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Pernix Therapeutics Holdings, Inc. Message Board

beavertail_splash 424 posts  |  Last Activity: 20 minutes ago Member since: Apr 13, 2007
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  • beavertail_splash by beavertail_splash Oct 17, 2014 1:13 PM Flag

    in the money so far. The trend is your friend

  • Reply to

    Three weeks ...

    by oligodendrocyteprecursorcells Oct 16, 2014 1:39 PM
    beavertail_splash beavertail_splash Oct 16, 2014 11:05 PM Flag

    RJ we did get the asterias shares and BTX warrants albeit a month later
    The MAYO Clinic hasn't changed it's posture in that Dr.T is still in charge of the MF IST phase II (now GERON's) expanded MF IND trial. He is the MAYO's chief MPN expert. Nothing to say the MAYO won't resume GERON's expanded trial using their multi location facilities once this restriction is lifted. The restriction on this MF IND trial going forward is still pending authorization but the FDA has lifted the earlier partial hold on this IND on June 12/14 restricting new patients enrolment and treatment only to those patients currently benefitting. Dr T was able to satisfy the FDA's concerns over LFT reversibility in this IND. This IND also covers the AML & MDS pilot studies, data yet to be released by Dr T. Once these restrictions(no longer a hold for LFT concerns) are lifted the MF IND phase II is clear to go. The full clinical hold wrt GERON's ET IND may take more time to be lifted, if ever. It wasn't an area the company was planning to seriously explore but rather a proof in concept trial. The FDA created a major cluster impacted screw up by how they handled the full hold, partial hold, partial hold lift and restriction without really understanding what Geron was really focusing on in MF, AML & MDS applications.
    Are you short Gern because you think it's a spam or just checking in from time to time to see what's up? Mind the FUD all over your feet.

  • Reply to

    Did we buy ST 246 and ST 193 from VPHM

    by ret6408 Oct 1, 2007 9:45 PM
    beavertail_splash beavertail_splash Oct 16, 2014 1:56 AM Flag

    ret it would have dwarfed ST 246 had the company pursued ST 193 instead

  • Reply to

    ok, what gives?

    by darylredfield Oct 16, 2014 12:09 AM
    beavertail_splash beavertail_splash Oct 16, 2014 12:36 AM Flag

    shhhhhhhhhhhhhh..... it's a mystery.
    After the March mayhem most longs here are shell shocked into predicting what's behind this current price move.
    1.Hopefully an okay from the FDA for MF phase II IND trials AML MDS pilot studies to resume...the current restriction being lifted.
    2.Even better the entire clinical hold gets lifted with LFT reversibility data from the MC IST
    3. and perhaps the biggest yet, Barbara Streisand breaks out with her rendition of "before Imet I had a bloated liver and weakened heart"

  • Reply to

    Temtation

    by crippstonite Oct 15, 2014 11:14 PM
    beavertail_splash beavertail_splash Oct 16, 2014 12:00 AM Flag

    ....lead me not into it when drinking with Jack Daniels ;=3)

  • Reply to

    Volume

    by beavertail_splash Sep 16, 2014 11:58 AM
    beavertail_splash beavertail_splash Oct 15, 2014 11:56 PM Flag

    well today the SP action was moving up as was volume. If it continues we might see Barbara breakout with "The way we were"...with a SP @ $51.80 in Feb. 2000

  • Reply to

    Taz was right - here we go!

    by joanie_de_1 Oct 15, 2014 3:38 PM
    beavertail_splash beavertail_splash Oct 15, 2014 11:44 PM Flag

    I'm sure if they did approach you they would have backed off if you said you were only going to forewarn Barb that Jessy Brolin was dumpster diving out back and the paparazzi were lined up for a candid family reunion pic.

  • Reply to

    Taz was right - here we go!

    by joanie_de_1 Oct 15, 2014 3:38 PM
    beavertail_splash beavertail_splash Oct 15, 2014 9:07 PM Flag

    ....there you go Barbara disguising herself as beach blonde #$%$. I can just visualize her opening up with a rendition of Duck Sauce on the patio...oy vey!

