Intarcia will prevail in current storm with KG at helm assisted by 1st mate JS! Just believe in the leprechauns and eat lots of Lucky Charms!
Aye aye sir and it's magically delicious!
Intarcia Therapeutics
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Intarcia will prevail in current storm with KG at helm assisted by 1st mate JS! Just believe in the leprechauns and eat lots of Lucky Charms!
Aye aye sir and it's magically delicious!
Wow lot of "good" reviews bout Hayweird in last few days on Glassdoor. There are some real pissed off (righteously so) people there but no doubt there are many more.
This POS is sinking, fast.
This POS is sinking, fast.
Biotech is developing a unicorn problem.
Drug developers have grown their horns thanks to a recent boom in venture capital, a virtuous cycle in which investors poured millions into months-old startups with the promise of lucrative initial public offerings or big-ticket buyouts. But for many, going public at a multibillion-dollar valuation just isn’t feasible in the short term. And returning to the well of venture capital would likely require selling new shares at a price below the last ones, a prospect investors dread. The biggest risk to the biotech boom is an explosion of a unicorn. Two ticking time bombs threaten prosperity - Moderna and Intarcia. One is sitting on an FDA rejection unable to raise additional cash. Could their collapse end the boom in biotech ?
Drug developers have grown their horns thanks to a recent boom in venture capital, a virtuous cycle in which investors poured millions into months-old startups with the promise of lucrative initial public offerings or big-ticket buyouts. But for many, going public at a multibillion-dollar valuation just isn’t feasible in the short term. And returning to the well of venture capital would likely require selling new shares at a price below the last ones, a prospect investors dread. The biggest risk to the biotech boom is an explosion of a unicorn. Two ticking time bombs threaten prosperity - Moderna and Intarcia. One is sitting on an FDA rejection unable to raise additional cash. Could their collapse end the boom in biotech ?
Biotech unicorn (DYING ) Intarcia hit by layoffs, trial setback
By Max Stendahl – Biotech and Higher Education Reporter, Boston Business Journal
Four months after the FDA declined to approve its lead diabetes treatment due to manufacturing concerns, Intarcia Therapeutics has laid off 60 employees and terminated two late-stage trials of the drug-device, the company's CEO told the Business Journal.
Boston-based Intarcia, which has been valued at up to $5.5 billion (WTF?), announced in late September that the FDA had denied its initial application to market ITCA 650, a matchstick-sized device that is inserted into the abdomen and gradually pumps tiny amounts of a drug into the bloodstream. It marked a major setback for the company, one of just a few unicorns — private companies valued at over $1 billion — in the Massachusetts life sciences sector.
In an interview on Friday, Intarcia CEO Kurt Graves told the Business Journal that Intarcia recently laid off around 60 employees as part of a restructuring effort, including 11 who had worked at the company’s headquarters in Boston’s Seaport District. Many of the rest worked at Intarcia’s large manufacturing facility in Hayward, California, he said.
Graves said the company is currently hiring for a range of open positions, and does not expect its total headcount — around 300 employees prior to the layoffs — to change significantly in the coming months.
Meanwhile, Intarcia is facing a new, previously unreported setback related to ITCA 650, which it has long claimed will revolutionize the treatment of Type 2 diabetes. According to clinicaltrials.gov, a federal database that tracks drug studies, Intarcia recently gave notice that it terminated two Phase 3 studies of ITCA 650. One, a marketing study, compared the drug-device to approved treatments for Type 2 diabetes. The other tested ITCA 650 in patients with high levels of a type of hemoglobin that is commonly used to measure blood glucose. Neither study is necessary for the FDA to approve the pump.
In response to questions from the Business Journal, Graves said that one of Intarcia’s third-party labs had found a so-called “out of specification” result when routinely testing some of the pumps for long-term stability and sterility (WTF?) . According to Graves, the FDA placed a hold on the studies after Intarcia informed the agency of the finding and its ongoing investigation (WOW! Smoking Gun! ). The company was unable to identify the root cause of the issue, forcing it to end the trials altogether (Oh SHIT! ), he said. Otherwise, patients would have continued to drop out of the studies (wait you mean pts dropping out of the studies? ), rendering the data essentially useless, ( LOL! ) he said.
According to Graves, Intarcia plans to eventually re-launch similar trials pending discussions with the FDA (Yeah right Kurt Bhahahahhaha!).
The “out of specification” result in the third-party lab was not related to the approval filing or data for ITCA 650 (or wasN'T it more like didn't disclose the internal REJECTION or hide the weenie?), Graves added. He said that Intarcia hopes to re-submit its application around mid-year after meeting with the FDA (Yeah right Kurt Bhahahahhaha! ).
