Intarcia Therapeutics

When you come to INTARCIA, your experience and contributions are valued and the spirit of innovation is very high. We are all centered on a common goal: creating therapies that can make a difference for patients. People here want to collaborate and there is an unbelievable amount of optimism. If you have unbridled talents, great ideas and a willingness to put in a very strong effort, this is your place to be. And the requirement of being a douchebag. That’s why I’m here

LOL wonder if this DB bloke will be around when they round up the lemmings like him for the funeral pyre.
 






Responding to and fixing manufacturing problems cited in a CRL and underlying warning letter can take time, and FDA may spend up to six months reviewing a resubmitted application. Raffat, the stock analyst, has analyzed all warning letters in the past 20 years that specifically relate to cGMP problems on finished drug products. For this set of 31 letters, he found that it takes anywhere from four months to four years to resolve the issues. The average resolution took 17 months.

SME say 18 months ? Gee isnt that the average time for resolution ?
 






Lie about the little things, Lie about the big things..

Did you ever hear the story of the football player ? Hmm what do you think true ? or false ?

Linebacker leads Novartis' charge.(Headliner)(Kurt Graves is the new chief marketing officer of Novartis Pharma AG)
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Tosh, Mark | https://www.highbeam.com/doc/1G1-112085317.html
As the new chief marketing officer of Novartis Pharma AG, Kurt Graves talks more like the football standout he was back at Hillsdale College in Michigan than someone who spent his under graduate days studying physics, biology and chemistry

But don't let the competitive nature of this former linebacker and team captain fool you. Graves also understands the finer points of the science and marketing playbook, particularly as they relate to understanding the consumer.

 






2008 Biography
Mr. Graves is our Executive Vice President, Chief Commercial Officer and Head, Strategic Development, a position he has held since joining us in July 2007. From 1999 through June 2007, Mr. Graves held various executive positions at Novartis Pharmaceuticals, including Global Head of General Medicines Business Unit & Chief Marketing Officer, Pharmaceuticals from September 2003 through June 2007. Prior to that, Mr. Graves served as Senior Vice President & General Manager - US Pharma & Commercial Operations; Vice President, Head of US Marketing & Primary Care Franchises; and Vice President & Business Unit Head: Respiratory, GI, Dermatology and Bone Franchises. Prior to joining Novartis, Mr. Graves was GI Business Unit Head - US Gastrointestinal Franchise, at Astra Pharmaceuticals, LP from 1997 to 1998. From 1993 to 1997, Mr. Graves served in a variety of roles at Astra Merck Pharmaceuticals including Executive Director, Business Unit Commercialization Leader. He has extensive training in marketing & sales and general management, including training at the University of Michigan Business School, Wharton School of Business and Harvard Business School. Mr. Graves holds a B.S. in Biology from Hillsdale College. On September 30, 2009, the Compamy announced that the employment of Kurt Graves, our Executive Vice President, Chief Commercial Officer and Head, Strategic Development and one of our named executive officers, would terminate in October 2009. The Company expect that his last day of employment will be October 26, 2009.


*Bio from Vertex Pharmaceuticals SEC filings.

Really ? What happened to Biology and Chemistry ? Why has Harvard Business School disappeared ? What degrees does this guy actually have ? July to October to Unemployed ? Why ?
 






Assistance and information from a whistleblower who knows of possible securities law violations can be among the most powerful weapons in the law enforcement arsenal of the Securities and Exchange Commission. Through their knowledge of the circumstances and individuals involved, whistleblowers can help the Commission identify possible fraud and other violations much earlier than might otherwise have been possible. That allows the Commission to minimize the harm to investors, better preserve the integrity of the United States' capital markets, and more swiftly hold accountable those responsible for unlawful conduct.

The Commission is authorized by Congress to provide monetary awards to eligible individuals who come forward with high-quality original information that leads to a Commission enforcement action in which over $1,000,000 in sanctions is ordered. The range for awards is between 10% and 30% of the money collected.

The Office of the Whistleblower was established to administer the SEC's whistleblower program. We understand that the decision to come forward with information about securities fraud or other wrongdoing is not one taken lightly, and we are here to answer any questions you may have. You can reach the Office of the Whistleblower at (202) 551-4790.
 












Its so depressing to be beaten by our own incompetence.

The biggest culprit of this long in making disaster saga is Tom Alessi the proud recipient of joke of all joke key disruptor award in 2014 for his, get this, innovations in chemistry and manufacturing. This joker headed every department except finance which was headed by his pal James, another bully and worthless 20 yr employee.

Tom snowed Kurt all the way till Kurt began to hear about the disasters in making from Sunita who had worked for real pharma companies was ratting about Tom's utter lack of experience let alone incompetence. Kurt finally got a clue and brought in Tony 18 months ago but it was too late for Tony even with his own cronies with big pharma credentials to undo 5 years of fuck-ups . Tom has zero experience in CMC and commercialization and has been a leech sucking money out of Intarcia since inception 20 years ago. We don't know why Kurt didn't fire Tom when he brought Tony in. Tom surrounded himself as incompetent cronies including some with zero pharma experiences and some real nasty people with zero people skills who would have gotten fired in any legit companies.

