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Turns out January 12, 2023 is an very important date for Anavex, more important than December 1st or December 5th.
The critics have gift wrapped all the questions they're using to discredit phase 2b/3 2-73-AD-004 trial results. They've been firing everything they have for a month. There will have been ample time to get ready for J.P. Morgan. Every question must be answered, every data point a stunning masterpiece of clarity. No equivocating, just shock and awe. It's a must.
"Will 2023 be the year the FDA FINALLY RECOGNIZES that the "Amyloid Plaque Thesis", as a causal path for AD is DEAD??? "
Excellent question. As a top Pharma CEO/CFO dedicated to Amyloid Plaque removal I can't even conjure what the pressure will feel like to write off billions in sunk research investments.
Some are likely clinging to the hope they can bully something past the FDA then quickly partner (even if it's with BiiB) so they can claim their new combo treatment is effective enough. Desperate times will require desperate measures.
Passing on a post from earlier today on the Yahoo board. As the poster suggested #4 and #5 could be relevant to Anavex fortunes if the publication has a crystal ball.
https://www.ddw-online.com/drug-discovery-in-2023-five-key-predictions-21106-202212/
Reviewing the December 14 announcement of Dr Grimmers appointment to the Anavex Scientific Advisory Board. Couple of items jump out. "Authored numerous peer reviewed articles". (That's timely) " Principle investigator in more than 70 drug trials". I also included references below to how widely he's been published and referenced via citations by other authors.
I think his addition to the Anavex scientific team is a much bigger win than many realize and I agree with others who have suggested he wouldn't have invested his sizable talents if he weren't fully committed.
Anavex Life Sciences Corp. today announced the appointment of Prof. Dr. Timo Grimmer, MD, to its Scientific Advisory Board. Prof. Dr. Grimmer served as National Coordinating Investigator for the ANAVEX®2-73 (blarcamesine) Phase 2b/3 ANAVEX®2-73-AD-004 study.
Prof. Dr. Grimmer is a board-certified psychiatrist and psychotherapist and an Associate Professor working as a Specialist Registrar at the Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany. Prof. Dr. Grimmer is head of the Centre for Cognitive Disorders, which specializes in early and differential diagnosis of patients with cognitive impairment. The main focus of Prof. Dr. Grimmer’s research is assessing the usefulness of biomarkers in predicting neurocognitive disorders.
He has authored numerous peer reviewed articles, amongst others the first studies that assessed the utility of amyloid PET for differential diagnosis of neurodegenerative diseases and to track Alzheimer’s disease progression. In addition, he has served as a national coordinating investigator and as a principal investigator in more than 70 drug trials.
He's been a contributor, author or co-author for 281 publications primarily addressing various Alzheimer's and Dementia scientific topics.
His writings have been featured in multiple top journals and his work has been cited over 8,000 times.
Alzheimer's & Dementia: the Journal of the Alzheimer's Association (58)
Journal of Alzheimer's Disease: JAD (11)
Journal of Nuclear Medicine (9)
Neurobiology of Aging (9)
Neurology (8)
"Well, if I were Missling and had finished working on the more detailed results that I was going to release, at this point I would wait until the beginning of the new year."
Agree... They have a big time slot to fill at the J.P. Morgan conference on January 12. I doubt we'll hear any new news before that event.
"SAVA - ouch. Tanking big time."
Down just over 13% on no news unless it's the encouraging news finally getting some press from a competitor.
Highly gratifying to read an upbeat assessment of December 1st results.
Really looking forward to the January 12 session at the J.P. Morgan conference.
From a poster on Yahoo.
Do these ask/ bid actions from a couple of hours ago seem like a normal trading pattern?
Price @ $8.81
Bid$ $8.71
Ask $8.74
Price @ $8.54
bid $8.19
ask $8.61
Price @ $8.60
bid $8.19
ask $8.70
I'll be crossing Fierce Biotech off my Christmas card list this year. Pushing back against this type of mud slinging can't happen too soon.
Fierce Biotech Rotten Tomatoes for 2022
Number 1 on the list - Anavex Life Sciences
"No matter how you describe the data from Anavex Life Sciences' phase 3 Rett syndrome study for Anavex2-73—“very large” and “large” is how the biotech wanted the effect size to be viewed—the February announcement was confusing.
