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I did some DD on the EU approval timeline. It goes something like this - it's 210 days from start to finish HOWEVER there is a "stop clock" built in during which the EU sends their findings to the company to ask for more information. This can last up to 3 months and can be extended to 6 months if needed. After the company responds the clock starts again and runs to day 210.
Of note:
- The 210 day timeline is by law the max. A decision can occur sooner.
- A decision is binding to EU member states.
- There can be a second "stop clock" during the second half if more outstanding issues are identified.
- The process is transparent. There will be monthly reports and press releases.
- There is an accelerated process in which a decision is made in 150 days instead of 210.
So best case scenario - Advaxis submits on Day 1 of Q4 or 10/1/2017. They are granted accelerated approval process and take 1 month in the stop clock phase and all goes well, thats a total of 180 days which puts approval at approximately 4/1/2018.
This is an approximation, remember, approval COULD take less time than even the 150 days they give themselves.
Worst case (ending in approval) - Advaxis submits on 12/31/2017, doesn't get the accelerated process, and takes the full 6 months in the stop clock phase and another 30 days in the second stop clock phase for a total of 420 days. That puts us in late February, 2019.
The mid-point of these two dates is sometime in September, 2018. Or about a month before the warrants expire.
I find it exciting to see that the process is transparent. We'll have to keep an eye on this after submission and look for clues as to the progress.
Has anyone been keeping an eye on institutional ownership? High vs where we are now? This was a hot topic a few years ago but hasn't been talked about it awhile. Thanks.
My thoughts on DOC. I've been in Hawaii for a few weeks so haven't been able to post. Back now, had a great time. Koko Crater trail on Oahu kicked my ass, but it was worth it.
It's really funny actually, how this boards attitude changes with the tide. A few weeks ago everyone was talking about multi-billion dollar market caps and buy out offers in the 10-20B range. Then the slow take down, expected by some, then the investor conference that most here had too high hopes for and now today and everyone's calling for Dan's head.
So say you're DOC and have this game plan developed. The science is proceeding well, just one minor hiccup but other than that things on that end are going well. You're putting together deals that are criticized by some, but they don't know all the details because you CAN"T tell them. In your mind they were the best option at the time. You've also, because you HAVE to, informed the board of directors of your plan every step of the way and most of the things you've done they've signed off on. [And let's not forget the're some pretty heavy hitters on the bod.] All this and the share price is down. But you know, because you have all the inside information on trial progressions, that approval is all but guaranteed. Perhaps you're giving it an 85% chance of EU approval by this time next year. And again, you've had these discussions with the bod. You've got plenty of cash to avoid another dilution [which really would put your job in jeopardy] so you have to find a way to reassure your investors that all really is going according to plan but things take time. So what do you do?? What do you do??
Simply put, you put your money where your mouth is. You buy shares with your own personal income, and not a small amount - 25% of your income, to send the message. Hopefully your major investors will get the message, but they have their own agendas and time lines that you can't, or should, consider.
You know other that that there isn't much you can do to reassure everyone. Trial results will speak for themselves, but they are on their own time line. When they are published you know the sp will appreciate significantly.
You're working on deals RIGHT NOW that if leaked would certainly increase the sp, but you can't even tell anyone what those are. You could, certainly play the line and hint, but you know deep down you don't look good in orange and you hate flip-flops.
The bod is behind you, you've shared both your long-term and short-term agenda with them and they have approved it. Trials take time and deals need to be made at the right time to maximize value. If some retail investors jump, it's not your fault and you won't lose any sleep over it.
My thoughts exactly. Correct me if I'm wrong, but aren't they starting to hire technician level manufacturing people? Sure there's a learning curve, but it shouldn't be more than a month or two, tops.
Agreed. I've always wondered at what the conversation must have been between Adage and DOC and whether or not it broached insider information. It was a bit out of the blue when they bought.
Hey tx. I took a very quick look on pubmed. I'll give you my thoughts here as I don't subscribe to IH because I'm cheap. I don't know if the mods will delete this for being off topic, they seem to have a pretty low tolerance for such things.
Pros
- other drugs in same class already approved for vet uses
- new class of antibiotic, not a "me too" type drug
- low rate of bacterial resistance development - this is pretty
encouraging actually.
