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Pain Therapeutics Inc. Message Board

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  • Reply to

    NDA

    by mike59sc Mar 3, 2016 10:39 AM

    Zogenix sold Zohydro ER (ADF only) for $300 mil. Pain should be worth $8-$10 if they can get same or better deal...

    gl

    Sentiment: Strong Buy

  • Reply to

    NDA

    by mike59sc Mar 3, 2016 10:39 AM

    Thanks - your example with Zohydro fully supports my price tag for PTIE. Perhaps we can get more ....
    hofno

    Sentiment: Strong Buy

  • AUSTIN, Texas, March 29, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (PTIE) announced today that it has resubmitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for REMOXY®, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules. Pain Therapeutics expects to be notified by the FDA of a Prescription Drug User Fee Act (PDUFA) action date within 30 days. The original REMOXY NDA has a Priority Review designation.

    Sentiment: Buy

  • Are you still out there? Remember you back at least 11-years ago. I guess you needed a lot of valium to wait this long ! Give us a 'Sign of Life' if you're still out there please.

    Sentiment: Buy

  • PTIE could quickly quadruple - New video at StockMarketVideoc (Google them)

  • Hopefully Remi provides an update on last years grant before the NOVA program.

    The NIH's National Institute on Aging awarded this innovation grant to Pain Therapeutics following an in-depth evaluation of PTI-125 for scientific and technical merit. This competitive review process relies on academic, clinical and industry experts in Alzheimer's Disease and other neurological disorders. The science that underlies PTI-125 was initially published in The Journal of Neuroscience (2012-32:9773-9784), the highest-ranking journal in its discipline.

    PTI-125 prevents the formation of both amyloid plaques and neurofibrillary tangles (composed of tau protein), the hallmarks of Alzheimer's Disease (AD). Its novel mechanism of action and early data suggest this drug may improve cognition and protect against the toxic effects of amyloid in neurons, raising hopes for a treatment to combat cognitive decline in patients with AD.

    With this NIH award, Pain Therapeutics will conduct pre-clinical studies that are expected to enable an Investigational New Drug (IND) regulatory filing for PTI-125. PTI-125 is an oral, small molecule drug candidate that was designed in-house and characterized by outside collaborators. The Company owns exclusive, worldwide commercial rights to PTI-125 and related technologies.

    About PTI-125

    AD patients suffer from progressive cognitive and memory impairments, widely believed to be caused by a protein in the brain called amyloid. Many drug candidates for AD focus on reducing or clearing amyloid from the brain. In contrast, PTI-125 blocks the toxic signaling of amyloid and reduces aberrant tau protein. PTI-125 binds to a novel target critical to amyloid's toxic cascade: the scaffolding protein filamin A (FLNA). By binding FLNA, PTI-125 blocks amyloid's toxicity and tau phosphorylation. In animal models and human postmortem AD brain tissue, the beneficial effects included restoring neuronal function and reducing neuro-inflammation. These effects suggest P

  • A little more from the PR: These effects suggest PTI-125 may improve cognition and reduce neurodegeneration. The mechanism also indicates the development of a non-invasive, blood-based biomarker and diagnostic for AD.

  • Since PTIE doesn't provide many CC's or PR's.

    "REMOXY has the opportunity to be a highly differentiated product. REMOXY takes a straightforward approach, abuse-deterrent, by not requiring the addition of a second agent that may be detrimental for the patient. It is an oral capsule with the formulation that is highly viscous.

    It isn't just another tablet that may be harder to crush. Even after crushing, REMOXY's viscosity makes it practically impossible to inject through a needle nor can one snort it. If one mixes it with common drinks in an attempt to release the drug more quickly, the oxycodone does not burst out.

    So we believe REMOXY has the potential to be a best-in-class product, providing the pain relief you'd expect for the legitimate chronic pain patients while deterring multiple common modes of abuse."

    Sentiment: Buy

  • Good looking chart - First target should be $5

  • Breakout formations $ONCS $QBIO $OPXA $PBMD

    Sentiment: Buy

  • Allergan has lots of money now

    Sentiment: Hold

  • LONDON — GBI Research published a report Thursday that noted the U.S. market for opioids will be growing in the coming years. According to the report, the opioid market will hit $17.7 billion by 2021, up from $11 billion in 2014, with a compound annual growth rate of 7%. 

    ........

    “The result of these possible market restrictions, however, is that opportunities may open up for the development of abuse-deterrent opioids and of products that treat or prevent overdoses,” Allavarapu  said. “Such drugs include Naloxone, which reverses the effect of opioid overdose, Remoxy, a form of controlled-release oxycodone, and Embeda, which combines morphine with an antagonist to reduce the effects of the morphine if necessary.”

