Intarcia Therapeutics

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hey sherlock - what ever happened to Europe ?? It's been a year are you saying this dog hasn't even been submitted for review ?? MIKE DROP - WTF

Who is running this shit show ??????
 






I was lulled into a false sense of confidentiality talking to him. We were working together and this subject mysteriously got started by him. He said he was an same-sex abused child. I responded that my child was too. I told him that the guilty party should be punished. He said to let it go and that all I wanted was money. It was the strangest discussion I've ever had. I felt betrayed since he discussed my disclosure to other people. Whatever happened to confidentiality?
 






I interviewed for a medical affairs position and turned down an offer. On interesting question for me is if IT650 improves compliance for exenatide. That is great benefit to the noncompliant diabetic patient. But how does that make the non-compliant patient compliant on their other medications.

Usually hospitalized patients come in with an A1c of >10 on 2-3 medications and usually insulin. At best exe decreases A1c 1.6. They are still walking around with 8.6..

Also they do not have favorable MACE data unless it was recently published.
 






anonymous said:
I was lulled into a false sense of confidentiality talking to him. We were working together and this subject mysteriously got started by him. He said he was an same-sex abused child. I responded that my child was too. I told him that the guilty party should be punished. He said to let it go and that all I wanted was money. It was the strangest discussion I've ever had. I felt betrayed since he discussed my disclosure to other people. Whatever happened to confidentiality?
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What are you talking about? Did Intarcia interviewer pull this off during the interview?
 






anonymous said:
hey sherlock - what ever happened to Europe ?? It's been a year are you saying this dog hasn't even been submitted for review ?? MIKE DROP - WTF

Who is running this shit show ??????
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The partnership with Servier who has the rights to ITCA outside US is in complete disarray... Servier is reportedly waiting for FDA approval before filing in EU and Hayweird to complete the process validations which keeps on getting pushed back due to myriad of issues like on-going contamination nightmares not to mention impurities issues.

As another person said on 8/4 here it's not clear who is running the Hayweird 3-ring circus.
"Hayweird is crazy - no one is in charge. Jetsetters fly in, take a dump, and fly out. Hey its a paycheck until something better comes along. Its funny to read people talking about sales. We have so much shit to clean up."
 












anonymous said:
I interviewed for a medical affairs position and turned down an offer. On interesting question for me is if IT650 improves compliance for exenatide. That is great benefit to the noncompliant diabetic patient. But how does that make the non-compliant patient compliant on their other medications.

Usually hospitalized patients come in with an A1c of >10 on 2-3 medications and usually insulin. At best exe decreases A1c 1.6. They are still walking around with 8.6..

Also they do not have favorable MACE data unless it was recently published.
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Excellent point on much touted A1c reduction claim and reality that typical patient is on multiple meds including insulin. ITCA is just another off patent reformulated exenatide and Teva's entry with cheap as dirt Byetta point to lot of GRAVE challenges ahead for anyone desperate enough to join the fray.
 






Has anyone been offered a DM job? This process has gone on for months and it has started, then stopped, then stalled, then restarted, and now it seems stalled again. The recruiters seem clueless as to what is going on. Recruiters say one thing then hiring manager says another. This seems like one hand doesn't know what the other hand is doing.

Anyone else have similar situation occur?
 






anonymous said:
Has anyone been offered a DM job? This process has gone on for months and it has started, then stopped, then stalled, then restarted, and now it seems stalled again. The recruiters seem clueless as to what is going on. Recruiters say one thing then hiring manager says another. This seems like one hand doesn't know what the other hand is doing.

