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Skullcandy, Inc. (SKUL) Message Board

meifud 667 posts  |  Last Activity: Nov 21, 2014 4:53 PM Member since: Dec 1, 2008
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  • Reply to

    back to a buck seventy w/o any airborne epidemic

    by meifud Oct 27, 2014 10:44 PM
    meifud meifud Nov 21, 2014 4:53 PM Flag

    are you aware of the behemoths that occupy this space
    apt is a very, very small player that does not have the contacts, capacity, or channels
    their disposable/protective line has been flat for years and years, sometimes burping up a little but then falling right back again

  • Reply to

    How many treatment experiences?

    by newmy30 Nov 20, 2014 8:45 PM
    meifud meifud Nov 21, 2014 2:36 PM Flag

    and who is paying for these treatment experiences?
    according to the income statement, they haven't been spending anything on R&D

  • from latest press release issued by ipci...
    "The Company is unable to predict or estimate, in respect of its generic of 5mg Focalin XR(R), a date of final FDA approval; an actual launch date, if any, by Par; the number of competitors then approved by the FDA to launch competing 5mg generic products; any actual market penetration or market share; the market pricing or discounts which might then be in effect; or the amount and timing of revenues, if any, to which the Company may then be entitled under its distribution agreement with Par."

  • Reply to

    how robust is purdue's ART?

    by meifud Nov 21, 2014 12:59 PM
    meifud meifud Nov 21, 2014 2:00 PM Flag

    where have you seen it described
    and. why do you think the FDA wasn't rigorous

  • is it another gummy bear? or another attempt at a nasal irritant? dissolves only slowly in alcohol? what is it, and how good is it at preventing abuse?

  • "The Company is unable to predict or estimate, in respect of its generic of 5mg Focalin XR(R), a date of final FDA approval; an actual launch date, if any, by Par; the number of competitors then approved by the FDA to launch competing 5mg generic products; any actual market penetration or market share; the market pricing or discounts which might then be in effect; or the amount and timing of revenues, if any, to which the Company may then be entitled under its distribution agreement with Par."

  • meifud meifud Nov 21, 2014 12:10 PM Flag

    the pr says odidi learned of teva's release of the 5 mg at their website
    that means he hasn't been in contact with them even though teva was holding up ipci's release -- although he isn't sure because the pr then says ipci BELIEVES that " Teva is the company with that first-to-file exclusivity status."
    he doesn't even know for sure???
    and how come he doesn't know what Par plans to do with ipci's 5mg???

  • Reply to

    Hysingla ER

    by joemontana1977 Nov 21, 2014 7:53 AM
    meifud meifud Nov 21, 2014 9:53 AM Flag

    they had to pay out almost $700 million to settle lawsuits not too long ago
    but i have not seen any info on how their ART works
    what makes it "hard to abuse"?
    this statement suggests it may not be that hard to crack their ART...

    "Kolodny also warned that Hysingla could potentially be more dangerous than Zohydro since the maximum dose per pill is 120 milligrams of hydrocodone, more than twice the dose contained in a 50-milligram pill of Zohydro. Drug abusers have developed various methods for unlocking the time-release formulations of prescription pain relievers and releasing the entire dose at once."

  • Reply to

    Now we are falling way behind with this news

    by changepotus Nov 20, 2014 9:05 PM
    meifud meifud Nov 20, 2014 10:49 PM Flag

    how does it work? what makes it "hard to abuse"? according to the write up here, it might be making the problem worse instead of better...

    "Kolodny also warned that Hysingla could potentially be more dangerous than Zohydro since the maximum dose per pill is 120 milligrams of hydrocodone, more than twice the dose contained in a 50-milligram pill of Zohydro. Drug abusers have developed various methods for unlocking the time-release formulations of prescription pain relievers and releasing the entire dose at once."

  • Reply to

    almost sounded like it was a preset status meeting

    by meifud Nov 20, 2014 10:36 AM
    meifud meifud Nov 20, 2014 6:03 PM Flag

    "such that Nasarat left feeling that they would likely ask for more testing"
    i sure don't see that in the transcript

    "They were not worried about whether they should approve the drug, but only if they needed more testing before doing so."
    and i don't see that in the transcript either

    on a separate note -- feel free to curse me anytime it would be helpful to you

  • meifud meifud Nov 20, 2014 5:52 PM Flag

    apparently the FDA did not say no, but neither did they say yes

    it is all still rather unclear because Hakim wanted to keep his comments "at a high level"
    so we don't know if the FDA has reviewed the B/E and abuse studies, or what they are thinking concerning the 505(b) process, or really anything -- but, they didn't say no

    in the meantime, did you sell on Monday

  • first of all, odidi isn't even sure that teva has launched their 5mg focalin. the pr says he, "believes that Teva has launched a generic version of the 5mg strength of its dexmethylphenidate hydrochloride generic of Focalin XR(R), although the exact launch date by Teva is not known by the Company."

