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Navidea Biopharmaceuticals, Inc. (NAVB)

NYSE American - NYSE American Delayed Price. Currency in USD
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1.6800+0.0200 (+1.20%)
At close: 4:00PM EDT
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  • B
    BB
    Is Jed’s departure a good sign or bad?
  • J
    James
    Jed will have to go get a real job in accounting for a lot less money more in line what he's worth.
  • T
    Teresa
    He made a lot of promises without the results.
  • J
    Joseph
    in my opinion , what ever was discussed with the FDA on September 1st amounts to nothing , otherwise. why is he getting the boot
  • P
    Palantir777
    Fidelity lending shares as of yesterday, 10-13-2021.....

    "Navidea Biopharmaceuticals Appoints Thomas Forest Farb-Horch and Agnieszka Winkler to the Board of Directors".....
    ..
    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Thomas Forest Farb-Horch and Agnieszka Winkler to its Board of Directors, effective October 7, 2021, each with a three-year term ending concurrently with the Company's 2024 annual stockholders' meeting.

    Thomas Forest Farb-Horch has over three decades of experience as an investor in and senior executive of numerous life science and information technology companies both in the U.S. and internationally. Mr. Farb has served as the Chief Executive Officer, President, co-founder and director of Thrive Bioscience, Inc. since May 2014. He has also served as President, Chief Operating Officer and in other C-level positions at several other companies, including Interneuron Pharmaceuticals (NASDAQ), Indevus Pharmaceuticals (NASDAQ), and Cytyc (NASDAQ). Mr. Farb currently serves on the boards of directors of North Shore InnoVentures and AutoImmunity Biologic Solutions, and is a member of the scientific advisory board of Emervax. Mr. Farb previously served on the boards of directors of Fair Isaac (NYSE:FICO), Redwood Trust (NYSE:RWT), HNC Software (NASDAQ), Retek Systems (NASDAQ) and Symon Communications (NASDAQ). Mr. Farb earned a B.A. in sociology from Harvard University.

    Agnieszka Winkler has extensive professional and board experience with start-up, mid-cap and Fortune 500 companies. Ms. Winkler currently serves on the board of directors of Virco (NASDAQ:VIRC) and the board of trustees of each of Santa Clara University and the African Diaspora Network. She also serves as Chair of the board of directors of the Jesuit School of Theology and as President of the board of Catholic Charities of Santa Clara County. Ms. Winkler has previously served on numerous public company boards such as SuperCuts (NASDAQ), Reno Air (NASDAQ), The Cheesecake Factory (NASDAQ:CAKE), and Inter-Tel (NASDAQ), as well as private company boards including Ascension, a $22B healthcare system, Ascension Network and IPLocks. She was the founder and former Chair and Chief Executive Officer of TeamToolz, a software company, and Winkler Advertising, both of which were acquired. Ms. Winkler earned a B.A. in history from Holy Names University, an M.A. in history from San Jose State University, and an M.B.A. from Santa Clara University.

    Navidea Chief Executive Officer Jed Latkin said, "Navidea is pleased to add two highly respected and exceptionally talented individuals to its Board of Directors. Their combined experience will help guide the Company through its next phases of growth and development."

    Navidea Chair of the Board Alexander L. Cappello said, "I am proud to join Jed Latkin in welcoming seasoned directors of such high caliber as Thomas Farb and Agnieszka Winkler to the Navidea Board of Directors. Their combined management experience as CEOs, operators, public company managers, all aspects of leadership and every possible committee brings a wealth of maturity, relationships and experience to Navidea."
    Bullish
  • B
    Bill
    I’ve bought more yesterday and today. They are obviously positioning them self’s well w a great team. That means to me they think they have something. Hope the smoke signals are really a fire. I think that’s PC.
  • B
    BB
    I’m glad you guys no longer get worked up over the after hours trade of two shares.
  • P
    Palantir777
    FDA minutes release.... courtesy of moneyonomics, IV-NAVB mb
     

     ..The answer is fluid on what/when a bio/pharma company could/must release summary of minutes  in an PR/8K disclosure for an important FDA Type B(EOP) meeting minutes..If Navidea thinks the meeting minutes and goals, etc.  are clear and precise and directions and goals agreed would not be misleading they could/would release a PR/8K 4 business days after meeting say Oct 5 or 6 if received on Sept 30.

