"aniustudent • Apr 21, 2014 6:03 PM
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Since that is well known, she should not have been in a Phase II trial with low hyaluronan. Do you know how clinical trials for terminal diseases work? We're beyond proof of concept here. Earlier you debated with someone who stated only 5% of pancreatic cancer patients have high hyaluronan. Do you think it's that low now (based on one study)? If so, why the change of heart?"
Wrong, wrong, wrong....
OK Fgnoms- you are going to have to pull your own disgraced handle out of mothballs if you want a direct answer from me- I tried to have a civil conversation - but you just deflect with the Pentech and F Student handles- done.
FDA Will OK HALO
I will not directly address you again- just cover your posts with new ones until you admit to trying to put words in my mouth about "Roche New Plant for HALO products". If you don't you're just a sick eel slithering your way around this board. The FDA point was asked, answered, commented on and asked again.
MNKD's Adcom consultant did a great job stressing lowered hypoglycemia rates- HALO can walk in their footsteps and surpass them with the FDA to get label.
Quote me- Where Did I say That- Never Did- You are covering (attempting to and failing actually) your error- Like your error in substituting Shire for Viropharma when the decision to go with the parallel program was mad BEFORE the buyout- and the error that Nonneutralizing ab's are associated with clots-no one but you has ever made that innuendo- I'm waiting- find the thread or tweet where I posted anything about a new Roche facility making Only HALO products- HALO makes Enhanze- Roche makes IV MabThera- Combine the 2- MabThera SC- WAITING................................................................
"a mockery of your statement that Roche's new plant is just being built to manufacture HALO products"- That's about as accurate as you get- You are wrong again- the right answer is Baxter- and no not ONLY Halo products- lot of plasma related products- but since in the end 40% of AD which is ApoE-e4 will be treated w Gammagard SC/HyQ- a big part of the factory being built in Ga will be generating royalties for HALO.
I did address them and ypu answered my address- Frost/Loudwig said ALL FDA questions on titers were addressed and this last bit of followup data also addressed these answers- 7/31 is coming soon- the track record on Enhanze is 3-1 with Viropharma- NOT as you say Shire- forfeiting. On the other hand, Shire is selling Viroparma's Cinryze to a very limited audience compared with - say - INSULIN- I'm happy Doug Muchomre- ex Lily and Steve Daly- es Amylin marketing are on board to get that through- certainly the Afrezza approval shows how the FDA values low hypoglycemia rates- and HALO's were much lower than Afrezza's.
Not at all. SQ Cinryse was dropped after the FDA stopped its Phase 2 trial for the second time due to titer concerns- By whom? Viropharma- not Shire. Could they have done the work? Yes. Did they have a paralel program in place? Yes. Did you address it? No.
Peg, Cancer, and Abraxane cause TEs- LMW Heparin addresses that. In the history of FDA approved Hylenex use- there have been no increase in TEs in the treated population, nor have there been in the many Insulin or multiple Enhanze trial- Grape soda may cause more.
No the situation has changed- Greg Frost and Ludwig Hantson have both guided at their respective earnings calls that all of the FDA's questions have been answered. The recent delay was in fact due to a belt and suspenders provision of even more data by Baxter to further support the answers given with follow up data.
Shire had no role to play in Viropharma's business decision to perform the same work that Baxter did to support HyQ. They had a parallel product in trials- it stung the patients more but cost them less, so they accepted the "infusion reactions" over spending more before a buy out they probably knew was coming. Shire then in fancy bought them out. You'r again inaccurate and your failure to do DD about the parallel Cinryze SC is lazy.
The Adcom is for HyQ- Enhanze-not Hylenex. Thrice passed by the very conservative PRAC- the safety wing of the EMA. You and I are anonymous message board posters- our opinions are to the PRAC's what a gnat's opinion is to a stampeding elephant. You argument "How does Fezz know" is that of a 5th grader- maybe grape soda causes thromboemboli too- but in the whole history of biology, no one has successfully tied NONneutralizung antibodies or grape soda to TEs in any causative way.
1 last thing- nonnetralizing antiPH20 antibodies Were found in the Phase 2 Hylenex trial- in the PREexposure blood tests- seems exposure to acrosomal PH20 is not that unusual in Human Beings.