PS - Kurt hates Vertex with passion. Guess it took Vertex only a year to figure out the ex-linebacker's (midget as linebacker?) whimsical follies and fired him.
 






More leaks from Hayweirdland:

Intarcia has to develop and validate a new manufacturing process. This probably involve major facility work, new equipment with associated process. and revised formulation resulting in complex comparability studies. This alone will take about 1.5 yrs but there probably will be a need to perform limited clinical trial demanded by FDA based on the scope of changes.

Granted the clinical study can be done in parallel during process validation but you are looking at good 2 to 3 yrs which coincidentally is in line with leaked plan for IPO via NYSE in 2019. That is big if on the long awaited IPO.

People are freaked bout getting laid off as does Intarcia have enough cash on hand to pay payrolls for another 3 years with no revenue? No wonder they misled and held off on hiring the sales people.
 






Kurt knew all about these problems all along - he's been here for 7 years- notice the Board Members and Executives who are running away. They know there is a big giant crater when this asteroid crashes. Layer after layer of ponzi scheme cash based on the lie of giant revenue. Are there enough stupid asian investors to keep the scam running ?
 






He tried to strong arm the FDA while at Novartis and it blew up all over him and the company. Can't say he has the best relationship with our most important regulator. Such an arrogant prick, karma baby!
 






Captain ?? Try walk on - wasn't recruited only played when game already in hand. Lucky he was allowed on the team as a sophomore. Funny he was 6'1' at Hillsdale how tall is he now ?? Typical exaggeration (lie)
 






Captain ?? Try walk on - wasn't recruited only played when game already in hand. Lucky he was allowed on the team as a sophomore. Funny he was 6'1' at Hillsdale how tall is he now ?? Typical exaggeration (lie)

He is about 5'8" I reckon so he shrank by 5"? Guess osteoporosis pills haven't been helping? With the CRL he must feel like a real midget?
 






Kurt knew all about these problems all along - he's been here for 7 years- notice the Board Members and Executives who are running away. They know there is a big giant crater when this asteroid crashes. Layer after layer of ponzi scheme cash based on the lie of giant revenue. Are there enough stupid asian investors to keep the scam running ?

Give Owen some credit for reeling in the Chinese and Korean investors, oops meant the bagholders. It was too funny for the Chinese investors to scoop up the shares put up for the grabs by the investors who wanted to get the hell out last year Goitta give more credit to Big O for selling some kind of esoteric convertibles against 1.5% of future, to be non-existent, revenue. Ponzi reinvented.

Say do ya hear that sucking sound and rats about to flee the sinking ship while Kurt and his brown nosed worshipers play fiddle?
 






Emperor of Intarcia Announces That FDA Approval Isn't Necessary
Sept 30, 2017

Intarcia announces plan to achieve blockbuster sales with disruptive launch plan. "For too long the Industry has developed new drugs, new pills and new injections. By taking the outdated osmotic pump withdrawn from the market by Bayer and combining it with AstraZeneca's soon to be generic exenatide we have created a new category of unapproved drugs that can be sold without FDA Approval. This approach will allow Intarcia to disrupt the business model of complying with FDA regulations" said Emperor of Intarcia Kurt the Magnificent.

"We do not need to meet with the FDA, run pivotal trials, or do any expensive manufacturing stuff" his highness continued, "Our office is bigger than Vertex and they never fired me". Intarcia plans to continue to eliminate senior executives as the Emperor can build a blockbuster using minions. "We planned all along to have Senior people leave during the ponzi period. Replacing them with people that know nothing keeps our story fresh" explained the Emperor.

Intarcia plans to be listed on the New York Stock Exchange in 2019 based on the sales generated by the disruptive launch program.
 






I kind a wish they got the FDA nod because the launch would have been a complete disaster. Add to this the lengthy time and effort (including additional studies) to get the codes and they would have been sitting and dying unicorn duck all the while trying to educate the masses. Salt on wound - generic Teva GLP-1 launch in Oct.

As for investors - suckers born every minute.
 


















Get ready for more senior execs to walking out the door. Management trying hard to portray "all is well" atitude but word is CRL much bigger mess than ever

Kurt and his henchmen need to slaughter a few scapegoats in Hayweird - mostly well deserved. Most leadership team members in Boston won't be touched. Maybe a good thing to bring experienced high level consultants to take over the Hayweird management positions in acting interim roles. No need to keep those whose competences led to CRL on payroll. Also heard that CRL is bigger can of worms mired in excrements.
 












So how bad is the CRL really? I have to make some personal decisions:confused:

Don't know how bad the CRL is as it has not been shared or published which only means it is as bad as it can be. KG demands FDA approval within a year when general consensus is 18 to 24 months. Apparently money is no object at this point.

No heads rolling nor whip of layoff - business as usual and if anything job security for the most in Hayward.