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Heard from her today.
Blue, deciding when to let go is the hardest decision we pet owners have to make. I've always been with them to the last, holding them in my arms when they draw their last breath. It is never easy. My last one died in my arms as we waited to see the vet. I'm not an emotional person by nature yet, each time I go through this, the tears just roll down my face as I kiss them one last time. Non-pet owners sometimes don't "get it". They say, "Oh, it's just a dog." No, they're not, they're a member of my family and I love them as such. Blue, I know you'll do what's right for your little guy and my heart is with you.
I think Aratana's approval for AT-014, sent by snail mail, is actually being delivered by a snail.
From the clinical trial page:
Estimated Enrollment: 450
Study Start Date: September 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
A lot can happen between now and the trial completion date. Changes in FDA protocols for approval, trial stopped for overwhelming efficacy, accelerated approval, etc. Just guesses on my part. So two to four years depending on how long it takes the FDA after the NDA is submitted. Again, just my guess. I would be happy to be proven wrong.
Thanks, Dew. A very good read.
AT-014 conditional approval is looming (hopefully). While it may not give a huge pop, I think it will give more leverage to getting a better price on selling/licensing HER2.
$30pps gets me my house on Cape Cod.
My suspicion, also. BOD and he had different ideas for the path forward. He got on-board with Oncosec pretty quick, didn't he?
And what is this data to which you allude?
Big Tony is for using reasonable, realistic timelines. My feeling is he'd rather meet or beat a timeline than have to announce a delay.
I think Dan planned for the best and hoped for the best. Big Tony plans for the worst and hopes for the best. He seems very conservative in his timeline guidance. I'd rather them beat a milestone than miss it.
" I DID SOLD...". Where did you try to learn English?
Dew, you seem to be more confident now with your investment. I know I am. I thought Big Tony did a very good job. As for AT-014, I'm not sure how much of a pop we'll get but I WOULD like to see us with an approved product, even if it's just conditional approval for now. Good luck to us all.
On the speculation that AT-014 will be approved, what kind of a reasonable pop would you expect for the PPS?
What an improvement in Big Tony's presentation. I think he's hitting his stride.
Lst's hope jet lag doesn't kick in. Double espresso, Big Tony!
Ah...to be back at the bridge of sighs...
Here's hoping his staff coached him. He has to know how off the mark he was with the last presentation. This is his chance to show show he can engage an audience.
From the Aratana call:
"Swayampakula Ramakanth
So the last question for me, if the USDA approves the conditional licensure, how quickly do you think your folks are ready to start commercializing the product?
Steven St. Peter
So the way that that works with USDA is you get the approval, you’re going to have to obviously go get the individual manufacturing lot, approve that takes a few months perhaps, but you’re able to quickly get in in the market and we do have the commercial supply plan obviously that’s fit along with this idea of after conditional licensure in a couple of months, be in the market. But more than a work a smaller subset of veterinarians, it is a conditional licensure. Make sure that there is an additional safety study as part of getting a full license that we just talked about needing to. So we’ll be working immediately within months. We have a number of those oncologists.
I think last week or, but in the last couple of weeks, we’ve actually had the investigation meeting with those several sites that are going to be bringing that product into the market. So we’re ready though. We’re waiting on conditional licensure, unlike the FDA, there is no statutory kind of timeline. The USDA works through and ultimately you get your conditional licensure by snail mail. They literally mail it to you. So we literally check the mail to see if we have the conditional licensure and as of this morning, we did not.
So, but we're ready to go, but again, it’s not -- to your point, it's not going to be a big product that's promoted with amongst all of the therapeutic specialists. It will be a lot of our VMLs working on it, working with the oncologists to clearly know. But I'll tell you oncologists see an appetence and on Saturday, there was a breakfast we hosted at the Veterinary Cancer Society meeting and the room was packed, 100s of oncologists in the room learning about ENTYCE. So I think those products work well together, but to your point, what we’re going to be doing with 014 is a lot smaller commercial effort, appropriate for where that drug is and the specialty nature of it."
If Aratana is checking their mail for it everyday, they may have gotten verbal approval but need it in writing before announcing. I can think of no other reason they would have made the "mailbox" comment.
I was also told by IR a search for the new CMO was on.
Event: Jefferies 2017 London Healthcare Conference
Presentation Date: Thursday, November 16, 2017
Presentation Time: 8:00 a.m. GMT
Location: Waldorf Hilton (Aldwych) in London, UK
Webcast: http://wsw.com/webcast/jeff108/adxs/
And $4 below PETX...
I remember someone posting here that they thought all the dogs were dead. That's apparently not true. The fact that the first two dogs (and more) are alive is mind-boggling.
Glad Advaxis won't be one of them.
If the conditional approval comes before the Jefferies conference, I hope he uses a megaphone to scream it out.
I suspect PETX will get the greatest boost when it happens but, it will be the first approved (conditionally) vaccine for Advaxis and that's a big win, at least to me.
And it's Advaxis' vaccine news that's driving the PPS today.
My understanding is, after conditional approval, AT-014 will be rolled out to a select group of veterinary oncologists for the treatment in canines. I assume full approval will come after enough dogs have been treated without adverse effects. The fact that it more than doubled OS in the UPENN trial gives me hope it may find full approval within a reasonable time-frame.
Sorry if someone already posted this:
https://www.bizjournals.com/kansascity/news/2017/11/07/aratana-cancer-immunotherapy-dogs-at-014.html?ana=yahoo&yptr=yahoo
Well, he was left with a sound science, a product, AT-014, possibly near conditional approval, a PIII for cervical cancer and more. When I see what we have in the pipeline, it's unbelievable that the share price is so low. Many missteps have been made along the way. I hope Big Tony can turn it around. I would be lying if I said I wasn't nervous about the Jefferies conference after the way the last one went but hope springs eternal.
Excellent post, Gantor and, I think, a fair assessment of the situation.
I did hear he is much better in smaller groups and in one-on-one meetings so time will tell, sooner than later, I hope.
I disagree here, Iggy. An articulate, well-thought through presentation can convey confidence in the company and it's products. I'm sure you heard his last presentation. Can you honestly say you wouldn't want to hear a more enthusiastic and energetic (interim) CEO giving the presentation?
I believe he can use this platform to present a better image and, perhaps, stir up more interest from BP. I'd love to hear your suggestions on what he should do there.
I can only hope Big Tony learned from his last presentation. Energy, confidence and enthusiasm can do a lot to put forth an engaging presentation. I'm hoping he gets coaching from his staff and has associates to jump in if it looks like he's losing steam. He really does have a chance to turn things around, even in a small way, by what he says and what he doesn't say. I'd like him to say they're engaged in active partnering discussions and will be making an announcement soon. I'd like to hear there is interest in our other products from other companies willing to license and fund the trials. Announcing a new CMO would be pleasant. I don't want to hear about anymore delays. As far as the EMA, I do believe it was caused by the need for the GOG to supply additional info. This delay does not fall on the company. Come on, big guy. Do your stuff. Make them pull out their checkbooks.
I believe they'll have some data by year's end. If really good, I would expect they'd release the data at a conference. Just my guess.
I'll say probably a mix of 4 and 5.
I expected this.
I don't believe so but there's an active search on.