Intarcia Therapeutics
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You sound desperate enough to work in hell. Guess there is a place for you in Intarcia hell then!
Good luck selling, rejections across the board by the payers and waste time educating the masses. Lastly better have a good pitch as to why pt has to pay tens of thousand out of pocket cos payer won't cover ITCA and refer the pt and doc to formulary including Teva's new generic exenatide.
Listen up dufus, based on the PAI failure and process modifications required to fix, + the statutory timeline turnaround for a major CRL, this puppy isn't launching until the end of 2018 at the earliest. DREAM ON
Real insider aye?
More leaks about PAI disasters are trickling out and it ain't pretty. They need to develop new processes, acquire new process equips, characterize and validate the process with the fingers crossed on variety of fronts from the on-going micro issues uncovered by FDA during PAI, contaminations and questionable test methods to name a few. In other words best case is approval in Q4 2018 or year after CRL which BTW is typical turnaround but more likely mid 2019. In the mean time some dept has seen mass exodus like the validation dept and better talents are actively looking to bail in Boston and Hayward leaving the bottom of the barrel jokers and $150-$300/hr consultants to mop up the mess. Truly a clusterfuck.
Ridiculous SR MGMT rakes in the cash but sits on their ass. Failure at all levels. No leadership poor communication and lack of understanding of compliance. Telling the FDA to fuck off always ends in disaster. This is clown patrol
not like delay is unexpected check out Xconomy Luke Timmerman 2010
“Intarcia could be in position to file its new drug application with the FDA by the end of 2012, and to potentially introduce its product to the market by the end of 2013 or early 2014, Graves says.”
He says a lot of things that don’t come true
REJECTED
“Intarcia could be in position to file its new drug application with the FDA by the end of 2012, and to potentially introduce its product to the market by the end of 2013 or early 2014, Graves says.”
He says a lot of things that don’t come true
REJECTED
WHOA, you mean KG has been lying all along? Say it ain't so.
So I reckon he is lying about approval in lickety split too?Yep the trust starved arrogant drama kings and queens literally told FDA to fuck off (and die). LOL! What a bunch of ass clowns trying to undermine each other while busy reshuffling deck chairs while the ship is sinking.
Sadly bonus will suck this yea though HR told me people got 200% of their target for FY 2014. Oh how dearly regret join this 3-ring circus with tainted company on my CV soon to be HBR case study example of pulling biotech version of Bernie Madoff on par with Elizabeth Holmes...
Cockroaches run from the light
Post any FDA correspondence related to the Complete Response Letter
Or email john.carreyrou@wsj.com
The Wall Street Journal’s reporting and editing of Theranos was an unusually long and painstaking process, taking 10 months before the first article was published amid denials, attempted intimidation of sources and multiple litigation threats.
The blood-testing company first came on the radar of the Journal’s John Carreyrou when he read a profile of its founder Elizabeth Holmes in The New Yorker magazine in late 2014. The article described a brilliant scientist and entrepreneur who’d achieved great things at a young age. Some passages gave him pause, including this one: “What exactly happens in the machines is treated as a state secret, and Holmes’s description of the process was comically vague: ‘A chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result…’ ”
A few weeks later, Carreyrou got a tip that everything might not be what it seemed at the company. He was intrigued, given that Theranos had achieved a $9 billion valuation and become one of Silicon Valley’s hottest startups. He spent several weeks digging further until he reached a former employee who, after much give-and-take, agreed to become a confidential source. Theranos lawyers were harassing the former employee and threatening him with litigation. It took several more months to corroborate what this source was saying with other former employees, some of whom let Mr. Carreyrou review documents that backed up their claims.
Post any FDA correspondence related to the Complete Response Letter
Or email john.carreyrou@wsj.com
The Wall Street Journal’s reporting and editing of Theranos was an unusually long and painstaking process, taking 10 months before the first article was published amid denials, attempted intimidation of sources and multiple litigation threats.
