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Beyond Air, Inc. (XAIR)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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6.21+0.14 (+2.31%)
At close: 04:00PM EDT
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  • D
    David
    a lot of companies are getting FDA approvals lately - seems the FDA started working again... maybe we'll be lucky too...
    disclosure: i am long.
    Bullish
  • c
    cd
    Being beholden to the FDA over the last 2 years has been the biggest pain trade i can remember. What a waste of time/money.
  • m
    morgan
    Typical behavior before a big move up. Get ready for approval folks!!!
    Bullish
  • r
    ritak
    Anybody know where support is at on Xair?
  • D
    David
    short interest is up again. waiting for the squeeze to come soon.
    disclosure: i am long. not recommending...
    Bullish
  • c
    cd
    r they just trying to close the gap..... i mean seriously... down 15% on what again? Rates rising?
  • A
    Adam
    The company has $50 million in cash, so how can it's evaluation be only 150 million?
  • m
    morgan
    Another strong day. Approval coming within the next 3 weeks. Bears getting scared :-)
  • m
    morgan
    Fda approval within weeks people! Load up now vs when it is at $16
    Bullish
  • c
    cd
    Honestly... what is the FDA actually doing every day now? Why are they so dysfunctional at this point of the pandemic?? I'm not saying they have it ez but they've been a complete disaster across the board for just about everything they're responsible for. They aren't approving and I keep seeing delays and more delays for countless pfuda dates...I think I'm bout to lose it! Lol
  • m
    morgan
    Robert Carey bought in $12’s, $8’s, $7’s and $6’s yet not in the $4’ last week. It’s because fda approval is close!!! Let’s go Brandon!
    Bullish
  • d
    david
    FDA 8 Steps in the PMA Application Process:
    1-Filing review
    2-Statistical review for filing
    3-Review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
    4-PMA filing decision
    5-Day-100 Meeting
    6-Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection may be conducted for all original PMAs and may be conducted for PMA supplements requesting approval of alternate or additional manufacturing and sterilization facilities.
    7-Bioresearch Monitoring (BIMO) Audit (audit of clinical study data)
    8-Substantive review coordination and completion in areas such as:
    a) Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
    b) Nonclinical Studies
    [Microbiological, Toxicological, Immunological, Biocompatibility, Shelf Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue, etc.)]
    c) Clinical Studies
    d) Panel Meeting Decision and Mailing (if panel meeting is appropriate)
    e) Panel Date (if appropriate)
    f) Transcripts Received, Reviewed and Placed in Administrative Record
    g) QS/GMP Clearance
    h) Final Response for GMP/BIMO
    i) Final Decision Memo
    j) Approval Package
    k) Approval Order, SSED, Final Draft Labeling
    XAIR passed Step 6 on 9/23/2021 with FEI#3015861988.
  • O
    Ouch
    XAIR was one dumb short last year at $5, and a double down on dumb this year(at $5). At what point will shorts lose more than everything?...

    You have:

    1) Two imminent potential upcoming approvals for XAIR's very first indication(PPHN). Its always easier getting any additional indications after the first indication is in the bag.

    2) BOD Carey & CEO Lisi locked and loaded-up with absolute boatloads of shares purchased with their own capital. All one needs to do is check out the wildly successful history of specialty pharma, HZNP, and then look into Robert Carey's latest stock activity....

    3) Removing Beyond Cancer's valuation out of Beyond Air, it appears Beyond Air is close to being free right now(OR, another way to look at it, Beyond Cancer($30M for a 20% stake) is the freebie. It appears, with brand new CFO, Beyond Cancer is moving forward. So, when does XAIR spin this off to officially unlock what is likely to be double the current stock price valuation, minimum?
  • A
    Aladdin
    We've got a leak!
  • m
    morgan
    Pumped for fda approval within the next 1-3 weeks. Gonna rip
    Bullish
  • d
    david
    Just wonder how many people in the market knows we are waiting for FDA?
  • r
    ritak
    Low volume sell off, can’t believe how manipulated this stock is.
  • m
    morgan
    Fda approval late may to early June. PMA clock was reset December and 180 days from that lands us then
    Bullish
  • m
    morgan
    Huge volume today. XBI down. AXSM down. Xair up. Something is gonna happen and it starts with FDA and ends with approval! Approval within the next 2-3 weeks
    Bullish
  • A
    Amir
    is approval today or tomorrow?
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