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I stand corrected.
My mistake. NSCLC.
It's on the corp presentation, slide 4.
Sounds good to me. I know all the sites are participating. Here's a list from a vet information site:
Southern Arizona Veterinary Specialty and Emergency Center, Tucson, Ariz.
Veterinary Cancer Group of Los Angeles, Culver City, Calif.
SAGE Centers for Veterinary Specialty and Emergency Care, Campbell, Calif.
Veterinary Specialty Hospital by ETHOS, San Diego, Calif.
VRCC Veterinary Specialty & Emergency Hospital, Englewood, Colo.
Veterinary Cancer Center, Norwalk, Conn.
Southeast Veterinary Oncology and Internal Medicine, Jacksonville, Fla.
Blue Pearl Specialty + Emergency Pet Hospital, Tampa, Fla.
MedVet Medical & Cancer Centers for Pets, Carmel, Ind.
Iowa State University, Ames, Iowa
Blue Pearl Specialty + Emergency Pet Hospital, Overland Park, Kans.
New England Veterinary Oncology Group, Waltham, Mass.
Blue Pearl Specialty + Emergency Pet Hospital, Southfield, Mich.
Oradell Animal Hospital, Paramus, N.J.
VCA Veterinary Care Animal Hospital and Referral Center, Albuquerque, N.M
Katonah Bedford Veterinary Center, Bedford Hills, N.Y.
MedVet Medical & Cancer Centers for Pets – Columbus, Worthington, Ohio
Veterinary Cancer & Surgery Specialists, Milwaukie, Ore.
Hope Veterinary Specialists, Malvern, Penn.
Upstate Veterinary Specialists, Greenville, S.C.
Sugar Land Veterinary Specialists and Emergency Care, Sugar Land, Tex.
Veterinary Specialist of North Texas, Ft. Worth, Tex.
The LifeCentre, Springfield, Va.
Bridge Animal Referral Center, Edmonds, Wash.
Wisconsin Veterinary Referral Center, Waukesha, Wis.
Though I am now loath to embrace the "2015-6-7-8-9 will be our year", we have more possible catalysts coming in 2019 to give your comment a ring of (optimistic) truth. We shall see.
The extended field safety study has been ongoing for almost a year but I don't believe Aratana has released any updates on a timeline for full approval.
Yep I give as I can to Make a Wish, Wounded Warriors and animal groups. If this pans out I'll add St. Jude and Shriners Hospital
Hopefully, Advaxis may be able to utilize this new program in the future for FDA approval.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm?utm_campaign=111618_PR_FDA%20approves%20first-line%20treatment%20for%20peripheral%20T-cell%20lymphoma%20under%20new%20review%20pilot&utm_medium=email&utm_source=Eloqua
I'm not doubting her qualifications (which look pretty good, thanks for the link). My point was Noelle did respond. From what I've read, Miriam Weber Miller isn't responding. I've tried to contact her but didn't get a response back. Anyway, hoping for positive data in the next six months that will put the PPS where it should be.
Noelle, whatever anyone may think of her, was very responsive to call and emails, until that weird period at the end. I did get to talk with her again after that period. She apologized for being incommunicado. She didn't give a reason for it and I didn't ask. I did hear back from KB recently in response to an email. From his words he seemed positive and enthusiastic about the data coming in the next few months. His answer was what I had expected as I made comments as opposed to asking questions. I was pleased that he took the time to respond.
Just passed 500K shares traded. Haven't seen that this early in the trading day for a while. Any thoughts?
How are the good results we've had so far explained if the science isn't sound? Not one trial has been halted for futility. I believe the science will be proven to be an effective, efficacious treatment for cancer. There is never a guarantee of a deal or buy-out but Amgen is building up it's cancer arsenal. Our products would fit in nicely with the rest of the ones they are developing. We can be had for a song.
For me, the jury is still out on KB. I believe the company he inherited may have been in dire straits than we realized. In spite of the missteps of former management, I believe he is trying to do what he can to turn this company around sooner. The fine-tuning of the AIM2CERV trial is a case in point. It could get us to a partnership sooner if the FDA agrees and should cut costs. Nobody can force a partner to take us on but I feel KB is what he can to rope one in.
"Sure, Jim. I’ll try to answer the question. But as with everything, it’s never really black and white. You look at a number of different factors, so it’s really a multifactorial analysis to determine what the best path forward is, especially when you have so many different portfolio items or so many different drug candidates within your portfolio, right? So as I said in my prepared statements, that over the past five months, we’ve looked at and talked to a number of folks, and rather than get into the details of those discussions, which are confidential, I could say that we’ve become more optimistic about the AIM2CERV study and we believe that the portfolio that we are now moving forward with gives the company the best chance of success to demonstrate how effective our Lm-based drug candidates are, right? So it’s important to remember, we’ve had clinical trial success in the past."
I guess the GOG is a co-conspirator, lying about trial results and falsifying articles. I'm sure someone will report them to the FDA.
https://www.onclive.com/conference-coverage/sgo-2017/immunotherapy-axal-tops-survival-mark-in-cervical-cancer
We will delay until early 2020 the clinical testing of our Advaxis HOT constructs in prostate cancer and bladder cancer in order to ensure adequate funding for these aforementioned programs.
To me it sounds like AIM2CERV is working and the reason why it was not shelved.
