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“RE PETX, remember the USDA is not the FDA”
Interestingly Bourbon, as part of following the USDA / PETX saga I learned that while the USDA takes the lead on Veterinary drug reviews they still must involve and get a nod from a section within the FDA before proceeding to the approval stage.
One might suggest if the USDA is not sufficiently knowledgeable or comfortable in making decisions about veterinary drug approvals and as a result, the process to approve new veterinary drugs is greatly extended, they probably shouldn’t be entrusted with ownership of the process.
Did I mention I dislike incompetent bureaucrats because of the terrible consequences of their incompetence.
G.B.
“You get a conditional (license) approval based on relatively few data”
Since it took nearly three years to collect relatively few data points to approve a limited license for 24 veterinary practices, the assumption is the USDA was jerking PETX around during the process or gaining the limited license wasn’t a priority for PETX. Let’s hope the assumed years of effort for the full license study isn’t orders of magnitude longer.
I’ll quickly acknowledge a very low personal tolerance for bureaucratic inertia and ineptness.
These interminable delays may well be why Dr. Mason is now running her own separate canine trial effort involving HER2 with 80 dogs in support of ultimately leveraging HER2 in the treatment of osteosarcoma in children. Just a guess... She has a much higher sense of urgency.
G.B.
You’re correct...From Aratana 1st Quarter IR...
“As is required by the U.S. Department of Agriculture to progress from conditional licensure to full licensure, Aratana has initiated the extended field study for its Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014) at approximately two dozen veterinary oncology practice groups across the United States and study sites have started enrolling dogs.”
So... A field study was required to gain conditional approval and a further field study is now required to move from a conditional license with 24 sites to full licensure. Requiring an indeterminate number of field studies is obviously the USDA’s way of slow walking full approval so they can delay making a decision or taking a position for as long as possible. Bureaucrats doing what bureaucrats do best.
G.B.
Traderbx - (except in AZN combo cases).
A consideration that gets lost in the shuffle is ADXS has likely still not determined optimum Lm dosages for all of their constructs. That fact coupled with certainty about valid medical biomarker targets could safely dial overall efficacy data up significantly over time. Most assume toxic PD-1 and PD-L1 vendors represent the combo dog and Lm is the additive tail. I’m not convinced that’s the case at all and may in fact be ass backwards.
Regardless, we still have a long road of trials to tune and enhance the science, assuming the money doesn’t dry up first.
G.B.
From Aratana 1st Quarter IR...
“As is required by the U.S. Department of Agriculture to progress from conditional licensure to full licensure, Aratana has initiated the extended field study for its Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014) at approximately two dozen veterinary oncology practice groups across the United States and study sites have started enrolling dogs.”
Dr Mason’s breakthrough study results are now more than 4 years old. What an extraordinary group of CYA bureaucratic cowards populate the halls of the USDA.
If memory serves an extended field study was required to gain the conditional license.
G.B.
M6677 - I would normally have posted the link...
Sign up for company releases on the Aurora website by providing your email address. You’ll get company news hot off the presses.
GLTA Long Investors.
G.B.
Release from Aurora a few minutes ago...
Aurora Cannabis Responds to Media Reports Concerning Rumoured Transaction with MedReleaf
TSX: ACB
EDMONTON, May 3, 2018 /CNW/ - Aurora Cannabis Inc. ("Aurora" or the "Company") (TSX:ACB) (OTCQB:ACBFF) (Frankfurt: 21P; WKN:A1C4WM), today is responding to a request from the Investment Industry Regulatory Organization of Canada ("IIROC") regarding media reports with respect to a potential transaction with MedReleaf Corp. ("MedReleaf"). The Company's policy is not to comment on speculative media reports. The Company does confirm that it engages in discussions with industry participants from time to time, including MedReleaf. At this time the Company confirms there is no agreement, understanding or arrangement with respect to any transaction with MedReleaf.
G.B.
The FDA Hold was announced March 13th...
