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Re: Opdivo/keytruda lawsuit. Heck, if Merck tries to steal our technology maybe then we can have some validation in our science, lolol....
Bristol-Myers Squibb and Ono Pharmaceutical on Friday announced that they have reached an agreement with Merck & Co. to settle patent-infringement litigation regarding the latter's PD-1 antibody Keytruda (pembrolizumab). Under the agreement, Merck will make an upfront payment of $625 million plus sales royalties of 6.5 percent from January 2017 through December 2023 and 2.5 percent from January 2024 through December 2026. Bristol-Myers Squibb CEO Giovanni Caforio stated "[our] agreement with Merck protects our scientific discoveries and validates the strong intellectual property rights we secured as the early innovators in the science of PD-1."
In the lawsuit, which was filed in 2014, Bristol-Myers Squibb and Ono contended Merck's sale of Keytruda infringed their patents related to the use of PD-1 antibodies in the treatment of cancer in the US, certain EU countries, Australia and Japan. The companies added that the settlement will result in the dismissal of all patent litigation filed against Merck.
As part of the settlement, the drugmakers awarded certain rights to each other under their respective patent portfolios concerning PD-1. The royalties received from Merck will be split between Bristol-Myers Squibb and Ono on a 75 percent/25 percent basis.
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Opdivo was launched in Japan in September 2014, becoming the first PD-1 inhibitor available anywhere globally. The therapy was later authorised for use in the US, EU and Canada.
Meanwhile, Keytruda became the first PD-1 inhibitor authorised in the US in 2014 following its approval for the treatment of advanced or unresectable melanoma. The drug was subsequently approved in Canada in June 2015, while the therapy was cleared by European regulators the following month. Opdivo and Keytruda have since been approved for a number of tumour types.
fbg, from Dan's latest Loncar etf video he starts off by saying, " Successful companies, like successful leaders, serve other people." If you watch the video you will see the compassion in his face as he says this (key word is "serve"). In all of my 35 years of life, the only people i have met to say that type of comment are genuine people and nothing but. In contrast, i have NEVER heard of a shyster, con artist, greedy pos say anything remotely along those lines and i have known plenty.
Thanks phyto, there is a wealth of information out there...just have to find it.
"As for data, we will submit data for presentation at medical meetings once we have it." - That kinda speaks for itself. Also, i would think asco would be classified as a medical meeting from an IR perspective.
Question: Who IS presenting at ASCO this year? If anyone could provide that data it would be appreciated. I tend to like comparisons (if available) when determining conclusions. Quite frankly, i never got the hype about asco in attribution to my investment in adxs. I think the first year i was invested i witnessed a run up in shp but i cannot remember anything major happening before or after asco since then. I get it that its the place to be/present but like the NE Patriots, people get tired of seeing the same team win (or present in our case) year after year. I could be wrong but historically what has asco done for us?
Iggy, i found this which might help:
"Although sponsors may request breakthrough therapy designation when the IND is first
submitted or at any time thereafter, they should not send breakthrough therapy designation
requests until they have preliminary clinical evidence indicating that “. . . the drug may
demonstrate substantial improvement over existing therapies on 1 or more clinically significant
endpoints.”43 FDA therefore expects that in most cases breakthrough therapy designation
requests would be submitted as an amendment to the IND. Ideally, FDA should receive a
breakthrough therapy designation request before initiation of the clinical trial(s) intended to serve
as the primary basis for demonstration of efficacy if most of the benefits of designation are to be
obtained. Because the primary intent of breakthrough therapy designation is to develop evidence
needed to support approval as efficiently as possible, FDA anticipates that breakthrough therapy
designation requests will rarely be made after the submission of an original BLA or NDA or a
supplement. If a sponsor’s drug development program is granted breakthrough therapy
designation for one indication and has subsequently obtained preliminary clinical evidence to
support breakthrough therapy designation for another indication, the sponsor should submit a
separate request."
I decided to do some research a while back on BTD timelines after we received FTD which is where if found the Phase 2 threshold. Of coarse i could not find the source but if its on the internet it has to be true :) I will post if i can find it again.
ADXSW up 7.78% today. Did trading stop at 12:20 p.m.?
