Intarcia Therapeutics

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Hey Gravsie what happened to your claim “this is the lowest regulatory risk of any program I’ve ever been a part of” ???

since you completely screwed the pooch - come on who follows two rejections with three failed attempts to whine your way to approval ?

you must be THE biggest fucking loser in this industry. Pissed away almost 2 BILLION on bullshit
 








Intarcia Fight For FDA Approval Of Exenatide Twice-Yearly Reaches Endgame; FDA formally published a notice of its intent to reject the NDA for the GLP-1 inhibitor delivered via privately-held Intarcia’s DUROS “osmotic mini-pump” device. FDA has issued two “complete response” letters for the application and rejected three layers of appeal under the Center for Drug Evaluation & Research dispute resolution process. Intarcia requested a hearing as a final step in the appeal on March 16; the Sept. 1 notice allows Intarcia to submit a justification for a hearing, which the Commissioner will decide whether to grant. FDA notes that the complete response letter lists a series of deficiencies in the application, including (1) risk of severe kidney injury; (2) cardiovascular outcomes trials that suggest a potential increase in risk of adverse events; (3) concerns about in vitro dose delivery specifications for the device; (4) concerns about device failures; and (5) adverse inspection findings. “Any hearing request from Intarcia must address all of those deficiencies” in order for a hearing to be granted, FDA notes.
 
















Patients in the hospital with acute kidney injury. Increased risk of major cardiovascular events - stroke heart attack. Unsterilized contaminated products. Unsupported claims of gigantic value. Outrageous compensation. Multiple failures. Multiple rejections. Financial ruin.

typical Kurt Graves outcome. What an a**hole.
 
































Intarcia Demands FDA Hearing on Anti- Dwarfism Bias

Clearly the core of the FDA rejection in bias against the only Dwarf led biotech Company in the Industry. Once towering over 6 feet tall as a Major College Football Captain, late onset dwarfism has caused Kurt Graves to shrink every year. Much like Dorian Grey, as the picture of the truth becomes clear, the shriveling is now taking place at a faster rate. Why he is so tiny, we can hardly hear the claims of why the Unicorn will transform the Industry. The only reason why the FDA would reject this Multi Billion Dollar Peak Sales Once A Year Magic Pump is due to anti-dwarf bias.

Speak up now ! The smaller the man the bigger the lies. End bias against dwarfs.
 








anonymous said:
Will KG and OH claim mental condition affecting "issue of guilt" like EH, ex-Theranos CEO, not to mention delusion and believing their own lies as defenses to the upcoming criminal and civil lawsuits?

Will OH snitch on KG to save his skin or KG play dumb and blame it all on the street wonder boy OH for pulling in the pharma scam of the century?
Click to expand...

OH will say “hey I left” KG said no problems, no trials, no CMC
 








Newsflash!

Intarcia faces FDA refusal to approve as push to get diabetes delivery system to market enters endgame
by Nick Paul Taylor |
Sep 7, 2021 10:50am

Intarcia Therapeutics has hit another roadblock at the FDA in its effort to win approval for a GLP-1 delivery system. After issuing two complete response letters and denying three dispute resolution requests, the FDA now plans to refuse to approve Intarcia’s filing for approval in Type 2 diabetes.


Boston-based Intarcia raised more than $1 billion on its route to the FDA but has been hit by a series of setbacks since filing for approval of a small implant designed to deliver the GLP-1 receptor agonist exenatide. The FDA issued complete response letters in 2017 and 2020 in response to two requests for approval.

In a Federal Register notice (PDF), the FDA set out events since the second rejection. Intarcia submitted three formal dispute resolution requests last year, all of which were denied by the FDA. The FDA also denied a request for an advisory committee meeting.


Intarcia responded by submitting a request for a hearing on whether there are grounds for denying approval of the new drug application. The FDA plans to issue an order refusing to approve the filing because of concerns about the safety of the candidate and issues with its production.

RELATED: FDA once again rejects Intarcia's 6-month diabetes drug implant

The proposal puts the ball in Intarcia’s court. If Intarcia wants to keep pursuing the matter, it needs to ask for a hearing and provide information to justify its request. The request will be granted if there is “a genuine and substantial issue of fact that requires a hearing to resolve,” the FDA wrote. As the FDA sees it, that means Intarcia’s request needs to address its criticisms of the submission.

Some of the criticisms, which the FDA lays out across several pages, relate to the delivery system. The FDA said the “in vitro device performance data demonstrated inconsistent day-to-day drug delivery,” contributing to the FDA’s conclusion that the evidence doesn’t support the safe and effective use of the device.
 
























Ah the poor investors all lined up bent over with lube of their choice for rounds of good ol run a train bathhouse actions with strap-ons (cuz small tool sizes) by the midget gang KG and his midget money raisin/lubin henchman OH!

Well enjoy it midgets as you will be on the receiving end and blowing off giant Bubbas in the federal penitentiary!
 








Did anyone notice the dates when the FDA first informed Intarcia of the various safety and device problems ?

the wire fraud will focus on “how” they continued to raise money and “what” they said

seems like the FDA has provided continuous feedback that the pump doesn’t work, wasn’t able to be manufactured, and patients were harmed

Some people might say “lies, lies, lies”
 








Is TA lawyering up? KG will plead ignorance about everything and especially the joke implant with reams of email shreds of evidences from clueless ahole TA claiming everything is oki doki on the device front.

Hey TA - sold your Ferarri and Porsche yet? You were with this shitter for 20+ years so you are responsible, motha xcker!
 
















One thing is for certain KG’s Golden Rule is take all the credit and blame others for everything that goes wrong

burn thru a couple of billion ? Must be….OH’s fault ? TA’s fault ? FDA’s fault ?
 
















anonymous said:
Is TA lawyering up? KG will plead ignorance about everything and especially the joke implant with reams of email shreds of evidences from clueless ahole TA claiming everything is oki doki on the device front.

Hey TA - sold your Ferarri and Porsche yet? You were with this shitter for 20+ years so you are responsible, motha xcker!
Click to expand...

TA's lawyer is working the tyrannical, egomanical, indentured servitude angle and trying to keep the people who toed his lying corporate line from telling the truth (Stockholm syndrome is real). KG's is working the millions spent at island retreats where he learned how to maximize his profits while telling someone else to fly the plane into the mountain and his boondoggle trips to SF so he can indulge his fetishes away from the happy family. The rest just saw $$$ and decided to jump on board for an easy payout. The real victims are the employees. Hopefully they can see how they were used and abused and will spill all the tea. They haven't been skimming off the top all these years, unlike others, and ended up unemployed and abandoned while the corp thieves drive off in their fancy pants cars laughing all the way to the bank.
 








Janet Woodcock just announced Intarcia's Medici Pump has been retroactively approved for marketing as of Jan 1 2014. The announcement includes a CMS reimbursement compensation of $7.3 Billion to Intarcia due to the gross FDA errors that resulted in these lost sales. President Biden scheduled to speak on the debacle tonight at 5pm analysts expect the President to apologize and announce that COVID19 Vaccine Boosters will be administered using the Medici "Magic" Pump. Earlier today thirty seven Senior FDA administrators resigned as a result of these actions.
 








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