Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Amen, with ya on that.
Everything in time, one way or the other, but these minor perturbations daily for the upcoming month are not the game.
Btw, I always look forward to your allotted one post per day, thx!
Cap
Yes, awaking to news our dear friend & longtime local NBC news anchor, Wendy Rieger, passed Easter morning greeted us all in the DMV metro area, a very sad awakening.
She was diagnosed with GBM about 12 months ago, had surgery & treatment (not NWBO), then retired in December, intending to savor life with her long-time companion and new husband, Dan, only to succumb to cancer when it returned aggressively several weeks ago. She was just 65.
Wendy was an amazing person, a life-force really, with a wonderful blend of humor, intelligence, warmth and compassion. She was an advocate and supporter of many causes, where her involvement was never superficial, whether it be trying to save animals, mental health wellness, equal rights, and so many more.
We can not get NWBO’s treatment approved and saving lives fast enough :(
Precisely!
Thank you Bio, I appreciate you and so many others who make meaningful contributions!
Hi Gary,
Yes, the Masters restrictions initially takes some aback, but (to me) the genius of forbidding cell phones becomes evident if one just observes the total engagement of the patrons. It’s so refreshing having everyone engrossed and IN THE MOMENT :)
Carmel is gorgeous!
Warm regards Gary, thank you for all you contribute to our board.
Cap
SM,
One day you’ll get there … and it’ll be worth every moment of the wait!
The course, grounds, landscaping, manicuring, all are beyond belief. As beautiful and stunning as it looks on telecasts, that pales vs what you behold there. The National’s Executive Committee has a tight rein on every aspect of the tournament, especially including the Masters brand. E.g., any authentic clothing, goods, accessories, whatever on which you see with the famous Masters logo on it, can only bought at a shop, inside the Augusta National GC during Masters Week. So an attendee only. One cannot get any of it online, vended through a string of shops, etc, just at their shop there. So either the person with it bought it while at the Masters, or someone they knew got it for them there. Very smart, savvy folks run The National, and they have BIG plans as the Club property continues to expand, as it buys up & razes surrounding houses, the reroutes long-existing roads. Not that’s power!
My first Masters was in ‘86 when Jack came back to win it @ 46yo, at the time the oldest Masters winner. It’s just as exciting each time now as it was then, tho the unlimited $20 Par Three Wednesday passes are sadly a thing of the past.
So soak it all up when you do ultimately make it to The Masters, it’s worth it all. And while there, have a pimento & cheese sandwiche, served only on white Wonder Bread, wrapped in Saran Wrap, it’s tradition … and still just $1.00.
Cap
I regularly attend The Masters, had a house very close to the golf club. You can not bring a cell phone onto the grounds of Augusta National Golf Club. No phones, cameras, electronics, etc are allowed, so leave them in your car. But while there, do get a pimento & cheese sandwich!! Enjoy!
I appreciate this post Ike, thank you!
Bio,
I share the sense something very real is coming, and soon.
I like the visual analogy of an Hourglass (activity:time): while the stream of sand is constant, movement of its level is almost imperceptible early on, but as the level moves down, it’s as if time is accelerating. And so it seems to me with recently with NWBO vis-à-vis sensing something real — and perhaps big — is impending.
Ok, sorry about that, back from lalaland.
Cap
Bio, you’re an excellent landscape artist!! The picture you’ve portrayed has been much discussed by many, the pros & cons, but I see the landscape as you do and look forward to seeing the finished work.
Bio, I think your first two paragraphs are spot on.
I’ve interacted -- and dealt — with any number of regulators & legislators, including (fortunately) a number of private conversations; not FDA specific, but in many areas. My personal takeaway is they’re all very conscientious, work hard for the best end-result, but also realize they’re frequently just a cog in the system’s wheel. One very political, with definitely ways of doing things to get to the ultimate objective, tho sadly all too often, prolonged.
When I think of a potentially seismic paradigm change in the FDA analytical regulatory framework we’ve been discussing, after my near 30 years in DC, I just do not find the timeline surprising. I apologize here, just been here, seen it.
Ultimately, it’s just the way Washington works, but I truly believe we get there, not only for our benefit as investors, but most importantly, for the afflicted.
GLTA, especially for the afflicted!
Cap
Bio, you may be subtle at times, others perhaps less, but (to me) always insightful, and NEVER nonsensical, thank you!
Precisely, thx Senti for this an your recent posts!!
I’m so anticipating looking at all of this in retrospect, whenever that may be,because I think it’s gonna be very interesting/riveting!
Highwayman4life, I think you could work on being more succinct :) … I appreciate you, thx!
Hoff, I so agree with you words about Bio, thank you for saying them, I’m glad you did.
few times recently I’ve read what I consider (at the least) a subtle complicity innuendo with NWBO re Bio’s postings; and regretted letting them slide. It’s just how they came across to me. Nevertheless, I am also one who appreciates Bio’s significant contributions to this board.
Thank you again, Bio, for helping keep dialogue focused, and avoiding obfuscation/subterfuge, intentional or not.
Amen Hoff !!
Yikes!!!