"Just three and a half years ago, Advaxis (NASDAQ: ADXS) had five employees, was trading as a penny stock and was millions of dollars in debt. Under O’Connor’s leadership, the company up-listed to NASDAQ in 2013, raised more than $250 million and is now putting the finishing touches on new manufacturing and laboratory facilities at its Princeton headquarters. Advaxis has received support through the State’s Technology Business Tax Certificate Transfer (NOL) Program. More information about Advaxis, a graduate of the CCIT in 2011 that now has over 100 employees, and the EDA resources it used to grow, can be found at www.njeda.com/advaxisfeature."
I first invested 3 1/2 years ago and they had 17 employees but regardless it is impressive what DO has done with the company. Blah, blah, blah yes we all know about share price.
Invitations for monetary gains. Humanitarians are borderline extinct and nothing is for free.
Dafreaks, so are the interviewers supposed to pay the inerviewee's to be on their show? Fair question. if so why would they pay them to be on the show?...no biotech are the kardashians. lol. Another option is everyone could draw straws?
PR machine is out...? Keep it up the good work DO. The CEO of Advaxis rubbing shoulders with super models, governors, and BP exactly the way it should be, :)
Breakthrough designation comes no later than the end of phase ll. I think we can EXPECT to see at least one if not all the following: BTD, FT, AA for ADXS-NEO. Not solely because the tab is on Amgen......wait, no, precisely because of Amgen.
Meishairwin, you are right, everyone invested needs to take the time to listen to that presentation. I was very impressed with the data discussion about AXAL+durvalumab and extremely impressed with the neoepitope technology discussion. We have some top notch employees working for Advaxis for sure! Could you sense the tone in (forgot his name) when talking about Aduro's approach (and "most" other companies using the algorithm approach) with their 9 antigen algorithm compared to our potential 100 antigen delivery? Plus all the other areas of focus ADXS is branching out to that they discussed...I was bouncing off my chair listening to it. I admit, the talk was way above my pay grade which is why it took me 2 1/2 hrs to listen to the whole thing after rewinding multiple times, but wow! They also mentioned having a product approved in EU by this time (ish) next year. Not to much about k9 osteosarcoma, of coarse, but wow this company is legit in the short and long term!
link: SITC reception 2016 audio and slide presentation. Provides in depth breakdown of ADXS-NEO, AXAL+durvalumab.
www.youtube.com/watch?v=_1uS6V5WtO4
For the love of all thats Holy, fbg, EMAIL THE MAN. When you do get back with us and give us YOUR take of how it went. You are always very appreciative of others when they share conversations with whomever they speak with at hq. Its time to pay it forward, email the man. I look forward to hearing what was said and thank you in advance for doing so. Pretty please with a cherry on top, do it.
I think a BP, ESPECIALLY AZN, knows exactly the likelihood of ADXS getting approved in EU. But, if I were Astra I would want US rights as well, with eyes set on competing head to head with avastin down the road.
VERY low volume today. Up on low volume and then held up with low volume. not typical adxs trading. Maybe some anticipation for unexpected news next week.
Iggy, if you relate why keytruda was approved (below) in eu, then i would say odds are good.
"The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Keytruda’s benefits are greater than its risks and recommended that it be approved for use in the EU."
"The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma. The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable."
"With respect to NSCLC, the CHMP noted that Keytruda helps prolong survival and slows the worsening of the disease. The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of chemotherapy."
Fbg, i found this on the ema website under FAQ's:
"In general, the Agency will issue an opinion on its evaluation within 210 'active' days. However, the clock may be stopped during the procedure to allow companies to answer questions posed by the Agency's Committees. This leads to the actual evaluation time being longer."
"The European Commission follows the opinion of the Agency in almost all cases. It takes around two months (60 days) for the European Commission to approve a medicine after the Agency has given a positive opinion."
Also, i found this below under the FAQ "How can i keep up to date with the agency's opinions" for those that may want to subscribe. i didnt have time to look any further into it.
"After every meeting of the main human and veterinary committee meetings, the Agency issues a news release with highlights of the meeting. To stay up to date with the latest news, features and publications from the Agency, you can subscribe to our RSS feeds.
