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My pleasure!
There's always the possibility they could go for an Accelerated Approval after a PII.
"But it also could signal an increasing tolerance for other approaches. And this is the biggest implication for those looking for diamonds in the rough with the stock market. Lots of small up-and-comers are exploring cell-based immunotherapy in various forms. To name just a few:
Company Lead product
Inovio (NYSEMKT:INO) SynCon vaccines
Advaxis, Inc (NASDAQ:ADXS) Listeria-based vaccines
Aduro Biotech (NASDAQ:ADRO) Listeria-based vaccines
Northwest Biotherapeutics (NASDAQ:NWBO) Dendritic cell vaccine
Sorrento Therapeutics (NASDAQ:SRNE) Solid tumor CAR-T cells
OncoSec Medical (NASDAQ:ONCS) Interleukin-12 DNA pulse
Oncolytics (OTCQX:ONCYF) Reolysin,tumor-killingvirus"
Brief mention of Advaxis in this SA article but any publicity is good publicity.
https://seekingalpha.com/article/4062480-car-t-cell-therapy-means-lot-one-two-new-drug-approvals?app=1&uprof=45&isDirectRoadblock=false
Interesting find from another board. Here's the parts on H&N and colorectal cancers.
Pfizer has broken ground in head and neck (H&N), colorectal and breast cancers. Its Bavencio drug is now being investigated in all major solid tumors, such as those from Bristol-Myers Squibb and Merck. This contrasts with Roche's Tecentriq, which is still absent from H&N and gastrointestinal (GI) cancers. Roche has expanded its patient enrollment in ovarian cancer with two new Phase III trials, taking over Pfizer's lead. Similarly, Bristol-Myers has increased its presence in GI cancer with late-stage trials.
AstraZeneca is still waiting for the first durvalumab approval in bladder cancer, despite entering the immuno-oncology race much earlier than Pfizer. Although it has trials in all major tumor types, its share of patient enrollment is relatively small in all tumor types except lung and H&N.
Bristol-Myers Squibb and Merck & Co. lead IO with the most approved indications for their PD-1 drugs Opdivo and Keytruda. Merck has the most regulatory catalysts, but the focus remains firmly on the FDA's decision for first-line lung cancer. While lung and bladder cancers are highly competitive, gastric, breast and ovarian are still largely up for grabs. Merck and Bristol-Myers are vying for the first colorectal cancer FDA nod, but Keytruda's colorectal label will be broader than Opdivo's if both are approved.
Two new intern jobs just added under Careers.
I would hope we hear something at the shareholder's meeting. If not, they should share at ASCO.
Well, there were two sites in Louisiana, Marrero and Shreveport.
If approved for the EU, perhaps Biocon can approach the Indian govt. again.
It only makes sense that a deal is struck soon. While nothing is a shoe-in, AXAL has the data to back approval. I would like to see a nice bundle of cash up-front and royalties in the double-digits.
James, I've felt a deal was coming for the EU soon. It makes sense with the application there. I'm sure Ranya will have a big hand in that deal. Let's see how she does!
I don't think MINE would be considered as "has been". More like "soon to be the best".
Shouldn't we be able to go for AA with this? Did we try some time ago?
Your last on on RNN, "no news on this loser..just being pumped up by the mo. people...watch this fall hard in next week's trading."
You wouldn't be trying to scam people, would you?
Several trials were updated on the clinicaltrials.gov site on 1/18, this one included.
Thanks, TX. That was an excellent read!
So, for the anal cancer trial, the historical 3 year recurrence rate in similar patient populations is around 45% and 4 of the 11 living patients have passed that mark, per the corporate presentation. Let's hope the other 4 do as well.
I believe so. It makes the most sense.
1,812,070, you weren't too far off!
Bill, I also remember that about the EMA. I did find this PR which may provide a bit of clarification.
http://ir.advaxis.com/press-releases/detail/1229/european-medicines-agency-committee-classifies-advaxis
Probably an update on enrollment. Hopefully, it will move swiftly.
Thanks, obi. I will do as you say!
There has to be something in the data to be considered for a late-breaking abstract. We'll soon know.
Great post! I like that even better!
You may want to check your quote provider, the price
has already risen to $9.17 and rising hard.
"ADXS's therapies are worth probably $10B+ if they work..." I think it's safe to say they work, especially after the GOG trial. I agree with much of what you said in the rest of your post. I would have preferred an upfront payment and a higher royalty rate but it does provide further validation. Once the IND is filed, Sellas takes over development which could be an enormous cost saver to Advaxis.
Interesting reading on WT1 from the Sellas website. Together with Advaxis technology, this could be a potent cancer killer.
http://sellaslifesciences.com/wt1-cancer-vaccine/
IBB is down.
Agree, James. I think we're miles ahead.
Oddly enough, Inovio today announced they are working on an a WT1 cancer immunotherapy.
http://seekingalpha.com/pr/16753781-inovio-s-syncon-wt1-cancer-antigen-breaks-tolerance-highlights-potential-universal-cancer
Is the race on?
Wow, he's been dead a whole 12 days. Why don't you send them an email and tell them you don't like it?
Looks like two jobs were filled recently. Down to seven openings from nine. Don't know which ones, though.
Not sure if this was already posted:
Short interest as of 1/31 - 8,595,060, per NASDAQ.
Obviously, nothing is a sure bet but I've had this on my radar for a while. Might be time to take small stake.
Celator Pharmaceuticals had a successful PIII with a cap of less than 300M. Stock went to $15 and as bought out for about $30 b y JAZZ. "And although JAZZ stock owners may be pinching themselves over the fact that CPXX stock is fetching $30 a share despite trading well below $2/share prior to its Phase-3".
Per Morningstar, Vanguard added 67,146 shares over three funds by 1/31/17. Marshall Wace Asset Management Ltd added 119,105 by 12/31/16.
Yes, he has. I bought in the $3's. Next question, please.
Probably poor money management skills.
It would appear things are moving swiftly at Advaxis. Now, if the canine vaccine is approved soon, even though the revenues may not be stellar we would move from a developmental to a commercial enterprise. That should be worth a little boost.
Three new job openings at Advaxis:
Director, Global Program Leadership & Alliance Management
Associate Research Technician
Senior Director, Investor Relations and Corporate Communications
Good things afoot! Something smells rosy in New Jersey!