Thanks for the info, I feel such a slacker (:
I arrived here on iHub 10/2009 vs Bio just 6 mos later in 2/2010, and I’ve hardly ever said anything worthy in my 400ish posts vs Bio, who is actually nearing 18,000 posts now, of VERY worthwhile information.
I’m humbled and thank Bio for his commitment to us all here!
I third Nick & Danish Dude! … Bio, your ability to seemingly effortlessly & daily put out such much meaningful content is so impressive, thank you for your contributions!
Bio, thanks for this & your PM, both appreciated!
This silence and wait is not easy for any of us, so I am all the more looking forwarding to when events turn, the strategy successfully plays out, and patience is rewarded!
All the best, Cap
Bio, I continue to appreciate your thoughtful posts & comments. Thank you!
We can have no real idea what is going on behind the scenes with NWBO & their experts/consultants. But I suspect, as you suggest, there are many going’s on, driving toward a specific goal of accelerated manufacturing capacity, while concurrently moving forward with RA approval.
Digression: In an wholly unrelated context, I worked fairly extensively with a PE consortium fund including KKR, Bain, Silver Lake, Apax and others on an activity. I mention this to say I’ve noticed a certain “genetic“ commonality with these folks’ approach to deals: Business is a very serious business, no time to waste, always doing everything to realize the objective. And the lid is always tight to avoid conveying any of the many moveable parts inside to the outside; many times these PE activities are only clear retrospectively.
OK Back to NWBO: So with that PE experiential backdrop, I look at NWBO. I am assuming the same genetic commonality, but also factor into that very personal family experiences with GBM, and get: highly motivated personal missions to do everything possible for NWBO to prevail.
I have an opinion on the strategic end-game, and am excited about the possibilities. I sense (my opinion) a very sophisticated approach by LP et als, one largely out of the public eye, with an accelerating convergence on what may be a brilliant long-term plan for something revolutionary.
Who knows, time will tell, but based on what we know publicly, plus lots of breadcrumb following & tea leaf reading, I’m content to sit back with my vote placed (ie investment) and wait to see.
Cap
Ah yes, John Sculley, what a saga.
I remember when Jobs brought him in (like ‘83?), Jobs in his mid-20’s, Scully mid-40’s. Shortly after I was on a flight to Hawaii, reading either Fortune or Forbes?, anyway they were both on the cover. It was a big move and big news, and considered a smart move from old school corporate America’s view, that a precocious “young whippersnapper”like Jobs, to wisely(?) bring in an experienced “businessman” to help transition this start-up into an institution for the long haul. (Hopefully some of the tongue-in-cheek is coming thru.)
On the surface that was the story, ie smart move for young in the article, but what I found interesting was a different theme therein: comparing runners, viz, sprinters & marathoners, to entrepreneurs.
The author’s point was entrepreneurs are overwhelmingly sprinters, not marathoners, and very few were equipped to survive/have the requisite attributes to successfully transition into long-haul corporate marathoners. In fact, in the article, the writer’s only example of someone who did so successfully was Ken Olsen of Digital Equipment Corp.
Times have changed greatly, and Jobs returned to bust this theory wide open in his case … as have eg Bezos, Musk, Gates … but I’ve also seen the analytical concept of sprinters v marathoners vis-à-vis entrepreneurship be apt too.
I just thought the analogy very thinking-out-of-the-box at the time, and still, several decades later, think it very creative.
Sorry for all my digression lately … Cap
Bio,
Thanks for your post, I appreciate it and agree with much if not all of what you said.
And just for the record, given a comment in the last paragraph, I definitely listened to your posts, subtle at times, on the topic & importance of finalizing these regulatory guidelines. It’s why I’ve brought it up occasionally on this board. I feel (just my personal opinion) it is a much bigger issue/roadblock/hurdle (many adjectives could apply), than perhaps it’s given credit re our timeline. Time will tell …
Cap
Hoff,
Slowly catching up on this board and finally made it to this gem!
Thank you, Hoff, I really appreciate worthwhile posts, if not excellent posts, as here, to make working through all the chaff worthwhile! :)
Cap
Hoff,
I appreciate the subtlety of your humor, and your contributions on our discussion board. Thank you here and for your message to me, v appreciated!!
Cap
Hi Bio,
First, saying it again: I appreciate you, and thank you for your thoughtful contributions.
Second, I thought the same re the timeline on finalizing these regulations & guidelines, expecting it would be sooner, definitely thinking by 2021 year’s end … tho with less basis for my opinion than yours :)
In my experience, but not FDA-related, I’m a bit familiar with the agency rulemaking process, federal register publication, comment submission periods, etc, preceding finalizing revised regulations. So I guess the surprise here for the wait, as I’ve not seen anything like this long process.
Sorta analogously, but from experience, I do understand how strong the BP lobby is, not that I’m inferring anything here. There was a period in my career when I, together with a number of my contemporaries/colleagues from different corporations, were meeting with members of Congress, on both sides of the House, re a particularly significant legislative reformation effort. We were a fairly high level corporate delegation. It was surprising and eye opening as well.
