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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!
TDA wasn’t always 100% no margin re CVM, it went that way in the aftermath of Robinhood, GameStop, AMS, etc, along with CVM cracking $40+. Coincident with this change, TDA did the same with CTXR, NMTR, among others. NWBO wasn’t marginable either, but that was more re share price.
Sorry to hear it’s an ongoing issue, mine too, but whew, 12th surgery! Good to hear it’s basal/addressable, sending good vibes it continues to be so!
I was also planning to attend the meeting in person, as it’s only like 15 miles away, but changed my mind. For some reason my gut tells me it would only increase my sense of frustration, irritation, anger, disappointment … so many adjectives apply, but guess I just don’t want to see this human specimen up close … All that aside, wishing you best of luck with your skin issues, I can relate.
@sab63090
Yes, the Supremes really kicked the appeal/remand pendulum on this one before adjourning until October. It will take some time for this to work through the system. Interesting note re your Congress comment: IMHO I believe we’re going to see more cases where the Court will decline to fill the holes Congress left in the legislative interstitial lattice. A strong philosophical bent of newer Associate Justices, one I support.
Glad your daughter & grands had a nice trip & are back safely. I hope their dog appreciated your efforts re the A/C ahead of your pet sitting duties :)
ExWannabe,
What you said is close, but you have to exchange 17 & 20.
Pre-TRIPS & WTO (‘95), the patent term was 17 years from grant date. After TRIPS/WTO was ratified, and subject to certain grandfathered conditions upon ratification, the patent term scheme shifted from 17 years from grant date, to 20 years from the date of filing.
Sab, re you comment:
“… I really hope we do not see that, especially at the USPTO where the US Supreme Court has given undeserved power to the Director; we currently have an temporary director since Mr. Iancu has left.”
SCOTUS did issue a ruling this week seeming to say that, in certain situations, decisions of an ALJ are subject to review by the USPTO Director or Acting Director (of which there are currently neither).
Drew Hirshfeld is presently filling this function, with the title of “Performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO.” And the Administration is pretty clear that Drew is not the Acting Director, but has yet to nominate a USPTO Director/Undersecretary of Commerce. Considering the global strategic importance of IP, hopefully soon tho …
SCOTUS Ruling - Two Things: (1) it was a plurality opinion/ruling, so time will tell how it’ll shake out as binding precedent, and to what effect; (2) in the case of a final rejection of a patent claim or claims, review of this rejection goes to the US CAFC, if appealed, so it is not solely within the agency’s purview, in case that helps allay fears re big biz influence in the USPTO.
W_W,
You are v welcome! I regularly check in, but rarely ever post unless I think I have something to add.
That said, kudos to you on your 10+ patents, impressive! Re pendency in the USPTO, it varies greatly, depends on the Art Unit; eg, BioPharma & IOT can be 2-3X longer vis-à-vis a mechanical patent application. To address in certain situations, that is why (in part) the Patent Term Extension (PTE) is available. Something definitely useful for types of patents, such as a patent relating to drug products & medical devices, which are subject to a lengthy review process at the FDA.
Here is a good, high level article on PTE, if anyone is interested:
https://www.fr.com/intro-patent-term-extension/
Cap (aka @NavyYardSteve elsewhere)
It can just take that long to go thru the patent preparation & prosecution process, esp in this Art Group.
Once the patent issues, the public can look at the transaction history in what’s called the USPTO PAIR System (Patent Application Information Retrieval)
Here is a link to PAIR. Just choose Patent Number for your search, input in the Patent # (11,041,013), hit Search button, and you can then check out information specific to this patent in the “Transaction History“ tab. It shows every transaction between the USPTO & inventor(s) in obtaining the patent. You can also root around to see other info that may be of interest re continuing applications, assignments, and so on.
https://portal.uspto.gov/pair/PublicPair
I think this is a great (and v logical) thesis, thank you for sharing Sushi!!
FYI: You can track the holdings in ARKX here:
https://ark-funds.com/wp-content/fundsiteliterature/holdings/ARK_SPACE_EXPLORATION_&_INNOVATION_ETF_ARKX_HOLDINGS.pdf
Also on the Ark-Finds.com site you can sign up for the daily trading email summary, which lists the buy & sell changes by Ark fund.
From what I can see, I think Cathie Wood sold about 208k shares, but still holds roughly 443k shares of ACIC in the ARKX fund, assuming the pdf of fund holdings I just checked is current & accurate. I can always be wrong, so there is that ...
ARK said $3,000
Caught me by surprise, where was Reddit when we needed it!!! ... now if they could just move the decimal point over a couple digits ...
