As Feb ticks away, more likely cuts continue, unlikely resubmission
Who gets the blame TA ? TH ?
Intarcia Therapeutics
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As Feb ticks away, more likely cuts continue, unlikely resubmission
Who gets the blame TA ? TH ?
Y'all watch your backs and especially the back stabbin coworkers and management. Document everything! Blood letting to be intensified with pittance for severance. Heard the prospect is getting grimmer by days.
Bet TH is looking to get the hell out when the right opportunities come along. Proud man like TH don't want to be associated with CRL and FDA stopping trials due to myriad of issues on his CV.
Thought TA was being forced into retirement? It is really ALL his fault anyway but he might get a pass for now in case TH leaves.
What KG needs to do though is to get rid of SZ and her servant boy GK for the screw ups on the submission, PAI and horrible quality dept.
It is true that every clinical trials test dummies must get their ITCAs removed ASAP?
Kurt is a genius. We will IPO at the largest valuation ever for a biotech company $5.5. Billion. We will disrupt diabetes with the fastest uptake curve in the history of the biopharm industry. Medici pumps will be the #1 market leading choice based on annual prescription volume, annual gross sales, and annual gross margin. Intarcia is the #1 Biotech Company is the world led by the greatest CEO in the history of business.
Please ignore the FDA rejection and being placed on clinical hold for failure to meet manufacturing standards.
Please ignore the FDA rejection and being placed on clinical hold for failure to meet manufacturing standards.
Yes. Sites are sending back supplies too. Part of study shutdown.
So the rumor was true - complete shutdown of clinical trials. Talk about being down and out and dissed by FDA based on all fronts from shitty NDA, embarrassing PAI, nightmare CRL to now forced shutdown of on-going trials. What's next from the FDA - demand for complete shutdown?
This is another take in bulletpoints:
https://www.beckershospitalreview.c...tes-2-late-stage-trials-8-things-to-know.html
Drugmaker Intarcia Therapeutics cuts 20% of workforce, terminates 2 late-stage trials: 8 things to know
Written by Alia Paavola | February 09, 2018
Intarcia Therapeutics, a biopharmaceutical company based in Boston, laid off 60 employees and terminated two late-stage trials of its lead diabetes treatment, reports the Boston Business Journal.
Here are eight things to know.
1. Eleven of the layoffs affected employees at the Boston headquarters, while the other layoffs occurred at Interacia's manufacturing plant in Hayward, Calif. Intarcia CEO Kurt Graves told the Boston Business Journal the layoffs were part of a restructuring plan and were not a result of the trial setbacks.
2. Mr. Graves does not expect the company's headcount, which was around 300 total employees prior to the layoffs, to significantly change in the upcoming months.
3. The company's lead diabetes treatment, ITCA 650, is a small device that is surgically inserted into the abdomen and gradually pumps tiny amounts of the drug exenatide into the blood stream.
4. The trial setbacks for the ITCA 650 began in late September when the FDA declined to approve the drug-device. Despite the setback, the company will still fight for approval.
5. However, the company hit another snag. Intarcia recently announced it terminated two Phase 3 studies of ITCA 650. One study, a marketing study, compared the device to other approved treatments of Type 2 diabetes. The other study tested ITCA 650 in patients with high levels of hemoglobin. While neither study is necessary for FDA approval, Mr. Graves said Intarcia needed to halt the studies to investigate an "out-of-specification" result.
6. According to Mr. Graves, one of Intarcia's third-party labs found issues regarding the long-term sterility and stability of the device. The FDA placed a hold on the studies while they investigated the issue. Because the drugmaker was unable to identify the root cause of the issue and was unable to address the FDA's concerns over the device, the trials were terminated.
7. According to Mr. Graves, patients would have continued to drop out of the studies after the issues were brought up, which would have rendered the data useless.
8. Pending discussions with the FDA, the company plans to relaunch similar trials and is still seeking approval for the device.
This is another take in bulletpoints:
https://www.beckershospitalreview.c...tes-2-late-stage-trials-8-things-to-know.html
Drugmaker Intarcia Therapeutics cuts 20% of workforce, terminates 2 late-stage trials: 8 things to know
Written by Alia Paavola | February 09, 2018
Intarcia Therapeutics, a biopharmaceutical company based in Boston, laid off 60 employees and terminated two late-stage trials of its lead diabetes treatment, reports the Boston Business Journal.
Here are eight things to know.
1. Eleven of the layoffs affected employees at the Boston headquarters, while the other layoffs occurred at Interacia's manufacturing plant in Hayward, Calif. Intarcia CEO Kurt Graves told the Boston Business Journal the layoffs were part of a restructuring plan and were not a result of the trial setbacks.
2. Mr. Graves does not expect the company's headcount, which was around 300 total employees prior to the layoffs, to significantly change in the upcoming months.
3. The company's lead diabetes treatment, ITCA 650, is a small device that is surgically inserted into the abdomen and gradually pumps tiny amounts of the drug exenatide into the blood stream.
4. The trial setbacks for the ITCA 650 began in late September when the FDA declined to approve the drug-device. Despite the setback, the company will still fight for approval.
5. However, the company hit another snag. Intarcia recently announced it terminated two Phase 3 studies of ITCA 650. One study, a marketing study, compared the device to other approved treatments of Type 2 diabetes. The other study tested ITCA 650 in patients with high levels of hemoglobin. While neither study is necessary for FDA approval, Mr. Graves said Intarcia needed to halt the studies to investigate an "out-of-specification" result.