) Intarcia hit by layoffs, trial setbackBy Max Stendahl – Biotech and Higher Education Reporter, Boston Business Journal
Four months after the FDA declined to approve its lead diabetes treatment due to manufacturing concerns, Intarcia Therapeutics has laid off 60 employees and terminated two late-stage trials of the drug-device, the company's CEO told the Business Journal.
Boston-based Intarcia, which has been valued at up to $5.5 billion (WTF?
), announced in late September that the FDA had denied its initial application to market ITCA 650, a matchstick-sized device that is inserted into the abdomen and gradually pumps tiny amounts of a drug into the bloodstream. It marked a major setback for the company, one of just a few unicorns — private companies valued at over $1 billion — in the Massachusetts life sciences sector.In an interview on Friday, Intarcia CEO Kurt Graves told the Business Journal that Intarcia recently laid off around 60 employees as part of a restructuring effort, including 11 who had worked at the company’s headquarters in Boston’s Seaport District. Many of the rest worked at Intarcia’s large manufacturing facility in Hayward, California, he said.
Graves said the company is currently hiring for a range of open positions, and does not expect its total headcount — around 300 employees prior to the layoffs — to change significantly in the coming months.
Meanwhile, Intarcia is facing a new, previously unreported setback related to ITCA 650, which it has long claimed will revolutionize the treatment of Type 2 diabetes. According to clinicaltrials.gov, a federal database that tracks drug studies, Intarcia recently gave notice that it terminated two Phase 3 studies of ITCA 650. One, a marketing study, compared the drug-device to approved treatments for Type 2 diabetes. The other tested ITCA 650 in patients with high levels of a type of hemoglobin that is commonly used to measure blood glucose. Neither study is necessary for the FDA to approve the pump.
In response to questions from the Business Journal, Graves said that one of Intarcia’s third-party labs had found a so-called “out of specification” result when routinely testing some of the pumps for long-term stability and sterility (WTF?
) . According to Graves, the FDA placed a hold on the studies after Intarcia informed the agency of the finding and its ongoing investigation (WOW! Smoking Gun! ). The company was unable to identify the root cause of the issue, forcing it to end the trials altogether (Oh SHIT! ), he said. Otherwise, patients would have continued to drop out of the studies (wait you mean pts dropping out of the studies? ), rendering the data essentially useless, ( LOL! ) he said.According to Graves, Intarcia plans to eventually re-launch similar trials pending discussions with the FDA (Yeah right Kurt Bhahahahhaha!
).The “out of specification” result in the third-party lab was not related to the approval filing or data for ITCA 650 (or wasN'T it more like didn't disclose the internal REJECTION or hide the weenie?
), Graves added. He said that Intarcia hopes to re-submit its application around mid-year after meeting with the FDA (Yeah right Kurt Bhahahahhaha! ).Must read!
Wow things are really fxcked up...
https://www.bizjournals.com/boston/...ch-unicorn-intarcia-hit-by-layoffs-trial.html
Wow things are really fxcked up...
https://www.bizjournals.com/boston/...ch-unicorn-intarcia-hit-by-layoffs-trial.html
Just keep lying .... Just keep lying.... Just keep lying
Disrupting Diabetes Through Careless Manufacturing And Disregard For Compliance
Disrupting Diabetes Through Careless Manufacturing And Disregard For Compliance
Intarcia announces that third party vendor catches faulty manufacturing of shoddy device. Company intends to deny that this is a problem and continue to insist that sales will begin in 2017. Kurt Graves, Emperor of Intarcia said "We are creating a new path to Unicorn Disruptive Innovative Transparent Transformation. Did I tell you that Bill Gates cried ?".
Employees huddled outside with unemployment checks wondering where their dreams have gone.
Employees huddled outside with unemployment checks wondering where their dreams have gone.
Rejected by FDA, stunned by clinical hold, fresh employee kills, back stabbing politics, unhappy partners, loser leadership, what is better than watching an angry midget !
Scums blaming 3rd party lab who caught the obvious and DANGEROUS sterility failures and can't even figure out why which is another complete LIE as they KNOW pump is a POS design manufactured manually with little to no controls nor QC inspections. Add to this joke that the drug is not released in controlled manner!
1. Intarcia needs a whole NEW pump device design as well as NEW process not to mention NEW Ph 3 study or extensive bridging study with nightmare comparability studies... In other words - they are royally screwed!
2. There is no way in hell they can re-submit in 2018 let alone 2019. New design, mfg and clinical studies mean starting from the very beginning with 3 to 4 yr time horizon!