In February, Anavex claimed that the late-stage study was a success, but there’s just one problem: It wasn’t a phase 3 to begin with. The study was changed midway through, with some new endpoints added to the ClinicalTrials.gov entry associated with the AVATAR trial.
CEO Christopher Missling, Ph.D., however, told Fierce Biotech at the time that "there was never a change of endpoints," and the late amendments noted on the database should not be relied upon as evidence of a change to the study protocol.
While the company said one thing, investors were clear on their opinion of the data. They sent shares sliding 18% to $10.70. Analysts questioned whether the new endpoints were a meaningful way to show Anavex2-73's effect.
Apparently, Anavex didn’t learn its lesson from February. The company recently touted some new data on Anavex2-73, this time in Alzheimer’s disease, claiming the therapy reduced clinical decline in patients with mild cognitive impairment. That prompted a nice share price spike, from $8.85 to $12.81 on Dec. 2—but Anavex was once again dogged by reports of a “spin job,” as Stat put it.
The company said Anavex2-73 “demonstrated visible improvement” in patients, who were 84% more likely to have improved cognition compared with placebo. But that doesn’t tell us how much they improved—just that they were likely to improve.
It’s not a good look to give Alzheimer’s patients and their families false hope. It’s a brutal disease, and these patients desperately want an effective treatment. For this, we lob the rottenest of rotten tomatoes Anavex's way."
"I sincerely hope that Missling and team are working on a fool-proof presentation for the regulatory agencies."
Your hope is worthy of our concern. Equally important, and I don't want to presume to advise TGD and his team but, they better bring it on January 12 at the JP Morgan event. Forty minutes is a big time slot and a rehash of old news or stunted data references from the garbled December 5th call following CTAD won't be well received. We need new rock solid clarifying input to clear up nettlesome questions about the Phase 2B/3 results that robs the flying monkeys of further ammo. It would be a darn good idea to throw in some material updates and references to impending news about other initiatives that are now due or overdue.
I especially hate that someone on another board just dropped a suggestion comparing Anavex with Theranos. Missling should stop that BS in its tracks.
Motley Fool 12/17/2022 - "when something sounds too good to be true, it usually is. And there's reason to believe that blarcamesine isn't all it's cracked up to be."
Can't wait to see how this statement ages. You have to wonder how The Fool would have initially assessed the Salk Polio vaccine, the discovery of Penicillin or the common aspirin. The title of their stock market rag seems entirely appropriate.
Passing on another excellent post on IV Prime from amstocks82.
It is very disappointing that Anavex is sitting right now at about $8.50 a share - which is down from what they were a month ago. This is after releasing news that Anavex 2-73 succeeded in passing their trial.
However, short traders succeeded in making it seem like Anavex 2-73 failed.
The fact remains that they did not fail and indeed the results were very good.
Going forward, it will become more and more obvious that Anavex 2-73 succeeded. Not only succeeded, but patients with the high dose who responded in 48 weeks didn't on average change very much staying very close to the same. In normal circumstances, the average Alzheimer's patient would decline hugely in 48 weeks.
One of my relatives wife had Alzheimer's disease. After having the disease for about 2 years, she was very forgetful but still somewhat herself. One year later, she could not remember the names of her children or even her husband. She looked at them with surprise and pain as if they were strangers. Yet, her mental deterioration kept her from being able to do much more than stare and pace around.
Patients who take 50 mg of Anavex 2-73 from the start of getting Alzheimer's disease based on the data so far, patients will likely die their natural death before getting to the point of not even remembering who they are and who their family is. (Assuming they are part of the 80% of the population that responds well to Anavex and don't have the gene mutation that reduces effectiveness). Even if they are part of the 20% of the population that doesn't respond well, the drug will still reduce how rapidly they decline allowing the patient another year or two of clarity.
I never have a problem with short traders. I've been one as well a couple times in my life when I tended to trade a lot. However, what I despise is short traders who work with financial publishers to lie about companies and distort news. The second group I despise is those who are attached to financial institutions and can short without borrowing shares and have ways of getting around restrictions. Some laws in the last decade have slowed this practice down, but not stopped it.
