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Pulse Biosciences, Inc. (PLSE)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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11.56-1.58 (-12.02%)
At close: 4:00PM EDT
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  • C
    Chari
    Look at the volume. Its impressive. This may just be the beginning ahead of the 510k submission and other news. GL!
  • m
    mike
    Here we go! On our way to $25
  • R
    Ron
    what irks me about the market are these jumps in volume and increase/decrease in values PRIOR to news in almost every single stock trading on all exchanges.
    It can ONLY mean people are trading on insider information and we are just pawns in someone's game.
    I'm in with 4,000 shares and have been for 3 years, but seriously?
  • T
    Thomas
    Every day, a little more. Seems like it would be a poor time to be short selling (unless you're a heck of a gambler).
  • G
    Gunn
    PLSE have filed for mixed shelf offering. What does that mean? Doesn’t sound good
  • H
    Hohum
    Nibbled in the sub 10 range. Hope revised 510 submission is soon and approval by end of the year.
  • L
    Lee
    Where is everyone? Are you waiting for bob to tell you everything is OK?
    Bullish
  • m
    mike
    $11.83 bid AH ..NEWS COMING!
  • H
    Hohum
    I think the market is optimistically looking forward to the 2Q CC next month for potential updates on nano pulse submission progress. Certainly the stock is showing some strength here.
  • S
    Steve
    510k approval should be soon! Also another positive analysis review sharing some good market sizing data for the first use cases, this will be huge when they start selling in Q4
    Bullish
  • r
    romeo
    Well the best insider mr Duggar is punting his money again in this company in order to fund a new Capital increase. Not all the money will be lost and clinical trials will load up to more relevant numbers to make the case more compelling. Short time it will indeed be painful but you can expect this to rebound on Tuesday post conference call and during the year as a new 510k applicato k will be submitted . Stay strong
  • T
    Thomas
    Apparently no one makes a similar product.

    From FDA's site:

    The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).

    There are two options for De Novo classification for novel devices of low to moderate risk.

    Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
    Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.
    Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

    Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.

    Also, definition of NSE from FDA:
    An order declaring a device to be NSE (NSE letter) is a letter issued to a 510(k) submitter stating that FDA has determined that the device described in the 510(k) submission is not substantially equivalent to any legally marketed device and may not be introduced into commercial distribution in the U.S.Oct 2, 2017
  • m
    mike
    I just got off the phone with CFO. PLSE will not PR the refiling of the 510K. Only upon the FDA's response to the submission. This Definitely seems like it will take down the stock in the short-term, because they could file and we not even know, But, long-term, everything sounds on track.
    Bullish
  • D
    DTM
    Any ideas why we're having a meeting vs what company originally said would be approval by end of year. Any estimates on where does approval put share price?
    Bullish
  • D
    DTM
    anyone have a good take on the sa article. Is there any real truth to what they are saying?
  • m
    mike
    Where are the buyers? I assumed there would be some buying coming in?
  • R
    Ryan C
    FDA Meeting should be complete by tomorrow (“first half of the month”) Expect final formal responses and probably a company update soon...likely prior to FDA review complete.

    “We understand this timing is important to all our stakeholders and we will continue to provide updates as appropriate."

    Expectation management: FDA review complete could likely not mean an announcement of approval. Government time.
  • H
    Hohum
    My only takeaway is that they are going wait till 4:00 pm to announce any news. I think they don’t usually release major news during the trading hours. But this whole gap down stock action at the open is very weird and makes me worry. If any of you think differently, please chime in!
  • D
    DTM
    told you the fire sale wouldn't last for long. insiders are probably scooping up all the shares they can right now. This goes back about 20 before you know it. This technology is going to change everything sort of like the CyberKnife was to surgery