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About time to add a good CMO, too. Wouldn't be surprised to see that happen soon.
Ig, You may find this interesting reading regarding accelerated approval.
http://www.healthaffairs.org/do/10.1377/hblog20170320.059267/full/
cattdog, obviously I don't know how your interactions with her went. My experience was totally positive.
Most definitely I'm giving him a chance.
I have talked to her several times. I have found her to be responsive, professional and as candid as she can be considering there is a limit to the info she can share. She's listened to what I had to say and I've never felt she was brushing off my concerns. IR at some other companies won't even return your calls. She may not say what you want to hear but she is always accessible to converse with.
Hopefully, Big Tony's learned from this debacle and will let someone else lead future presentations or load up on a 5-Hour Energy shot! I still think he'll put a great deal together. He's probably much better with small groups and one-on-one meetings.
So, email the company with your concerns and let us know what they say.
I don't think we'll hear talk of selling the company, at least until the prostate combo data comes in (Q1 2018?). CI's have been ineffective in prostate cancer, I believe, so if the data is good Merck may want a big share of the pie. I think they'll wait to see how it turns out. I wouldn't mind multiple companies making offers. JMHO.
It will be a controlled roll-out so I don't think we'll see too much revenue (yet) but, as you say, it's income.
Arantana, on their call today, continues to anticipate conditional approval for AT-014. I'm hoping (could be wrong, often am) that if there WAS a problem with the submission, they would have heard back from the USDA/FDA by now. I don't know how much of a boast an approval would give to us but an approved product, even conditionally approved, would be a good thing.
I think HOT is pre-clinical with IND filing in 2018. DOC's timelines may have been too optimistic for starting trials. I believe Big Tony reset the timelines to a more realistic goal. Maybe he'll surprise us and and beat some of them. The EMA delay had noting to do with the company. GOG will have to supply the needed data and I believe they agreed to release it.
Here's a link to the EMA procedural timelines if anyone is interested.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000330.jsp&mid=WC0b01ac05803d8b9c
Sara Bonstein
Found this on stocktwits, posted by a Vet, concerning Advaxis AT-014.
"$PETX had dinner with sales reps last night, confident on AT-014 before 2018. Took our orders for entyce and nocita. Ships soon Bullish"
Link below. Look for post by DrMorganDVM from Oct. 25 Take it for what it's worth.
https://stocktwits.com/symbol/PETX?q=PETX
I think it's fair to say the delays are affecting the share price as much as anything else. If Big Tony had given plausible, detailed explanations for the reasons along with enthusiasm for the future, I don't think we'd be sitting here.
As for HER2 and the other franchises I, like you, want to see great deals made with up-front cash.
"They’ve botched communications badly a couple times since June and are probably being extra cautious so they don’t make things even worse." This is a likely case. While a fan of the science, Big Tony's presentation was lackluster, to say the least. Now, if he's as savvy as he supposed to be, he will learn from it and be more energetic and enthusiastic next time. No doubt, he'll get coaching from more seasoned employees. A good leader always listens to their advisers. I believe Big Tony is setting a reasonable timeline to get things done. Obviously, the data request from the EMA to the GOG is out of the companie's hands. If any of the timelines is beaten, that may have a positive effect on the PPS. Hoping for Aratana approval by year's end, the submitting of the EMA marketing
authorization application, a new registration quality trial, positive prostate data and, possibly, submitting for AA on any number of trials.
And I'm concerned as anyone on our future. I tend to focus on what I hope are the positives that can happen here. The negatives are pretty much covered by a lot of others. I still believe we will be successful and 2018 will be our pivotal year.
I've been here longer than most. I neither complain nor feel entitled. I AM tired of the whiny azz armchair CEO's who, no doubt, could do much better than the management. Oh...wait..they're the ones spending their time complaining about the running of the company. This is a biotech. There are no guarantees. Move on or, at least, make some constructive criticism.
Sorry if this is a duplicate post. I've spoken with Noelle several times. I would not be able to do her job and keep my sanity. What information she can share is limited, no fault of hers. She was very open to any suggestions I gave and as candid as she could be regarding the slipping share price. She stated nothing fundamentally has changed regarding the platforms or trials. I have no reason to doubt her. My thinking (FWIW) is, with the revised timelines on trials and the EU filing, some felt they could move money around and not miss out on any catalyst. There'd still be time to jump back in before the EU filing. This could account for some of the bleeding. Buying could pick up as the year end approaches, especially if news of a licensing or partnership deal is announced. Also, buyers may want back in as the combo prostate data comes in. If it's good, watch out. Merck would be very interested if ADXS-PSA and Keytruda showed a pronounced improvement in patient's lives. All my own opinion, of course.
