Liar - and Moron- How would ANYONE KNOW?! NO HYALURONAN CONTENT TEST is being done for Entry into Ph 2 !!!!!!!
The "Student" Knows Nothing- Makes it up as he goes along and lies- see one on my FDA Fast Track Thread- caught red handed.
"aniustudent • Apr 21, 2014 6:03 PM
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."
OOOPS - Liar!
Breakthrough Status is requested by the company, generally on Phase 2 data- see ICPT and Aduro- on EFFICACY data not Ph1 most;y SAFETY data- Geez- use your computer once in a while - it's embarrassing- like your hyaluronan test for ph2
Breakthrough status usually comes on Ph2 data- count on PegpH20 getting it- nothing has ever come close to the little Ph1b study's 529++ day MOS with Gem= 3x Gemcitabine's alone. Aduro Biotech just rec'd Breakthrough status by adding 2.2 months survival in the same patients. Your point is ludicrous. (I'm still waiting for your answer to my point that 1 Injection of HyQvia a month is superior for stockpiling for emergency situations to 20 injections of Hizentra- limited by volume per injection and duration of activity- in spite of the need for readily available refrigeration.}
529 day Median Overall Survival in High Hyal Grp (87% of Panc Ca IS) extended at least 2 mos per Greg Frost at Q3 2013 Earnings Call = "Not yet Mature". ESMO releasing Poster info 9/17 and papers 9/24. GLTAL
6 month guidance on 12/2 then new data with 3 month dealyu announced 5/21
Post ADCOM Note
IV Immunoglobulin is GENERIC- The Invention that was Developed is rhupH20- by Greg Frost- coFounder of Halozyme- He's combined it with Roche products and now Baxter- this is not mere supplying, this is creating- the competition can only deiver small quantities of Ig so a patient gets stuck 25 times a month with the competition, instead of ONE stick a month w HyQ- That's the advantage HALO developed. Baxter is marketing it.
$900M US $300M EU per Barclay's Analyst Huang- Pretty Big= $1.2B Actually
HyQvia - Actually 2 Yrs Not 18 mos as I Previously wrote- Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
So You don't think the National Strategic Stockpile has Generators and Refrigerators for Blood Products? You think they'd want to store 2-4x as much product requiring that much more labor to distribute and supervise administration in order to avoid refrigeration? I don't. In emergencies, Less Work for More Effect is Key.
Eye on FDA - Rx for Pharma Industry Communications and Planning
From - When Does FDA Extend a PDUFA Date?
August 30, 2010
18 month shelf life is more than sufficient specifically because HyQ can be given once a month vs Multiple times a month- such as with other SC Ig Products- so less stock is required per population and less ancillary healthcare is required at a time when that staff will be otherwise occupied.
IVIG is already stockpiled- so what formulations and why?- the addition of rhupH20 to Ig does nothing to reduce it's duration of activity. Explain your theory.
Well HyQvia will be as well- as a subcutaneous Rx it is more Mobile and faster to administer for same level of protection. It will be packaged like the Imitrex shots Migraine pts give themselves now (sort of Spockian).
I agree with most, but clearly the estimation of the new leadership's innovation should have been held until the partnering therapy for PegpH20 in the new NSC Lung Ca indication is revealed- Abraxane? Avastin? Xalkori? They all signal very different and promising directions.
Cervical cancer is not listed as high in hyaluronan in Therapeutic Targeting of Hyaluronan in Stromal Tumors- So I'm more interested in Avastin for NSC Lung CA- Avastin fails in Squamous cell lung ca and in all NSC Lung CA in those over 65 yo- perhaps Peg will change that.
The market acts as if Abraxane is generic and HALO is studying it- when in fact it's an important part of Celgene's portfolio and is in need of help tio keep Dr Leonatrd Saltz and those oncologists who think like him from taking it off formulary at their hospitals ( his is Sloan Kettering).
So, Celgene is potentially involved in 2 sites with Peg------- As Don Corleone Said to Michael- Whoever comes to you with the deal is gonna take you out (GSK, LLY, Roche, PFE, and Celgene all have horses in the NSCLC race).