    The article written by DAVID SALAZAR from DSN(drug store news) - 4/1/2016

    Sentiment: Strong Buy

  • It's easy to do a small math in order to get a clue about a fair price tag, given that Remoxy finally is approved:
    - its a low ball estimate if we say that Remoxy may get a high single digit market share of the US oxycontin market, which is anywhere between $2.3 - $2.5 billion. 8% market share would give $200 million revenue for PTIE/Remoxy.
    - at three times revenue we should get a market cap of PTIE of 3 x $200 million = $600 million.
    - actually we sit at $100 million market cap of our tiny company.
    This means the upside potential is 6 x actual market cap == 6 x actual share price = 6 x $2 = $12.

    Thats reasonable and fair. We will approach a double digit share price stepwise within the next 6 months, additionally driven by take-out or partnership speculations which will emerge soon. Its clear for me, PTIE will not build a full commercial infrastructure for Remoxy - it will outlicence the drug or outright sell the whole company, thats my take.

    Great reward:risk ratio at PTIE.

    hofno
    The best is yet to come.

    Sentiment: Strong Buy

  • Reply to

    PTIE price target: $12+. Here is why.

    by hofno2003 Apr 13, 2016 2:09 AM

    PTIE forgot to mention that the priority status was again granted with the review - thats a nice committment again concerning the value of Remoxy and FDA's opinion concerning the urgent need of new ADFs (abuse deterrent formulations).
    From FDA:
    Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review)

    Sentiment: Strong Buy

  • Reply to

    PTIE price target: $12+. Here is why.

    by hofno2003 Apr 13, 2016 2:09 AM

    Better yet Pain owns worldwide rights. Your calculation is for US pie

    Sentiment: Buy

  • Reply to

    PTIE price target: $12+. Here is why.

    by hofno2003 Apr 13, 2016 2:09 AM

    Thanks - you are right. The rights for EU and ROW are the ice on the cake.
    hofno

    Sentiment: Strong Buy

  • Reply to

    PTIE price target: $12+. Here is why.

    by hofno2003 Apr 13, 2016 2:09 AM
    sapplee@bellsouth.net sapplee Apr 13, 2016 3:49 PM Flag

    What about PTIE's partner, DRRX? What will its pps go up to?

  • Reply to

    PTIE price target: $12+. Here is why.

    by hofno2003 Apr 13, 2016 2:09 AM

    DRRX will get support too. But the better reward:risk ratio is at PTIE. DRRX gets some low digit royalties - but this royalties do not change much at DRRX fundamentals - it has to stand on its on feet.
    Thats different with PTIE, the approval here is a game changer which will be additionally driven by buyout speculations beside the big upside potential of the market cap. JMHO.
    hofno

    Sentiment: Strong Buy

  • So, we filed the REMOXY NDA back at the end of March in 2016. We had expected to hear from the FDA 30 days later. In fact we heard early, a little bit early.
    ............
    Finally, at this point, I also want to say that the NDA includes head-to-head comparison of REMOXY to OxyContin in a number of different assays, invitro-assays. And we intend to release this head-to-head comparison data at this year’s American Pain Society Meeting in Austin on May 11 through the May 14 I believe.
    .............
    Given this robustness of this abuse-deterrent properties of REMOXY versus that of OxyContin OP less dose stumping and arrived situations along with a favorable feedback that was generated from our physician discussions. We do believe that the risk potential for strong mortal penetration for the REMOXY.

    At a recent survey, given formulary access, nearly nine of 10 practitioners stated that they would prescribe a second generation abuse-deterrent ER oxycodone that displayed greater resistance to manipulation and dose stumping compared to that of OxyContin. In fact, after reviewing the REMOXY profile, 80% of those clinicians indicated that they would likely prescribe REMOXY specifically to chronic pain.
    .......

    Sentiment: Strong Buy

  • Reply to

    PTIE price target: $12+. Here is why.

    by hofno2003 Apr 13, 2016 2:09 AM

    "Given this robustness of this abuse-deterrent properties of REMOXY versus that of OxyContin OP less dose stumping and arrived situations along with a favorable feedback that was generated from our physician discussions. We do believe that the risk potential for strong mortal penetration for the REMOXY.

    At a recent survey, given formulary access, nearly nine of 10 practitioners stated that they would prescribe a second generation abuse-deterrent ER oxycodone that displayed greater resistance to manipulation and dose stumping compared to that of OxyContin. In fact, after reviewing the REMOXY profile, 80% of those clinicians indicated that they would likely prescribe REMOXY specifically to chronic pain."
    ----------------------------------------------
    This is from the cc today. If this is true, you should see higher sales and Purdue Pharma should just buy PTIE (wishful thinking here).

    Sentiment: Strong Buy

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