FWIW, and along the same line, this site provides some info re shorts & NSS; scroll down to see daily #’s re CVM trading & short volume trending:
https://www.nakedshortreport.com/company/CVM
Boozeman, that is precisely my sentiment too!!
Would love CVM to knock it out of the park re P3 results (wouldn’t mind it if NWBO & NMTR did as well), then do as as you suggested. This is bs ... Just have to figure out where to move my acct; open to thoughts on this.
RoboDroid,
I’m sorry about the ??, I didn’t realize iHub does not allow emojis. It was just a thumbs up & thx.
It still annoys me that TDA included CVM; and possibly gave cover for NSS’s to escape their well-deserved judgment day. I very rarely post, but have been here — and in CVM — for a long time. Not a huge shareholder like some of you are, just a few thousand shares, but just wanted to say I appreciate so many of you here. Thank you!
Probably so, thank you ??
I know this is true for TD Ameritrade, but is is so across the board? I’ve tried searching this and cannot find any mention of any other stock brokers placing restrictions on CVM ??. If TD Ameritrade is uniquely doing this, I’m switching brokers and open to suggestions. TIA
Too bad this didn’t happen when EIGH & CDIV were still in the game, woulda been one heck of a squeeze.
Re CPA firm change, appears from below Cherry, Bekaert & Holland press release on December 20, that Cherry largely absorbed/merged Berenfeld Spritzer Shechter & Sheer into the firm:
PRESS RELEASE
Contact
August P. Keller, III
Director of Marketing, Strategic Growth & Specialization
800.849.8281
akeller@cbh.com
Links
Cherry, Bekaert & Holland
www.cbh.com
Download
lo res | hi res
Cherry, Bekaert & Holland
Adds Experienced Talent in South Florida
Addition of 14 Partners and Approximately 100 Professionals Expands Critical Mass for CB&H
Miami, Fla. | December 20, 2010 – Cherry, Bekaert & Holland, L.L.P. (CB&H), one of the largest regional accounting firms headquartered in the Southeast, is pleased to announce the addition of approximately 115 professionals in the South Florida region.
Effective December 20, 2010, CB&H anticipates adding 14 partners and 100 associates formerly with Berenfeld Spritzer Shechter & Sheer to its professional staff. As one of the 30 largest CPA firms in the country with more than 750 professionals firm-wide, CB&H has added significant service capacity and resources to position the Firm for continued growth.
Partners joining CB&H include Michael Spritzer, Emery Sheer, Philip Shechter, Marc A. Berenfeld, Ana Martinez, Madeline Elias, Monte Gordon, Mike Everett, Vicki Simmons-Hinz, Gus Perez, Isabel Goldberg, Bob Bedwell, Jeff Lefcourt, and Jack Yesner.
With the larger service platform of a $130M revenue firm, CB&H will incorporate the talents and expertise of these new partners and associates into their existing industry groups and specialty practice areas of real estate & construction, technology, litigation support, sports & entertainment, international business, transaction advisory, and high-end tax consulting.
“Expanding our talent pool and adding specialty resources is a key strategic initiative for our Firm,” said Howard Kies, Firm Managing Partner of CB&H. “We are very pleased to add the experience and expertise of the former Berenfeld partners and associates and incorporate these resources into our overall growth plan.”
CB&H anticipates that many of the new staff will work out of their existing Coral Gables office located at 255 Alhambra Circle.
Any inquiries about the Berenfeld firm can be directed to Emery Sheer at 305.274.4600.
About Cherry, Bekaert & Holland
As the Southeast’s accounting and consulting Firm of Choice, Cherry, Bekaert & Holland, L.L.P. (CB&H) is uniquely positioned to provide quality, cost-effective and value-added services to a diverse and successful client base. The Firm sets itself apart by delivering the extensive industry specialization and service opportunities of a national firm, but with the accessibility, service continuity and level of personal relationship expected from a local business. Ranked among the 30 largest CPA firms nationally, CB&H’s resource network stretches regionally across six states, including the large metro markets of Atlanta, Charlotte, Hampton Roads, Miami, Orlando, Raleigh, Richmond, Roanoke, Tampa Bay and Washington D.C., and nationally and internationally through an alliance with Baker Tilly International, a worldwide network of independent accounting firms.
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Ok just got to the Nats Ballpark but just had to reply to you !!! You have to admit I toned it down for the general population compared to the Pitt version . ... And if Rick had any inkling of how I worked him into the story he would be very thankful I am very sure
Hope your ride back to NJ was good, car sickness and all, just please be careful in the future with those red stilettos !! Just sayin (to quote a favorite poster of mine).