- shows activity against bacteria resistant to other classes of
antibiotics (this isn't unheard of in new classes of antibiotics)
- it is probably bactericidal (actually kills bacteria), not
bacteriostatic (keeps them from multiplying)
Cons - already in PIII, opportunity for early entry gone
- small company, will need to partner to distribute.
Don't know yet -
- Spectrum of activity - this is key. Ideally you want something
very broad spectrum that will be used lots, before culture
results are available and treatment is changed to something more
specific and more affordable.
- Side effects - like I said, I haven't looked too deeply into
this, I'm sure this information is out there.
- Cost of drug - All things being equal hospitals will use the
less expensive alternative.
- Failure rate - it can kill the bugs all day long in the test
tube, but how it does in a human can differ (you may hear this
referred to as in vivo vs in vitro activity)
It's interesting to think about. Too many irons in the fire? If successful it's the fastest path to realizing the fullest potential of the technology. It must be balanced against the burn rate to ensure Advaxis doesn't screw over existing shareholders by dilution. Seems like a balancing act for sure. Hope DO's up to the task....
An obscure sentence from the interview that didn't get the recognition it deserves:
Daniel O’Connor: As we move ADXS-NEO into the clinic this year, we have a few more intriguing preclinical programs which we have publicly disclosed, and several additional projects for which we are generating preclinical workups. In other words, projects in development that haven't been disclosed yet.
So we know there's a PIII for advanced cervical, we know DO's really really excited about neo, and now we know there are additional projects beyond neo. My guess is infectious disease as he alluded to in the interview.
The success of the PIII will only be the beginning if a very long and prosperous journey for shareholders.
Focus on the milestones guys, instead of all this gloom and doom stuff. The milestones is what will drive the sp. BP deals may be in the works, maybe not. I personally believe there's a EU deal in the works now only because we may have axal approval in Europe in about a year and I haven't seen any hirings for distribution (correct me if I'm wrong about that). And a year lead time is certainly not too soon to hire for that position. So at any given moment we may see an announcement for a EU deal, and we can fairly anticipate the timeframe for study updates. These are the things we should focus on.
LOL - You make is sound like Trump appointing Goldman Sacks and ExxonMoble execs to high ranking cabinet positions is draining the swamp.......
Dead link
Thumbs up.....
"Advaxis is basically a vaccine adjuvant company"
There's a big difference between vaccines that prevent and vaccines that treat and sometimes cure. Your wording seems to me to downplay the truly novel approach Advaxis has in treating fatal diseases, and thus it's financial potential.
It's just wishful thinking tx...common on this board. Patience is key when you own a clinical stage biotech. That said, it appears we're on a one year timeline to EU approval. Maybe I'll get that leverage from the warrants after all!!
It's difficult, at best, to speculate if there even is a "terminal" value for Advaxis, no less what that might be. Advaxis has about 15 antigens under patent, only 4 are currently in clinical development. Other companies are approaching Advaxis, giving us their antigens and asking to incorporate them into Lm to make them more effective. New antigens are being discovered all the time. And it's not just tumor specific or tumor associated antigens that are useful, lets not forget about infectious disease which will (in my belief) open up a whole new world for Advaxis and its' shareholders. Seems like some here are focused on a very short time line of 2-5 years, but just take a minute and think about what Advaxis will be doing in 10, 20, 30 years from now. Sure, most of us will be safely dead, but I have kids, and this is very potentially generational wealth. If anyone knows of another company with this kind of potential I'd really like to know about it.....
Partially right. The warrants will trail the stock by no more than $5 which is the conversion price. Do the math on if you buy $1000 worth of warrants vs $1000 worth of stock at todays sp. Then carry it forward to say a sp of $50 for the cs, and say $46 for the warrants Warrants work the same way as options in that they give you leverage, but with a longer timeline. Advaxis warrants expire in Oct 2018 and if you don't convert or sell before they'll be worthless, so plan accordingly.
Not the way I remember it - Do you know where to look to confirm? I bought in in the teens; close to approval DNDN was in the low to mid 40's. On approval it popped to the mid 50's. Soon after, about a week or two at the most, some insiders sold causing the stock to pull back into the 40's. (You should have heard the howling on THAT board!!) A few months later DNDN didn't meet some sales target and it lost 65% overnight and, well, you know the rest.
