Intarcia Therapeutics

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anonymous said:
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.
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Isn't bit too early to be drunk while taking bong hits while on meth?
 


















Class act Intarcia!

From Fierce Biotech today
https://www.fiercebiotech.com/medte...rcia-cuts-60-jobs-halts-two-late-stage-trials


Months after FDA rejection, Intarcia cuts 60 jobs and halts 2 late-stage trials
by Amirah Al Idrus |
Feb 5, 2018 10:15am

Intarcia Therapeutics hit a roadblock in September when the FDA pooh-poohed parts of the manufacturing plan for its matchstick-sized, diabetes-treating pump. Now, the company has laid off 60 employees and pulled the plug on two phase 3 trials of the treatment.

The layoffs are part of a restructuring plan, the Boston Business Journal reported. But CEO Kurt Graves said Intarcia is hiring for a number of open positions and does not expect its total workforce to “change significantly in the coming months.”

The Boston-based company seemed to hit its stride in 2016, announcing in June that it was looking to double its employees to about 800 and netting $215 million in the first close of a financing round in September, funds slated for the commercialization of its diabetes drug-device treatment and for the development of other pipeline candidates.

The Medici drug-delivery system includes an osmotic pump implanted beneath the skin to deliver the temperature-stable exenatide, ITCA 650. Designed to be replaced twice a year, it could potentially improve patient adherence.

Of the two phase 3 studies that Intarcia terminated, the BBJ reported, one was a marketing study pitting the drug-device therapy against approved treatments for Type 2 diabetes, while the other tested it in patients with high levels of baseline HbA1c, which is commonly used to measure blood glucose. Neither study is required for the FDA to approve the treatment.

The FDA placed a hold on the studies after Intarcia reported one of its third-party labs found an “out-of-specification” result in the routine testing of pumps for long-term stability and sterility, the BBJ said. The company halted the trials because it couldn’t pinpoint the underlying cause of the issue, but it plans to begin similar trials after discussions with the FDA.

The company now hopes to resubmit its application for the diabetes treatment around midyear.
 


















anonymous said:
Delete your browser history - under no circumstances access cafe pharma ,- leaker hunt is underway
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Right, heard a rumour 3rd hand about IT asked to snuff out the leakers. Do not access cafe pharma from office and company iPhone. If you do access cafe pharma outside then delete the browser history. Better yet use your own private laptop, pc, tablet and phone to access cafe pharma and glassdoor.
 






Let’s play “Truth or Lie”

Bayer withdrew pump from market, change name to Medici - that means it is “new” - Truth or Lie

AstraZeneca sells exenatide, put it in pump - that means it is “new” - Truth or Lie

Upon approval will have upto 1 year duration - Truth or Lie

Intarcia has completed study showing better compliance - Truth or Lie

Clinical hold for out of spec or lack of sterility shows patient focus - Truth or Lie

Intarcia will complete IPO at valuation of $5.5 billion - Truth or Lie

Manufacturing issues have been known since 2014 - Truth or Lie

Launch in 2017 - Truth or Lie

Investors were informed of serious manufacturing issues when they occurred - Truth or Lie
 


















Terminating studies? What a waste of money. Guess we don't need the clinical team anymore.

That would only be done if:
1- It was determined that the studies could not be completed (data not usable); or
2- Investors worried about approvability overall so they don't want any more money spent, even if it means walking away from studies mis stream.

Both bad news.
 












anonymous said:
Donkey-corn

First biotech to be run by jackass and lose over $1 billion of investor money
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Reallyimagine this.So much money wasted.Fancy offices,dinners,first class travel for CEO,peoloton bike,unlimited IT budget.Layoffs of technical people to save money while apparently some fat arrogant ass consultant who has no clue of the industry and only plays politics and spreads misery got paid $2 million last year.Heard this shit recently from a senior person.This gets better and better.Feel blessed to be in CA and outside the shithole and not in Boston.happy that I never visited.
 