This legislative effort had bipartisan support on the House of Reps side, but when discussions with Senators and their Legistative Directors (LD) then ensued, it became apparent the legislative reform supported by corporate America writ large, would die. Why, one can really never know, but during a subsequent, and private conversation I had with a key senator’s LD, I sorta clearly sensed that if BP didn’t support legislative reform here on the Senate side, it was doomed; and it died. One of my colleagues (and former clients) was head of a big corp organization, similar to mine, different industry. He was there at these meetings and we had many shared corporate interests, but not all apparently. He subsequently became the executive Director of PhRMA. Looking back, for me, the bottom line is BP is (to me) incomprehensibly powerful and not to be taken lightly.
Through that experience and subsequent investments, a lot can fit in about why NWBO management may be proceeding with cards closely held. I have a sense of the power & capabilities of BP. Any sophisticated David, versus a Goliath, would be foolish not to tread very carefully. There could be many answers re what’s going on within NEBO and this excruciating “quiet period”, but I’d never discount the fact that there are big powerful forces working to blunt NWBO’s objective and possibly provide a rationale for what we’re watching on the sidelines.
Cap
I know I haven’t hidden my sentiments, but think formalizing, what I’ll call, the new regulatory paradigm is so central to moving forward … and realizing NWBO’s ultimate objective for broader applicability of this methodology.
Precisely, I couldn’t agree more with what you thoughts are m, in toto, thank you Bio!
As usual, thanks for all you contribute to this board and discussion.
I do have a question for you or anyone else who may know or have any insight: does anyone know where things stand with & within the FDA — after a couple years now and 2 rounds of comments — on the proposed change re comparing Phase 3 trial results, TLD, etc to historical data, rather than trial placebo data vis-à-vis SOC improvement ? (I know it’s not artfully asked, sorry.)
I had it in my mind final FDA approval of this new analytical framework may be a key factor, perhaps even roadblock for NWBO and others.
Thx, Cap
Gary, my heart goes out to you. It’s so odd that at the end of a long day planning travel i just read your post on the sad loss of your sister. Yesterday I got notice my cousin’s youngest passed over the weekend, her brain & body ravaged throughout by cancer at a too young age of 59. I could not agree more there has to be another way than a decade or more of testing for approval of promising treatments/therapies. I will pray for you and your loved ones.
Stingman49, thanks to you too for your contribution. With this additional purchase by BlackRock, though I’m awaiting 13-F filings, it should put them at nearly 3.2 mil shares. And depending on what State Street & Vanguard report, the 3 of them will own nearly 10 mil CVM shares. Not quite 20% of outstanding, but a sizable investment.
W_W, The_Q, Henkel (but not Sushi),
I just wanted to thank you for your periodic posts & ongoing belief something positive will ultimately happen. Not an avid poster, just hanging & waiting …
Cap
Just for clarification, the description in a patent does not define the legal metes & bounds of the invention for which a patent is allowed/granted, it is just the patent claims. While it may be informational background- & context-wise, its not the enforceable part of a patent against possible infringement, just the allowed claims. Not legal advice, just a comment. And I may be missing the point, it’s good the government supposedly has legal rights in the patent because … ?
Excellent post ieasadiver, many thanks, my sentiments exactly & right there with you! Cap
Thank you for your further comments, Dan88, truly appreciated!
Flipper,
It took me a while to figure out how to get to Post 408169 (eye’s rolling), but ultimately did. Thanks for that and your additional comment here!
I’ve been invested in NWBO for a number of years, as many here have, and added recently. I’m a long-time lurker here, but just want to thank you and so many others who make meaningful posts, I appreciate you!
Cap
Oops, sorry, it wasn’t Doc I was thinking of re tea leaves, think it was biosectinvestor (?)
Dan,
Thank you for providing info on FDA request for comment so I could do some searching here. I’m quite a neophyte re FDA rule making guidelines, process, timelines, and so on. Tho certainly not sure, I’ve sensed/wondered if this is relevant to tea leaves I’ve thought Doc was leaving, at least in part, as it relates to something beyond NWBO’s control vis-à-vis TLD release?
Ok, that said, I see that in this Sidley writeup, the deadline for Comments was yesterday, Nov 29, 2021. Do you or others think that these revised guidelines have a bearing on the release of TLD by NWBO ?? (And wonder if this has a bearing on CVM being in seemingly a similar quite period.).
I hope this isn’t a dumb question …
Thanks, Cap
https://www.sidley.com/en/insights/newsupdates/2021/11/fda-articulates-high-benefit-risk-expectations-for-drug-developers
$OTLK is delighted to report that NORSE TWO met its primary endpoint with highly statistically significant and clinically relevant data. We look forward to bringing ONS-5010 ophthalmic bevacizumab to the @US_FDA as a BLA for #wetAMD. Read more: https://t.co/YGCuCA6OcO $OTLK pic.twitter.com/bmyzaTVyIW
— Outlook Therapeutics (@OutlookTx) August 9, 2021
Right, thx … and meant AMC, not AMS … duh on both accounts … that’s what happens when one gets older and thinks mental acuity hasn’t changed :) Thx again!