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You are correct, it's not a done deal yet. BMS must have a feel for getting it through regulatory hurdles so I hope they can get the green light from the FDA.
"Advaxis and Bristol-Myers Squibb have begun a clinical development collaboration for a global, randomized and controlled registrational study to evaluate Advaxis’s ADXS-DUAL and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab), as a potential combination treatment for women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix."
Thanks, samk. I had forgotten they're moving directly to a PIII.
"No management and partners jumping ship." That's a good sign, not a bad sign. It's all in the syntax.
New scientist job opening:
Overview:
Candidate will be responsible for the for execution, interpretation, and trouble-shooting of molecular biology and microbiology-based laboratory work and experiments in support of advancing our Listeria based immunotherapies. Candidate should be prepared to follow established protocols, identify and incorporate improved methods, analyze data, and keep meticulous notes.
Responsibilities:
Perform molecular biology and microbiology-based experiments, and routine laboratory work to support the advancement of our Listeria based immunotherapies. Maintain proper research records as well as data entry/compilation.
Reagent preparation, identifying and ordering proper supplies.
Qualifications:
EXPERIENCE:
2+ years experience in a molecular biology or microbiology laboratory setting
Experience executing established protocols and applying fundamental knowledge of molecular and micro-biology principles for troubleshooting
Ability to work independently as well as coordinate effectively within a team environment
Competency with routine laboratory principles and maintenance, including biosafety requirements, basic autoclave operation, and reagent/buffer preparation
Experience working with bacterial culture, DNA and proteins
Hands on experience with basic laboratory techniques including PCR, bacterial DNA prep, bacterial transformations, qPCR, SDS-PAGE, Western blotting, and cloning.
Working knowledge of common computational tools for routine molecular biology data analysis and manipulation, including DNA/protein sequence analysis and alignment, vector design, and primer design
Preferred skills and experience:
Experience working with gram positive bacteria.
EDUCATION:
Minimum BS in molecular biology or related field. Preferred MS in molecular biology or related field.
WORKING CONDITIONS:
Flexible work schedule to coordinate with ongoing projects and current company needs, including occasional evening and weekend hours.
4 now. New one: Bioinformatic Scientist
I thought that was odd, also. I'm seeking a clarification on that.
From a new Arantana SA article, "...A third anti-cancer immunotherapy, AT-014, is being developed with a product license with USDA for osteosarcoma in dogs. The company is a pioneer in the canine cancer space. It was estimated that in 2015 pet owners shelled out over $15 billion dollars for cancer treatment in animals, with $500 million being estimated for dogs alone."
How much of that $500 million is spent on osteosarcoma I do not know nor do I know how much of the revenue will go to Advaxis but getting this approved will be a major milestone. All IMHO.
Apparently not.
“We look forward to our continued work with Advaxis to explore the ground-breaking potential of ADXS-NEO in the clinic and across multiple tumor types,” said David Reese, Amgen’s senior vice president for Translational Sciences.
I'm not sure what Amgen has in mind for cancer types but I would think they would go for those that would garner the largest market, breast, lung, etc. Just my thought.
Very nice!
Crcook, starting at page 15, you'll find info on AA. Based on what I read, it would seem a viable alternative for us.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
Recent institutional and fund ownership of NWBO:
https://fintel.io/so/us/nwbo
I believe the FDA could give an AA to AXAL based on the P2 and have them run a phase 4 confirmatory trial.
Lombardo could have actually tweaked Noelle's response for his own PR:
Moving forward, our board, management team and I are dedicated to continuing to aggressively pursue the same mission: optimize and expand our Lm Technology pipeline, and leverage it in ever-expanding ways to innovate targeted cancer immunotherapies...
BASTA!!!! Enough about this! Yes, 20 to 25 does sound good to a lot of us but things have changed. DOC is gone so let's give the new, old guy (old, new guy?) a chance. Let's see where we are in a few months. We've waited this long.
Any reason why GOG or a cervical cancer group couldn't come up something like this to present to the FDA?
https://virtualtrials.com/PDF2017/FDAProposalv20.pdf
While this article is addressing GBM, the basic premise of what it proposes would be very good for Advaxis.
https://virtualtrials.com/fda2017.cfm
She disappeared shortly after PIII results. One day she was photoshopped in the leadership (!?) pic and was soon photoshopped out.
Stock opened at .297, contrary to an earlier prediction.
Advaxis mentioned in a favorable light...
https://seekingalpha.com/article/4087787-3-things-biotech-learn-today-july-16-2017
While Advaxis is not mentioned, the neoantigen approach to treating cancer is. Interesting reading.
http://medcitynews.com/2017/07/why-immune-system-is-best-bet-battle-cancer/
And who can argue with you based on your track record.
I half expect to see Milner boasting about a new short.
Also heard back from Lombardo. I mentioned having his interest aligned with shareholders. His reply was, "Thank you for your kind note. Our goal is creating shareholder value. Thanks again for the confidence you have placed in the team."
Heard back from Noelle. She thanked me for passing it on. She believes the company is hesitant to acquire debt as they do not have revenue generation at this time, but it is something to consider.
She responds=ed back promptly. Other companies don't respond back at all.
I believe we are waiting for the last two. This is what I hate about these trials. I hope and wish for no one's death, yet without it we don't get the results. Someday, I hope, there is a better way. God bless (if you so believe) these brave people who put their hopes in a treatment that may help them and others.
BTW, there is absolutely NO ignorance in asking a question if you don't know the answer. It's how we all learn.
My understanding is they do not trade after-hours or premarket.
Yes, Indian gov't wanted some PIII data.
My pleasure. Now, let's hope they apply for it!
With the way the FDA is approving cancer treatments, now would seem to be the ideal time to apply for AA. I would go for all three as they all had good to great results. I would also like to see Biocon try for Indian approval again.
Attila, would you mind if I forwarded your idea to Noelle?
Hi, tx. I have a relatively small position in NWBO. Between Larry Smith's analysis (Smith On Stocks) and the low price (0.175 at the time), I took a small stake. I have no idea if it will pan out but the risk ratio was to my liking. Results should be coming soon (within a few months, I think) and I hope, of course, they're positive. There are some very detailed posters here who give a lot of their time with their own analysis. After your DD, just make the decision you're comfortable with and I wish us all good luck (for our other stock, too!"
Sincere thanks for the time and effort you have put in these models.
"Phase IV studies look at drugs that have already been approved by the FDA. The drugs are available for doctors to prescribe for patients, but phase IV studies might still be needed to answer important questions."
https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html
Didn't work for me, either.
He's posted on the FB page before. It's him.
Mayes.