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Hi Jochen, the Phase 3 Trial with Axal is for I believe high-risk locally advanced carcinoma of the cervix. It seems like probably most of our past trials have been with metastatic cancers that have possibly spread to other parts of the body. So one would speculate that our Phase 3 Trial with Axal should possibly have better results than what we have seen in the past? Also what line of treatment do you think will work best with metastatic cancers; not sure if this would possibly be something that NEO would tackle?
Agree with your post on shorting. I was just looking at trade date versus settlement date, and what I could find on rules for end of year tax purposes.
Personally I have no idea; but for what it's worth the rules appear to possibly be different for closing a short position at a loss rather than profit?
http://fairmark.com/investment-taxation/capital-gain/stocks-and-other-securities/last-day-sell/
Trying to understand possibly why Axal seems to have worked better on a localized cancer versus metastatic?
Is NEO something that would be possibly utilized with a metastatic cancer?
Also trying to decipher the attached article:
https://www.the-scientist.com/?articles.view/articleNo/45445/title/Mutations-Not-Tied-to-Metastasis/
"But while the researchers found no changes in mutation patterns to explain a tumor’s metastatic behavior, they did find hundreds of genes that were expressed differently between primary and metastatic tumors. Genes downregulated in metastatic patients included those involved in the immune system, while upregulated genes had roles in translation, endocytosis, and other cellular activities."
I wonder what the correlation if any would be between large dog years to human years; isn't it something like one year span to a large dog is like a 7 year span in human time?
Wow, that is thinking outside the box. If that concept is actually viable, then wow; endless possibilities.
If that is even remotely possible; it may be a freaking radical paradigm shift for modern medicine in my demented opinion.
Makes me wonder about the neonatal work that was being kicked around at the University of British Columbia; preventing allergies, etc. Radical concept to immunize neonatal with LM aye?
As the immortal Yogi B. would say; it ain't over till it's over.
Q: What did the termite say when he walked up to the bar?
A: Where is the bartender?
It appears to me that Axal may possibly work better in certain types of HPV related cancers, example of anal cancer versus cervical cancer. Is there a reason for this? Thank you for your input!
Hi Jochen, do you think that our PSA prostate results will be comparable to Axal? Or possibly better?
I think that DNDN may have been close to a $6 Billion dollar MC after the approval of their expensive prostate treatment?
One trick pony with limited efficacy perhaps?
My drunk half arse estimate puts the infectious disease market close to the cancer treatment market. We have endless potential with our platform.
I'm confused. Was it Axal or PSA that was used on prostate?
Interesting link to differences between seasonal flu virus and pandemic:
"identifies a novel process by which pandemic influenza A viruses may evade the host immune response"
https://www.nature.com/articles/s41467-017-02035-9
Also heard on the radio that they might have possibly missed the boat with this year's flu vaccine, which I got back in October. Seems to me that flu shots take a long time to create; seems like an area that would possibly be in our wheelhouse for possibly a faster development time?
Thanks Gold. Wasn't there some analysis done awhile back perhaps showing that they have identified biomarkers that if present possibly raise these survival numbers to a higher level?
My investment thesis is based on the premise of once it gets dialed into the biomarkers, results should possibly be even better. Thus I speculate that pre-screening for biomarkers and eventually NEO should possibly yield better survival numbers.
Hell I thought 2012 was going to be the year. I think of the Biotech approval process like those TV commercials with the three toed sloth; guy throws the frisbee in the park for the sloth to fetch and the other one is where the sloth is trying to draw a picture for that guessing game Pictionary.
Don Quixote, that's how I roll. Ignorance is bliss in my world. Skol!
Here is an older patent that talks about lyophilizing (freeze drying):
https://www.google.com/patents/WO2007061848A2?cl=en
Not really sure how long patents are effective?:
http://www.ipwatchdog.com/2014/07/26/how-long-does-a-patent-last/id=50534/
But the key thing in my humble opinion is coming up with a dried version of the vaccine that can be stored at room temperature or higher?
Thanks for taking the time to research the information. I know from freeze drying vegetables, which were placed on a tray inside a vacuum chamber. The trays have hot oil recirculating through them which heats up the trays and chamber to around approximately 150 or 160 F, then through a sublimation process the water (moisture) vapor leaves the vegetables and freezes on chilled refrigeration coils located on the side of the vacuum chamber. So the water (moisture) inside the vegetables gets heated out as steam and freezes on the chilled refrigeration coils; and goes from gas to solid state without passing though the liquid state (i.e. sublimation). I know that LM can survive freezing, but unsure about how hot the vegetables got on the tray? I suppose one could possibly adjust the vacuum levels on the chamber to drive the water out without hitting a temperature lethal to LM?
I believe that Advaxis created a shelf stable vaccine years ago with their German manufacturing partner. Did Aranta also invent the internet? Just kidding.
Have you ever worked for a public company? Few want to go out on the limb and take a chance without the Nth degree of validation? Otherwise you may get cast as Hey-Zeus in the annual company Passion Play.
Right there with you brother on the negative paper return. Back in my younger days from (23 to 46) when I abstained from alcohol I directed all of my 401 K into a guaranteed fund from which I could not transfer out of, because of this now I have been limited the past 8 years to only be able to invest 23% of my total 401 K holdings into ADXS. Seriously though, I think we are on to something epic here with the science; and I can't wait for this to unfold.
I have been around the ADXS message board long enough to see many of the sell the beech for $12 to $20 posters once predicting a market cap of over 8 billion; so one has to wonder about their motivation for a cheap buyout? I believe that our science works once it gets dialed into to the biomarkers, so I am buying as much as I can down at these levels.