     

    However, if after receiving FDA meeting minutes/letter Navidea feels any PR/8K would be misleading  such as all material goals or agreements with FDA are not yet finalized (FDA only has to provide 90% of goals in the minutes see below), Navidea would not have to disclose/summarize in those 4 business days (see legal letter below) of what was in the important meeting minutes until final material goals or agreements are settled with FDA

     

    Also bios/pharmas would generally never routinely issue the exact minutes as minutes would contain sensitive/confidential business data again see legal letter below) 

     

     So to re summarize Navidea could issue a PR/8k in 4 business days
    after they received a FDA response if letter was clear and precise and agreed in its direction and goals.  This may not happen as again FDA directions for Type B (EOP) state 30 day letter will only give 90% of goals, so that suggests Navidea may not be in a position to issue and 8K/PR 4 days after receipt of letter if agreements and the last 10% were major unsettled goals and could been viewed as misleading to issue a PR/8K to investors. So we may not see a PR/8K until last 10% of goals or agreements are clear with FDA  which JL pointed to ASM posted before (.. hope to give everybody an update once those meeting minutes have been received and everything has been signed off between us and the FDA?)

     

     

    Excerpt from a legal letter

     

     "...If a public company does choose to disclose information contained in these
    action letters, it must ensure that its public statements are not materially misleading.68 An uncertain materiality standard and lack of guidance from the SEC, however, have made that determination difficult
    and nuanced.69...

     

     

     If a company  chooses to disclose information, however, that information cannot be materially misleading.74 Since pharmaceutical companies face unique pressures to disclose information regarding clinical trials and the FDA approval process,75 they must make nuanced decisions as to which information is material and what is and is not misleading.

     

     

     
    https://www.nyulawreview.org/wp-content/uploads/2018/08/NYULawReview-82-4-Sukhatme.pdf

     

     Excerpt from FDA process for a type B EOP meeting

     

     6. Meeting Minutes...Type B(Eop) meeting 
    a. Procedure: The Agency will prepare minutes that will be available to the sponsor 30 calendar days after the meeting. The minutes will clearly outline the important agreements, disagreements, issues for further discussion, and action items from the meeting in bulleted form and need not be in great detail.  Meeting minutes are not required if the Agency transmits a written response for any meeting type.

     

    b. Performance goal: 90% of minutes are issued within 30 calendar days of the  date of the meeting

     

     https://www.fda.gov/media/99140/download

     
    Bullish
  • A
    AG
    Courtesy of StockVestor99 and Moneyonomics, IV message board

    Slide deck on Navidea website updated. Addition of End of phase 2B pre phase 3 fda meeting marker to RA path to NDA submission slide. Phase 3 expected to start in Q4 according to slide. Sounds like we are close. GLTA.
  • A
    AG
    Would like others opinion on this. My believe is that NAVB should receive the FDA minutes update at some point today and the PR for the event would follow. However, reading other message boards has me questioning my confidence in that. Was the FDA minutes update an approximation or a firm date for finalization? Any thoughts are welcomed.
  • P
    Palantir777
    Navidea Biopharmaceuticals Appoints Michel Mikhail, Ph.D. as Chief Regulatory Officer
    Download as PDFSeptember 27, 2021
    DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea, effective October 1, 2021.