Anyone else have similar situation occur?
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After more than 6 months in this stupid process another delay. That was the last straw and I am out. If they can't even execute a hiring process right imagine what will happen when they launch the product (if ever). You can't keep good talent on hold for that long. I am out! Good luck but I don't think this dog will ever hunt.
 






anonymous said:
After more than 6 months in this stupid process another delay. That was the last straw and I am out. If they can't even execute a hiring process right imagine what will happen when they launch the product (if ever). You can't keep good talent on hold for that long. I am out! Good luck but I don't think this dog will ever hunt.
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Sorry bloke. Just suck it up cos we are too busy mopping up excrements in all fronts. Talents are dime a dozen now and have plenty of eager and willing back-up candidates patiently waiting in the wing for the once in a lifetime opportunity to join the elites to disrupt the Type II diabetes market!
 






anonymous said:
Sorry bloke. Just suck it up cos we are too busy mopping up excrements in all fronts. Talents are dime a dozen now and have plenty of eager and willing back-up candidates patiently waiting in the wing for the once in a lifetime opportunity to join the elites to disrupt the Type II diabetes market!
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I hope this is a joke response. The only thing Intarcia has proven so far is how they can screw up a sales force build up. What a joke!
 












Ohh they havent called me ... waaaa waaaa waaaa if you are not mature enough to wait for the #1 most disruptive technology in the history of pharmaceuticals if you are not dedicated enough to patiently wait to hear the starting gun on the biggest launch in the US pharmaceutical business then YOU ARE NOT WORTHY
 






anonymous said:
Ohh they havent called me ... waaaa waaaa waaaa if you are not mature enough to wait for the #1 most disruptive technology in the history of pharmaceuticals if you are not dedicated enough to patiently wait to hear the starting gun on the biggest launch in the US pharmaceutical business then YOU ARE NOT WORTHY
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I smell a problem with the FDA. All of these delays can only mean one thing....manufacturing issues.
 






anonymous said:
I smell a problem with the FDA. All of these delays can only mean one thing....manufacturing issues.
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Indeed there are myriad of manufacturing and compliance issues in Hayweird. No wonder big shots fly in and out from Boston like they did last year to push thru the NDA filing which had lot of gaping holes cos Graves & company was in dire cash flow situation and filing the NDA triggered milestone payments by the investors.

Hayweird facility is beset with contamination issues as result of poorly planned and executed facility expansions as well as impurities issues from processing expansions. It's beyond Hayweird with their contract manufacturers. And there is growing fear of the scarlet letter CRL from the Feds.

So that's all folks and thus the reason for seemingly knee jerk stop & start of the field sales force hiring as there is nothing worse for cash strapped company to hire y'all sales folks and sit idle for up to 18 months till they get around to remedy the FDA concerns.
 






anonymous said:
Stop lying as there is no once a year ITCA! 1st year requires 3 implants in all 3-month starter, 6-month and 9-month the longest dose thereafter as well as each time interval implant requires 2 surgeries."
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Intarcia often mentions 1 year implant but their website only shows initial 3 month and 6 month? Is there 9 or 12 month implants? Has FDA been in Hayward to perform NDA audit yet?

Looks like the naysayers managed to silence the insider(s) who resorted to wishful dreams at best. Honestly what are the realistic pros of joining Intarcia?
 












Managed Care will require patients to step through generic Byetta before accessing any of the longer exenatide generics like ITCA650

Generic Byetta® (exenatide) Multi-Dose Pen • Teva announced settlement with AstraZeneca and Amylin which allows Teva to launch on October 15, 2017, pending FDA approval • Teva filed ANDA in December 2014 and it is under review – Teva has first to file status and 180 day marketing exclusivity • Symphony retail sales of Byetta in 2015 ~$300 million • Managed care plans require Bydureon patients (extended release Byetta) to step through generic Byetta
 






Not really once a year according to the European Medicines Agency

Type 2 diabetes mellitus; subdermally placed osmotic mini-pump providing 3 or 6 months continuous delivery of exenatide - second or third-line
Information
Entry type
New formulation
Company name UK
Servier
Company name US
Intarcia Therapeutics
Development and Regulatory status
UK developmental status
Phase III Clinical Trials
EU developmental status
Phase III Clinical Trials
US developmental status
 






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