My thinking (FWIW) is, with the revised timelines on trials and the EU filing, some felt they could move money around and not miss out on any catalyst. There'd still be time to jump back in before the EU filing. This could account for some of the bleeding. Buying could pick up as the year end approaches, especially if news of a licensing or partnership deal is announced. Also, buyers may want back in as the combo prostate data comes in. If it's good, watch out. Merck would be very interested if ADXS-PSA and Keytruda showed a pronounced improvement in patient's lives.
I believe this one is...
https://clinicaltrials.gov/ct2/show/NCT02291055?term=advaxis&draw=2&rank=3
Just because the trials are highly controlled does not mean they couldn't fail. If the trial was failing, I can't see why the company would have the Vienna event. If I didn't see so many smaller buys after big sells, I may have had the same idea as you. I'm not one for conspiracy theories (other than candy bars seem a LOT smaller now than when I was a kid), but looking at the chart on Yahoo and seeing big sells followed by smaller buys, I find it hard to believe this is not all orchestrated.
"When the Lombardment lets up..." Thanks for the one laugh on an otherwise unfunny day.
"Would someone ask Noelle if Amgen has paid us for our milestone payment yet?"
What's stopping you from asking her? She's very good about responding to emails. Let us know what she says. Thanks in advance.
The FDA seems willing to provide conditional approval in a more expeditious manner than just a few years ago and with fewer participants. A time frame of a couple of years may be feasible.
CPXX was bought for $30 so this could be worth more.
I could live with that.
James, any thought on a time frame for good news? Won't hold you to it, just interested in your thoughts.
"AXAL is a dud". Tell that to the patients it has helped. Let us know what they say. Thanks in advance.
"Talked to Han and the GOG is the delay,not Adxs." See Blue's post 38116. That said, a PR would have been the proper way to handle it with an explanation of the delay. Delays can often happen but the way it was done makes it appear to be sweeping it under the rug. Hopefully, GOG can send the requested info in a timely manner.
Time for Big Tony to step up the game. We should be going for AA as much as possible. Perhaps we are and they are not announcing it. Oncosec just started a registration directed trial that plans to enroll just 48 people. Hopefully, our future trials can enroll less patients and take less time to complete.
Terry, I must have missed your reply on the reasons you have for stating Aratana is not pursuing approval for AT-014. Would you mind posting them again? Thanks in advance.
Hopefully, Big Tony doesn't wait until Dec 31st to submit.
Thanks!
I thought I may have missed a PR from Aranata. I assume, if they chose not to pursue approval, they would make a statement stating it.
"Why do you imagine PETX will not continue to pursue the HER2 vaccine against osteosarcoma?"
As of 9/27 at Cantor, AT-014 was on the presentation slides and Arantana was still expecting conditional approval by year's end. Has there been a new development where they stated they will not go for it?
I asked Noelle the same question about a month ago. She said the company is looking at all options. I assume she meant that it is being considered but she did not elaborate. You could contact her and see if there are any new developments. She's very good at responding to investors inquiries.
I was quoting from another poster. I think the results were excellent.
Easy, I did not mean to imply the HER2 trial in canines did not do well, I was just quoting from a post. When I saw that it more than doubled OS, I was floored. Those are great results. My thought, like some others here, is Big Tony is pushing those constructs that are far along enough (and partially paid for) to get us to approval in a quicker fashion. Some have stated the longer it takes us to get to the promised land the quicker competition will overtake us. Advances are coming at an incredible rate now as opposed to just a short time ago and there will always be newer, better treatments coming up behind us (and everyone else. The beauty of Advaxis, I think, is it can be and will be used in combination with just about anything that is current or new. When the HER2 results from the human trials are released and assuming they are good, that could up the interest and value that licensing could bring.
"So our PETX deal isn't going to happen now? No USDA approval?" He is talking about PETX.
From what I can see, they only have two P1 trials at the moment. We should be far ahead of their PPS.
"Join us for a reception following the symposium at Hotel Meliá Vienna, located in the iconic Danube City Tower. Enjoy drinks and light fare with 360-degree views of Vienna!"
Wein, weib und gesang. I can see Lombardo waltzing and wooing big pharma to buy a franchise. let's make a deal! The agenda and speakers look good and maybe they'll be hobnobbing with some of the EMA committee members.