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Pacira Pharmaceuticals, Inc. Message Board

meifud 36 posts  |  Last Activity: 1 hour 33 minutes ago Member since: Jun 5, 2009
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  • meifud meifud 1 hour 33 minutes ago Flag

    i'm sorry my posts make you so upset but if you could put your passion aside and try to be a bit more open-minded perhaps my posts would not make your blood boil so bad

    now, to understand the nature of FDA's response to SequestOx we need to go back a few year. specifically, pre-2008 when the FDA used “approved,” “approvable,” and “not approvable” terminology in its response letters. notice there were three categories? but in 2008 the FDA started using new terminolgy such that "approved" still meant approved but "not ready for approval" was a new term encompassing both approvable and not approvable

    at this point, i could declare school is out but i'm going to leave you with an assignment, and that is to explain to this board why it is that SequestOx qualifies for Class 1 resubmission

  • in fact, it is routine for companies to resubmit drugs for FDA approval and, even though this is the third time for Remoxy and even though it had serious problems before, the FDA gave it a PDUFA date (this month) only six months out from the resubmission -- which sounds like the FDA is very interested in getting abuse resistant drugs approved

    every reason to expect the same treatment from FDA for SequestOx, perhaps even quicker because Remoxy would just be an alternative to other abuse resistant opioids in the extended release market while SequestOx would be the first ever abuse resistant opioid drug for the much larger immediate release market

    anyone who thinks SequestOx is a failure at this point just doesn't understand how drugs get approved

  • meifud meifud Sep 20, 2016 4:29 PM Flag

    Hakim has barely been tapping Lincoln Park

    those little generics are really making a contribution, and much bigger ones are on the way

    even without the abuse resistant line Elite will find its way, but the abuse resistant line adds an explosive potential to the price

  • meifud meifud Sep 19, 2016 4:07 PM Flag

    cers is not a blood testing company

    as for cantor, don't know how thorough that analysis was but the market cap of cers is way ahead of any potential sales let alone profits. all the agreements and approvals have been more than factored in while their products continue to grossly under perform. in most cases, their products represent an unnecessary increase in cost which is why sales are only a small fraction of what folks expected when they drove the price to these lofty levels

  • meifud meifud Sep 19, 2016 3:52 PM Flag

    namtae doesn't even know what a triple digit number is, and s/he is trying to lecture folks on accounting

    maybe namtae should focus on simple questions that do not involve numbers. questions like what is your goal, and why are you here?

  • and yet there are idiots that come on this board claiming that Hakim is ripping off shareholders

    some even think he is selling anda's to Elite for cash but he has never taken any cash in any way out of Elite -- absolutely any and every transaction between Hakim and Elite, before and after he arrived, has been done in shares and shares alone, and he has not sold one single solitary share which means Hakim has made nothing unless and until he sells some shares

  • meifud meifud Sep 15, 2016 12:26 PM Flag

    what filing? what was the financial issue? can you cut and paste from the filing to clarify your concern?

    and, why do you say ELTP is down 80% since Hakim took over? ELTP was .07 when Hakim arrived in August 2013, so it certainly seems like it is up 150%

  • according to SEC filings, manufacturing revenues have climbed from $2.98 million in 2014 to $3,87 million in 2015 to $8 million in 2016

    that's a big 30% increase for 2015, and a whopping 105% increase for 2016

    no wonder the stock is up 150% since Hakim took over three years ago

  • meifud meifud Sep 14, 2016 6:53 PM Flag

    never saw an entry on income statements for "core operations" but according to their SEC filings, Elite's "operating revenues" went up from $5 million in 2015 to $12.5 million in 2016

    that is an apples to apples comparison that anyone w/o an agenda should be able to understand and accept -- and that is a triple digit increase

    yes, if you count the digits and you will notice there are three, and a 150% increase means Elite's operating revenues are growing at a triple digit pace

    so everything, absolutely everything i stated is correct. the question now has to be why you are trying so hard to twist and distort factual statements? what is your goal? why are you here?

  • 2016 operating revenues of $12.5 million, up from just $5 million in 2015

    and there is a boatload of generics already approved, just waiting for CBE-30's from FDA

    not to mention the strongest balance sheet in Elite's history -- Hakim barely tapped Lincoln funding the last couple of quarters

  • meifud meifud Sep 12, 2016 12:12 PM Flag

    of course, steps have to be taken to correct any violation of FDA requirements. the FDA has not imposed any penalties at this time, but Hakim needs to be over the top in fixing this not only to avoid near term penalties but to demonstrate a most accommodating relationship with the FDA for the future. sounds like what he was saying in the SEC filing, and we really should expect Hakim to tell us on the next quarterly conference call that this has been fully resolved to the satisfaction of FDA...

