KG is an arrogant asshole who will never take responsibility for the disaster that he has created. Keeping JS is so he can kill JS and then blame everything on other people. Ask Vertex - 100% feedback - KG total narcisstic jerk. KG made it clear that bad news is not tolerated. No interest in fixing problems. Complete interest in pretending there are no problems. KG must go.
Intarcia Therapeutics
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KG is an arrogant asshole who will never take responsibility for the disaster that he has created. Keeping JS is so he can kill JS and then blame everything on other people. Ask Vertex - 100% feedback - KG total narcisstic jerk. KG made it clear that bad news is not tolerated. No interest in fixing problems. Complete interest in pretending there are no problems. KG must go.
Don't know much about JS and SG the Boston goons but heard JS is a real asshole protected by KG.[/QUOTE]
I supported commercial and as far as I could tell “goon”is the right word to describe the two. Especially SG. People said he was an arrogant sob,liar and manipulator. JS does KGs bidding only. The entire Boston next levels hated the two. Other leaders seemed ok, nothing to say.
I supported commercial and as far as I could tell “goon”is the right word to describe the two. Especially SG. People said he was an arrogant sob,liar and manipulator. JS does KGs bidding only. The entire Boston next levels hated the two. Other leaders seemed ok, nothing to say.
Survived the massacre but I feel dirty. Watching people cry knowing that they didn't do anything but work hard makes my stomach hurt. Started smoking at breakfast totally baked and depressed. WTF happens ?
Shut up loser. We are shedding the dead weight. Coddling inept whiners has to stop. Fire them all .
Your thinking about this ALL WRONG! The question is what would a SHARK do?
Does a SHARK care if someone cries?
Does a SHARK care if someone gets hurt?
Does a SHARK go on Glassdoor to complane?
NOOOOO!!
A SHARK wakes up everyday and gets what it wants. It bites, spits, rips, kicks. welcome to Intarcia sucka
Does a SHARK care if someone cries?
Does a SHARK care if someone gets hurt?
Does a SHARK go on Glassdoor to complane?
NOOOOO!!
A SHARK wakes up everyday and gets what it wants. It bites, spits, rips, kicks. welcome to Intarcia sucka
JS is the best can’t understand the backstabbing comments. Truest friend I’ll ever have and such a heart of gold. JY lacked belief so he’s got me wondering.
JY AKA Dr. John Yee who is too smart and figured out this flim flam hoax soon after he joined KG's rat pack and dared to bolt across the street to KG's nemesis Vertex right before the CRL?
JY brought tons of credibility at the beginning so to speak and drew in seasoned folks from the industry to apply at Intarcia but...
Adios MFs (mother f'ers)!
JY AKA Dr. John Yee who is too smart and figured out this flim flam hoax soon after he joined KG's rat pack and dared to bolt across the street to KG's nemesis Vertex right before the CRL?
JY brought tons of credibility at the beginning so to speak and drew in seasoned folks from the industry to apply at Intarcia but...
Adios MFs (mother f'ers)!
Got it. Thanks.
As rumoured, another bloody layoffs continueth in Hayweird. More layoffs to come thus lot of panicked and freaked out people.
Another mini massacre yesterday.
Layoff ax 2 weeks ago targeted and fell on TA's right hand man KK's dept heavily. These were the old timer process and validation engineers who got thrown into to fix the crap TA had no clue what to do and let it fester for years. KK was KA's henchman and much disdained for his ruthless bully style. All KK got for his loyalty to TA, who should have been FIRED years ago, was royal kick in the balls. No sympathy there and the poor guy now has terrible reputations for mistreating FTEs and contractors in the SF bay area.
What is truly puzzling though is that GP the weasel and TH the Genentech's finest -- their people were spared from the ax, for now. Only person laid off from Quality, the most incompetent dept, was an old timer. In fact most of the people laid off were old timers. Really unfair as lemmings TH brought from Genentech are real fun to watch in action for lack of action; just plain stupid and helpless eager to bring high price consultants to do their job. Talk about waste.
Blood in the streets. Live to kiss ass or die. Plain and simple.
It's not looking good in Hayward. The ones to get fired are the management above Sr Director levels!
I survived and I'm telling you. Serious shit gonna hit the fan. How can you treat people like dirt and expect them to be all " oh yeah we built on trust". Like you have any freaking idea what trust is even all about. I'm keeping papers just try to get all up in my face. I will kick your ass.
