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I'm with you on that. $16 gets me a new house.
Let's hope history repeats itself.
Can you provide evidence, unequivocally, that Ken was responsible for what happened at ROSG? I don't mean, "Well, who else was responsible" but cold, hard evidence.
Better cut losses now, then.
"If the company is unable to secure a partner within a limited period of time..." Obviously not shelved yet, if it ever will be.
If you look at ADAP (Market Cap 1.08B) or IOVA (Market Cap 1.233B), we should be at least $15. We have a conditional approval and going for EU conditional approval. That puts us ahead of much of the competition. If Ken can turn this around, he could probably write his own ticket. Every bio on life-support would probably want him, IMO.
Looks like one new job opening:
Associate, Manufacturing
Job Locations US-Princeton
Posted Date moments ago(7/5/2018 8:12 AM)
ID
2018-1123
Overview
The Manufacturing Associate will perform various biological manufacturing unit operations which includes aseptic cleaning, media/buffer preparation, fermentation, clarification and purification in a cGMP clinical manufacturing facility. Initial job responsibilities will include working with a group of manufacturing personnel responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation.
If a deal is announced concurrently, I would say we'd see a bump. It's possible the filing by itself could give us a bump but I think with a deal we'd see a better rise.
Batermere, you echo many of my sentiments. If this goes to $10 or $15, I'll be in a good place. I won't be filthy rich but I'll have enough that I can make the contributions I want to. Good luck to us all and a safe, happy 4th to all!
Apparently, with Noelle gone, no one is taking on the task of updating the corporate presentation.
The clinical trial page shows sites open in Asia and Latin America. Don't know who's paying for these.
October $5 calls are only $.05. That might be an option for you. If ADXS hits $10 by then I'm a millionaire.
I suppose a reason for not filing the IND for HOT by month's end (at least, that was my impression) is a possible deal in the works. I say I suppose as this company has confounded me time and time again and I'm one of the cautiously optimistic longs here. However, if a good deal in announced, all will be forgiven and the cry will be changed from "Sell the beech" to "Long live the beech!"
Thanks, NY.
NY, all the more reason Amgen should step up now, cash in hand. I understand they may wish to see POC but they're making it a feature on the link you shared and that leads me to believe they are solidly behind it.
If NEO can stimulate natural killer cells, efficacy should increase even more.
https://immuno-oncologynews.com/2018/06/29/combination-immune-cells-improves-immunotherapy-success/?utm_medium=desktop-push-notification&utm_source=Notifications&utm_campaign=OneSignal
Somebody brought a cow to the airport? Sorry...couldn't resist.
There appears to be some posters who think NEO may be a "gimmick" or a shot in the dark. Some may be unaware the neoantigen research has been going on for some time. NEO is based on our LM platform which we know works (if you don't believe it, that's your problem). Neoantigens combined with LM could possibly could become a safe, less expensive, more efficacious treatment that will make a difference to many cancer sufferers. Maybe some of you are smarter than the doctors and researchers working to relieve the suffering of millions but, for now, I'll put my faith in a treatment I think will bring relief to those millions.
https://www.fiercebiotech.com/biotech/glimmers-hope-for-cancer-vaccines-as-two-neoantigen-shots-hit-mark
Even if Amgen offered two or three billion, it would be a drop in the bucket to them. They should strike now before someone else makes a better offer. I would love to see a bidding war but, realistically, I am getting tired of waiting.
I haven't seen any medical or scientific individuals calling it a gimmick.
The corporate presentation needs updating. I doubt anybody's touched since Noelle left.
Bioinformatic Scientist job opening is gone. Let's hope it's money well spent. Of course, they also could have decided not to hire anyone.
This is one of the most moving posts I have ever read. I hope to read more like this.
Virus vector vs. LM platform. Both equally effective or is one superior over another? We are already in the clinic so that is one advantage. I imagine if NEO shows early signs of efficacy and continued safety, Amgen might step in sooner rather than later.
Do you know ANY long (I'm talking at least a couple of years) who is not feeling frustration now?
To me, anything to reduce cash burn is transitional. Moving a treatment candidate into the clinic is transitional. Of course, the items you mentioned are also transitional. Just because they have occurred yet doesn't mean they won't.
...and we are yet to see any transformational move from him.
I believe Dr. Gutierrez said they planned to file by end of Q2, so it may happen.
If Amgen bought us now, they may be able to use their clout to get breakthrough therapy designation and/or accelerated approval for NEO/HOT. I think Advaxis tried for those earlier with AXAL but were turned down (please correct me if I'm wrong). The FDA may pay more attention to Amgen.
Blue, I know your buddy said Amgen would rather pay more later for a proven concept but, I think, if NEO shows early signs of efficacy they may act sooner than later.
There's a few of us here who feel the same way.