Again, my point is, nearly full valuation will occur BEFORE approval, so long as the market thinks it will be approved.
Meis - I was in DNDN years before approval and if I remember correctly it was nearly full value well before approval. There was a pop upon approval that pulled back pretty quickly. My point is that approval isn't necessary for most of the value to be realized. I'm looking forward to the discussions at the time as to how to deal with the impending FDA announcement. Personally I might protect my downside with some put options. (Something I should have done last year....)
FBG - I was going to post this as a reply, but wanted everyone to see it. While your attitude may be understandable, and even a bit predictable considering your constant maligning of management, it is shortsighted. Many here, including myself, believe the true value of Advaxis' constructs will be in the combination realm. I recently reviewed the data on combination treatment on the mouse cervical cancer model with PD-1, and it is outstanding. You don't need to be a statistician or Ph.D., anyone can see the value just by looking at the graphs. I'm not sure, but I think it's also in the corporate presentation. So much the better if we get approval of Axal by itself first, but if it pans out as hoped we'll get another nice bump.
To rejuvenate your enthusiasm for Advaxis go take a look. And we don't have to wait much longer either - I believe the first look at combo results are due this half. (Someone please correct me if I'm wrong.) If these results are similar to the mouse model they'll be nothing stopping us.
I'm still adding when I can and am hoping to still get leverage out of the warrants, but may have to plan an exit from those if nothing materializes by the fall.
Your patience is wearing thin; I think you've been here longer than me and I've been here since 2010 and I still think Advaxis will not only give me a much better retirement, but give me something that Neal Stephenson refers to as F*** YOU! money!!
FBG - With all due respect, oncologists are a completely different breed of physician. They keep up to date with new therapies and treatments to a degree unlike any other branch of medicine. All's Advaxis has to do is bring something to market that is better than SOC and these oncologists WILL know about it and WILL use it. While some marketing will need to be done, I'd imagine it would be more to help physicians figure out how to help their patients pay for the treatment than it would be to get them to use it because they'll already know it works better.
This tweet from Advaxis is interesting:
"#Clinicaltrials are mistakenly thought of as last resort treatments. Know your options!"
This can be looked at in two ways, depending on your level of optimism I suppose.
1. Enrollment in Advaxis trials is slower than expected and they are trying to raise awareness of their trials.
2. Advaxis treatments work, they know it (hence the ! at the end), and want people to enroll in order to save their lives.
I'm going with option two.
As always, GLTAL's
I came across this on Medpage Today - what caught my attention is this paragraph:
"The results compare favorably with those seen with bevacizumab (Avastin) in GOG-227C (12-month survival of 30%), which subsequently gained regulatory approval in first-line combination with chemotherapy," he added. "This is significant given that about half of the patients in [the current trial] had received prior bevacizumab."
This is certainly something that oncologists will consider when treating cervical cancer. Even in the unlikely event that response rates can be described as similar, there is a signal that a subset of patients will respond to Axal and not to Avastin. Or will respond to Axal after Avastin fails. So it would only make sense to start with Axal rather than Avastin.
HD, respectfully, it's not how much is spent on Vet care, it's how many dogs actually get osteo and how many owners of those dogs will pay for treatment. The number of dogs is, if I recall correctly, not all that impressive, less then 10K/yr I believe.
The true value, imho, is in the legitimacy the approval will bring to the human constructs.
I do. It's actually pretty high, around 70%. BP won't invest in trials that are that expensive without a fairly good idea they will succeed.
I'd be interested to hear your definition of when a construct is "mature".
We have NEVER had a bad outcome in any trial.
We have a construct in PIII.
We have effectiveness and safety in multiple constructs.
What do we need - 6 billion in annual sales to be considered "mature"??
More than 1 PIII will NOT be required. That was the whole reason for the SPA.
Hence the tinfoil hat. And after that flash crash I can believe anything.
Did you really just say Advaxis should have completed a PIII by now?? OMG you have no clue how long these things take. While I admit there were some wasted years under TM, since DOC took over things have been moving a lightning speed. We went from one construct in clinical development to 4 under his leadership, successfully completed a PII and put our lead construct in a PIII with special protocol assessment, which will vastly speed approval when the vaccine proves safe and effective. Oh, and BTW, it's the interim results which will drive the sp up if it's not up sooner due to other factors such as a partnership. And interim results are due in just over a year from now. And expect some increase in the months before the interim results are published.