This boat is sinking fast. ULT is re-arranging the deck chairs and playing fiddle while KG is busy making sure there is a lifeboat for him and his clowns.
As for getting over the CRL upended and trumped by stability sterility device nightmares - it ain't gonna happen this year. Best case is launch in late 2019 and more like 2020 given how screwed up Hayward is. Alas there is only enough money to last til maybe Q1 2019 even with the drastic RIF (reduction in force).
PS - Expect more firings and tears
As for getting over the CRL upended and trumped by stability sterility device nightmares - it ain't gonna happen this year. Best case is launch in late 2019 and more like 2020 given how screwed up Hayward is. Alas there is only enough money to last til maybe Q1 2019 even with the drastic RIF (reduction in force).
PS - Expect more firings and tears
Intarcia Reopening Generic Manufacturing Scandal With Failure To Meet FDA Manufacturing Standards
The beginning of the modern generic drug industry was marked by fraud and other criminality on the part of some companies that almost destroyed the industry before it got started. The fraud was pervasive from 1984 to 1989 and became collectively known as the Generic Drug Scandal. The generic drug scandal reduced consumers' perception of the quality of generic drugs. Intarcia has announced their plan to be the first generic company to market exenatide through the re-introduction of Bayer's implantable osmotic pump. Generic companies have long focused on being the first approved generic product in order to attract relatively high prices and take the majority of the generic market share. The stakes are high for the generic industry and tens or hundreds of millions of dollars in potential profits are at stake.
Fraud began on day one of the generic industry. One company, Bolar Pharmaceuticals, was reported to have driven to the FDA and filed 40 ANDAs . It would later be found that all of these ANDAs were fraudulent, fabricated for the purpose of filing first to ensure a timely approval. One generic company, Mylan Laboratories, had complained to the FDA-CDER Division of Generic Drugs (DGD) that ANDAs were not being reviewed according to the “first in, first reviewed” policy and that some applicants were receiving favored treatment. Mylan became frustrated with the lack of response to their complaints of favoritism and hired a private detective to investigate. Evidence of bribery of DGD reviewers was found and turned over to the US House of Representatives Energy and Commerce Committee's Subcommittee on Oversight and Investigations (the Subcommittee). The Subcommittee began an investigation that revealed bribery and fraud, and resulted in charges against FDA officials and generic drug companies and some of their executives, managers, and employees. The investigation continued for several years and investigators from the Department of Justice and Department of Health and Human Services discovered that not only had there been bribery, but that some companies had submitted fraudulent data, substituting brand product for generic product as samples in bioequivalence testing.
In all, thirty individuals and nine companies were either found guilty or admitted their role in FDA corruption. At one point, in the subcommittee investigation during a press briefing, it was reported that subcommittee staff stated that “of 39 generic drug companies… (investigated) … only about a half dozen appear to be free of criminal or regulatory taint”. Representative John Dingell, Chairman of the Subcommittee, declared that the generic drug industry was “the most pervasively corrupt this subcommittee has ever uncovered”.
Clearly the public's faith in generic drugs and in FDA's ability to regulate the drug industry has been severely shaken. Among the 1009 consumers of a broad range of ages surveyed by Gallup in to ascertain their attitudes toward generic drugs after the manufacturing scandal, 51% feared that generic drugs were not manufactured to the same standards as brand medications and more than 70% indicated that the scandal had affected their confidence in generic drugs to some degree. Intarcia has demonstrated why these fears of the public are well founded. Rejected by the FDA for inadequate manufacturing processes, Intarcia recently halted ongoing clinical trials when a "third party vendor" found that Intarcia was unable to meet the required standards for manufacturing human therapeutics. Only now are the patients in these Intarcia trials being informed that they have been implanted with ITCA650 pumps that may have been inadequate for human use. Realizing the risks of lack of trust in FDA and the generic drug industry, FDA will act aggressively to root out fraud. Indeed so aggressive was FDA's approach that one industry analyst reported “everybody is scared to death about the FDA because they know the FDA means business”. This aggressive approach may be successful in restoring public confidence in both FDA's ability to regulate the drug industry and in generic drug products. The recent reports on Intarcia have reopened an awareness that public confidence in generic drugs has been shaken, some suggest confidence has fallen to levels observed at the height of the generic drug manufacturing scandal.
