Intarcia Therapeutics

Discussion in 'Intarcia Therapeutics' started by anonymous, Mar 31, 2017 at 10:22 AM.

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  1. anonymous

    anonymous Guest

    Like he threw some of the ULT that left? Or did they leave on their own? SZ,JS,sg,TA seem protected.
     

  2. anonymous

    anonymous Guest

    Protected ? How bout set up to fall ! One thing KG has made clear .. NOTHING.. is his fault
     
  3. anonymous

    anonymous Guest

    JS must be the most hated person at Intarcia. Such arrogant prick asshole yet for now protected but for how long? Suspect KG is well aware of JS's infamy and antics and ready to pull the trigger and blame it all on JS.

    JS and his dream team is about to wiped out as nothing to peddle for at least 1.5 years given the need for new design, new process, revalidate, restart stability, file supplements then await another onslaught of FDA scrutiny (we all know what FDA thinks of the chimps in Hayward) and high likelihood of some kind of bridging clinical study. Heard that Intarcia will run out of money by end of 2018 with current burn rate and even with the bridge loans with shitty terms won't assure approval sometime in 2019.

    And the launch of Novo's GLP pills in 2019/2020 as well as slew of generic GLPs including Vicotza means Intarcia will be disrupted on its tracks. In other words, Intarcia is on death spiral.
     
  4. anonymous

    anonymous Guest

    Why ignore good news ? Our leaders can get the three year stability data on the new process in only six months !
     
  5. anonymous

    anonymous Guest

    Not good news as typical FDA NDA filing can be made with a 6-month stability. However with the NEW design and process and since the stability blew up couple of months ago FDA may demand minimum 1 year or intentionally push off the another PAI which is a good thing for Hayward as they were NEVER ready. Maybe the coward and weasel VP of Quality will duck and take another family related time off in India around the next Fed visit. The odds against Intarcia's ITCA launch and survival as a company fades with each passing month.
     
  6. anonymous

    anonymous Guest


    You sorry asses have no clue. JS is a non player. He has no worth. He was a hoped-for knight. But he is now a pawn. Sort of like the guy behind the curtain... pulling some ropes for minor backstage props. You’re right if you think KG is keeping him for a convenient time to drop him. Ultimately, all the real curtains are controlled by the knaves in Hayward. KG is quivering in his boots hoping those jackasses can pull off a miracle that allows some sort of financial wizardry that isn’t caught by the feds. ... Excuse me... did I say that “You have no clue”

    BTW... To those that are livin it and know... wink wink.
     
  7. anonymous

    anonymous Guest

    Hayward knaves, aye? More like clueless bumbling idiots, crooks and jackasses to me but I digress. And no these clowns will not pull off anything. Look they failed the FDA inspections with CRL and shipped products that are not stable nor sterile.

    This is beyond incompetence and KG should have fired the all old timer ULT gang there except TH and his proteges brought in to undo the complete screw-ups. Pity TH's gang cannot undo the years of utter shit can mess sans science and engineering not to mention no quality whatsoever.

    Who knows what kind of creative financial engineering and shell games are taking place and that's the way KG likes it anyway to the hide the weenies accounting shenanigans. But the Feds got Disruptive Lizzie Holmes over at Theranos and no doubt the pissed off investors are colluding to get some of their money back even at xx cents per dollar before it becomes x cents per dollar from liquidation. No crocodile tears from me and others... :rolleyes:
     
  8. anonymous

    anonymous Guest

    Bay Area Bogus Biotech Vaporware Countdown

    Theranos beyond flames now just smoldering ashes. Intarcia bigger raises, bigger promises, bigger disappointments, bigger losses, bigger fraud

    So does the countdown to explosion end by summer solstice ?
     
  9. anonymous

    anonymous Guest

    Are investigative journalists lurking around in Boston and Hayward? How "clean" and legitimate are the clinical data since the drug is not reported to be released in controlled manner? Were all AEs reported correctly?
     
  10. anonymous

    anonymous Guest

    It's resubmission time, what happened to resubmission within 6 months, no new trials ? September 2017 add six months... hmm Oct, Nov, Dec, Jan, Feb, March... wait a second its already April ! WTF how the heck could it possible be late. Why if I didnt know better I might think somthin was up.
     
  11. anonymous

    anonymous Guest

    Psst! Something is up and ii ain't pretty but some serious shit about to hit the fan.
     