FBG - You raise a good question, why are shorts targeting Advaxis? But the another question may be just as important. Who is targeting Advaxis? This assumes, of course, that shorts come in different flavors. A "pure" short, so to speak, may target Advaxis for the reason you state - that is they don't believe mgt can overcome their shorting and the company will go belly up despite the science. But no one on this board believes the science is bad (why invest, or stay invested, if you don't believe in it?). Indeed, the science proves itself over and over and over. All who have done even a modicum of due diligence knows that by now.
But what if it's not a pure short that is shorting? What if it's someone with a more determined agenda? What if it's someone, or some company or companies more specifically, that have a lot to lose if Advaxis actually is successful? As you can see, I have my tinfoil hat on right now, but bear with me. Could it be that a consortium of BP is shorting because they don't want the disruption in the market a successful Advaxis may bring? Will Advaxis be a disruptor in the market if successful? I keep reminding people here that the cost to produce a dose is under the cost of about 2 cups of coffee - that sounds disruptive to me, though what they charge for the vaccine will be a whole other matter.
That's one possibility. Here's another: What if some company knows Advaxis will be successful? What if this company is trying to accumulate shares at this reduced sp? I know you remember the flash crash in the sp awhile ago. Tell me that wasn't orchestrated. I freely admit I'm not knowledgeable enough to comment further on this but others here are so I invite them to put in their 2 cents.
So I suggest there are at least three types of shorts:
1 - Pure shorts
2 - Shorts that don't wan't Advaxis to succeed because it will damage them somehow.
3 - Shorts that know Advaxis will succeed and want a piece of the pie.
Are there other types? Feel free to speculate, as I've said, I have my tin foil hat on!!
Actually, I wrote it over there and copied it over here.
I feel the same way iggy. I've personally witnessed a PhD try to discredit a few studies for seemingly no reason. When I checked the conflicts section (small type) it became apparent he was a paid spokesperson for the pharmaceutical industry.
Or perhaps the answers simpler than that - maybe he's not done accumulating yet!
Just posted my own reply to the good Dr.:
There is more to the equation than efficacy, Dr. and you neglect to mention side effects and cost. Unfortunately the therapies you’re talking about as being more effective are also much more costly. Treatment costs will be well north of $100K for many of the ones you mentioned. Can society bear this cost? I highly doubt it. This seems to me to be an attempt to bankrupt individuals just before they are to die. And let’s not forget also that we’re not just talk about the American health care system, but the worlds. India, where cervical cancer is practically endemic, would NEVER be able to afford these treatments. (A select few may engage in reverse medical tourism and come to the US) Advaxis vaccines cost less than $10 a dose – you read that right – about the cost of 2 cups of coffee. This technology, which has NEVER failed a clinical trial, can be brought all over the world and offered to all people and the cost can be adjusted to reach the most people possible.
We can also have a discussion on cytokine release syndrome, which requires some of the treatments you mention to be given in an ICU setting. Advaxis vaccines rarely cause more than a grade II reaction and are given in an outpatient setting.
And lets not also forget that because this is a different mechanism of action, there are clinical trials now underway that use combination treatments. Kinda of like stepping on the gas and releasing the breaks to get the best response.
Also, you don’t mention how this tech might work in the infectious disease realm, where the patients do have an intact immune system.
So let’s wait and see before you rush to judgment on how bad this approach is.
Interesting - speculation that there is a fundamental flaw in the science or management team.
Science - There has NEVER been a bad outcome in trial results. The one patient death wasn't due to the vaccine, but rather the patients disease. Multiple constructs, Phase III trial ongoing, and NOW - tada!! - other companies approaching Advaxis asking them to make their vaccine better!!. Nope, not the science.
Management - as stated in prior threads, nothing DOC has done is out of the ordinary, despite what FBG is shouting about. Personally, as someone who has been here since the TM days, I think DOC has done an outstanding job. Nope, imho, not the management.
