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I sure hope so! Though I'm reluctant to read too much into the upcoming call, the timing of it does seem a bit suspect. Hopefully, Big Tony doesn't put coal in our stockings for Christmas.
The submission portal is closed until January so I'm not sure she would say that.
And they will discuss the advantages of the LM-based platform.
I'm not expecting anything spectacular but I wouldn't be surprised by some timeline updates.
There seems to be a lot more about NEO than I remember from previous corp presentations.
All your guesses sound good to me.
If the news was bad, I would think the call would be on a Friday after the market closes. The fact that it's not makes me believe the news may be on the positive side. Certainly, "...which will include a discussion of the advantages of its Lm-based antigen delivery platform and clinical pipeline.", sounds positive.
So, what could they announce? There has been an ongoing search for a new CMO, Big Tony could be seated as permanent CEO, a possible deal or trial update (enrollment or other) or EMA update. Since senior management is presenting, I guess we'll hear from a few people, which I think is a wise move. We'll know soon enough.
"Advaxis’ senior management will host a conference call...". Maybe some commentary from Dr. Petit and others. I don't expect new news but, hopefully, Big Tony may confirm the EMA submission date.
I thought we had the EMA equivalent of "fast track" so you may very well be on the money.
Though I may be wrong, from talking with Noelle, I believe the GOG data was a precursor to submitting the actual application.
The portal is only open one day a month for new applications. Once an application has been submitted I'm sure there is communication through other venues. Anyone here familiar with the process?
It has also already been sent to the EMA.
$50 gets me a house on Cape Cod and several trips to Europe, maybe a couple of cruises, too.
Who knows what 2018 will bring. I'm cautiously optimistic the EMA will get filed in January as the info required has been completed. I'd love to see a partnership with big bucks upfront either before or concurrently with the filing. I've never doubted the science and, with the recent Aduro announcement, there may be more investor interest in our platform. Big Tony is in charge now and I hope he's surrounded himself with the right people to get good deals. I can't believe how this Aratana approval is being dragged out, though.
That is true. The submission portal will be closed until January.
Just confirmed with Noelle that the GOG has indeed finished the paperwork requested by the EMA. Hopefully, 2018 starts out with a bang.
Decent volume so far.
I believe the snail, delivering the conditional approval news, ended up on a plate at a French restaurant...
Actually, the new CEO addressed several of your concerns on the last call. You should give it a listen.
Tutes may be waiting to see if AT-014 is given conditional approval (seriously, what is taking so long. It's basically another safety study with limited product distribution). Also, may be watching EMA process or since the company stated they are in active partnering/licensing discussions, they may wait to see how that plays out. All IMO. Would love to hear other views.
Bourbon, I do believe there is that proverbial light at the end of the tunnel. I'm hoping you, I, and everyone will wake-up one morning and be thankful we stuck it out.
ADXS-PSA
Absolutely. Any possibility they can amend the screening process to include that for the PIII?
There was nothing in the email regarding delays in the ovarian trial. Clicking on the email, I did find a link to a FiercePharma article (12/6) that had this to say:
"TapImmune’s lead candidate, TPIV200, a multiple-epitope anti-folate receptor alpha (FRa) immunotherapy, with an FDA orphan drug designation, has paired up with AstraZeneca’s checkpoint inhibitor Imfinzi in platinum-resistant ovarian cancer patients. What’s more, in order to tap a larger patient base, TapImmune has also initiated a phase 2 trial that focuses the vaccine as a maintenance therapy in women with late-stage ovarian cancer who are in remission, and it has been fast-tracked by the FDA for that usage.
According to TapImmune’s third-quarter update, the AZ-partnered phase 2 combo study will have preliminary results with tumor response data on the first 27 patients in the first half of 2018, and an interim futility analysis from the platinum-sensitive maintenance trial is expected in early 2019."
Bourbon, you make many valid points but, "And how can we get early EU approval when ADXS is too lazy to get the paperwork in? It is still not filed yet. and nothing put in to the FDA" is not one of them. The EMA wanted additional info to be provided by the GOG. According to James S., it seems to have been done already. The submission portal is closed until the New Year, as has been stated here and also by IR. At least this can not be blamed on the company.
What I would like to see is a PR confirming that the GOG has submitted the requested info.
Bourbon, like you and almost all here, I have watched the erosion of our investment. I understand your view and feel the same in many ways. I do feel that, if we are to succeed, 2018 will be the year.
When I talked to IR a while ago, they said that Merck was pretty interested in doing the combo of CI and AXAL. Merck was impressed with AXAL's solo performance in prostate cancer. It seems no CI's in prostate cancer were very impressive on their own so, if combining one with AXAL works well, it could be a game changer. Of course, that's a big "if" as many things are in clinical trials. The company should have some data by year's end but probably won't release until a big conference in 2018. If the data is really good, they may do a "teaser" before an actual conference. I know it's been said before that 2016 would be our year. Then it was 2017. I believe that 2018 WILL be our pivotal year and things may start moving very quickly.
At this point, $8 - $10 would suite me fine.
This stock is so starved for good news that I think the PETX approval could push it to $5. If, by Jan. 31, we get PETX approval, the EMA submitted (if the GOG has already sent the requested info to the EU, it may save precious time) and get a partnership with a nice chunk of upfront cash, I see no reason why we could not be between $10 - $15 dollars. Does anyone believe that given this scenario there is any reason we could NOT reach that level. If so, give your reasoning why not.
I think it could have been a contributing factor. However, Aratana seems confident conditional approval is coming. Basically, it seems like an opportunity for selected vets to treat dogs and run another safety study on the path to full approval.
gbrown, your part about the sweetheart deal sounds totally plausible. Cut a quick deal for a pittance but get a quick approval for your product. Didn'r work out that way but your theory makes sense.
I think we all expect conditional approval by year's end. The discussion is pretty much about Aratana developing a freeze-dried version of the vaccine, possibly without permission and Dan's deal to license AT-014 for peanuts.
Thanks for this post. So the question is, does Advaxis have a dried formulation that they perfected? If so, why the to-do with Aratana?
I will lift a glass (or two) to his health tonight!
I emailed IR (Advaxis) the other day as I am curious about the other three licensed products to Aratana. I was told, as I suspected, that announcing those products is at the discretion of Aratana. I left a VM with the Aratana IR person asking about them. I've not heard back yet but, if I find out anything, I'll post it. Perhaps, when AT-014 is approved (maybe the approval was sent via sloth mail) we'll hear more.
If that happened, I'd be a millionaire. I'm sure many others here would be that many times over!
James, I had talked to IR a while back and knew the info the EMA needed was being supplied by GOG but I'm impressed that they did it so fast. I was led to believe it was quite a bit of paperwork to go through. Looks like Advaxis might be able to complete their submission as soon as the New Year starts. If Big Tony beats his own timeline, I'll be a happy camper.
I am so glad, Blue. You may want to join a breed-specific group for your buddy on FB. They are very supportive people, often in similar situations and can provide help and support. I am truly happy for you and the little guy.
Babe, when do you expect this to happen?
Attila, you put a smile on my face with your post.
James, the last time I talked to Hans (weeks ago) was that GOG agreed to supply the info that the EMA requested. They must have done so most expeditiously.