Some insider buying, Amgen seems to be solidly behind NEO based on recent tweets. Nothing earth-shattering but positive to me.
Would make terrific sense for AMGN, since they could pay one billion while reliving themselves of $400m of NEO milestones.
Please provide a link or some sort of proof that BP thinks AXAL is a dud. Thank you in advance.
Appears the can get the conditional approval renewed, yearly, for a total of five years. The vaccine has already extended OS by more than double. Not sure how much more effectiveness they would have to show, probably just continued safety.
"The drug company has up to five years, if FDA grants all four annual renewals, to complete the effectiveness requirement and get the drug fully approved. If the company does not do so, the conditional approval automatically expires five years after the date of the initial conditional approval. If this happens, the drug company must stop marketing the drug because FDA now considers it to be unapproved."
I have spent thousands of dollars to save my dogs lives and payed out of my own pocket as do many of millions. If you don't put a value on their lives, that's your prerogative. The canine vaccine has the first opportunity to be our first fully approved product. I put a value on that. Any revenue coming in to the company is welcome.
Sounds great to me:
"Therapy Dog Provides Greater Service: Helping Define Osteosarcoma Treatment
Denali, a therapy dog, inspires patients in hospitals, but is also an inspiration himself. Diagnosed with osteosarcoma, Denali is part of an ongoing clinical study using the ADXS-cHER2 immunotherapy (AT-014). The study is being conducted at the University Of Pennsylvania School Of Veterinary Medicine by Dr. Nicola Mason. Watch the news story from the CBS affiliate in New York City.
The current standard of care for dogs with osteosarcoma is amputation of the affected leg followed with chemotherapy. Some dogs are not good candidates for limb amputation, however, and these dogs are treated with palliative radiation therapy, which helps to reduce the pain associated with the tumor. Denali is participating in a study that examines whether the addition of ADXS-cHER2 immunotherapy to radiation therapy helps to prolong survival of these dogs. This study is currently enrolling participants.
An earlier clinical study examined ADXS-cHER2 immunotherapy (AT-014) in 21 client-owned dogs with osteosarcoma. In this study, dogs were treated with ADXS-cHER2 immunotherapy after the standard of care (amputation and follow up chemotherapy). So far, there has been a statistically significant prolonged overall survival benefit (p = 0.003) compared with dogs that received standard of care without ADXS-cHER2. The median survival time for dogs that did not receive ADXS-cHER2 immunotherapy was eight months, whereas the median survival time for those dogs treated with ADXS-cHER2 has not yet been reached. There were no short- or long-term complications associated with the immunotherapy and only low-grade, transient toxicities were reported in the study."
https://www.aratana.com/therapy-dog-provides-greater-service-helping-define-the-treatment-of-osteosarcoma-in-dogsand-potentially-humans/
AT-014 is in an extended field study. I'm not sure how long it would last. I believe 24 or so animal centers are participating.
If this has been covered before, I apologize for rehashing it. I believe there were questions some time ago about Aratana payments and royalties to Advaxis. I found this in the 10-K from 12/17. I thought it may be of interest to help answer those questions.
"Aratana has been granted exclusive worldwide rights by us to develop and commercialize ADXS-HER2 in animals. Aratana is further responsible for the conduct of clinical research with ADXS-Survivin in canine/feline lymphoma, as well as pending investigations of two additional Advaxis constructs in animals.
Under the terms of the Aratana Agreement, Aratana paid an upfront payment to us in the amount of $1,000,000 upon signing of the Aratana Agreement. Aratana will also pay us (a) up to $36.5 million based on the achievement of milestone relating to the advancement of products through the approval process with the USDA in the United States and the relevant regulatory authorities in the European Union (“E.U.”) in all four therapeutic areas and up to an additional $15 million in cumulative sales milestones based on achievement of gross sales revenue targets for sales of any and all products for use in non-human animal health applications (the “Aratana Field”) (regardless of therapeutic area), and (b) tiered royalties starting at 5% and going up to 10%, which will be paid based on net sales of any and all products (regardless of therapeutic area) in the Aratana Field in the United States. Royalties for sales of products outside of the United States will be paid at a rate equal to half of the royalty rate payable by Aratana on net sales of products in the United States (starting at 2.5% and going up to 5%). Royalties will be payable on a product-by-product and country-by-country basis from first commercial sale of a product in a country until the later of (a) the 10th anniversary of first commercial sale of such product by Aratana, its affiliates or sub licensees in such country or (b) the expiration of the last-to-expire valid claim of our patents or joint patents claiming or covering the composition of matter, formulation or method of use of such product in such country. Aratana will also pay us 50% of all sublicense royalties received by Aratana and its affiliates."
That was a very interesting read. I would hazard a guess that giving probiotic supplements after antibiotics may help to rebuild the intestinal bacteria. Perhaps increasing the effectiveness of the treatment?