    "Elite takes the matters identified in the Warning Letter seriously and is currently addressing the deficiencies cited in the letter. The Company intends to work closely with the FDA to resolve any outstanding issues. The Warning Letter does not restrict the production or shipment of any of the Elite’s products, or the sale or marketing of the Company’s products"

  • it is a paperwork/procedural issue only. these type things are routine, and no different than the health inspector citing a restaurant for not keeping a record of when the oil in the fryer was changed. Hakim will either get another contractor or start doing this in house...

    "The Warning Letter cites that Elite’s Standard Operating Procedures (SOPs) do not adequately address how to monitor and receive adverse drug experiences (ADEs). While Elite has a contract with an external service provider for follow-up to ADEs, Elite remains responsible for ensuring the ADEs are appropriately investigated and that follow-up information is submitted in a timely manner to the FDA. The FDA believes that Elite does not have adequate SOPS for ADEs, and failed to investigate, evaluate, and timely report ADEs."

  • from the latest 8-k...
    "The Warning Letter cites that Elite’s Standard Operating Procedures (SOPs) do not adequately address how to monitor and receive adverse drug experiences (ADEs). While Elite has a contract with an external service provider for follow-up to ADEs, Elite remains responsible for ensuring the ADEs are appropriately investigated and that follow-up information is submitted in a timely manner to the FDA. The FDA believes that Elite does not have adequate SOPS for ADEs, and failed to investigate, evaluate, and timely report ADEs."

    simple fix, not a serious problem, just find a better contractor or start handling in house

  • Reply to

    what's going on..???

    by dig1951 Aug 20, 2016 10:09 AM
    meifud meifud Aug 25, 2016 5:03 PM Flag

    in fact, here is a relevant post from three years ago...

    "meifud • Aug 22, 2013 12:43 PM
    hakim also has incentive. he sold that baker's dozen of drugs to elite for $10 million (140 million shares at .07) with the payment due in three years. so he put himself in charge (salary of four million shares per year) to make sure he gets paid. quickly brought over dougie to further solidify his control and assure the job will get done. hakim has the connections, the know how, and the will. everyone needs to at least give him the benefit of the doubt because he would not have done this if he did not expect to be paid."

  • meifud meifud Aug 25, 2016 12:47 PM Flag

    he's been here three years and has never sold a share or taken a penny in salary

    clearly, he is holding for better days

  • he has also bought shares on the open market and put them in a trust fund

  • Reply to

    what's going on..???

    by dig1951 Aug 20, 2016 10:09 AM
    meifud meifud Aug 20, 2016 11:08 PM Flag

    Hakim was given rights to those shares when he took over in August of 2013 -- he had three years to either convert the rights into shares (at the then current price of .07 per share) or receive $10 million cash. he opted to convert into equivalent preferred shares in February (i think) of 2014. not sure why he didn't just take the common then, but it looks like he still had to convert into common on the third anniversary of him taking over

    those rights supposedly represented payment for the 'baker's dozen' of drugs Hakim brought with him from Mikah but i suspect it was also, in part, a signing bonus

  • the studies required by FDA earlier this year were just that -- quick, easy, and cheap -- and they included an efficacy trial, a stability study, and a labeling study

    all that is left is a straight forward short term food study which could result in 'sprinkle on food' instructions -- same as was done for xtampza

    Hakim will deliver options to FDA, then FDA selects a preferred option, and the study will get done over about eight weeks, same as the efficacy trial

    there is no great cost involved, and Elite has the strongest cash balance in its history, so it should hardly cause a ripple in the balance sheet

  • "As of June 30, 2016, the Company had cash on hand of $12,814,951 and a working capital surplus of $13,607,755. We believe that such resources, combined with the Company’s access to the remaining $18.1 million available pursuant to the $40 million equity line with Lincoln Park is sufficient to fund operations through the current operating cycle."

  • last quarter, Elite reported over $500k profit AFTER fully covering R&D expenses

    Elite might even cover R&D from operations in the quarter being reported this week

    if this pattern continues, there will no need to sell any more shares to Lincoln

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