The blood-testing company first came on the radar of the Journal’s John Carreyrou when he read a profile of its founder Elizabeth Holmes in The New Yorker magazine in late 2014. The article described a brilliant scientist and entrepreneur who’d achieved great things at a young age. Some passages gave him pause, including this one: “What exactly happens in the machines is treated as a state secret, and Holmes’s description of the process was comically vague: ‘A chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result…’ ”
A few weeks later, Carreyrou got a tip that everything might not be what it seemed at the company. He was intrigued, given that Theranos had achieved a $9 billion valuation and become one of Silicon Valley’s hottest startups. He spent several weeks digging further until he reached a former employee who, after much give-and-take, agreed to become a confidential source. Theranos lawyers were harassing the former employee and threatening him with litigation. It took several more months to corroborate what this source was saying with other former employees, some of whom let Mr. Carreyrou review documents that backed up their claims.
Heard from Boston that a sales VP has resigned. News has been kept quiet. Any guesses who? Hayward management said filing cannot be done according to the newly concocted timeline. What a bunch of losers all.
TRUST is our first value. We are not TRUST starved but are overflowing with TRUST. Thou shalt TRUST KG. That is the rule.
I hear no way for filing before 3Q 2018 cannot complete required validation before Labor Day. If this happens it’s a miracle. Anything goes wrong and you are talking 2019
Ah shucks. Iffy approval in late 2018 and maybe even 2019? Why are these monkeys re-starting the hiring of the reps and managers again?
Lot of capable and talented people got disenchanted and pissed off by the chaotic amateur hiring process and sounds like same BS will be pulled again. Way to go Intarcia!
Lot of capable and talented people got disenchanted and pissed off by the chaotic amateur hiring process and sounds like same BS will be pulled again. Way to go Intarcia!
Best case Q3 2018 and worst case Q3 2019.
Nightmare case - eventually approved but flames out within a year after getting Medicare code due to lack of demand as payors will not pay for 20-30X the cost of Teva's new generic exenatide daily injections and slew of GLP-1 daily and weekly injections from big pharmas including Victoza with clinically proven and coveted CV reduction.
No sane reps will leave their job to sell this POS. Caveat Emptor!
the worst case is running out of cash and the investors up in arms demanding KG's head for lying thru out the years.
Bye Bye Pump Boi
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide) a once-weekly glucagon-like peptide (GLP-1) receptor agonist
The approval of OZEMPIC® is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, OZEMPIC® showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.
Interview ? Rude ! Condescending ! Arrogant !
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide) a once-weekly glucagon-like peptide (GLP-1) receptor agonist
The approval of OZEMPIC® is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, OZEMPIC® showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.
Interview ? Rude ! Condescending ! Arrogant !
novo was very late to the once weekly GLP-1 drug and why not with the blockbuster like once daily Victoza with proven CV benefits.
novo is also workin on the holy grail of GLP-1 - oral pill in Ph 3 trial which will just about kill all GLP-1 drugs including joke ITCA!
http://www.chicagotribune.com/lifestyles/health/sc-hlth-diabetes-pill-blood-sugar-1025-story.html
Diabetes pill might replace injection to control blood sugar
Serena Gordon
HealthDay
October 18, 2017
An injectable class of diabetes medication — called glucagon-like peptide-1 or GLP-1 — might one day be available in pill form, research suggests.
Based on the results of a global phase 2 clinical trial, the study authors reported a significant drop in blood sugar levels for people on the oral medication, and no significant increase in low blood sugar levels (hypoglycemia) compared to a placebo over six months.
The findings also showed that people taking the highest dose of the pill lost a large amount of weight — about 15 pounds — compared to a weight loss of fewer than 3 pounds for people on the inactive placebo pill.
The research was funded by Novo Nordisk, the company that makes the drug, called oral semaglutide.
"Semaglutide could transform diabetes treatment," said Dr. Robert Courgi, an endocrinologist at Southside Hospital in Bay Shore, N.Y.
"Glucagon-like peptide receptor agonists are agents that are highly recommended according to diabetes guidelines, but rarely used because they require injection. Most patients prefer a pill," Courgi explained.
novo is also workin on the holy grail of GLP-1 - oral pill in Ph 3 trial which will just about kill all GLP-1 drugs including joke ITCA!
http://www.chicagotribune.com/lifestyles/health/sc-hlth-diabetes-pill-blood-sugar-1025-story.html
Diabetes pill might replace injection to control blood sugar
Serena Gordon
HealthDay
October 18, 2017
An injectable class of diabetes medication — called glucagon-like peptide-1 or GLP-1 — might one day be available in pill form, research suggests.