Overall, the future of Anavex does not depend on traders or investors. Anavex has sufficient cash to get to the end and get drug approvals and partnerships with other drug companies. With a drug that works very well on Alzheimer's disease, Parkinson's disease, RETT syndrome, Fragile X, and many OTHER diseases to be proved in the future, really, the sky is the limit!
Posted earlier today on ST by ConfirmationBiasSuxs... Feels like solid rational thinking.
"$AVXL Despite my rampant chaotic neutral pragmatism and general cynical opinion on the massively corrupt mechanisms of the "free" market... this is really bad for shorters... Anavex has a bunch of preplanned catalyst moments pending.
JP Morgan conference on January 12th (gotta be data dump he gets like 40mins)
Upcoming PDD data next 2-6 weeks (I bet an ice cold coke the slides will be super tight)
Peer reviewed article detailing the phase 3 AD data 4-12 weeks (sexy picture time)
FDA meeting about phase 3 data 4-12 weeks
If I was CEO after the CTAD presentation flop I would want to come out guns blazing... collect testimonials from patients in Australia and launch a buncha clips right after presenting on the 12th hit all the social media sites... create buzz... and just start pounding the market with good news story after good news story... start doing the media rounds... find a BP partner for the distribution right at the peak... This stock is Dynamite and the fuse is lit... "
Perhaps a much bigger opportunity than some realize with 8,000 anticipated attendees. Anavex has a 40 minute time slot (08:15 am - 08:55 am) Pacific time on the last day. I don't anticipate they will show up empty handed. A live audio webcast will be accessible at the investors section of the Anavex website. An archived copy of the session will be available later in the day on the 12th. I tracked down some summary information about the conference.
41st Annual J.P. Morgan Health Care Conference - January 9-12
"Attendance is by invitation only. There’s no trade show floor. And, good luck tracking down information on speakers and schedules if you’re not invited — a public website for the event doesn’t even exist. Safe to say, this is not your typical conference or trade show.
The J.P. Morgan Healthcare Conference, to be held January 9 - 12, 2023 continues to be one of the life science industry’s largest and most frenzied conferences of the year. It reliably draws thousands of investors and executives across the healthcare sector to the Westin St. Francis Hotel in San Francisco as hundreds of companies present their latest innovations and dreams in an attempt to pique the interest of venture capitalists and potential partners."
Let's trust the right people are there paying attention.
I wasn't a buyer as early as many on the board so I'm still averaging down. As long as shorts keep engineering "Blue Light" specials on the shares in the short run, I'll be happy to take advantage. Just an opinion but... I don't think these low ball opportunities will last much longer.
An outstanding post by amstocks82 on IV late yesterday... A helpful chart didn't transfer during the copy / paste.
"Trial data and comparisons
Clinical trials data for Anavex Alzheimer's trial:
Current Primary Outcome Measures:
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
Result:
ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks.
Mean difference in ADAS-Cog score change of -1.85 points.
==========================================
ADCS-ADL (Activities of Daily Living) [ Time Frame: 48 weeks ]
Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)
Result:
ANAVEX®2-73 treatment was 167% more likely have improve function compared to placebo, at clinically significant ADCS-ADL score change of +3.5 points or better at 48 weeks.
Clinically significant response categorization in function defined as ADCS-ADL ≥ +3.5-point change from baseline.
===============================================
Current Secondary Outcome
CDR-SB (Clinical Dementia Rating Scale Sum of Boxes) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared with placebo using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Result:
ANAVEX®2-73 treatment slowed clinical decline in cognition and function assessed by 27%.
compared to placebo, ANAVEX®2-73 treatment difference in mean score change of -0.42 points.
===============================================
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Result:
Similar TEAE rates in Active and Placebo arms.
Adverse Events ≥7.5% were predominantly mild or moderate.
No clinically significant changes in vital signs, lab values and ECG parametersin Active and Placebo groups.
Dizziness consistent with CNS drug effects. Will be mitigated in the future by bedtime dosing.