I think the writing is on the wall for Intarcia... it's time to sell or quit. The recent layoffs have lost any momentum the company had heading into the next inspection. Removing 25% of the company's knowledge-base and trying to fill it with new, specific talent is going to take too long to get the company back up to speed. As for talent, the layoffs are also going to scare away any new talent they are wanting to attract, or they'll be paying a premium to get anyone to come aboard. If they haven't found the right people yet, how do they expect to find them now? They had knowledgeable and highly skilled people, but they didn't have the benefit of properly skilled guidance. Why throw away knowledge, when you can mold them into what you need? Be assured that none of those let go were offered a chance to attend training or enhance skills needed to bring the company to approval. They were stretched too thin anyway and asked to do too much. The people chosen for the layoffs appear to be more politically motivated than ability motivated anyway. Management turn-over in Hayward has not happened yet, so the people holding the site back are still in control. The CEO cannot make that one tough decision to catapult the company forward, and it shows a huge crack and weakness in his leadership. The board is not holding the CEO accountable, so the cracks run to the core. The CEO made a huge misstep in opening the Boston location. It became a huge distraction while issues at the Hayward manufacturing facility began to accumulate. The CEO was throwing away money on 1/2 million dollar toys and basking in the glossy veneer of the Boston office, while he was kept in the dark and misled about the state of things in Hayward. Had he stayed in Hayward, he could have led the company where it needed it most. Every day Intarcia does not have a product on the market, they lose potential market share to the up-and-coming competition. They are not the only implantable or new delivery technology coming to market. Who will want to have a medical procedure done when other devices won't require a needle, scalpel or stitch? New and better diabetes treatments come to market several times a year these days, while Intarcia is floundering with Exenatide. The once bright rainbow of this "unicorn", has turned into just a horse of a different color. Sell now while you can still get some of the value that defined your "unicorn" status. I would love to be proved wrong in this assessment, but I don't think the CEO has enough charm to talk the board out of a sale a second time, especially after the failed inspection and tremendous loss of momentum.
 






[QUOTE="The once bright rainbow of this "unicorn", has turned into just a horse of a different color. Sell now while you can still get some of the value that defined your "unicorn" status. I would love to be proved wrong in this assessment, but I don't think the CEO has enough charm to talk the board out of a sale a second time, especially after the failed inspection and tremendous loss of momentum.[/QUOTE]

You are beating a dead horse pal. This piece of unicorn manure was never bright but stunk like horse dung.

Who in the hell would buy this piece of horse crap? CRL and forced by FDA to stop the trials due to stability and sterility issues they supposedly can't figure out the root cause (it's a LIE) is death knell!

Y'all know that KG and his super duper arrogant cronies are despised and frowned upon by the big pharmas and frankly heard they can't stand Intarcia assholes cos they are REAL ASSHOLES at trade shows?
 












anonymous said:
Let’s play “Truth or Lie”

Bayer withdrew pump from market, change name to Medici - that means it is “new” - Truth or Lie

AstraZeneca sells exenatide, put it in pump - that means it is “new” - Truth or Lie

Upon approval will have upto 1 year duration - Truth or Lie

Intarcia has completed study showing better compliance - Truth or Lie

Clinical hold for out of spec or lack of sterility shows patient focus - Truth or Lie

Intarcia will complete IPO at valuation of $5.5 billion - Truth or Lie

Manufacturing issues have been known since 2014 - Truth or Lie

Launch in 2017 - Truth or Lie

Investors were informed of serious manufacturing issues when they occurred - Truth or Lie
Click to expand...

Lies lies lies yeah (They're gonna get you)
Lies lies lies yeah (They won't forget you)
Lies lies lies yeah (They're gonna get you)
Lies lies lies yeah
Oh you know I know
 






anonymous said:
Reallyimagine this.So much money wasted.Fancy offices,dinners,first class travel for CEO,peoloton bike,unlimited IT budget.Layoffs of technical people to save money while apparently some fat arrogant ass consultant who has no clue of the industry and only plays politics and spreads misery got paid $2 million last year.Heard this shit recently from a senior person.This gets better and better.Feel blessed to be in CA and outside the shithole and not in Boston.happy that I never visited.
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Money wasted? NOT! Hey it's OPM and OPP (other people's money and problems or uh, pussy). Ain't nothin wrong with that!

As for enrichin the pals AKA "fat ass consultants" - it's another, drum roll please, OPP! And guess what this shtick goes on Hayweird too. Just ask SZ about how much she gave away to her favorite pal's company BTL.
 












anonymous said:
Let’s name leadrship team members who should go for incompetence.JS, SZ, SG.Others?
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SZ and TA need to go as heads of regulatory/quality and dev/mfg. TA should have been fired years ago for all the Hayward factory fuck-ups and especially lying to KG. SZ ratted on TA but KG didn't listen. SZ's quality dept and her SE Indian servant GK is the biggest joke - read the reviews on glassdoor. Add to this JA the finance asshole and his dept has the highest turnover. Both TA and JA have been with the company way too long and should have been shit canned years ago.

Don't know much about JS and SG the Boston goons but heard JS is a real asshole protected by KG.
 






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