3. No way in hell the investors will sink more money into this dying unicorn! Rumour has it that they will run out of cash by end of 2018.
As suspected Intarcia is indeed another Theranos with flamboyant, lying and narcissistic CEO without clothes.
From the beginning I found it astonishing how you can make so much noise with a little tube...
Add to that how can a drug company screw up a generic drug inside little tubey gizmo already approved and once marketed (withdrawn due to lack of demand) by Bayer?
Incompetence and plain ignorance are the per-requisite to get a job there along with lying at every level from the factory to fancy schmancy HQ overlooking the bay.
Predict this scam will unwind slowly till it runs out of cash as it is beset with investor lawsuits. BoD is controlled by KG so he might be the last 1 to turn the lights off.
Huuuuge IPO biggest ever in 2016. Uh well um 2017 err ahh 2018 oops ohh 2020
We so huuuge have to stay private to be nimble
Worth BILLIOOONNNSSSS
Fucking joke
We so huuuge have to stay private to be nimble
Worth BILLIOOONNNSSSS
Fucking joke
When does Servier launch ? Good thing they gave Intarcia $170 million dollars up front - they must be so glad !
Hey dont blame me ! Everyone knew about these problems for the last 4 years. There has never been a time when the specifications were consistently met. Retesting until pass has been the SOP with harrassment of anyone who wouldnt fall in line. It is totally unfair to say we didnt do as much as we could under the circumstances. Firing lower level people to cover up mistakes isnt fair. Our hand were tied.
Servier was real pain in the ass to deal with. Thought they were just being ahole French but they did poor DD and after inked the deal immediately realized they were in deep shit when they began to send technical people to Hayward. Servier had rights to ROW ex US & Japan or something. They deserve it for being arrogant French and got coned by KG. Classic!
Yep - they liked them Asians and Indians who didn't know better and culturally inclined to do what the crooks told them to do. Intimidate those who wouldn't fall in line. Nevermind they might end up in jail. Retest, question the specs and the results and worse change the test method so everything passes. How many people in QA and QC got fired or left in last 2 years?
Biotech unicorn (DYING
By Max Stendahl – Biotech and Higher Education Reporter, Boston Business Journal
Four months after the FDA declined to approve its lead diabetes treatment due to manufacturing concerns, Intarcia Therapeutics has laid off 60 employees and terminated two late-stage trials of the drug-device, the company's CEO told the Business Journal.
Boston-based Intarcia, which has been valued at up to $5.5 billion (WTF?
In an interview on Friday, Intarcia CEO Kurt Graves told the Business Journal that Intarcia recently laid off around 60 employees as part of a restructuring effort, including 11 who had worked at the company’s headquarters in Boston’s Seaport District. Many of the rest worked at Intarcia’s large manufacturing facility in Hayward, California, he said.
Graves said the company is currently hiring for a range of open positions, and does not expect its total headcount — around 300 employees prior to the layoffs — to change significantly in the coming months.
Meanwhile, Intarcia is facing a new, previously unreported setback related to ITCA 650, which it has long claimed will revolutionize the treatment of Type 2 diabetes. According to clinicaltrials.gov, a federal database that tracks drug studies, Intarcia recently gave notice that it terminated two Phase 3 studies of ITCA 650. One, a marketing study, compared the drug-device to approved treatments for Type 2 diabetes. The other tested ITCA 650 in patients with high levels of a type of hemoglobin that is commonly used to measure blood glucose. Neither study is necessary for the FDA to approve the pump.
In response to questions from the Business Journal, Graves said that one of Intarcia’s third-party labs had found a so-called “out of specification” result when routinely testing some of the pumps for long-term stability and sterility (WTF?
According to Graves, Intarcia plans to eventually re-launch similar trials pending discussions with the FDA (Yeah right Kurt Bhahahahhaha!
The “out of specification” result in the third-party lab was not related to the approval filing or data for ITCA 650 (or wasN'T it more like didn't disclose the internal REJECTION or hide the weenie?
That was a fun dime I dropped.
And sure, I guess headcount will stay the same, so long as Boston keeps hiring more consultants.
Get outta here troll. Intarcia is gonna be fine. Refiling this month, approved by fall, blockbuster by 2019. We are curing compliance. Other companies waste money on new pills, or new injections, not us. We are curing patient compliance the single biggest waste is patients who dont take their medicine. Intarcia is way better than any new drug. We are disrupting the discover new drugs model. Once we jam that pump into their stomach patients have no choice. Fu*k ya they get our drug. So sit back an watch Intarcia our IPO will be the biggest IPO in the history of Biotechnolgy. Just ask our investors they are super smart to know that Intarcia is worth $5.5 Billion.