Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Here's the area that GBP covers for the vaccine and , damn, it's a big area.
http://www.gbiopharma.com.tw/en_company.php?pid=4
Ditto!
As much as I would like to see good news tomorrow, based on history, I doubt it. I would love to be pleasantly surprised, however.
"Biocon Limited (“Biocon”), our co-development and commercialization partner for axalimogene filolisbac in India and key emerging markets, filed a Marketing Authorization Application (“MAA”) for licensure of this immunotherapy in India. The companies will evaluate next steps regarding potential registration in India."
Are they referring to the previous filing or a new one?
I think, if the FDA is on-board with revamping of looking at interim data, Biocon could potentially reapply to the Indian FDA for approval.
Since it was chosen as the first HOT target, the company probably saw some positive signs of activity.
At least one positive development from the 10K:
Global BioPharma Inc.
On December 9, 2013, the Company entered into an exclusive licensing agreement for the development and commercialization of axalimogene filolisbac with Global BioPharma, Inc. (“GBP”), a Taiwanese based biotech company funded by a group of investors led by Taiwan Biotech Co., Ltd (TBC).
GBP is planning to conduct a randomized Phase 2, open-label, controlled trial in HPV-associated NSCLC in patients following first-line induction chemotherapy. GBP has obtained Taiwanese regulatory approval for this trial and plans to initiate this trial in 2019. This trial will be fully funded exclusively by GBP. GBP will continue to explore the use of our lead product candidate in several other indications including head and neck, and anal cancer. GBP also plans to conduct registration trials with axalimogene filolisbac for the treatment of advanced cervical cancer.
GBP will pay Advaxis event-based financial milestones, an annual license fee, and annual net sales royalty payments in the high single to double digits. In addition, as an upfront payment, GBP made an investment in Advaxis of $400,000 by purchasing from the Company 108,724 shares of its common stock at a price of $3.68 per share, GBP also received 100,000 warrants at an exercise price of $5.52 which expire in December 2018. GBP exercised all of its 100,000 warrants. As a result no warrants remain outstanding under this agreement.
GBP will be responsible for all clinical development and commercialization costs in the GBP territory. GBP will also reimburse Advaxis $2.25 million toward AIM2CERV. GBP is committed to establishing manufacturing capabilities for its own. Under the terms of the agreement, the Company will exclusively license the rights of axalimogene filolisbac to GBP for the Asia, Africa, and former USSR territory, exclusive of India and certain other countries, for all HPV-associated indications. Advaxis will retain exclusive rights to axalimogene filolisbac for the rest of the world.
I think EVERYONE'S past assertions (at least for a positive outcome) have proven to be wrong.
blue, what you've hypothesized may or may not come true. It does NOT mean you're in denial or delusional. You have an opinion, just like everyone else here. I, for one, would be delighted if your hypothesis comes to fruition.
That puzzled me, also.
Nothing devastating revealed, either.
Settlmnt Date Short Interest Avg Daily Vol Days To Cover
12/14/2018 2,228,243 816,486 2.729065
It's one thing to be bearish but it's another thing to urge people to sell and say the science is a dud or worthless and BP knows it. I can't explain why we've had no luck in getting the partnerships or big cash investments I think we deserve. An approval after a PIII would pretty much prove, once and for all, the the treatment(s) work but I believe now that they do work. I've never told anyone to buy or sell, that's up to the individual but I do think there are people who insinuate that the company is on a death-spiral. They may be right and I may be wrong but I'm still hoping for a positive outcome.
Over 4 mil. now. Thoughts on where we'll end the day?
2.5+ mil. shares traded so far
It appears somebody sure is!
Over 2 mil. shares traded so far.
What's going on with price and volume now!?
I'm not disagreeing about the lack of follow-up or they spread themselves much too thin. I agree that the science must be proved. If Aratana gets full approval (that safety trial should be finishing up soon. Been close to year, I think) that should count for something. Some here claim the science is a dud but they have yet to provide anything to backup their claims. Why we don't have a buyout, more partnerships, why current partners are doing nothing (that we know of), Amgen bailing? I wish I knew the answers to these questions.
"Importantly, should a clinically meaningful increase be observed in patients receiving the TAVO beyond that which they receive from KEYTRUDA alone, OncoSec plans to seek accelerated approval of TAVO in this patient population."
Let's go, Ken!
I don't believe anyone can point to a reputable scientific article that refutes the science. No one seems able to provide a link to back up their claims.
There are some here who say, no it doesn't work, it's a dud. Everyone is entitled to their own opinion. I believe the science does work, is sound and, if we can through the coming months, I'm hopeful there will be positive data. The waiting game is getting tiresome and the recent movement of volume and price has me wondering if we hear sooner than later.
Thanks, JK!
We all get things wrong with this company. To paraphrase an Oscar winning song, "Never On Friday".
Friday, AH...worst possible time but I think Ken did one on a Friday some months ago that was positive.
Sonicty, your guess is as good as anybody's here. I feel the same way about where this may be going.
Thanks, James, for putting that in perspective.
You should contact the sites where the clinical trials are being run and let them know a fraud is being perpetrated on them. You owe it to those poor patients.
I tend to believe the GOG results (best ever for the indication) and Dr. Mason's work, "Median survival in control dogs was 316 days (n= 13), and at the time of Dr. Mason’s presentation, the median survival in treated dogs had not yet been reached, with 80% of the dogs that received the complete vaccine series remaining alive (n= 15)." over random posters. Rather like climate change deniers.
I think it's safe to say the treatment(s) is efficacious. Whether or not the company can successfully bring it to market is another thing. There have been many, many missteps along the way and I still believe the company was worse off than we were led to believe when KB came in. He has tried to stop the bleeding and, if the FDA goes along with the revision of the AIM2CERV, I think we have a shot of being a commercial company. Once again though, timeline targets have not been met. We'll see what happens this year. GLTA.
You sound disappointed.
dawson, thank you for the link. Excellent find!
Umm...listeria is NOT a virus..just saying...
So, you saying that the complete responses reported, the patients who have gone on video believing that AXAL saved their lives are all lying. If the science is not real then this is, in fact, what you must believe.
We've gone through periods of silence before where nothing worthwhile transpired. Maybe, just maybe, this time will be different.
The corporate presentation could do with a make-over, also.
Decent volume so far. Some good buys between approx. 11:30 - 12:30.
Any significance to the career page being down all this time? Cost-cutting measure? Perhaps they'll list the jobs in-house?