6. According to Mr. Graves, one of Intarcia's third-party labs found issues regarding the long-term sterility and stability of the device. The FDA placed a hold on the studies while they investigated the issue. Because the drugmaker was unable to identify the root cause of the issue and was unable to address the FDA's concerns over the device, the trials were terminated.
7. According to Mr. Graves, patients would have continued to drop out of the studies after the issues were brought up, which would have rendered the data useless.
8. Pending discussions with the FDA, the company plans to relaunch similar trials and is still seeking approval for the device.
This sick puppy (no offense to dog lovers) is sinking fast. Device always sucked and the hall way rumor is new design, new process, new validation, new stability, new clin trials (and wait for data since previous data are questionable), new submission (since everything changed), another round of PAI, etc. = 3+ years
Adios Intarcia
Next layoff will not spare Boston. Expect about 20% on the chopping block.
Intarcia Announces Medici Magic - Disrupting Refrigeration For Ever
Are you one of those outdated losers who owns a refrigerator ? Why throw it away today !
Medici Magic allows proteins to stay at elevated 98.6 degrees for FOUR YEARS with out degrading
Why that's right MEDICI MAGIC now refrigeration required
So throw out that bulky refrigerator, let your ice melt, Medici Magic NEVER freeze again !
Act now and you will receive two sets of never need sharpening knives and can't be broken bowls
Why Medici Magic !!
This offer not available to regulatory agencies detecting pesky or annoying impurities, degradation products, lack of sterility, lack of consistency, or a callous disregard for compliance.
Are you one of those outdated losers who owns a refrigerator ? Why throw it away today !
Medici Magic allows proteins to stay at elevated 98.6 degrees for FOUR YEARS with out degrading
Why that's right MEDICI MAGIC now refrigeration required
So throw out that bulky refrigerator, let your ice melt, Medici Magic NEVER freeze again !
Act now and you will receive two sets of never need sharpening knives and can't be broken bowls
Why Medici Magic !!
This offer not available to regulatory agencies detecting pesky or annoying impurities, degradation products, lack of sterility, lack of consistency, or a callous disregard for compliance.
But waiiit! If you call now at (617) 936-2500 you get the 2nd Medici free, that's right flee, just pay only shipping and handling!
Disclaimer - Medici is known to contain lot of impurities and various unknown contaminants especially from spray drying, known to degrade once it hits body temperatures surrounded by wet blubber and not sterile cos your tummy is not sterile environment. FDA adamantly rejected it but hey who cares?
Ohhh that Graves special touch - Achillion fires employees as failed strategy crushes shareholders
What a jerk
What a jerk
WHAT ?? A COMPLIANCE PROBLEM ?? WTF WHERE IS THE CURING PATIENT COMPLIANCE BULLSHIT ?? LIES LIES LIES GONNA GIT U
PATIENT DROP OUTS ARE AN EXAMPLE OF POOR PATIENT COMPLIANCE
KG certainly has the midas touch to turn worthless pharma companies touted as disruption (so sick of this word) into what they really are - used TP (toilet paper).
KG certainly has the midas touch to turn worthless pharma companies touted as disruption (so sick of this word) into what they really are - used TP (toilet paper).
PT Barnum of the biotech - "Theres a sucker born every minute, who can be fleeced of their nickels for a good story"
Oral beats surgery every three months
Highly anticipated phase 3 results for Novo Nordisk’s oral GLP-1 diabetes therapy, semaglutide, are here, and investors of Novo rival Eli Lilly are taking note.
Positive study data showing that each of three semaglutide dosage strengths could outdo placebo at improving the blood-sugar measurement HbA1C sent Lilly shares downward Thursday, with investors fearing a serious threat to the Indianapolis drugmaker’s own GLP-1, Trulicity.
Novo cheered the data, with CSO Mads Krogsgaard Thomsen adding that “we look forward to … an expected regulatory submission in 2019."
So Clown Patrol when semaglutide launchs will we hear your silly stories about surgical implants ? Your days to extinction are approaching. Bye Bye Pump Boi
Highly anticipated phase 3 results for Novo Nordisk’s oral GLP-1 diabetes therapy, semaglutide, are here, and investors of Novo rival Eli Lilly are taking note.
Positive study data showing that each of three semaglutide dosage strengths could outdo placebo at improving the blood-sugar measurement HbA1C sent Lilly shares downward Thursday, with investors fearing a serious threat to the Indianapolis drugmaker’s own GLP-1, Trulicity.
Novo cheered the data, with CSO Mads Krogsgaard Thomsen adding that “we look forward to … an expected regulatory submission in 2019."
So Clown Patrol when semaglutide launchs will we hear your silly stories about surgical implants ? Your days to extinction are approaching. Bye Bye Pump Boi
Intarcia is fucked.
Implode within due to gross negligence and incompetence, Feds after them and now GLP oral in addition to daily/weekly injections with proven cardio benefit.
Say what's the annual cost of 4 ITCAs, 4 implant and 4 explant surgeries (added benefit of external scars) and additional doc visits?
Guessing game. Name the biotech?
Regulatory - fucked
Manufacturing - fucked
Med affairs - fucked
Sales force - fucked
Marketing - fucked
Exec team - ha ha ha ha ha
Regulatory - fucked
Manufacturing - fucked
Med affairs - fucked
Sales force - fucked
Marketing - fucked
Exec team - ha ha ha ha ha