Intarcia Therapeutics

Journalists sniffing around for break-through story that will bring fame and expose the fraud AKA Theranos 2 InFARTnos.

 

Who paid Taylor to write promotional materials for Intarcia ? When is the resubmission ? review in "6 months or less" ? So 2019 Launch of ITCA in US ?

Taylor Bertsch, tbertsch@wsu.edu

Intarcia does not expect that new trials will be needed to satisfy FDA requests, and with transparent guidance provided by the agency, Intarcia’s ITCA 650 is on a clear path toward release (16). If the ITCA 650 is processed via a Class 2 resubmission, review of an original application can be done in 6 months or less (17).

17.↵
U.S. Food and Drug Administration. Classifying resubmissions of original NDAs, BLAs, and efficacy supplements in response to Complete Response Letters. 2 February 2015. Available fromwww.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm.

 

“The charges against Theranos, Holmes, and Balwani make clear that there is no exemption from the anti-fraud provisions of the federal securities laws simply because a company is non-public, development stage, or the subject of exuberant media attention,” said Steven Peikin, Co-director of the SEC’s enforcement division.

 

HOW DO YOU SAY DUMB ASS IN FRENCH ?

Server pays $171 million upfront to license ITCA650

Regulatory filings around the world in the first half of 2016

 

And Servier is still not able to submit any file in 2019. When will be the trial?

 

servier s'est fait baiser

 

No, Non, Nope, Nyat. Did you say trial? As Curly would say nyuck nyuck nyuck. It's truy comical to see you idiots show hope in Infartnos... Suckas!

 

Hey Novartians how many times was KG busted by the FDA for exaggerated or false promotional claims for Novartian products ? Buddy was telling me that the dude is a compliance train wreck.

 

Graves Chief Marketing Officer for Launch of Exjade

Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Office of the Federal Bureau of Investigation ("FBI"), Gregory E. Demske, Chief Counsel to the Inspector General of the U.S. Department of Health and Human Services ("HHS-OIG"), and Scott J. Lampert, Special Agent in Charge of HHS-OIG's New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. ("NOVARTIS") in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic. The settlement resolves claims under the federal False Claims Act, 31 U.S.C. § 3729 et seq., and numerous state false claims act claims. The settlement also provides for resolution of claims against NOVARTIS under the federal civil forfeiture statute, 18 U.S.C. § 981 et seq.

 

History repeats and so do who perpetrates the cons.

As for the soon to be bagholding investors, they were merely playing with OPM (other people's money). Give this shady outfit another quarter or 2 till it goes into full implosion and spontaneous combustion.

 

I dont want to be stuck in Intarcia for the rest of my life, hanging along with idiots. I want to go out and look around. Swirling the toilet is not for me.

 

Longer you stay on more stale and stinky you will become What's worse is the reputation of Intracia amongst the recruiters, consulting/contracting firms and quality of people who used to and still work there - call it a real stinky cesspool. Heard it's so bad that 1 of many ex-temp recruiter was heard saying lot of shit about it. In other words - you are fxcked.

 

ROFL no it's not in The Onion

Try alumni news

Kurt Graves: Pharmaceutical Prodigy

OMG can't make this shit up

 

KG the emperor is deaf and more akin to parading naked king as in emperor in new clothes.

 

Failed stability and impurities tests have pushed resubmission into 2020. Another round of firings on tap.

 

Failed stability and impurities tests have pushed resubmission into 2020. Another round of firings on tap.

 

.

Told ya. That's what happens when clueless and spineless Hayward LT monkeys bends over to the whimsical whims from Boston LT gorillas. Hayward has been real good at cutting corners and that's how Intarcia got to where it is today and as predicted cut corners again on shitty 20 plus year old design, process development and validation on old shitty equip listening to worthless consultants who charges $250/hr rather than people who are toiling in the cleanroom.

As Einstein said "The definition of insanity is doing the same thing over and over again, but expecting different results.” Bingo!

 

this is not good news

 

there just isn't enough money for this perennial money loser to resubmit in 2020 and maybe (big if) approval in 2021. here comes another rounds of layoffs.