Agree, intrigued by the following statement from the article:
"Currently, such approvals are based on endpoints like tumor shrinkage that are believed to be “surrogates” for clinical benefits, such as survival. Dr. Gottlieb’s new proposal would be based directly on overall survival “in a rare or deadly cancer,” he testified. The concept could be used for drugs that don’t have FDA approval or to expand the approval already in existence."
Good luck getting anything done with our government in that same time period.
https://www.bloomberg.com/view/articles/2017-04-26/europe-sticks-with-socialism
Blue, sorry I missed your post. Damn that is tough!
The village I live in is named Waterloo, so this is one of my favorites. But agree that ABBA is awesome! Real men are not afraid to crank ABBA out on the radio from their 4x4 trucks. I married a Swedish gal 20 years ago, best damn decision of my life!
I think the key here is your actual profit off of the product. In-house manufacturing will also be a benefit in my opinion. Regardless if your product cost $15 or $100,000 to produce, you still have to look at the profit per patient. Not trying to be disrespectful to cancer patients, but we are still running a business.
Anybody know to get a cheap download or copy of "Handbook of Listeria Monocytogenes" by Dongyou Liu?
Thanks for posting. The article really explains everything in simple terms. Seems to be in our wheelhouse; but time will tell once NEO gets rolling in trials.
Initially here at the Cro-Magnon science camp I was personally thinking of regenerative as stem cells; but the term "cell therapy" seems very broad. But I am only guessing here; but looks like it would have to be designated as RMAT on the IND?
https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
Here is an example of another company that obtained the RMAT designation:
https://www.streetinsider.com/Corporate+News/Athersys+%28ATHX%29+Announces+RMAT+Designation+From+FDA/13363899.html
I have not spent a great deal of time researching the 21st Century Cures Act; but it seems there are many other items that potentially apply to our products?
Good point, we may be in the 120 day question period right now? 120 days? Trying pulling that off in the private sector business world. Got to love the public sector, ha,ha.
Some folks get frustrated about our manufacturing facility not cranking out product 24/7. But I compare this to a simplistic analogy of making 5 personalized buttons for all of your friends, each with a logo unique to each friend. If you try to use an outside button manufacturer they will probably want a minimum order of 25,000 buttons, thus it would cost less to make the buttons yourself. This is my simple viewpoint on NEO manufacturing, which you want to do in house. Versus Axal which you can mass produce at outside manufacturing facilities. So I guess I view our manufacturing facility as being set up for personalized small runs, and also new construct R&D. Along with the option of mass production if needed.
Thanks for the post. Initially our vaccine was manufactured in Germany. Just guessing it would make sense to also manufacture in Europe?
https://ir.advaxis.com/press-releases/detail/64/advaxis-and-vibalogics-to-co-develop-stable-storage
https://seekingalpha.com/filing/85236
Regarding PSA "The product is being manufactured by Advaxis' contractor, Vibalogics, in Germany. The Company plans to file the IND application later this year to initiate a Phase I/II safety study in humans."
https://ir.advaxis.com/press-releases/detail/210/advaxis-immunotherapies-classified-as-non-pathogenic-materials-by-the-cdc-in-the-u-s-and-the-zkbs-in-germany
Harleyman posted this back in 2011:
"Advaxis Agents can now be transported between production, clinical and/or research sites in the U.S. and Germany without import permits. For additional information on these classifications, please visit these websites: CDC’s glossary of terms, the CDC Biosafety website and Germany’s Federal office for Consumer Protection and Food Safety, Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL). "
Agree, typically nothing gets done between Thanksgiving and the first week of January. I still believe in the science, but snails pace of progress gets old, I will be buying like crazy the next two months. Happy Holidays.
Saw the Red Rocker in concert out in Rapid City SD back in the early 80's, that dude was in perpetual motion climbing and jumping off anything near the stage. It was awesome to see his Energy.
Not 100% sure but seems that section 512 of the Federal Food Drug and Cosmetic Act (i.e. the FDA drug approval requirements) can be bypassed for New animal drugs for investigational use exempt from section 512(a) of the act. I am still confused by this whole process when it comes to USDA APHIS versus FDA?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=511.1
http://www.ahi.org/about-animal-medicines/regulation/usda/
https://www.aphis.usda.gov/publications/animal_health/content/printable_version/vet_biologics.pdf
I have to admit that the animal drug approval process is very confusing regarding USDA versus FDA. But I think there are three paths, all going through the FDA; and my very limited understanding is that we are going for conditional approval for a minor usage in a major species (i.e. affecting less than 70,000 dogs per year)? Originally thought USDA approved animal drugs, and I have to admit that this still confuses the hell out of me.
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UnapprovedAnimalDrugs/default.htm
Thanks for posting this article. To my drunk arse Cro-Magnon Brain, the following statement from the article is profound: "Pharmaceutical companies don’t tell you on TV that cancer drugs don’t work in 75 percent of the patients. If you’re a lung cancer patient with certain mutations, for example, those drugs won’t work on you. You need a personalized treatment".
I see those commercials all the time on TV when my wife watches her favorite channels.
To me this is freaking profound; and we are dialing in the biomarkers and have a massive arsenal of potential neo-antigens. I believe that our science works when it gets dialed in properly. I also believe that the moon landing never happened with 1960's Pre-Atari technology. Cro-Magnon logic would dictate that the Russians or Chinese would have done it by now.
So take it for what it's worth based on my deranged system of logic. As for me, I am buying like crazy at these levels.
No idea.
Yes on the Canine correlation, and I e-mailed this information to IR many months ago:
https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-17-001.html
https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-17-002.html
https://www.cancer.gov/news-events/cancer-currents-blog/2017/moonshot-funding-opportunities
http://www.cnn.com/2017/02/03/health/dogs-cancer-partner/index.html
Damn, I could have saved millions by buying Natty Light all these years.