IMFINZI (a.k.a. Fatal cases have been reported) is an FDA approved treatment even in light of the following side effects information taken from an AZ Durvalumab website. It continues to be administered for previously approved conditions. The nearly two month hold on the ADXS side of the combo trial is ludicrous. ADXS should be more careful doing combo trials with partners who have toxic scientific constructs. You can get slimed and derailed unfairly by an FDA who cannot distinguish between reasonably safe and deadly.
Immune-Mediated Pneumonitis
IMFINZI can cause immune-mediated pneumonitis, defined as requiring use of corticosteroids. Fatal cases have been reported.
Immune-Mediated Hepatitis
IMFINZI can cause immune-mediated hepatitis, defined as requiring use of corticosteroids. Fatal cases have been reported.
Immune-Mediated Nephritis
IMFINZI can cause immune-mediated nephritis, defined as evidence of renal dysfunction requiring use of corticosteroids. Fatal cases have occurred.
Immune-Mediated Colitis
IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids. Administer corticosteroids for Grade 2 or greater colitis or diarrhea. Withhold IMFINZI for Grade 2 colitis or diarrhea; permanently discontinue for Grade 3 or 4 colitis or diarrhea.
Immune-Mediated Endocrinopathies
IMFINZI can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, and hypophysitis/hypopituitarism. Monitor patients for clinical signs and symptoms of endocrinopathies.
Other Immune-Mediated Adverse Reactions
IMFINZI can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system. While immune-mediated reactions usually manifest during treatment with IMFINZI, immune-mediated adverse reactions can also manifest after discontinuation of IMFINZI.
G.B.
The hold and the FDA, who imposed it, is a running joke... There are countless FDA approved drugs on the market far more dangerous with a laundry list of very bad side effects, including death. Who do you know and how deep are your pockets to pay lobbyists to grease bureaucrats is what gets things done.
The trial in question is likely DOA. AZ who has clout is therefore disinterested. ADXS has zero leverage. Timing on lifting the hold will come at the FDA’s pleasure. We’re essentially running in place until the FDA yawns and lifts the hold.
Extremely unfair and more than a little irritating.
G.B.
Good post...
I have no insights into why others may be adding now, but I’ve been buying in the current range primarily because a significant number of the 8.2M shares that were short in February have been covered, dropping to 3.5M in April. I’m also encouraged Adage, as far as I know, is still holding a big long position and they have access to back channel insights I don’t.
I further think the new CEO and CMO are significant talent upgrades from the prior transitional caretakers.
Rationalizing my questionable actions has always been a strength / curse.
G.B.
I was struck by the “Tower of Babel” feel at ASCO looking through the number of sessions and abstracts last year. Big reason why ADXS leadership has to be effective aggressive communicators and promoters or intermediate stage progress just gets drowned out and overlooked due to competitive noise.
My opinion - Lack of effective communications and zero promotion of scientific progress has contributed significantly to the company’s swoon since last summer. That’s not typically been Dr. Petits style - I’m assuming long periods of deafening silence was Lombardo’s misguided preference.
G.B.
Too early to decide he has a dark heart and nefarious intentions Trader. If I were in his shoes I’d sure want the 250,000 RSU’s and 750,000 options to be worth a lot more than they are today as they represent a serious possibility for future wealth.
Give me a battle scarred veteran every time vs a leader who’s spent their charmed career in a big pharma, never breaking a sweat, with over inflated budgets and unearned product success.
After a long series of stumbles I hope the BOD accidentally got something right.
G.B.
Years of experience as a biotech CEO suggests Berlin absorbed a lot of relevant knowledge and he has a network of colleagues within the community. He’s the most experienced CEO ADXS has ever had at the helm. People who work for troubled companies naturally have broader experiences and more survival skills in dealing with adversity. Those skills are in high demand at ADXS.
All due respect, I’m guessing his dance card is full getting up to speed and responding to retail emails will be done on an “as time permits” basis.
Like it or not, our fortunes are riding with this guy and the team he stands up around him.
G.B.
