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Avenue Therapeutics, Inc. (ATXI)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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3.4100+0.0800 (+2.40%)
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  • T
    I have been watching this for about 2 weeks now. I am not a shareholder so not bashing or pumping. I like the low shares available, and the high insider ownership. Yet, I cannot get over the fact that they only have 4 employees! Can anyone offer me insight here? Thanks in advance.
  • a
    Do you really think an offer would be made around 14 if they didn't think an FDA approval wouldn't happen.........It will happen, but with so few shares, who is weak or strong or patient enough to just sit tight...........I mean come on!!!!!!
  • R
    The type A meeting with FDA it's fixed for December. Read the yestarday FBIO results to see that.
  • M
    When this thing runs, it'll be real hard to stop with the amount of shares there are available to retail!
    Insiders own 61%
    Institutions own 16%
    With 16.7 Million shares outstanding, there are only about 3.85 million for us!
  • P
    If FDA will approve, with Cipla’s agreement, share price will jump to 14-15 range...
  • P
    We need some news.
    But frankly I don’t really see the point of FDA to refuse it.
    Tramadol is way more bioavailable through IV and refuse it just because of the stacking up the doses.
    This looks like it was orchestrated...
  • J
    Still no update :-(
  • g
    So how do you address the safety issues mentioned in the FDA letter? A no combination with another drug warning??
  • T
    A good day for ATXI up over 5%.
    I'm still under water but hoping to stay a float.
  • P
    Anyone??? Anything good?
    Is this going bust???
  • Z
    Why is this falling hard now?
  • P
    I need 3.99 today😅
  • P
    They will get FDA approval and this can jump even higher than 10 due to shorts...
  • P
    “The investigation concerns whether Avenue Therapeutics and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.”

    When you double down...
    So if it wouldn’t be sabotaged, it would be approved...
  • j
    Any chance of a rebound???
  • V
    Venom Snake
  • s
    ATXI CRL from the FDA on their IV Pain Medication, down 50%... Surprised ACRX is not $5 on that news alone... Guess the surgeons last week were spot on Re: ACRX's DSUVIA "Too Good To Be True." "DSUVIA is just good medicine."
  • L
    At anytime pre NDA the company could have requested a meeting with the FDA to get their views. No termi al sterilization validation in Phase III?. They should fire their QA director.
  • P
    Shouldn’t they have already special meeting with FDA around these days?
  • S
    It seems that FDA is unclear about what they want in pain meds. Sure they want "safer, less potent but effective" but how do you achieve that? Yes there could be instances where IV tramadol is not providing enough pain relief and an additonal opiod is dosed (opiod stacking) with problems occurring if they both finally kick in. The same opiod stacking problem can occur if they start with a low dose of morphine and then have to give another dose or add on fentanyl. Is the answer to start with a more potent opiod? No.

    My suspcion is that FDA was unsure of under which conditions to approve so they punted with a CRL. Should they approve with a more restrictive patient population (types of surgeries, procedures) or should they add warnings about how to gradually dose other opiods in parallel? It is possible that they were going to give CRL anyway for the inadequate sterilization validation so they now have more time to discuss internally and with Avenue about conditions for approval. They would ask Avenue for more data to help in the decisision (hopefully not new clinical data).
    A delay but I expect that it will get approved.