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Zosano Pharma Corporation (ZSAN)

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0.4632-0.0418 (-8.28%)
At close: 04:00PM EST
0.4620 -0.00 (-0.26%)
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  • r
    'We can't vaccinate the planet every six months,' says Oxford vaccine scientist

    The most recent Press Release from Zosano/Mahmoud Ameri, et al., proves that the Microneedle and its competitive efficacy have been ignored by controlling factors such as the FDA, EMA, etc. for too long, and now feeding critical medicine to the masses is long overdue!

    Maybe the world needs a helping hand... That is the Microneedle.
    Best regards,
    A leading expert who helped create the Oxford-AstraZeneca Covid-19 vaccine said Tuesday that giving everyone in the world booster shots multiple times a year is not feasible.
    A leading expert who helped create the Oxford-AstraZeneca Covid-19 vaccine said Tuesday that giving everyone in the world booster shots multiple times a year is not feasible.
  • j
    great job Lo you deserve every penny of your pay check let your Accomplishment for the. month C meting with the FDA over a month = 0 news NDA over a month =0 news partnership =0 news
  • B
    In addition to other benefits this delivery of a vaccine has the huge advantage of being self administered rather than having to make an appointment with either a doctor,clinic or drugstore.
  • A
    Microneedle Drug Delivery Systems According to Harvard Business People - Zosano is worth $12.00 soon

    Microneedles are used in a wide range of low molecular weight drugs, vaccines, bio therapeutics and protein drugs owing to their transdermal penetration properties.

    Rising cases of chronic illnesses such as diabetes, migraine, and others have led to increasing demand for new drug administration techniques such as microneedle drug delivery systems.

    According to the International Diabetes Federation (IDF), number of people suffering from diabetes has reached 463 million already and is expected to increase exponentially in the next 10 years.

    Microneedles (MN) are emerging as a novel drug delivery carrier. Microneedle-based system of drug delivery offer minimally invasive and pain free administration of the task. Considering this, rising cases of diabetes are likely to bode well for the market.

    Also, huge number of needle stick injuries occur every year is expected to drive the drive uptake of microneedle delivery systems.

    Zosano Pharma with have Migraine a Patch - Covid Patch - Flu Patch - Diabetes patch - Cancer patch etc etc.

    Mitsubishi will partner soon or buy the company for 1.3 Billion
  • i
    We've been waiting for so long let's do it. resubmission of the NDA for M207 with receipt of top-line data from our pharmacokinetic study,”
  • K
    Does anyone have any insight on when the response for the Type C Meeting will come? I know it’s within 75 days but it seems that some publications don’t give a thorough timeline for when an answer will be shared ……thoughts?
  • A
    A Successful Formulation COVID-19 Vaccine Patch For Candidate ( Medicago waiting confirmation news)
    Plant-based COVID-19 Vaccine East Painless Patch One package, one dose. Coated microneedles that deliver directly to epidermal/dermal skin layers which leads to an improved response and potential for dose sparing vaccine therapies. Technology is aimed at transforming vaccine dosing paradigms. Extensive clinical applications:with no incidences of infection. Room temperature stable, unit dose vaccine, delivered to the patient's door for at-home dosing. No expensive cold chain refrigeration needed for shipping and storage

    Zosano formulations are stable at room temperature, deployment using standard mail delivery systems
    Easy disposal: Once applied the user would dispose of the unit in standard trash receptacles

    The patch is safe, prevents the user from inadvertently touching the microneedles and potentially removing some of the therapeutic.

    Each patch is a intuitive unit dose, mitigating the need for a weight-adjusted calculation of dose, and preventing overdose or incorrect administration.

    Zosano has a proof of concept, successfully formulated and dosed >30 compounds of which 6 have advanced to clinical trials –including a Phase 1 trivalent vaccine.

    Flu vaccine potential: Phase 1 clinical data for influenza vaccine showed that the microneedle coated tri-valent flu vaccine was comparable in immune response to the commercial IM injection.
    Medicago : Une petite idée qui bouleverse l'industrie / A small disruptive idea
  • W
    Soon we'll know why we held this stock so long.
  • T
    "We can't vaccinate the planet every four to six months. It's not sustainable or affordable," Professor Andrew Pollard, the director of the Oxford Vaccine Group and head of the UK's Committee on Vaccination and Immunization, told The Daily Telegraph in an interview published Tuesday.

    It’s possible and affordable with the microneedle patch!
  • M
    AUG 18, 2020 8:30AM EDT Zosano Pharma Announces Agreement to Collaborate with Mitsubishi Tanabe Pharma Corporation

    Mitsubishi Tanabe Pharma Corporation (MTPC) Group, the majority parent company of Medicago, is one of the large Japanese pharmaceutical companies, with its headquarters in Osaka, Japan. It positions vaccines as one of its key R&D areas under its Medium-Term Management Plan 21-25 and is also working to develop new modalities of vaccines. MTPC Group will further contribute to the prevention of infectious diseases which is one of the world's important social issues, by delivering a new option of plant-based VLP vaccine as a new type of vaccine.

    “Our agreement with Mitsubishi Tanabe Pharma Corporation allows us to combine our proprietary transdermal microneedle drug delivery platform with Mitsubishi Tanabe Pharma Corporation’s drug development candidate,” said Steven Lo, President and CEO of Zosano. “We expect through this partnership, to demonstrate the broad applicability of our platform for making a difference in the lives of patients when combined with pharmaceutical products that address significant unmet medical needs.”