“There is a vocal group of current shareholders who made the decision to hold their shares through years of loss, and they are upset about it.”
hov... Be so kind as to stop holding up mirrors. The reflections are too painful.
G.B.
The ADXS BOD collective decisions over time are perfect examples of how incompetent people, who are beyond the reach of accountability and have zero fear of repercussions, behave.
The motivating power of incentive based compensation that’s dependent on achieving performance milestones and mission critical goals, before it’s paid out, appears to be beyond their ability to comprehend.
G.B.
ROSG SP has been on a stomach churning ride... Unless I can’t read a simple chart, it’s gone from a mind bending high of $7K a share in 2007 and was still north of $40 a share in 2015 closing today @ .35. Since it was still north of $2K a share in 2009 when Berlin became CEO, it’s reasonable to assume he did ok before the botttom dropped out. His business scars are probably deep and well earned, which isn’t all bad.
Of course with my myopic track record with ADXS I’m sure I would have ridden it all the way down from $7K thinking it’s gotta turn around any day now.
G.B.
“The unfortunate reality is that this BOD has basically been Typhoid Mary to this company. I don't know why Dr. Yvonne Patterson agreed to license her technology to such an unqualified group of people (as evidenced by their decisions over the last 10+ years)...but we are where we are I guess.”
Valid observation G50. I’m guessing Dr. Paterson’s revolutionary use of Lm as a medical construct was too “out there” for mainstream medicine when she introduced it so she was stuck partnering with less reputable players to give her discovery a chance. I’m fairly sure at least one of the current ADXS board members is the same guy who convinced America the second “Sham Wow” was really free.
The best shot we have is AMGN, with its immunotherapy focus and scientific depth, trusting they have the foresight to see Lm as a revolutionary medical development.
I believe the rest of the BP’s we’re dancing with are simply running countless combo trials lumping ADXS in with the small biotech cattle call they’re all conducting. Throw enough startup biotech’s against the wall and who knows, maybe one will stick. AZ may really care about their tiny partner who’s suffering under an FDA hold they likely caused, but I have reasons to doubt it.
G.B.
I hereby claim dumbest idea of the day...
Coordination would be problematic but if retail share holders have 10% or more of the company shares and form the Advaxis Investors Mutual fund with individual shares loosely but collectively housed within the shell,
The AIM Fund gains insider status. Obviously executing the necessary filings would require special expertise and there would be organizational expenses to cover.
But... The shares have already been acquired and are in the hands of individuals. The question is can those shares be brought to bear collectively to create standing for insider status and gain insight into company operations.
Just idle thinking as we probe for a new bottom.
G.B.
James...Perhaps you should arrange a series of accidental encounters and bump into him just frequently enough it doesn’t appear you’re stalking him. The MB would be further in your debt.
G.B.
Great background information link on the announcement GF...
I’m reposting the link and encouraging others to read.
https://ih.advfn.com/p.php?pid=nmona&article=77236512&symbol=ADXS
A number of interesting considerations. Really like the deep communications background the CMO brings to show.
G.B.
New CEO... Ken Berlin.
This was posted by blue a day or two after the offering...
“I was told ( by Noelle ) the offering was oversubscribed and major health care funds participated. The company is seeking permission to use these companies names in a press release.”
No reason to doubt blues report. Obviously the companies involved had reasons to delay reporting their participation for as long as possible.
Not sure what to read into the actions, just more low value speculation while we wait.
G.B.
I tend to agree being blindsided by the hold could not have happened at a worse time. I suspect it’s the turd in the punch bowl that’s stopped progress on one or more important initiatives that may have come with much needed cash. In the mean time, they’re burning through precious reserves to keep the lights on.
One thing is for sure. Company leadership, BOD, mid-managers and likely at least some of the rank and file are sitting on a mountain of worthless ADXS equity. All options are currently underwater and worthless and restricted shares / grants that are vesting on a preset anniversary, like TL’s a couple of days ago, are paying out for a buck and change.
