Does anyone know if the vaccine used in the Phase I was produced in the exact manner and at the same manufacturing facility as that employed in the phase II ?
Thanks, in advance, for any information regarding the above.
From a clinical standpoint, wouldn't the number/percentage of patients alive in each arm at 3 and 5 years be a better indicator of obvious significant therapeutic value? Isn't 1 1/2 years of observation a bit early to prognosticate ( i.e. witness a major separation in OS ) on the longer term benefit of the treatment versus the control arm given the natural history of the disease with the present standard of care?
How dramatic a separation in overall survival could one reasonably expect at the approximately 1 1/2 year follow-up time frame..... given the typical course of this disease with present standard of care treatment? Perhaps a surveillance at 3 and 5 years, noting percent survivors in each treatment arm, would be much more informative regarding ultimate effectiveness in a significant number of patients?
Thanks, in advance, for your input.
Early reports in CLL with CTL019 are very encouraging, but at first glance not as striking as in ALL so far. Would be interesting to see future results in solid tumors ( Heme and non-heme ).
CTL019:"In studies of adult patients with CLL, 15 of 32 adult patients (47%) responded to the therapy, with seven of those experiencing a complete remission of their disease (abstract #4162 and #873).......
In the pilot study of CTL019 for the treatment of adult patients (n=14; median age=67) with relapsed/refractory CLL (abstract #4162)........A preliminary analysis through July 15, 2013 showed that in 10 adult patients, 20% of patients (n=2) achieved a complete response (CR) and 20% a partial response, for an overall response rate of 40% (n=4)."
Points well taken. I believe this is a quality board with well informed posters (such as yourself) whose combined research, insight and knowledge, taken as a group, helps level the investment playing field dramatically.
"I trust the Baker Bros..... know a heck of a lot more than any of us individual investors"
I think that this is a great message board with quite a few very knowledgeable people, who are individual investors, and who post quite valuable information and insight on a regular basis. Perhaps the Bakers, as well as some of our fellow message board members, have reviewed the same publicly available ASH abstracts and have come to similar conclusions.
Good luck to all !
Does anyone know what the below is about? It is listed in the Seattle Genetics press release about the upcoming ASH presentations:
"Fucosylation Inhibitor, 2-fluorofucose, Inhibits NF-ĸB Activation and Vaso-occlusion in Transgenic Sickle Mice (Abstract #730, oral presentation at 7:00 p.m. ET) "
Thanks in advance for any help.
Your questions seem rhetorical and may, at least for some, further support their long term investment thesis in SGEN as a, presently, "best in class" ADC pharma.
I think that some of the issues which have been noted with the basic IMGN linker system ( apparently ) highlight the fact that ADC technology and production is a complex process involving many exquisitely sensitive variables. It also may serve to remind us that it might, thus, be harder more than easier to produce generics or "bio-similars" that can precisely achieve the full efficacy and safety of the original well honed and time tested product.
Good luck to all!
I recently sold about 10% of my holdings in SGEN and CLDX close to their highs. The reason for selling was a purely technical one.......both stocks had reached approximately 10 times my initial investment and that was my predetermined trigger to sell ( regardless of political or market factors ). So, basically, I am still long most of my shares.
I cannot predict how long this political situation will go on. I suspect some sort of compromise ( or, more likely, essentially putting off the problem for another date ) will come sooner rather than later. However, I am not overly concerned as I am basically a "buy and hold" investor and customarily wait out / stand on the sidelines during political or economic upheavals. I usually don't sell with the idea of buying back into the same stock at a later date. I buy ( or add to my share position ) when I feel a stock is under priced and then patiently hold long term.......taking profits periodically based on my expectations. I will also sell if the original reason or investment thesis that I purchased the stock reverses or does not exist anymore.
Best of luck. I know how frustrating and hard this political and economic environment must be for other individual investors like ourselves.
If ( a big, "IF" ) this therapy is shown to clearly be of significant benefit, could the expanded 100 patient trial serve as a possible registrational study, in this clinical setting, under the FDA's new breakthrough designation protocol?
Opinions, comment welcome
Or actually go back to the ASH paper from 2011 to read about the Sgn33A preclinical data that Clay just called " some of the best he has EVER seen".
I do not recall seeing that data on SGN-33a.
Could you provide a link or some keywords to find it in a search?