Safety findings are consistent with the known safety profile of ANAVEX®2-73.
===============================================
Current Other Pre-specified Outcome Measures
No results announced yet for the following other measures.
Number of participants with change of brain volume assessed by MRI [ Time Frame: 48 weeks ]
To evaluate the effect of ANAVEX2-73 on structural and Arterial Spin Labeling (ASL) MRI scan assessments characteristic for AD pathophysiology compared to placebo over a 48-week treatment duration
Blood assessment [ Time Frame: 48 weeks ]
Blood assessment from baseline and compared to placebo at +48 weeks: Abeta40, Abeta42, T-tau, NFL, YKL-40, BACE1 concentration
CSF assessment [ Time Frame: 48 weeks ]
Changes in CSF parameters (Abeta40, Abeta42, T-tau, P-tau, NFL, YKL-40, neurogranin, BACE1 concentration) characteristic for AD pathophysiology from baseline and compared to placebo at +48 weeks treatment differences within subgroups will be performed
Number of participants with pre-specified genetic variants [ Time Frame: 48 weeks ]
AD relevant pre-specified genetic variants will be assessed. Statistical testing of treatment differences within subgroups will be performed
RSCAQ sleep score [ Time Frame: Weeks 0, 4, 12, 24, 36, and 48 ]
To evaluate whether ANAVEX2-73 improves sleep continuity as assessed on a serial basis (weeks 0, 4, 12, 24, 36, and 48) with a questionnaire that assess reported sleep continuity (RSCAQ)
===============================================
Additional information from the trial data released to date:
Overall, the ADAS-Cog group treated with Anavex 2-73 improved by -1.85 points over the untreated placebo group. Or another way to put it is that the placebo group declined over 48 weeks by 4.11 points and the Anavex 2-73 group declined by 2.26 points. But the surprising thing that they wrote is: "Among patients, who improved with ANAVEX®2-73 treatment, Mean ADAS-Cog score improvement -4.03 points."
This implies that the treatment group has many that don't respond very much. For the Parkinson's group, it was found that the 30 mg group didn't respond very much but the 50 mg group did.
What could cause a good percentage of the trial group to have 4.03 improvement over the placebo group but the average of the treatment group only improves over the placebo group by 1.85?
In this test, given that the groups are randomly selected (double blind), there are 1/3 started with the placebo, 1/3 with the 30 mg dose and 1/3 with the 50 mg dose. There are also ~20% of people who have a gene mutation that causes them to not respond as much from Anavex 2-73.
Assume that the Alzheimer's patients respond similarly as the PDD patients. Since 169 started with 30mg dose, with 20% having the gene mutation, 135 respond slightly better and 34 (the 20% with the mutation) respond less well. So, perhaps no noticeable response. In the 50 mg dose group, 135 respond well to the drug, 34 with the gene mutation don't respond as well but may have some effect. This would mean at the start, they have initially 338 in the treatment group but only 135 are high responders. (These numbers are initial before dropouts.) This means about 40% are in the group that are likely to be high responders due to the 50mg dose and not having the mutated gene that impacts effectiveness of Anavex2-73. But in that 135-person group of potential high responders, some may be impacted by other factors that reduce the effectiveness as seen by the scoring. I.e., elderly patient scores can be heavily impacted even by the time the testing is done. It works out that if 100 patients are high responders and improve by 4.03, and on average the others in the treatment group improve by 0.9, then the average comes out to around 1.85 improvement over the placebo group.
Why do these calculations? I'm trying to see if the results from the Alzheimer's trial line up with the PDD trial, RETT trial and prior Alzheimer's trial with respect to the effectiveness of the drug. My view has been that Anavex 2-73 is not actually an Alzheimer's drug in that it targets Alzheimer's disease. I think of it as a drug that increases overall cellular health. Some age-related diseases occur due to cellular health declining as part of the aging process. If cellular health is improved by a drug like Anavex 2-73, diseases like Alzheimer's or Parkinson's improve or perhaps in some cases go away.
