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PolarityTE, Inc. (PTE)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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0.6394-0.0786 (-10.95%)
As of 10:21AM EST. Market open.
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  • I
    IcensorDog&Ronjohn
    PolarityTE Announces U.S. FDA Approval of IND for Pivotal Phase 3 Study of SkinTE® to Support Chronic Cutaneous Ulcer Indication
  • f
    fanous
    They had some interesting insights about PTE on http://alert-sounds.com/. Definitely made me think twice about the company.
  • S
    S 4 BIO
    Great news. The fda could easily give them an early full approval, as it's apparent as early as 6 weeks, that PTE outperforms anything else.
  • S
    S 4 BIO
    PTE gave the fda the data on Dec 20th - I think we'll hear something from the gumint in the next 2 weeks. I would think we'll get a pretty nice move soon, on the expectation of being able to start the testing.
  • T
    Thomas A. Parmalee
    Looks like we're waiting until Tuesday for some news with the holiday being Monday. It will be an interesting week next week.
  • S
    S 4 BIO
    Wowzer, check out that volume.

    They had an investor presentation on the web-site, with pictures of wound closure, going back a couple of years. Anybody that saw those pictures understands what this is all about. Unfortunately, that slide deck is gone. Apparently the fda told them to take it down. That's unfortunate, but typical of how the gumint does things.

    Anyway, when the fda grants SOC approval, we should 3-4$ pretty quickly.
  • N
    Nuno
    There are days that good news are as good as bad news!!
  • S
    S 4 BIO
    We're finally starting to get some attention. I've been in the stock for almost 5 years, and this will be our year. I'll post some of my projections, over the weekend.
  • S
    S 4 BIO
    Pretty solid buying, is today the day to CLOSE at .74??
  • S
    S 4 BIO
    This has been a horrible year for smallcap biotechs, maybe that's about over with.

    Once the fda OK's proceeding with the testing, we already know how that's going to turn out. This is the best stock in the sector, and next year will prove it.
  • j
    jh
    The Company expects enrollment to begin later in Q1 or early Q2.

    That means this will take 1 year to get full approval.
  • K
    Katerina
    someone is loading
  • A
    Angie
    FDA Approves PolarityTE's Phase 3 Study Of SkinTE In Chronic Cutaneous Ulcer
  • S
    S 4 BIO
    50,800 on the bid, at 60 cents, a player.
  • S
    S 4 BIO
    Still some trading going on, must be short covering from somebody that just found it moving. Mkt has been closed for almost 3 hours.
  • S
    S 4 BIO
    SALT LAKE CITY, Dec. 20, 2021 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE) a biotechnology company developing regenerative tissue products and biomaterials, today announced that it has submitted its complete response to the U.S. Food and Drug Administration's (FDA) clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE® with a proposed indication for chronic cutaneous ulcers. As previously disclosed, the primary hold issues are certain Chemistry, Manufacturing, and Control (CMC) items, including the assay to demonstrate the potency of SkinTE.

    The Company's complete response to the hold issues was submitted on December 17, 2021. Under FDA's standard practices and regulations, if FDA agrees that the Company's response is complete, a decision from FDA should be communicated to the Company within 30 days, subject to potential delays or other unforeseen circumstances.
  • S
    S 4 BIO
    Highest print in a couple of months was .7379 - on Jan 2nd. So we need a CLOSE above there, to break out of this trading range. Always hard to tell when that will be.
  • K
    Katerina
    Told you someone is loading
  • S
    S 4 BIO
    Average retail trade is $6600, so we had a few almost tripe that. So it's not just a bunch of penny flippers here, maybe some good, solid investors.
  • I
    IcensorDog&Ronjohn
    The clock is in play. FDA review staff shall manage the next 30 days.