Company to seek patent coverage in 153 countries.
March 16, 2021 Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") today announced the formalization of corporate legal documents pursuant to Articles of Association forming International Medical Partners ("IMPL") a Bulgarian Limited Liability Company of which the Company is 50% owner. The agreements are with the Company's partners in IMBL formed with a group of successful Bulgarian businessmen.
March 16, 2021 As a team, the Company with IMPL is moving forward to complete the initial production and certification of its ITV-1 patented therapeutics for treating HIV leading to the planned clinical trials under the European Medicine Agency (the "EMA"). A commitment for funding of the cost of clinical trials under EMA guidelines and cost associated with the issuance of an EMA permit are part of the negotiated agreements. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company's belief is that issuance of the EMA permit for the ITV-1 compound should qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage Clinic Design to begin the clinical trials that is expected to be required under EMA standards. In addition, the Company is negotiating with an International known and respected European Contract Manufacturing organization ("CMO") to manufacture the required quantities of the ITV-1 Treatment to facilitate the clinical trials and permitting process under EMA guidelines.
March 22, 2021 Enzolytics, Inc. (OTC PINK:ENZC or the "Company") today announced it has filed NIH grant applications seeking funding for its production of monoclonal antibodies targeting the identified conversed epitope sites on both the HIV-1 and the SARS-CoV-2 viruses. Using its recent discovery of conserved sites on both viruses, the Company has filed updated NIH grant applications for funding for the production of monoclonal antibodies against these conserved sites on both viruses.
March 22, 2021 Using these new discoveries, the Company has bolstered its applications to the NIH seeking funding based on these additional discoveries. By renewing its applications with these significant additional discoveries, the prospect of grant funding is increased.
These revised applications incorporate the focus on the capability to produce multiple (a "cocktail" of) monoclonal antibodies for therapeutic treatment. While the Company sees value in pursuing NIH grant funding, the progress of the Company is not in any way affected or delayed by awaiting the review of such applications. Preparing such applications allows the Company to marshal its technology in a detailed confidential technical presentation that can be used in discussing our technology with potential biotech partners.
March 22, 2021 Additionally, the Company has entered negotiations with Pro Wave Ad Product ("PWA"), a Bulgarian Company, to supply the raw material for PWA's Contract in India for the production of a spray modulating the immune system under U.S. Patent No. 8,309,072 owned by Zhabilov Trust. This contract is valued at more than $50 million to PWA. This is the only approved use of this technology as a nutraceutical. The FDA issued a nutraceutical number to Harry Zhabilov on October 12, 2018. The first delivery under this agreement with PWA is expected to be in late spring 2021. The value to the Company is yet to be determined.
April 5, 2021 In a significant development, recent findings have revealed that the monoclonal antibodies being produced by the Company against targeted sites on the Coronavirus are directed against epitopes that exist conservatively on each of the variant strains of the virus from the UK, Brazil and South African. SEE NOTE 1
NOTE 1
The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
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