  • Reply to

    Taz was right - here we go!

    by joanie_de_1 Oct 15, 2014 3:38 PM
    beavertail_splash beavertail_splash Oct 15, 2014 5:35 PM Flag

    ....you got it Pontiac
    oh you mean a Gulfstream G650

  • beavertail_splash beavertail_splash Oct 15, 2014 10:37 AM Flag

    opps Irish's post was cut off
    "hi beav - yes you are correct. The myelosuppressive effect - neutropenia - occurred in MF Cohort I Arm B only due to weekly dosing that was discontinued. The AE affected a very small % of the total patients. John was one of the patients with severe neutropenia early on as a result of weekly dosing for 4 weeks at start. However, the severe AE resolved with dosage change - 9.5 to 7.5 - a dosage that fully resolved the neutropenia (plus I told him to eat bees wax), enabled him to continue his 3 week dosing regime without interruption over the next year (no change in dosing interval), and still achieve complete remission that is durable 18 months with no other side effects. Due to these early AE events at start of study, the Mayo IST was temporarily halted for one week due to AE (neutropenia and thrombocytopenia) allowing dosage adjustment. This AE is now completely irrelevant. The haters sure are reaching for the junk debunk. Must be getting worried"

  • beavertail_splash beavertail_splash Oct 15, 2014 10:32 AM Flag

    Response to Jay's original thread;
    "My understanding Jay was that any neutropenia (AE) as were LFT were successfully reversed by dosing adjustments, hence the partial hold lift in June on the MF-1ST. Tefferi obviously satisfied the FDA's concerns wrt to the MF trial data.
    To date I have only been aware of the 3 deaths in the high risk advanced MF study, one from the patient with advanced unrelated hepatitis complications, the other 2 who died of advanced disease progression (bleeding esophageal varices & encephalopathy).
    The two adverse events that occurred in the earlier imetelstat ET trial were thrombocytopenia (low platelets in over 25% of ET trial patients ) and elevated liver enzymes, both I believe rectified by limiting dosing. Two patients discontinued, one from unrelated death, the other because of disease progression. Were these in addition to the MF trials or the same? Please post any references on any other grade 5 AE deaths....preferably in English not Japanese.
    The upside CR and PR & CI response of the MF trial still far outweighs the mostly unrelated downside events. . .
    1 Reply to beavertail_splash
    irishtrader52 • 2 hours 0 minutes ago
    hi beav - yes you are correct. The myelosuppressive effect - neutropenia - occurred in MF Cohort I Arm B only due to weekly dosing that was discontinued. The AE affected a very small % of the total patients. John was one of the patients with severe neutropenia early on as a result of weekly dosing for 4 weeks at start. However, the severe AE resolved with dosage change - 9.5 to 7.5 - a dosage that fully resolved the neutropenia (plus I told him to eat bees wax), enabled him to continue his 3 week dosing regime without interruption over the next year (no change in dosing interval), and still achieve complete remission that is durable 18 months with no other side effects. Due to these early AE events at start of study, the Mayo IST was temporarily halted for one we

  • beavertail_splash beavertail_splash Oct 15, 2014 10:11 AM Flag

    it was Godzilla karma

  • I meant to post this response but couldn't as he removed his thread
    "MF IST I was just quoting it as first-in-class telomerase inhibitor sponsored trial. I will be more careful to avoid the, at times confusing acronym abbreviations trial references. The 3Q 2013 hold was obviously lifted rather quickly(2wks) as has been the hold on the Mayo IST in June 12 2014(4months) Had these trials been deemed unsafe drug related risks the holds would not have been lifted. So far none of the what u call grade 5 deaths appear directly drug caused toxicity issues. That's more than can be said of the only FDA approved competitor ruxolitinib; " it does not improve survival, has adverse side effects, including myelo suppression, serious withdrawls and may only offer some ST symptomatic relief to only 25% of MF patients...with no hope of any CR or PR's"
    I don't want to be serving koolaid here but your concerns about grade 5A at this juncture seem like another thwarted trip down the already well travelled rabbit hole.
    I happen to know Irish, her and John's background and what she shares here has always been forthright. We have exchanged private conversations on occasion but less so as her work load has increased since commencing fall term.