    Under the agreement, Zosano will evaluate the feasibility of formulating a pharmaceutical agent being developed by Mitsubishi Tanabe Pharma Corporation for administration in humans, with its proprietary microneedle patch system. Defined research and development activities will include both in vitro and in vivo phases. Mitsubishi Tanabe Pharma Corporation receives the right to exercise an option to negotiate an exclusive license to the relevant Zosano technologies in the defined field, which exercise will be dependent on the outcome of the studies. Financial terms and the identity of the Mitsubishi Tanabe Pharma Corporation
    molecule and development program are not disclosed.

    Zosano Pharma Announces the Successful Formulation of a COVID-19 Vaccine Candidate on its Microneedle Patch System

    Published: Nov 17, 2021

    Mitsubishi, doing a 30,000 clinical trial in Japan. Hope to be approved March 2022

    Plant - Based Covid -19 Vaccine patch is good for humanity. No cold storage, at home dosing - easy - painless
    The importance of Canada’s 1st home-grown COVID-19 vaccine
  • B
    Zosano Pharma announces publication of Phase 1 trial data on influenza vaccine 

    Zosano Pharma Corporation announced the publication of Phase 1 clinical trial data in an article titled, "Immunogenicity and Safety of Inactivated Influenza Split-Virion Vaccine Administered via a Transdermal Microneedle System" in the Journal of Vaccines and Immunology. The data demonstrated that a low dose of a trivalent influenza vaccine administered via its transdermal microneedle system produced antibody levels that met EMEA's three guidelines for influenza vaccine efficacy and was generally well tolerated. The single-center, randomized Phase 1 study enrolled 90 subjects between the ages of 18 to 40 years to receive a trivalent influenza vaccine containing strains A/H1N1, A/H3N2, and B. Volunteers were randomized to receive the vaccine either via a transdermal microneedle system patch worn for 5 minutes, the same patch worn for 15 minutes, or by intramuscular injection. Antibody levels were measured at Day 21 and compared to EMEA guidelines to assess immunogenicity of the treatment groups. All three EMEA criteria, including seroconversion rate, mean increase in hemagglutinin inhibition titer, and percentage of seroprotected subjects, were met for all three influenza strains in all treatment groups. Additionally, on day 21, most study participants considered microneedle patch application and removal to be less painful than intramuscular injection, and most considered the patch to be their first choice for mode of administration. The transdermal microneedle patch was generally well tolerated.

  • L
    Regardless of what some (Ferran) are suggesting, the deadline for complying with the Nasdaq minimum price requirement is on/about May 29, 2022.
    A lot can still happen in the next 5 months.
    Ferran, you want to dispute that date?
  • R
    In my opinion, few people understand the meaning of this news. It can revolutionize the vaccine industry, if it is true.
  • T
    The K
    Again, the potential on this company is huge. The leadership is also working fantastic so far, such as the deals they have made and the strategies they have explored/expanded.
    And yes, I do agree that they have to update the investors ASAP, BUT, I also do not see why the company will hold on the press if they got the negative response from FDA, cause eventually they have to announce it and if they hold it on purpose for the insiders to sell before the big dive that is against the law.
    I am more on that the response either got delayed or they got the positive response already and preparing for the resubmission then put them together in the further announcement, just my opinion.
  • R
    this was on their 8 k dated Oct 25 see below :

    On October 27, 2021, the Company submitted a briefing package to the U.S. Food and Drug Administration (the “FDA”) in advance of the Type C Written Response Only meeting request, previously granted by the FDA, to obtain feedback on the Company’s strategy for resubmitting the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application, as previously disclosed in the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on October 6, 2021.

    Forward-Looking Statements

    I am assuming the 90 days starts from Oct 27 that is why we haven't heard yet I may be wrong
  • m
    Uncertainty and negative sector bias is effecting majority of the small cap bios! ZSAN is no exception. The management should come up with positive PR to clear the uncertainty and give clear pathway for their resubmission . This company has huge potential with their micro needle technology ; all they need to get FDA nod for the last CRL. SP is undervalued at this level.
  • T
    Trading right now will be at every wise individual list. In few weeks you will be ecstatic with the decision you make today
  • j
    Has anyone called anyone at ZSAN lately? I just called and left a message, not impressed with their shareholder communication lines lately at all!
  • R
    Submitted on Oct 27 takes 75 Days you should know on or about January 15th

    Type C meetings are basically a “catch all” category and includes any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. The FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.

    When requesting a Type C meeting, Sponsors can request a written response to their questions rather than an in-person meeting, videoconference, or teleconference. A sponsor may request a face-to-face meeting, but the FDA may decide that only a written response is necessary.
  • L
    Need for cash and need for R/S...Let's look at the numbers (as of 09/30/21)...
    ~Cash: $18m...~Loss/qtr: $8m...Shares outstanding: ~118m...Shares authorized: 250m.
    So, as of the start of this year, let's say the company has ~$10m cash; that's enough for approx 1 more quarter of expenses. I will assume they won't wait for Q2 to get more cash, as they "need cash now". (JD Wentworth). Anyway, if they dilute 50m shares at $0.50, that's ~$24m (there are expenses with dilution), or ~3 more quarters worth of cash.
    Now, that is a significant number of shares to add (over 40%), but my point: The company can fund the remainder of 2022 via dilution WITHOUT the need of a reverse split.
    So, I'm expecting SIGNIFICANT dilution this year (you should to, imo). As for a reverse split, that is NOT needed to fund, although it MAY be needed to remain on the Nasdaq, but that decision need not be made until the April-May time frame.