    Dr. Mikhail has more than 30 years of experience in the pharmaceutical industry and a track record of achievement in R&D and international regulatory affairs at large multinational research-based pharmaceutical companies. Prior to joining Navidea, Dr. Mikhail worked in global regulatory consulting for various pharmaceutical and biotech companies from January 2016 through September 2021. Before acting as a consultant, Dr. Mikhail served in senior regulatory executive roles at BioNTech AG, Fresenius Kabi, Ranbaxy Europe Ltd. (now SunPharma), Pharmacia & Upjohn (now Pfizer), Knoll AG (now Abbvie), SmithKline Beecham (now GlaxoSmithKline), and Boehringer Ingelheim. Dr. Mikhail is a global expert in Regulatory Affairs dealing with the U.S. Food and Drug Administration (“US-FDA”), the European Medicines Agency (“EU-EMA”) as well as national agencies in Europe, Japan’s Pharmaceuticals and Medical Devices Agency, China’s National Medical Products Administration, among other regulatory agencies worldwide. He is a Chartered Expert in Pharmacology-Toxicology. Dr Mikhail served on the Safety working group and Efficacy working group of the European Federation of Pharmaceutical Industry Associations and as a Topic Leader for new guidelines. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America, on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (now Medicines for Europe), as well as on different associations and organizations. Dr. Mikhail is a lifetime member of The Organization for Professionals in Regulatory Affairs, and has contributed as volunteer at the Drug Information Association and the Parenteral Drug Association. Dr. Mikhail was part of the Transatlantic Trade and Investment Partnership negotiations aiming at harmonization of regulatory requirements and relying on each other’s inspections between the EU-EMA and US-FDA. Dr. Mikhail served as a volunteer member of the Expert Committee of the Governmental Federal Institute of Risk Assessment in Berlin, Germany and served as a volunteer member of the Expert Committee for Toxicology of the United States Pharmacopoeia in Maryland, USA. Dr. Mikhail holds a Ph.D. from the University of Paris and a Ph.D. from the University of Hannover.
    Bullish
  • B
    Bill
    What’s up w volume, they seem to be trading by appointment
  • J
    Joseph
    i wonder why they are not telling us what was discussed with the FDA.
    unless there is really nothing worth saying
  • P
    Palantir777
    The following courtesy of Fall1980, IV-NAVB mb.....

    "Just so we're all on the same page. The FDA document outlines the following process for Type B and C meetings:

    1. Sponsor (in this case, NAVB) submits questions to be addressed in meeting.

    2. FDA performance goal is to issue preliminary responses to at least 90% of those questions, five or more days before the meeting takes place.

    3. Sponsor (NAVB) then has until three days before the meeting to tell the FDA if the meeting is still necessary, and, if so, what the issues to be discussed are, based on their review of the FDA preliminary responses.

    4. Meeting occurs.

    5. FDA prepares minutes of the meeting encompassing all important resolved and unresolved issues considered therein, and provides those minutes to the Sponsor (NAVB) within thirty days after the meeting. The FDA performance goal is to meet that 30 day deadline at least 9 out of every 10 meetings."

    Reply to Fall1980, courtesy of moneyonomics......

    "very good, but need to add 30 day letter also references action items outstanding, etc. that need to be resolved before P3 that the FDA later clarifies/changes, so per SEC would delay an 8K/PR so as to not leave any misleading ideas/opinions with investors"

    My last post in this regard as that it would seem that this subject has been analyzed thoroughly, for those of an interest i hope the dd put forth on the IV and subsequently shared on this mb was helpful.....
    Bullish
  • c
    cbachand
    Well, I think it was a long time coming , tomorrow will show if Jed's departure was a positive move.
  • B
    Bill
    Good article by Cardinal Health on RA and the growing population and needs
  • J
    James
    Very good daily volume.
  • B
    Bill
    Something is moving, I hope it’s good
  • J
    Joseph
    what ever happened to the government report from some meeting on September 1st
  • B
    BB
    90 minutes until the market closes. Would be a good time for an SEC filing.
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