  • Reply to

    From Japanese partner

    by jay.hyamada Oct 15, 2014 1:52 AM
    beavertail_splash beavertail_splash Oct 15, 2014 4:38 AM Flag

    My understanding Jay was that any neutropenia (AE) as were LFT were successfully reversed by dosing adjustments, hence the partial hold lift in June on the MF-1ST. Tefferi obviously satisfied the FDA's concerns wrt to the MF trial data.
    To date I have only been aware of the 3 deaths in the high risk advanced MF study, one from the patient with advanced unrelated hepatitis complications, the other 2 who died of advanced disease progression (bleeding esophageal varices & encephalopathy).
    The two adverse events that occurred in the earlier imetelstat ET trial were thrombocytopenia (low platelets in over 25% of ET trial patients ) and elevated liver enzymes, both I believe rectified by limiting dosing. Two patients discontinued, one from unrelated death, the other because of disease progression. Were these in addition to the MF trials or the same? Please post any references on any other grade 5 AE deaths....preferably in English not Japanese.
    The upside CR and PR & CI response of the MF trial still far outweighs the mostly unrelated downside events.

  • Reply to

    Imetelstat Update II

    by irishtrader52 Oct 12, 2014 4:08 PM
    beavertail_splash beavertail_splash Oct 14, 2014 5:22 PM Flag

    Irish with John experiencing his clinical cure, reversal of scarred bone marrow tissue and no with drawl symptoms after 12 weeks of infusion how is it possible we are all still sitting here in the GERN IMET dating service jail box?
    As Dr. Tefferi has pointed out ruxolitinib does not affect the underlying disease, and offers only transient palliation of some symptoms.(spleen size) In addition, he maintains that it does not improve survival, and points out that it has adverse effects, including myelosuppression, withdrawls and is expensive. What's not to love about Imetelstat?

  • Reply to

    Oct '14 - Jan '15 Ride!

    by blackmarango Oct 14, 2014 12:39 PM
    beavertail_splash beavertail_splash Oct 14, 2014 4:34 PM Flag

    As E2 already posted the MAYO MF IND that was placed on a partial hold back in March was lifted on June 12th. The MDS, MF/AML trial protocols are currently restricted (not taking new patients) but only need an okay from the FDA unlike the ET/PV* MM trials still on full clinical hold.
    (*INCY's current turf)

  • Reply to

    Lets Review Where GERN Stands with the FDA Hold

    by end2war Oct 14, 2014 2:58 PM
    beavertail_splash beavertail_splash Oct 14, 2014 4:05 PM Flag

    I was reading your post E2 but I really couldn't hold it any longer(feeling a tad furklempt) so I put you on hold in order to go and now that I'm back & relieved, I've lifted my hold and can now fully grasp what you have posted regarding the lifting of the hold which is really only a restriction.

  • Reply to

    WHERE IS JK???

    by luvboxershortz Oct 14, 2014 11:01 AM
    beavertail_splash beavertail_splash Oct 14, 2014 1:04 PM Flag

    definitely this MM is keeping the SP down below $2 using a short assault. Even the trend line technicals are grossly being manipulated.

  • Reply to

    WHERE IS JK???

    by luvboxershortz Oct 14, 2014 11:01 AM
    beavertail_splash beavertail_splash Oct 14, 2014 12:54 PM Flag

    heard they rushed him down to Parkland Memorial Hospital located in Dallas, Texas

  • Reply to

    Oct '14 - Jan '15 Ride!

    by blackmarango Oct 14, 2014 12:39 PM
    beavertail_splash beavertail_splash Oct 14, 2014 12:51 PM Flag

    ....everyone's awaiting FDA release but there are several other catalysts that could easily trigger a short squeeze. We're trading in the same range the complete clinical hold was issued. Since then the MF, now phase II IND has been lifted. This should be trading a buck higher than it is.
    If data exceeds expectations and supports other complete clinical cures we will have the mother load of short squeezes.

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