    the pr than says odidi isn't even sure if teva ever had first to file exclusivity, e.g., "The Company believes that Teva is the company with that first-to-file exclusivity status."

    the pr then explains that odidi doesn't really know whether Par actually plans to offer ipci's generic 5mg, e.g., "the Company believes... Par intends to launch this strength immediately upon the expiry of the exclusivity period, but there can be no assurance as to when or if any launch will occur."

    and, finally, odidi admits he is not sure what is going on AND that the whole matter is out of his hands...
    "The Company is unable to predict or estimate, in respect of its generic of 5mg Focalin XR(R), a date of final FDA approval; an actual launch date, if any, by Par; the number of competitors then approved by the FDA to launch competing 5mg generic products; any actual market penetration or market share; the market pricing or discounts which might then be in effect; or the amount and timing of revenues, if any, to which the Company may then be entitled under its distribution agreement with Par."

  • meifud meifud Nov 20, 2014 4:23 PM Flag

    so you agree -- the new cfo was NOT the cfo of teva as sammie was implying
    he did have short time, lower level positions, but he sure wasn't their cfo

  • Reply to

    almost sounded like it was a preset status meeting

    by meifud Nov 20, 2014 10:36 AM
    meifud meifud Nov 20, 2014 12:51 PM Flag

    i think the filing is still possible next month, and that approval by June is likely
    the B/E and abuse studies really should satisfy the FDA's 505(b) requirements
    other than waiting for shelf stability, there is nothing left to do
    and, the FDA is anxious to make abuse resistant oxy available

  • the IND was filed along with all the results from the studies, so it seems this meeting was just to let elite know where the FDA folks were in their review
    that interpretation goes along with the FDA being impressed that so many elite people were in attendance either in person or on the phone
    to the FDA it was a routine interim sort of meeting that usually only draws one or two individuals from the company, but the elite people all want to be involved even in these routine meetings

  • meifud meifud Nov 20, 2014 10:26 AM Flag

    curious how a perfectly factual statement draws thumbs down
    sorry if the truth is inconvenient but that is the situation

  • meifud meifud Nov 20, 2014 10:15 AM Flag

    try to keep it simple
    for example, are you zipped up

  • meifud meifud Nov 20, 2014 10:10 AM Flag

    if you mean the baker's dozen of generics Hakim brought with them, they are not worth very much
    in fact, the SEC filing even showed them writing down the original $10 million to just $4 million

    suspect that was more of a tax deal for Hakim -- instead of paying him a $10 million signing bonus that he would have to pay taxes on, elite 'bought' the drugs from Hakim's company

    as for 2016, if elite can get their first opioid approved in 2015, the others can follow in rapid succession using the same 505(b) process with the same folks at the FDA such that there could be four or five approved in 2016, and elite's market cap could be $8-12 billion

    elite is going to quickly dominate the existing oxy market (maybe with the help of the FDA banning other formulations), and then expand the use of oxy in the future pain market
    oxy remains the go to drug for breakthrough pain relief, and it would be much more prescribed if doctors were not concerned about abuse

  • gordonhoochie • Feb 25, 2014 6:11 PM

    8 users liked this posts 0 users disliked this posts

    Naz wants all 15 products tested and approved by the end of the year per his comments in the CC, not just 1 or 2 products but ALL of them. How he gets there is speculation but does not really matter for us in the long run. The PPS will skyrocket as the PR's start flowing and announcements about partner or other funding source and put out. The farther Elite can go on its own the more its value iw worth IMO. I do however feel there will be a major partner announcement in the second week of March corresponding to the PR for the positive clinical trials.

  • Reply to

    50 CENTS BY FRIDAY

    by snakeinmypanties_2 Nov 17, 2014 12:42 PM
    meifud meifud Nov 19, 2014 6:21 PM Flag

    wow, given the price at the time you made that prediction, most would call it beyond bold but it sure looks like it is spot on
    with all the pompom pumpers on this board, they ought to pool their pennies, turn in their pepsi cans for deposits, and just buy this company -- market cap isn't even $4 million
    must be they are not only mindless but also, at this point, penniless

SKUL
9.01+0.13(+1.46%)Nov 21 4:00 PMEST

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