If nothing else, I got a sense of urgency from Ken that I never got from Big Tony. It's obvious that Ken is aware of the (somewhat) dire straits we are in and is taking measures to fix them. The market prospects must be big enough to support the continuation of AIM2CERV and, if the FDA supports the planned changes to the trial design and we have an earlier interim readout, it may spark more interest for a deal. The call went better than I anticipated but my expectations were fairly low.
Looks like Amgen intends to corner the market on cancer treatments.
You're not ranting. We are ALL frustrated with the company, I believe.
Still below average volume though we could see a sure before closing.
Every day it's been a spike of selling, today around 1:15PM, that tries to keep this thing down. So, is it a scare tactic or does someone know something? Ken going to pull a rabbit out of a hat?
Not sure what's going to go down Friday. The CC announced a week before. Low volume since. Doesn't look like everyone's bailing to avoid bad news or buying in anticipation of good news. Is the prospect of shelving cervical already priced in. I'm going through too much Tito's this week.
Cat, did you talk with the company?
Please give examples of the money Blue has cost other posters. Thanks in advance.
Had they said pipeline update as opposed to discussion, I might feel more positive. Anything truly bad would have to be released sooner than next Friday (I believe) but I have the feeling they will shelve AXAL for cervical. It's already been pitched to us so, I hope, if they do it, it won't cause a sell-off. Enrollment updates would be nice. The announcement of the IST would be most welcome. We'll know shortly...
If it's a material event like that, I thought they had to report on it sooner than a week.
Cat, I remember reading something very similar, just not sure if it was here or an on-line article. It alluded to CI's become ineffective over time.
I'm inclined to agree with your opinion. I do think they may also announce the start of the IST H&N trial as it is supposed to start this quarter. A pipeline discussion was mentioned in the PR, maybe picking another HOT target?
Sorry, bub. If axal is shelved it's only for cervical.
Since the PR mentioned a pipeline discussion, items brought up could be:
1) Shelving of the cervical cancer portion of AXAL. Some posters here are expecting that.
2) Announcement of the start of the IST for H&N cancer.
3) Enrollment updates of active trials.
4) They saved a bunch of money by switching to GEICO.
I'll take what's behind door number 2. Any other material events would no doubt be PR'd before the call.
He was only asking a hypothetical question.
I believe he was being sarcastic.
Thanks. I always look forward to your well-reasoned posts and the details that you provide.
Hov, you may have stated this before but have you had any personal interactions with Ken and, if so, what were your general impressions? Thanks!
I think it means the company sees biomarkers as the future, or part of it. They're not the only company working on them so they my be on the right track. Perhaps, Zach can expound on the issue but, yes, I think the management holds hope.
I suppose it's to be taken as a positive. Looks like a lot of emphasis will be placed on discovering biomarkers that will be symbiotic with NEO and HOT.
New job listing:
Director, Biomarkers
Job Locations US-NJ-Princeton
Posted Date 2 days ago(10/19/2018 2:31 PM)
ID
2018-1130
# of Openings
1
Category
Biotech/Pharmaceuticals
Overview
Advaxis Inc. is an immunotherapy company located in Princeton, NJ that develops products based on a proprietary live-attenuated vector technology to develop immunotherapies for cancer. Our programs encompass a late stage product in HPV+ associated cancers, ongoing programs in prostate cancer, and our future focus on neoantigen targeting immunotherapies. Our highly innovative and differentiated ADXS-NEO program provides individual neoantigen-targeted treatments based on identification of a patients’ own specific mutations identified from whole exome sequencing of tumor DNA. This program is already in the clinic and has been partnered with Amgen. Our ADXS-HOT programs employ multiple cancer type specific, “off-the-shelf” mutational hotspot-targeting immunotherapies. This first IND under our HOT program has been allowed for our non-small lung cancer (NSCLC) drug candidate and the first patient is expected to be dosed by the end of this year. We have several other drug candidates from the HOT program for prostate, bladder and other cancers at various stages behind the NSCLC drug candidate.
The challenge of immune monitoring and biomarker evaluation for neoantigen-based treatments is quite unique, and a critical pharmacodynamic index of treatment effects and this role will be at the center of the data generation and analysis efforts correlated with clinical treatment outcomes. We are seeking a highly motivated individual to join us as Director, Biomarkers. You will collaborate with the Research and Development and Clinical Development teams in this critical translational role in the exciting new area of cancer immunotherapy. Under minimal supervision, the successful Director candidate will be expected to develop immunologic monitoring and biomarker plans in collaboration with the research and development and clinical operations, assist in protocol development and site training, identify and vet third party laboratory service vendors, coordinate and oversee the collection, transport and analyses of clinical specimens for clinical trials organize and analyze results, coordinate the development of laboratory manuals, participate in the analysis and interpretation of immunologic and correlative findings, and communicate findings internally and at scientific meetings. You will also be asked to perform other duties as required. In this role you will report to the Chief Scientific Officer, with accountability to the Senior Director R&D, the Chief Medical Officer, and the clinical operations team.
Blue, I think even you would admit it's getting hard to keep up optimism here. Watching this drift lower and lower is not conducive to breaking into a happy dance. It's been very frustrating to know we have the science but can't seem to get a deal that really values it. That being said, God help me, I added some Jan and Apr call options.
Obi does not know that.