What the above implies is that Anavex 2-73 is really a drug to help with all types of age related diseases and conditions where cellular health is reduced such as RETT syndrome or Fragile X. It also means that Anavex 2-73 can be given at the same time as many other drugs. This makes Anavex 2-73 a potential blockbuster of enormous potential."
Posted on an IV message board sub group...
Harrier Capital
Harrier Capital had written a short attack on AVXL on Seeking Alpha. FWIW, the article is no longer available.
From SA: This article is temporarily removed pending fulfillment of Seeking Alpha's policy related to incorporating management responses to allegations.
One would prefer to think the FDA turns a blind eye and deaf ear to anything but the truth and the data facts when reviewing the merits of a breakthrough drug like 2-73 but... Puzzling actions and decisions particularly over the past 3-4 years have greatly eroded the moral high ground they occupied for years.
I'd love to see the Aussies and EU step up.
For those who scan StockTwits, frequent poster, BigBIO has several posts indicating he's been in touch with IR.
Just passing it on for anyone who may be interested.
Anyone have a sense for how well the Anavex poison pill is setup. Starting to wonder if the relentless engineered drop is more than just shorts and hedge funds playing reindeer games.
The howlers are demanding we blindly accept one of the following...
First - Scores of professional medical trial researchers across multiple disparate geographic locations somehow all colluded and sent falsified happy data to the independent third party CRO. That's not logistically possible and chances are ZERO.
Second, the reputation dependent CRO, who provides analytical services to multiple large BP's, allowed a gnat sized biopharma to browbeat them into falsifying their analysis. Ludicrous, absurd and the chances are ZERO.
Lastly, Anavex leadership who had a sliver of time to unwrap the dataset from the CRO before CTAD still had time to torture the numbers to fit their "met primary and secondary end points" narrative risking unimaginable consequences if that were false. Less than ZERO chance.
The field researchers, the CRO and Anavex leadership are all being unfairly discredited, should rightly have a major case of red A$$ and fight the lying SOB's supporting the AD status quo or newly rendered sub optimal BP solutions.
Suddenly everyone is in a big hurry... Posted on IV.
AVXL 'meets' study goal, biogen/eli lilly seeking approval after PH 2s?
Interesting.. whats going on with eli and biogen? You get big enough and believe you can 'skip' the ph 3s others have to complete??
Biogen/Eisai have already filed their biologics license application (BLA) seeking accelerated approval for lecanemab with the FDA, supported by data from a phase II study (Study 201). A final BLA decision is expected by Jan 6, 2023.
Eli Lilly has developed donanemab, an investigational antibody therapy, for AD. Eli Lilly initiated a rolling submission with the FDA last year, seeking approval for donanemab under the accelerated pathway based on data from the phase II TRAILBLAZER-ALZ study. A final decision on the BLA is expected in early 2023. Eli Lilly also expects a data readout from the pivotal phase III TRAILBLAZER-ALZ 2 by mid-2023. If positive, the data will form the basis of its application for traditional regulatory approval for donanemab.
The poker players among us are familiar with the term "the cards play themselves". No matter how badly a player bungles his play during the hand at the end of the hand the best cards win because the cards play themselves.
We have that exact process playing out. Even as we stumble during the timing, development and presentation of our data we clearly have the far superior hand. Thankfully, in spite of our communication challenges, our cards will play themselves.
Relax and enjoy the Holidays.
Posted on ST... Objective articles are starting to emerge.
https://www.streetwisereports.com/article/2022/12/05/co-reports-positive-results-in-ph-2b-3-alzheimers-trial.html
Ok we get it. It's obvious, Hedge Funds and Shorts are still in control. But not for much longer. Following CTAD and todays call, word is spreading quickly within professional medical and investor ranks. When it reaches critical mass we'll see the mother of all FOMO driven runs. The results, though somewhat poorly represented, are nothing short of miraculous and there's even better data/news coming. There's now real hope for millions of AD sufferers and soon Rett patients, Parkinson's patients Fragile X and a host of other maladies.
This game changing message can't be dismissed, discredited or contained for long.
Strong drug and very good safety profile. The FDA can always require a Phase 4 for air cover but a 2-3 year delay for a new expanded Phase 3 is totally unacceptable. I don't think other major regions throughout the world will sit on their thumbs and wait.
