In 2013 Remicade- an IV drug for Rheumatoid Arthritis- generated a tremendous $8.9B in global sales-its patent is due to expire in most of EU in 2015 and in US in 2018." JNJ Facing a big loss turns to HALO Enhanze, as Roche did for #11 and #24 drugs on the 2013 Top 100 Drug list.
He needs to believe that I have a million handles when I have only one.when you and confused trader tell h to leave - that makes 3 of us -
Do either of you two have any helpful science to contribute? It Would be a first- If Not - why don't you hold the door for each other and yes - leave. I have no connection to confused trader, but I totally agree with him.
Thank you for the kind words. I called him out early on one of his pompous tirades against me in which he declared authoritatively that a patient in 202 by definition could not have low hyaluronan content.
There is no hyaluronan screening in 202.
What a horrible short- bring back Fgnoms- some intelligence- this guy is a jock sniffing fast twitch ignoramus
J&J is NOT going to let Roche corner this market- Subcut means faster less costly therapy- favored by NICE, NHS and future 3rd Party Payers.
Janssen has a huge pipeline- Onc and Neuro especially- pleanty to keep funding PegpH20 trials for years to come!
.Yes So CFO was On time after all- Gave himself some wiggle room but came up with ANOTHER First Class Collaboration ! One two punch on target for 1/12 ASCO Embargo end...then 2015 the year of the compassioonate halt (on efficacy)
"In trading on Monday, shares of Halozyme Therapeutics Inc (HALO) entered into oversold territory, hitting an RSI reading of 29.3, after changing hands as low as $7.69 per share. By comparison, the current RSI reading of the S&P 500 ETF (SPY) is 35.7. A bullish investor could look at HALO's 29.3 RSI reading today as a sign that the recent heavy selling is in the process of exhausting itself, and begin to look for entry point opportunities on the buy side"
There is so much data on early study 202 patients that the CEO alluded to at Oppenheimer but that she can't tell us about- people who got "many cycles" of pegph20-gem- are they still alive a year later? Has their disease progressed? I look for clues- like why would they be laaunching lung with a preannouncement on Anti PD-L1 if there wasn't data from early 202 that supported the small sampling record data from 201? The PR dept can't say a word about what's truly important. The MabThera SC-Revlimid study I found is nice but, again, it's all about PegpH20.
And What has gone wrong to drop he PPS since? Sure the Halt which was quickly lifted with an improved and more clinically applicable protocol And the $13 offering. Otherwise Halo saw an FDA approval of HyQvia- something many critics said would never happen as it paves the way for an eventual diabetes label- and commercial launches of MabTheraSC in EU and HyQvia in The US. No piece of good news has been given its due and in fact they have been used as an excuse for a drop in pps. WHY? by Whom? By the 71%- the institutional owners accumulating HALO ahead of Jim Birchenough's prediction, and telling you black is white.
So we get a Lung Cancer trial this month- by EOY 2014 per CEO-what happens if that hits- as preclinical data suggests it will? What if PegpH20 Fails for Pancreatic- As I believe it Will NOT- and hits for NSCLC? Well Lung Ca is 3.5x more prevalent than Pancreatic and NSCLC is 85% of Lung Ca. I'm sticking around to find out.
Your concerns and questions are well founded. Please analyze 2014. Torley left AMGN's ONXX division and a long impressive career at both companies which helped lead to the buyout expressly for the drug she went to ONXX to launch- Kyprolis. She has said as recently as the Q3 Halo earnings call that she came to HALO for PegpH20. She came in December 2013 - about 3 months after the ESMO data when all know and discuss. Obviously she has given aces to more data. For all those who have questioned the validity of these incredible results, this post is titled ASCO has Koshered it- it has been reviewed by press in the field of oncology and found to be worthy. Let's analyze it for a second- because it has become so familiar that it just seems "OK"- like the guy who gets to wake up to your favorite hot movie star and just gets used to her looks. 7.3 month Progression Free Survival is longer than Folfirinox (6.6) in the same setting. Nice, but 529d Median Overall Surv is a new number that has never been approached before- Folfirinox the previous leader at 333d. AND Greg Frost the inventor and previous CEO Stated at Q3 2013 Earnings - 2 mos after ESMO that the data was still not mature. I cannot tell you why I'm the only one writing about this BUT The BMO Analyst Jim Birchenough is as big a fan of PegpH20 as Torley or I am. He has maintained is $24 PT till today expecting greta data and/or a buyout first. My advice is don't be the guy who sold Kim Basinger. And don't let someone tell you she's not beautiful (in her day) - see for yourself.
"That is all Ye know on earth, and all ye need to know."
This Trial is a Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma
This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by International Extranodal Lymphoma Study Group (IELSG)
International Extranodal Lymphoma Study Group (IELSG)
Welcome- and news maybe sooner than that- yes the ASCO GI Embargo on Peg1b final data lifts 1/12, but the CFO said he's hoping for a new Enhanze deal by EOY- so that can tide you over until the 19-22 mo Median overall survival is unveiled.
I'm hoping what they know about Peg from the early enrolled makes this all seem like idle chatter- imagine seeing 7-8 mo PFS and then welcoming those patients back week after week- makes Enhanze news seem petty- That's what I'm expecting.
Now the Liar Pentech chimes in - always had embarrassingly poor reading comprehension since his Fgnoms days- claims I want a "cheque' - read your fellow shorts explanation of why that can't be true you ignoramus.
Celgene's successful product is being teamed with Roche's partnered Halozyme product to fight Non Hodgkins Lymphoma- this shows how Halozyme's Enhanze platform will continue to spread into a wide range of protocols- funding PegpH20 trials for years to come.
Efficacy of Lenalidomide in Combination With Subcutaneous (SC) Rituximab + miniCHOP in DLBCL Patients of 80 Years Old or More
This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by The Lymphoma Academic Research Organisation
The Lymphoma Academic Research Organisation
Information provided by (Responsible Party):
The Lymphoma Academic Research OrganisationClinicalTrials.gov Identifier:
First received: April 23, 2014
Last updated: October 28, 2014
Last verified: October 2014
History of Changes Full Text ViewTabular View No Study Results PostedDisclaimerHow to Read a Study Record
First Received Date ICMJE April 23, 2014
Last Updated Date October 28, 2014
Start Date ICMJE June 2014
Estimated Primary Completion Date December 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE
(submitted: April 29, 2014) The overall survival (OS) [ Time Frame: OS rates at 2 years ] [ Designated as safety issue: No ]
OS will be measured from the date of randomization to the date of death from any cause. Alive patients will be censored at their last contact.
Original Primary Outcome Measures ICMJE Same as current
Change History Complete list of historical versions of study NCT02128061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE
(submitted: September 8, 2014) •Progression-Free Survival (PFS) [ Time Frame: PFS rates at 2 years ] [ Designated as safety issue: No ]
PFS is defined as the time from randomization into the study to the first observation of documented disease progression/relapse or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment.
•Event-Free Survival (EFS) [ Time Frame: EFS rates at 2 years ] [ Designated as safety issue: No ]
EFS will be measured from the date of randomization to the date of first