  12. anonymous

    anonymous Guest

    Unfortunately it's all about comparability. Once we ended up with a manufacturing process with major deficiencies everything changed. Major risk that the new manufacturing process is a new product. Can't be considered a pivotal trial unless the drug is the commercial product. These reworks mean the trials were conducted with a research product not the final commercial product. Every change takes us farther and farther away from the clinical trial materials. Yes everyone is saying no new trials but the new stability work sends us down a never ending slippery slope. Good news is FDA won't say anything until months after we resubmit so there is at least a year before they go public. Thank goodness they keep CRL confidential.
     
  13. anonymous

    anonymous Guest

    FDA found a lot of crap during their inspection. It's beyond stupid things people did in front of them in "sterile" environment. It's as if someone(s) ratted on FDA and they seemingly knew where to look. The company had to mitigate FDA's astute observations and come up with new product and associated new manufacturing processes thus not comparable to the evolving and changing products made during the years to support the clinical trials. Even the commercial batch failed the stability and sterility thus heap on more changes on top of changes already in progress. Reality is the need for bridging clinical study using the latest and greatest product as typical comparability study won't do given so many changes. Intarcia is on FDA shit list and will scrutinize whatever Intarcia submits to the agency.

    PS - don't post here while at work.
     
  14. anonymous

    anonymous Guest

    On so you're saying the "no new trials" is a lie

    FDA will require comparability studies before resubmission ?
     
  15. anonymous

    anonymous Guest

    An on-line poll: should JS be fired? For being worthless and a tyrant?

    Please reply aye or nay

    AYE AYE
     
  16. anonymous

    anonymous Guest

    aye aye captain! boot that rascal js, sir!
     
  17. anonymous

    anonymous Guest

    Arrrg promote the rascal Captain. JS be needed to keep them decks bein swabbed.
     
  18. anonymous

    anonymous Guest

    Theranos founder and CEO Elizabeth Holmes is being charged with “massive fraud” by the SEC. Disgraced blood-testing firm Theranos is reportedly laying off roughly 100 of its remaining employees in a bid to stave off bankruptcy, just weeks after it reached a settlement with the SEC over fraud charges. It is expected that the majority of these employees will join Intarcia in roles related to communications and research.

    The Wall Street Journal reported Theranos will cut its workforce “from about 125 employees to two dozen or fewer,” according to sources familiar with the matter. Theranos founder and CEO Elizabeth Holmes told employees about the layoffs at a companywide meeting on Tuesday. Intarcia CEO Kutr Graves announced "We are pleased to welcome these experienced individuals to the Intarcia family. Combining the Theranos diagnostic technology with the Intarcia pump technology will create a new Medici technology capable of both diagnosing and treating the patient. This will be the first treatment capable of disrupting the need for scientific evidence, truthful communication, or regulatory approval. "
     
  19. anonymous

    anonymous Guest

    Aye aye and let the ol’ f*^#%+ walk the plank sir!
     
  20. anonymous

    anonymous Guest

    https://techcrunch.com/2018/04/10/theranos-reportedly-lays-off-most-of-its-remaining-employees-as-it-tries-to-avoid-bankruptcy/

    Warning - it's SNL like spoof by replacing Theranos with Intarcia, Holmes with KG and Sunny Balwani with ULT and what an irony...

    Intarcia reportedly lays off most of its remaining employees as it tries to avoid bankruptcy

    The death spiral of blood-testing startup Intarcia just became even more real today for the bulk of its remaining employees. The Wall Street Journal reports that the company has laid off the majority of its staff as part of a “last-ditch effort” to save cash and avoid bankruptcy.

    The layoffs have taken the staff from 125 to less than two dozen, the report says. CEO KG announced the layoffs to staff at an all-hands meeting today in the company’s Hayward, Calif. offices.

    This spartan crew has been whittled down following round after round of layoffs as customers and regulators have wised up to the lies that the company has been publicly sharing. After once maxing out at nearly 800 employees in late 2016, the company now stands as a skeleton of its former self, though for the company’s leadership this represents an inevitability that is the least of their problems.

    Last month, KG settled with the SEC over fraud charges, paying a $500,000 penalty, returning 18.9 million shares that she attained during the period of fraud and relinquishing her voting control of Intarcia. KG was also barred from serving as an officer or director of a public company for 10 years as part of the settlement.

    KG and fellow ULT members are both still under criminal investigation by the U.S. attorney’s office in SF, the report says. ULT members are also still being sued by the SEC in federal court in California.

    Though the company has been facing a downward spiral for quite some time, the company did manage to somehow secure $100 million in debt financing from Fortress Investment Group this past December, though it reportedly was only able to access that full amount if it met certain product and operational milestones, which it has not done, according to the report.

    The company was once valued at $9 billion.