The Agency also publishes a monthly newsletter called 'human medicines highlights'. This newsletter provides key information on the Agency's recent activity on human medicines."
hovacre, i apologize if i seemed negative in actuality i am extremely excited that we could have an approved product in EU in less than a year. After being invested for 4 years its exciting that we could be treating someone battling cancer in as little as.....nobody has answered my question yet?
Fbg, so if we submit MAA in say,july (120 days) and add 5 months (150 days) for committee's reviews plus 2 months (60 days) for final review the earliest approval is Feb. 2018? Anyone know how long before we would actually be treating cancer patients after EU MAA approval?
Meish, thank you for taking the time and for your thoughtfulness in sharing your knowledge with the board. Priceless information.
I like how he is just as optimistic and excited when talking about Advaxis as he is every time I've heard him speak.
oh ya thats right, i am on an investment board... i forgot. and pet owners faced with amputation as the only option when faced with osteosarcoma probably forgot as well. how about the children? where does advaxis fall into place again regarding these issues? try pedaling your bike with one leg better yet watch a child do so, then maybe you will have some sympathy... or trade another stock, your choice.
and badarse, cancer fighting, life saving immunotherapies.
I like it james...and i can relate about predictions but something is coming soon.
how about suing the usda for cruelty to animals by allowing pets legs to be amputated... wheres peta? on the other hand, peta attacked my beef processor because a steer escaped from the processor and ran 2 miles down the road before caught. they even had a collection for people trying to save this animal, lolol. wish it was mine... 10 grand and i will retire him on the farm, lol. yet dogs legs are being cut off at the owners expense as the "right" decision. wheres peta?
I have to agree with James here, hd. We will hear about what happened today tomorrow, premarket (geez I hate predicting) because it makes sense.
Crazy indeed, easy, and our patient population was the largest from the graph presented. Which translates to statistically significant results and conditional approval...
Up 2.69% after close?
Advaxis granted Global BioPharma an exclusive license for the development and commercialization of AXAL for the treatment of cervical cancer in Asia. Global BioPharma is responsible for all development and commercial costs and activities associated with the licensed product in Asian territories. Global BioPharma is a Taiwanese biotechnology company funded by a group of investors led by Taiwan Biotech Co., Ltd., a top five pharmaceutical company in Taiwan.
What is there to report, though. until we have a product approved, based on the above, they are waiting for further advancements. They're not going to start stocking up on inventory and build our secondary manufacturing facility before approval is near. Until then the private investors and venture capitals of gbp are paying 250k yr for the privelage of one day (hopefully) have the rights to manufacture and sell our product if approved (and i thought buying the stock was risky) Supposedly gbp's reach is 84 countries and 3.8 billion people. Not a bad deal for us if gbp can deliver. Mostly just thinking outloud because this collab hasnt been discussed in eons.
I did not know adxs was receiving development and licensing fees from global bio pharma (GBP). It looks like on gbp website like the company was created just for adxs?
During the quarter ended January 31, 2017, the Company recorded revenue of $3,790,842. The Company recognized $3,540,842 of revenue from the collaboration agreement with Amgen related to amortization of the upfront fees received. In addition, $250,000 of revenue was due to the receipt of an annual exclusive license fee from GBP for the development and commercialization of Axalimogene filolisbac.
Thank you much iggy for the affirmation.
I can't agree more, mkc. Many criminals would have got away with their crime if they kept there yapper shut. I enjoy telling my loved ones though about ADXS and collectively we own around 30k. I am thinking about opening an account in my 8 yr olds name. Does anyone have any suggestions? Roth IRA?
Re: Al Blunt. If you want to know why this man was hired and what he brings to the table, follow this link. Reminds me of Petit.
http://blog.covance.com/2015/08/the-remarkable-rebirth-of-cancer-immunotherapy/
Anyone have the latest short numbers?
Also, the only requirement adxs has is the IND and Sellas covers the rest PLUS the payment$. I think Sellas approached Adxs wth the offer and our new hires (the deal makers) sweetened the pot for us, for good reason.
Starting to make sense that it might come after the declaration of milestone payments from Amgen after IND approval.
My apologies about jumping the gun with eu approval message. I was in the parent pick up line with the principal closing in on me and they tend to yell at parents on their phone. Not trying to spread fud. BUT at the same time why would they not expect the ema to approve, thats why they are submitting right? I have reread and my disservice corrected, all is well ;)