I think the hold is placing extrodinary pressure on the company and could force another disastrous dilution if not resolved quickly. I guarantee there are a lot of unhappy people in Princeton NJ who are feeling the heat and the last thing they want to do right now is field WTF calls from a bunch of pissed off investors. Likely why they’re not answering the phone.
I’ll state the obvious for TL’s #1 priority. Get the damn HOLD lifted.
G.B.
Ig - Simple case of ADXS investor fatigue. Yeah, I’m hoping they still have enough leverage to engineer a BO.
In view of their diminishing financial resources I’m increasingly concerned anyone interested in the IP will just drag their feet and wait them out.
G.B.
The faster they wind things down to a skeleton leadership crew, the more likely it appears the days of ADXS as a stand-alone operation are numbered.
G.B.
“Because he (TL) has 90K shares and when they sell for $20 plus he is a millionaire..............hello, chump change”
No doubt Keith, it’s good to be TL and stumble into a late career ICEO gig. While he’s left no doubt he’s happy taking shares granted or optioned from the company, my beef is he’s yet to publicly buy a single share with his own money like the rest of us. That singular, easy to take, action would speak volumes to his long suffering shareholders.
But it is consistent... He’s demonstrated he’s completely tone deaf on doing the obvious things that would signal confidence to the market and investors. We can only hope his negotiation skills are far superior to his messaging instincts. With a few painful exceptions it feels like we’ve been in a quiet period since last July.
G.B.
New investor... Did a fair amount of due diligence. ACBFF has more shares outstanding than similar Canadian competitors but that’s reflected in a lower share price entry point. Company appears well positioned for sustained growth.
GLTA
G.B.
I doubt he’s under any individual stock aquisition restrictions fb... Officers Sara B. and Dr. Petit have continued to buy via the open market as recently as April 3rd. If they can buy, he can buy. For whatever reason he’s chosen not to.
G.B.
Agree... Likely the one year anniversary triggered vesting for the restricted stock he was given as an incentive to join the company. Assume the total shares forfeited covered a 25% or 30% tax impact and he pocketed the rest.
Free money, but still an essential waste of a decent restricted stock award. Any options he’s been awarded are underwater.
As a shareholder I’m a little irritated that we’ve now observed a “D” next to his name on a stock transaction but we’ve yet to see an “A” as in personal actions to acquire stock at what many might think the ICEO would consider a smoking price.
In fairness, almost everything this company has done lately has irritated me.
G.B.
What can’t go on, won’t go on...
Pressure is mounting on multiple fronts:
EU partnership
FDA hold
Financial burn
Leadership void
NEO / HOT scientific / medical affirmation
Volume has dropped to a trickle. Something has to give.
G.B.
Unfortunately bad management rarely comprehends they themselves are bad until it’s too late. They rationalize events unfolding around them now as being caused by outside influences rather than the result of flawed actions taken in the past (getting in bed with Adage) or key decisions not made in a timely manner (selling a construct to build capital early).
The science still has great potential if it survives a series of questionable caretakers.
G.B.
Baseless speculation warning...
Mouse data, which sounds compelling, hasn’t always generated enduring excitement. Could be because there’s still a decade worth of required FDA human trials with HOT and NEO ahead that will have to be funded.
It’s increasingly difficult to see a path forward where ADXS has the scientific depth or financial capital to advance the Lm platforms on their own.
AMGN is the logical white knight with deep pockets and scientific chops to fully develop the science potential.
G.B.
The Bank of Montreal exit timing is curious. I would have thought they’d hang around until the end of the second quarter to see if ADXS hits scheduled milestones. The longer the hold persists perhaps the more spooked conservative Institutions, like the Bank will become.
Hard to read their actions as anything other than they think the SP is going lower.
G.B
Published on several news wire services today...
http://atlanta.cbslocal.com/2018/04/12/goldman-sachs-curing-patients-health-industry-report/
Goldman Sachs analyst posed the question if new and emerging one shot cures are a sustainable business model for pharma companies. Gilead made over $12B in 2015 on their Hep C vaccine. The pool of Hep C positive patients has been reduced to the point Gilead is projected to make $4B on the cure this year with a steadily diminishing patient base going forward.