Based on the results of a global phase 2 clinical trial, the study authors reported a significant drop in blood sugar levels for people on the oral medication, and no significant increase in low blood sugar levels (hypoglycemia) compared to a placebo over six months.
The findings also showed that people taking the highest dose of the pill lost a large amount of weight — about 15 pounds — compared to a weight loss of fewer than 3 pounds for people on the inactive placebo pill.
The research was funded by Novo Nordisk, the company that makes the drug, called oral semaglutide.
"Semaglutide could transform diabetes treatment," said Dr. Robert Courgi, an endocrinologist at Southside Hospital in Bay Shore, N.Y.
"Glucagon-like peptide receptor agonists are agents that are highly recommended according to diabetes guidelines, but rarely used because they require injection. Most patients prefer a pill," Courgi explained.
more on ITCA killer!
https://www.goodrx.com/blog/could-your-diabetes-injection-soon-be-available-in-pill-form/
Could Your Diabetes Injection Soon Be Available in Pill Form?
by The GoodRx Pharmacist on November 27, 2017 at 4:06 pm
New medications used to treat type 1 and type 2 diabetes are popping up left and right. From 2013-2016 there have been 15 new oral and injectable medications approved for the treatment of diabetes alone.
One new class of medications that you might have seen are GLP-1 agonists. This class includes injection drugs like Byetta, Victoza, and Trulicity to name a few.
What’s noteworthy about this class? There’s a possibility that we might see some oral GLP-1 inhibitors soon! This could mean no more painful injections.
Will we see oral treatments in the foreseeable future?
Possibly! A leader in diabetes care, Novo Nordisk, has been working on an oral GLP-1 formulation that’s comparable to the current injectable formulations.
Before the possibility of an oral GLP-1 agonist, Novo Nordisk will most likely receive approval for their once-weekly injection, semaglutide.
But have no fear, Novo Nordisk has been testing the oral form of semaglutide in patients with type 2 diabetes. There are two current clinical trials that show a lot of promise for oral GLP-1 agonists, PIONEER 2 and PIONEER 8. In both of these trials, oral and injectable forms of semaglutide were related to an average drop in A1C by about 1.9%, and an approximate weight loss of at least 5% for most people.
At this point, the possibility of a once-daily oral GLP-1 agonist may soon become a reality for those with type 2 diabetes. Stay tuned!
https://www.goodrx.com/blog/could-your-diabetes-injection-soon-be-available-in-pill-form/
Could Your Diabetes Injection Soon Be Available in Pill Form?
by The GoodRx Pharmacist on November 27, 2017 at 4:06 pm
New medications used to treat type 1 and type 2 diabetes are popping up left and right. From 2013-2016 there have been 15 new oral and injectable medications approved for the treatment of diabetes alone.
One new class of medications that you might have seen are GLP-1 agonists. This class includes injection drugs like Byetta, Victoza, and Trulicity to name a few.
What’s noteworthy about this class? There’s a possibility that we might see some oral GLP-1 inhibitors soon! This could mean no more painful injections.
Will we see oral treatments in the foreseeable future?
Possibly! A leader in diabetes care, Novo Nordisk, has been working on an oral GLP-1 formulation that’s comparable to the current injectable formulations.
Before the possibility of an oral GLP-1 agonist, Novo Nordisk will most likely receive approval for their once-weekly injection, semaglutide.
But have no fear, Novo Nordisk has been testing the oral form of semaglutide in patients with type 2 diabetes. There are two current clinical trials that show a lot of promise for oral GLP-1 agonists, PIONEER 2 and PIONEER 8. In both of these trials, oral and injectable forms of semaglutide were related to an average drop in A1C by about 1.9%, and an approximate weight loss of at least 5% for most people.
At this point, the possibility of a once-daily oral GLP-1 agonist may soon become a reality for those with type 2 diabetes. Stay tuned!