So then, what do I think it could be. Well - suppose for just a second, that Advaxis technology may be so versatile (cancer, infectious disease) and effective that it's a game changer, a once in a lifetime opportunity that will turn the company into the next Amgen. What then?? 2 years ago we watched this thing go from zero institutional ownership to 80% or so today. Is this, as they say in poker, a tell?? I believe so. Management continues to buy, buy, and then buy some more. Is this a tell? Yeah, most probably. We've gone from a handful of employee's to around 100. Is this a tell? Sure is. You starting to see a trend here?? Just because the sp isn't moving doesn't mean it won't ever move. The PIII is in progress and interim trial results should be out in about a year to 18 months from now. Before then we'll have EU approval submission and possibly a partnership deal. All this and you speculate that something is fundamentally wrong??
Also, don't forget, while other companies are developing treatments that are effective but possibly too toxic to use safely, those treatments are EXPENSIVE. Advaxis vaccines cost nearly nothing to produce, anything they charge will be profit.
Find a way to remind yourself from time to time just exactly what you're invested in - a company on the cutting edge of a treatment that is so versatile and effective other companies are knocking on our door to help them. Read the writing on the wall and be patient.
GLTAL's
If by "welcome to the party" you mean me, you're a bit presumptuous. I've been in this stock since 2010, much much longer than most here.
Nothing new to us, we've seen this all before. It's just a re-evaluation of the data. What I think is new is "The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02. A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months."
So...it works - already knew that.
So....it's durable in a subset of patients - strongly suspected that. Now we need to determine which patients which will require a larger patient population to determine.
I guess we may see a small pop today, followed by the usual pullback later this week. Please don't flame me for this....it's typical for Adxs.
James - You're usually one of the better posters and I haven't seen you anticipate things in quite the way you're doing now. Do you have any specific reasons to believe there will be significant news tomorrow or are you just expressing some hope?
Don't shoot the messenger guys, but here's the exact text:
"• Filing of GOG-0265 with EU (2H 2017)"
I thought (correct me if I'm wrong) that the filing was supposed to be in 1H 2017, not 2nd half. If so, then a short delay. With all on the plate it doesn't surprise me. I read somewhere along the line that the EU takes no longer than 6 months after filing to make a decision, so around this time next year we will hopefully be looking for one.
But still, the filing alone should cause a very nice bump in the share price. Before then I expect, along with many here, a licensing agreement to be reached for the EU. Looks like 2017 is the year my friends.
GLTAL's....
There is something unappreciated about the Sellas deal. You see, the WT1 antigen is already in clinical trials, and it already has had success in those trials. So essentially, Sellas took a look at what Advaxis is doing, told their science boys to take a look and see if they could further the success of this antigen using Lm tech, and ponied up big bucks when they decided it was worth it to try. This is not an antigen that Advaxis was developing, but one of another company. So the question we should be asking now is: How many other companies developing cancer vaccines with their own antigens are considering using Lm technology? Perhaps it is even likely that some are already in discussion with Advaxis? It's also likely this deal with Sellas will cause other companies to take a look at Lm tech much more closely.
I took a quick look at the WT1 antigen - this came up on Wiki:
"WT1 has been ranked by the National Cancer Institute (NCI) as the Number 1 target for cancer immunotherapy.[18][19]"
I believe this deal to be much, much more than it appears on the surface. It's likely this deal is one of many to come. The writing is on the wall folks, plain as day to those who can read. Anyone shorting is nuts, anyone selling will be missing out on the opportunity of a lifetime, and anyone not buying all they can afford is overestimating the risk. To me this is just a waiting game now.
So Vid, I haven't seen this mentioned here in quite a while and it may be something you're unaware of. Because Advaxis vaccines are a live, attenuated bacteria, the cost of production is estimated to be under $10 a dose. I've seen estimates as low as $5, but that was back in 2010. There was also some analysis a few years ago where we kinda sorta figured DO was going to charge 70K for a treatment. Again, this was years ago and we haven't been given a clue since.
The point being that once approved, it's here to stay. In the US, in the EU, in India and other the third world countries where the cost of treating cancer is prohibitive for many. Profits will never be in question, only how much.
This was one of the main driving factors for me to invest in Advaxis in the first place. It will be really difficult for society to spend 100K for treatments long term. Some patients would choose, sadly, to forgo the few added years (or longer) so as not to bankrupt their families.
It seems that you'll be a good contributor to the board, so welcome, and as always, GLTAL's.
I think this is fair........