No ideas on an answer, just thought it’s an interesting conundrum.
G.B.
I guess I take odd comfort from knowing, what cannot go on, won’t go on.
Still holding, but feeling increasingly ambivalent and indifferent about my investment....not the science, just the diminishing investment.
G.B.
I worked for a large Health Insurance company for a very long time. Your assertion is counterintuitive to my experiences. We (health insurer) pushed back very aggressively against expensive treatment options, particularly in cases where efficacy was marginal and of course we pounded hospitals and providers on length of stay.
Our pushback wasn’t because we were totally heartless, we were just trying to stay in business particularly in view of medical costs that were going up three times faster than inflation and state Departments of Insurance who hated to grant requests to increase insurance rates.
When in the last 20 years have you seen a hospital that didn’t have a building crane attached? Someone has to pay for all that brick and mortar, new patient capacity and new custom services hospital providers have deployed.
So in fairness, insurers are working the system hard to make money, as are health providers. Patients are paying the freight directly or indirectly via their tax dollars.
G.B.
Not the best response mm but I’m fairly sure there are entrenched interests on all sides of any attempt to change the current FDA trial process status quo. As is always the case, it depends on whose self-interests is threatened or whose ox is being gored. Insurers would no doubt carefully weigh the pros and cons of accelerated access to new treatments since they’re dominated by beady eyed actuaries, clothed in morbidity trending charts, and are by necessity slaves to the bottom line. Paying insurance customers (patients) only matter in the abstract, as in, how long are they going to live and inflict required treatment cost when felled by illness.
In the case of PD-1, PD-L1 and CAR-T, treatment costs are staggering. Hard to believe any effort to provide early access to these new therapies would have been cheered by insurers. In fact, the British Medical authorities have flatly rejected these new treatments as too expensive for the short average life extension benefits achieved.
Early access to ADXS and the Lm platform would likely be viewed more favorably. Proven safe so far with treatment costs that should beat the pants off the aforementioned emerging big pharma wonder drugs.
I like the argument of packing phase I and II drug testing with loads of safety rigor and opening up the broader patient universe for those who want to voluntarily help test new drug efficacy and perhaps survive a disease that otherwise would have taken their life.
G.B.
As I recall the Indian “wait for phase III” decision was rendered at least 4-5 years ago. How many women might have benefitted from a different position on accelerated access to the cervical cancer medical platform.
At least there are now countervailing opinions from medical groups suggesting the FDA three trial regimen is too lengthy, kills waiting patients needlessly and is crushingly expensive.
An example of building criticism of the current FDA bureaucracy.
“The FDA should be modernized so that new treatments become available to patients once they have successfully made it through Phase II safety testing. Patients who choose the new treatments would essentially be enrolled in Phase III efficacy trials. This would drastically cut the time and the expense it takes to get new medicines to people.”
“Revised rules would allow drugs to come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required. Payers and patients would be the ultimate judge about the quality of the product, and companies could learn from the experience to develop superior products if needed.
Companies would still be liable for unforeseen side effects, but patients and doctors would be warned -- through the drug's labeling -- that the product had been approved based on successful Phase II safety trials and promising provisional research.
Gradually replacing or reducing dependence on Phase III trials with smaller, faster adaptive trials and post-market surveillance would have a positive impact on medical innovation, timely new drug access and the U.S. (world) economy.”
No approach supporting introduction of new drugs is going to remove all patient risk. But, the current policy of holding critically ill people hostage while extending phrase III trials for years, after the successful completion of phase II safety tests, should be re-examined at least every 10-15 years.
G.B.
We could all go radio silent to punish them... At a minimum we can rob them of their biggest source of office humor. Huddling in Noelle’s cubicle reading our speculative frustrated posts laughing their asses off.
G.B.