Cancer, PegpH20, and Abraxane all interfere with antithrombin- it's inhibition enables thrombin to form clots- LMW Heparin prevents this formation-the F basher in his post Herceptin approval guise is throwing pasta against the wall to see what sticks- but he's got it all Asp Backwards- as usual. In any case, the PRAC- the European safety agency has passed on Enhanze- rhupH20 - 3 times- HyQ, Herceptin SC, and MabThera SC- non neutralizing antibody TITERS (he throws that word around like it's a curse- just represents a measurement) do nothing clinically. The only valid concern with Ph20- the hyaluronidase found on the acrosome of sperm- is fertility- so HyQ will likely have a warning about this when its approved in the US.
I examined all the preclinical worries about Ph20 and its breakdown products a while back- but no animal research ever correlated with a clinical example, so I'll stick with the independent, scientific PRAC on this one.
And MNKD gets 2 new big Partner-Repelling Studies to Do- Thanks FDA!
Hylenex 5.8 episodes Hypoglycemia/1oo subject-mos
Afrezza 8.5 episodes Hypoglycemia/subject mo.
CDC sounds alarm on deadly, untreatable superbugs (in Hospitals & Nursing Homes where SC RX w RhupH20 most effective & Cost effective)
Deadly bacteria that defy drugs of last resort
A new family of antibiotic-resistant bacteria, known as CRE, is raising concerns across the medical community because of its ability to cause infections that defy even the strongest antibiotics. The antibiotic resistance is spread by mobile pieces of DNA that can move between different species of bacteria, creating new, drug-defying bugs.
By Frank Pompa, USA TODAYLiz Szabo and Peter Eisler, USA TODAY 5 p.m. EST March 6, 2013Health officials are raising concerns that it may soon be too late to stop superbugs.
A lab specimen of antibiotic-resistant Enterobacter cloacae, which belongs to a family of infectious bacteria, known as CRE.(Photo: Handout)
Superbugs are extremely resistant to antibiotics
CDC urges hospital workers to help prevent spread of these germs
These germs have been linked to pneumonia, bloodstream infections
family of "nightmare" superbugs — untreatable and often deadly — is spreading through hospitals across the USA, and doctors fear that it may soon be too late to stop them, senior health officials said Tuesday.
"These are nightmare bacteria that present a triple threat," said Thomas Frieden, director of the Centers for Disease Control and Prevention. "They're resistant to nearly all antibiotics. They have high mortality rates, killing half of people with serious infections. And they can spread their resistance to other bacteria."
So far, this particular class of superbug, called carbapenem-resistant Enterobacteriaceae, or CRE, has been found only in hospitals or nursing homes, rather than in the community, Frieden said. But officials sounded the alarm partly because, if the bacteria's spread is
Reuters- Roche returns to antibiotic research as superbug threat grows
By Caroline Copley
ZURICH Mon Jun 2, 2014 10:29am EDT
ZURICH (Reuters) - Roche is betting the same tools that made it the world's largest producer of cancer drugs will help it tackle the growing public health crisis of antibiotic resistance as regulators and politicians encourage fresh research.
The Swiss drugmaker used its expertise in in vitro diagnostic tests to develop highly-targeted cancer medicines. Now it believes it can use those same skills to find out quickly which bugs cause which infections, and help doctors kill them.
Experts are currently warning that superbugs resistant to even the most powerful drugs threaten to undermine modern medicine - requiring a response on the same scale as efforts to combat climate change.
Research done in 2010 with Roche's Ceftriaxone-Rocephin- shows the advantages of adding RhupH20 to sucut antibiotic- added Maximum Concentration and Duration- see below- surely Roche will use all weapons in its arsenal to traet superbugs and win the race over Cubist, CEMP, etc.
HerceptinSC Royalty Number- the Newest and Biggest Yet- came in 60 days after Q1 ended! Won't be released till early Aug Q2 earnings call. Torley was too busy talking to Amgen about Embrel- 2x/week dosing is too often- needs rhupH20- Pfizer partners- can put it in the deal already in place.
Add RhupH20 and twice weekly can be once or twice monthly- the same story as Pfizer's antiPCSK9- I wonder if Helen has called her old cronies at Amgen to help move things along. It makes sense.
Q3 2013 Transcript
fezziwig2008@fezziwig2008 · 16h
Gloat"fezziwig2008 Jun 23 I believe Australia is aTest Launch for MabThera SC Registration#AUST R207334 Major European Launch any day" $HALO
AS I posted here AND Tweeted- Australia was a test launch with Europe following "any day now" Fgnoms. ie The Australian Open!
Tell us again about those important Ph2 Peg trial Hyaluronan screening tests you hallucinated about......(OMG)