The beginning of the modern generic drug industry was marked by fraud and other criminality on the part of some companies that almost destroyed the industry before it got started. The fraud was pervasive from 1984 to 1989 and became collectively known as the Generic Drug Scandal. The generic drug scandal reduced consumers' perception of the quality of generic drugs. Intarcia has announced their plan to be the first generic company to market exenatide through the re-introduction of Bayer's implantable osmotic pump. Generic companies have long focused on being the first approved generic product in order to attract relatively high prices and take the majority of the generic market share. The stakes are high for the generic industry and tens or hundreds of millions of dollars in potential profits are at stake.
Fraud began on day one of the generic industry. One company, Bolar Pharmaceuticals, was reported to have driven to the FDA and filed 40 ANDAs . It would later be found that all of these ANDAs were fraudulent, fabricated for the purpose of filing first to ensure a timely approval. One generic company, Mylan Laboratories, had complained to the FDA-CDER Division of Generic Drugs (DGD) that ANDAs were not being reviewed according to the “first in, first reviewed” policy and that some applicants were receiving favored treatment. Mylan became frustrated with the lack of response to their complaints of favoritism and hired a private detective to investigate. Evidence of bribery of DGD reviewers was found and turned over to the US House of Representatives Energy and Commerce Committee's Subcommittee on Oversight and Investigations (the Subcommittee). The Subcommittee began an investigation that revealed bribery and fraud, and resulted in charges against FDA officials and generic drug companies and some of their executives, managers, and employees. The investigation continued for several years and investigators from the Department of Justice and Department of Health and Human Services discovered that not only had there been bribery, but that some companies had submitted fraudulent data, substituting brand product for generic product as samples in bioequivalence testing.
In all, thirty individuals and nine companies were either found guilty or admitted their role in FDA corruption. At one point, in the subcommittee investigation during a press briefing, it was reported that subcommittee staff stated that “of 39 generic drug companies… (investigated) … only about a half dozen appear to be free of criminal or regulatory taint”. Representative John Dingell, Chairman of the Subcommittee, declared that the generic drug industry was “the most pervasively corrupt this subcommittee has ever uncovered”.
Clearly the public's faith in generic drugs and in FDA's ability to regulate the drug industry has been severely shaken. Among the 1009 consumers of a broad range of ages surveyed by Gallup in to ascertain their attitudes toward generic drugs after the manufacturing scandal, 51% feared that generic drugs were not manufactured to the same standards as brand medications and more than 70% indicated that the scandal had affected their confidence in generic drugs to some degree. Intarcia has demonstrated why these fears of the public are well founded. Rejected by the FDA for inadequate manufacturing processes, Intarcia recently halted ongoing clinical trials when a "third party vendor" found that Intarcia was unable to meet the required standards for manufacturing human therapeutics. Only now are the patients in these Intarcia trials being informed that they have been implanted with ITCA650 pumps that may have been inadequate for human use. Realizing the risks of lack of trust in FDA and the generic drug industry, FDA will act aggressively to root out fraud. Indeed so aggressive was FDA's approach that one industry analyst reported “everybody is scared to death about the FDA because they know the FDA means business”. This aggressive approach may be successful in restoring public confidence in both FDA's ability to regulate the drug industry and in generic drug products. The recent reports on Intarcia have reopened an awareness that public confidence in generic drugs has been shaken, some suggest confidence has fallen to levels observed at the height of the generic drug manufacturing scandal.
Link for the article above please.
The goon squads at Intarcia cannot even make generic drug inside already approved/marketed pump.
Say what kind of bullshit DD did the investors including Servier conduct anyway? I mean Bill Gates - understand he knows jack shit about drugs but how could so many investors get duped by fancy schmancy PowerPoint slides? Seriously after Theranos swindle? Guess PT Barnum said it best about suckers born every minute.
Protect yourself. Document what they tell you. Make records of all misconduct. Come forward with bad behavior by executives. Let transparency bite back.
Ladies and Gentlemen Start Your Chainsaws
Intarcia clinical trial dummies lift your shirts
May the pump removal begin
ZRZzrrrrzzz Splatter Gasp Moan
Intarcia clinical trial dummies lift your shirts
May the pump removal begin
ZRZzrrrrzzz Splatter Gasp Moan
The Biotech Donkicorn
Led by jackass while investors lost on $1 Billion dollars
A first in class
Led by jackass while investors lost on $1 Billion dollars
A first in class