Intarcia Therapeutics

Oncology is fun. Had to dump busted down pump. Forgot to tell Gates this pump was already unsuccessfully commercialized. He thinks KG discovered something new. That’s why I left

 

Few anecdotal facts to point out why ITCA will fail once it gets approved (that is big when) and commercialized:

1. Bayer's Viadur pump was not only a dud but in rather crowded prostate cancer drugs and treatments space like Type 2 diabetes
2. Viadur was not selling and there came a point Bayer had to stop bleeding money selling this unpopular treatment not to mention stuck with expiring pumps
3. Add to this creeping manufacturing cost and the clincher - limited long-term market viability
4. Onc docs are not surgeons like endocrinologist and primary care docs
5. Difference however may be that onc drugs can sell for premium vs. generic GLP1 drugs

https://www.fiercebiotech.com/biotech/marketing-of-viadur-r-leuprolide-acetate-implant-to-phase-out-by-april-2008

 

The fibrotic response to the pump requires that physician dig the pump out from a collection of connective tissue. If you can only see the damage on the removal sites yourself. OMG 20 minutes to cut the thing lose ?

Just wait until the Africans try this.

African Americans are seven times more likely than Caucasians to develop an excessive growth of thick, irregularly shaped and raised scarring on their skin – known as a keloid – following surgery, according to a new study from Henry Ford Hospital in Detroit

 

Why did TJ quit ? Lots of rumors but what is the real deal.

 

Keloids have a very small incidence among the general population, but dark-skinned individuals are much more susceptible. Keloids have an incidence rate of 6-16% in African populations. All populations with a higher skin melanin content are known to have a higher incidence of hypertrophic scars. These populations include people of African, Asian, and Hispanic descent.

Keloid scarring has been known to occur only in homo sapiens. No other animal species, including non-human primates, have been found to naturally develop scar tissue comparable to that of human keloids. Thus, keloids represent a disease process that is uniquely human, and establishes a challenging precedent to overcome.

In addition to the genetics, several other factors play critical roles in clinical presentation of KD. Most importantly, there must exist an injury to the skin that would trigger abnormal wound healing response which leads to formation of keloidal lesions. Obviously, there is a wide spectrum to the severity and extent of skin injuries, ranging from very minor insults to the skin from acne, or piercing, or vaccination; to more severe forms of skin injury from surgery or burns. Besides genetics and skin injury, other important factors are age, race, gender, chronicity, therapeutic interventions as well as location of the keloidal lesions. The wide spectrum of all these factors contributes to highly variable phenotypes of KD.

By far, the most important factor in development of a primary keloidal lesion is the injury to skin that leads to triggering of pathological wound healing response. Piercing of the ears is a well-recognized triggering factor for development of primary ear keloids. Knowing that KD is a genetic disorder of wound healing processes, it is counter-intuitive to resort to surgery as the mainstay of treatment. Surgical removal of keloids is a commonly practiced intervention, not only by ear-nose-throat specialists, but also by plastic surgeons as well as general dermatologists. Surgical intervention however, defies the very basic principal in keloid formation. The injury and insult from surgery to the skin that surrounds a keloidal lesion, on its own, will undoubtedly trigger a keloidal wound healing response that often leads to formation of a new keloid.

Additional treatments in form of post-operative steroid injections, or even radiation therapy are commonly incorporated in management of every KD patient who undergoes surgery, simply to counter the fully expected recurrence after surgery. Yet despite diligent use of all available additional methods, a significant number of keloid patients will have a recurrence, which is often worse than the original keloid they had, and they undergo second, third or fourth surgery. In many unfortunate instances, keloids keep relapsing and at some point, either the surgeon, or the patient, or both, give up and the unfortunate patient ends up accepting the truth about inability of surgery to treat their keloids and see no other choice but to surrender to living with huge tumoral keloids on their ears. Almost all very bad cases of keloid that you may see, those with the most horrible keloids, are among this unfortunate group of patients.

 

But, but they male look so easy on the dummy? Easy to shove in thru the soft latex tummy and golly gee easier to yank that puppy out from that, well used, dummy?

Just can see novice primary care docs calling 911 or ambulance unable to remove that darn entangled mess thang deeply embedded or heck can't locate on fat blubbers with blood spilling out and patient just freaking out in horror and pain. Docs horrified with malpractice claims and serious infection not to mention ugly scar. That's the ticket I tell ya!

 

does anyone even care about this toilet swirling mess ?

 

Hey Now. This is actually a cult. Everyone is supposed to believe the lies and pretend the Emperor is wearing clothes. Really the cult members hunt down the nonbelievers. It's Jim Jones Cool Aid. Worship Kurt or Die.

 

Calling Intarcia and senior management "disgraceful" is being far too kind...I would go as far as to say
they are truly evil, and that is not a word I use lightly. I was forced out over the disaster in Hayward, and their actions sent me on the verge of a nervous breakdown and PTSD which I still struggle with today. All the while, Graves and his cronies get richer, and lives and families are ruined. If the public only knew what Intarcia was all about...