The forces aligned against are at a terrible disadvantage and they know it. They don't have any more information than the rest of us so the negative views they're spewing are totally unsupported and without foundation.
Dr. Missling will cut their legs out from under them tomorrow AM and enjoy every minute while he's doing it.
Of course.
Thank you.
McMagyar - Remind me what TGD stands for. Thanks.
IBD, MF, SA/AF. None have enough information to spew hard negative opinions at this point. None have an ounce of journalistic integrity, which is in critically short supply these days. None will offer retractions when proven wrong.
There was a very tough 15 minutes Thursday afternoon in San Francisco for big Pharma. Confirmation that billions in amyloid tau research just officially went up in smoke. The noise from AF, IBF, Motley the ALZ Foundation and the like is just wishful thinking as BP knows it won't hide the truth, nor will it save their research investments. BP may participate in the denial campaign initially, but their ranks will break quickly as they will all be motivated by self interests to partner. The financial rewards are just too compelling.
AnaLilly, AnaRoche, AnaNovo, AnaPfizer, AnaMerck. Take your pick.
Ah the irony - If told they had early AD onset by their physician, AF and all his minion bashers would immediately recreate the George Costanza trash can fire scene from Seinfeld. Knocking people out of the way to get to the head of the line to beg for back door access to Blarcamesine.
Every single one of us knows it's true.
Agree Hoskuld... A number of posters across several boards have contacted IR for clarification throughout the day or have performed their own quick scrutiny including Mayo. The preliminary numbers are good and will knock the scientific medical communities socks off when they're broken down further, particularly the 50mg dose performance. The necessary complexity of yesterdays quickly compiled data presentation provided false openings for the "Borg" to attack. That was coming no matter what was presented.
There's a saying... "Every time a sloppy power point is created, God kills a kitten."
Part of me wants them to quickly clean up the unfortunate data questions they've created, part of me is afraid they will.
Remember where you were.
The hurdle obliterated this evening is the current 20+ year old SOC utilizing two ineffective drugs with minimal benefits, significant side effects and a death sentence. The old AD treatment paradigm has now been rendered obsolete.
It's hard to overstate the world changing implications of a 15 minute presentation in San Francisco on December 1st, 2022.
A big, name recognition partner with deep pockets will bring instant credibility. The rats aligned against will scurry and move on to their next target. Can't happen too soon.
"Todays share price takedown..."
Is laughable, predictable and straight out of the manipulators bottom feeding playbook. MM Pros are simply trying to frighten people into selling and if they're lucky take out stops. Agree, December 2nd will be a repeat even with good news.
For the record and for what it's worth, the 10 million shares currently held short are mostly in the accounts of large hedge funds who have developed specialized sections with talent in shorting biotech. Even with the TLR announcement they've stubbornly held their positions and without any qualms are rooting against good news this week. It sure seems like a smarmy business model to root against the advancement of medical science, but it's what they do for a living.
Let's trust for once, they're terribly wrong and they've made a very bad and expensive mis-calculation.
From a poster on ST... Seems like a rational take on why the data release won't occur until December 1st.
"CTAD used to have a requirement that all info must be unpublished. I can't find that anymore, but CTAD is a money-making organization that charges over $1000 / person to attend. And even at that price, is oversubscribed this year. How long would that last if all they talked about was stuff already public? Who would go then? "
"Don't expect anything till presentation day and it might be during the day to get it."
Bourbon - I can't decipher why they're proceeding with an earnings call with a possible existential level event just three days later. Perhaps it is to honor a regulatory reporting requirement, but a bullish poster on IV posed the same timing concern you did, although in harsher terms.
Q3 call
“Management will host a conference call on Monday November 28, 2022, at 8:30 am ET to review financial results and provide an update on the execution of the Company’s growth strategy.“
How will they do this with a binary event days away? I look at this as a bad sign. If the news were good they should have had the Q3 report after the event to say what they are really going to do. This whole discussion will be fake because they wont admit success or failure and hope to sail through the call without hard questions (answers)
Could just be more tone deaf timing. We'll continue to assume they know what they're doing until they prove otherwise.