 

Intarcia LT and Hayweird in particular is an overflowing cesspool. Seen few people fired for pissing off the thin skinned insecure weasel management and sincere desire to do the right thing. It is structurally corrupt and no wonder received CRL.

Kurt and LT still fantasize about getting out of CRL rathole they dug up but there are so much to do that approval in early 2019 is likely facing Teva's generic GLP-1, Novo's OSD GLP-1 and doubts about messy and costly surgeries to implant and especially explant.

PS - Karma is a bitch aholes!

 

From the manufacturing side of things, everything in Hayweird feels broken. Halls are filled with discussions about failed results and deviations in all aspects of the operation. Even simple projects become impossible- working to solve one issue uncovers three more. Site leads hung up on sunk costs of the facilities and equipment that support a slow, fault ridden, manual manufacturing process they've "developed". Must be the person who knew what they were doing is gone now... the architect of this current manufacturing process sure doesn't. It looks like someone blew up a benchtop lab experiment in the xerox- complete with mixing bowls and spoons! There are rarely sound rationales or good science behind critical design decisions, and when challenging why something is done a certain way, you learn the "experts" don't really understand the process or their product. They're unwilling to heed advice of numerous, expensive consultant groups and take that step back to rebuild things the right way.

Cancelled projects and rumors of shrinking headcount with at least reduced number of contractors in near term. This baby doesn't look like it'll have enough steam to make it to market... not to mention that if it gets there, it sounds like no one's going to use it.

 

Yeah cant sleep again. Tossing all night because I feel more used than the gals they picked up at that hotel near the airport. Sheeit. Anyone know of decent East Bay/Livermore openings ? As a single mom, I've got to stay local cuz the kids get out of Bowman and walk home. How bout Roche Molecular ? Anyone... Anyone... ?

 

Everyone stop piling on Teva generic as a threat. It's not coming. They are waiting for lira to get into diabetes. Not sayin' ITCA is going anywhere, but Teva won't be a factor for a while. NNI/Sema oral, on the other hand...
Kurt should've spent less time decorating his new offices and more time "disrupting" his CMC processes. Resubmitting in February? Joke.

 

Agree 100%. Hayweird is a hodge podge of weirdness and WTFs. Thought I walked into a time warp back to the benchtop lab development days at Alza with what should have been prototype processes literally done by hand. This kind of process should be done via semi-automation for clinical production let alone commercial but what the idiots did were to replicate more of manual mixing and filling cells rife with various faults and contaminations inside a warehouse.


There is 1 common thread and it’s complete lack of process characterization let alone control thru out as result of too many cutting corners and taking on huge risks across the board to speed things up. There appears to be little rhyme or reason let alone scientific or methodical approach other than just do what I say ASAP by clueless self proclaimed “experts”. One can get into trouble for asking why such piss poor decisions and wild ass assumptions were made. They bring consultants then argue with them and fire them for not supporting their positions. It’s amusing to see these guys keep on failing validation especially on manual process as they chose not to do feasibility and characterization studies to save time and results speak for themselves. FTEs and consultants are expected tacitly water down the awful results by the management but more, not less, issues are discovered along the way.


Just don’t see how these clown leaderships in 3-ring circus can ever get their act together to muster another run to remediate the ever growing issues beyond what the Feds found. Their best option is not palatable but a new commercial process and facility and 2 more years which should have been the case given how much money the company claims to have raised. Anyway it has been a nice and profitable ride for the contractors and consultants. Pity the demoralized FTEs and especially those who joined this circus in last 2 years. Some “employables” are planning to leave though many are just content collecting paychecks till Hayweird implodes within.

 

how dare you question the leadership of this company ! You are clearly an ungrateful unhappy person who should find some other job. Get with the program or get out.

 

KG already disrupted the CMC once and it didn't go well. He and his cronies camped out in Hayward to pester people to do the impossible (especially since some data weren't ready and even took out key section since failed, etc.) resulting in shoddy and incomplete NDA submission. Excuse given was to appease the investors and for the badly needed milestone payments.

History undoubtedly repeats as usual KG is calling the shots to re-submit by Feb when not even close to being ready. I have disdains for FDA but boy glad they are doing their jobs for calling out the flim flam work at Intarcia. LT is just hoping to snow the FDA but we shall see as heard the FDA people were surprised by what they saw whether it be the facility, processes, testing and device mess.

 

Ha Ha Ha that's just BS for the investors. Important to keep up a good disruptive story. What total crap try resubmit in 2019

 

All bout them lies. Just keep lying. Just keep lying.

 

Lies? Nah! Thompson Twins Lies song may be the new anthem for Intarcia? Just replace the word they with FDA, investors, maybe SEC, etc.

Lies lies lies yeah (they're gonna get you)
Lies lies lies yeah (they won't forget you)
Lies lies lies yeah (they're gonna get you)
Lies lies lies yeah

Oh you know I know

Lies lies lies yeah

 

What are the lies?