Life long Maverick: Seen it ALLl in 40 yrs of PROF. exposure as invest analyst/port mgr on the FRONT lines vs iHub Msg Bds.
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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150204019
Did you read that link in the above post sent to you yesterday?
https://www.drugwatch.com/fda/approval-process/
Critiques there should give you a sense!
https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/
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After reviewing LongFellow95’s final closing summation, judge hereby rules in favor of LongFellow95.
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https://www.ascopost.com/issues/june-25-2019/accelerated-approval-progra...
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Significant Regulatory Milestone Towards Phase 2 in Recurrent GBM
COVINGTON, Ky., July 30, 2019 /PRNewswire/ -- Bexion Pharmaceuticals, Inc. an oncology-focused company today announced the completion of a Type B End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) to discuss the End of Phase 1 and the design of a Phase 2 clinical trial for BXQ-350, the Company's lead candidate, for the treatment of recurrent Glioblastoma Multiforme (rGBM).
Bexion Pharmaceuticals (PRNewsFoto/Bexion Pharmaceuticals)
In the Type B meeting, the FDA provided guidance on various design aspects of Bexion's proposed Phase 2 clinical trial. The trial is expected to enroll 55-60 patients.
"An End of Phase 1 meeting with the FDA is a significant regulatory milestone for any new clinical development program," said Dr. Richard Schwen, Regulatory Consultant for Bexion. "Such meetings are granted by the FDA only when significant data on the drug are available. Bexion's recent meeting signals the FDA's interest in the BXQ-350 program, and an opportunity for Bexion to obtain input to refine the remaining studies required for an FDA approval."
The Phase 2 trial is designed with learnings from the Phase 1 program, which dosed 93 patients, with 21 having rGBM. The Phase 1 program reached the highest planned dose and demonstrated a strong safety profile for BXQ-350.
Based upon the FDA's feedback, Bexion will submit a Phase 2 clinical trial protocol and statistical analysis plan along with the requested Chemistry, Manufacturing and Controls (CMC) information to the Investigational New Drug (IND) application.
"The FDA has provided us very valuable advice on the design of the Phase 2 trial, and we are grateful for their comprehensive feedback," said Dr. Ray Takigiku, CEO of Bexion Pharmaceuticals. "Recurrent GBM remains an urgent unmet medical need, and we believe the initiation of a Phase 2 clinical trial of BXQ-350 for this devastating disease is a major milestone for both patients and Bexion. We are working diligently to incorporate the FDA's comments into the IND, with the expectation of initiating the Phase 2 trial in the first quarter of 2020."
About Bexion Pharmaceuticals
Bexion Pharmaceuticals is a clinical-stage biopharmaceutical company developing BXQ-350, a first-in-class agent composed of the multifunctional, lysosomal activator protein Saposin C and phosphatidylserine. BXQ-350 has demonstrated pre-clinical antitumor effects in vitro and in vivo, particularly in brain and other solid tumors, including those that may lead to brain metastases. Bexion has completed a multi-site first-in-human Phase 1 clinical trial of BXQ-350 for solid tumors and gliomas. A Phase 1 Pediatric Trial opened in April, 2019.
For more information, visit www.bexionpharma.com.
Media Contact: Margaret van Gilse - 859.757.1652 - mvangilse@bexionpharma.com.
https://www.bexionpharma.com/technology/
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Around the corner Aug 5-6 Immuno Oncology Summit (not likely NWBO)
Cambridge Healthtech Institute’s 4th Annual
Personalized Cancer Vaccines
Advancing Personalized and Combination Immunotherapy
AUGUST 8-9, 2019
Recent developments in personalized cancer vaccines are enabling the next generation of rational cancer immunotherapy. Cancer vaccines may now be combined with other immunotherapies, dendritic cells used for personalized immunotherapy, and neoantigens on the surface of cancer cells targeted, matching vaccine components to each patient. mRNA- and DNA-based vaccines present an additional opportunity for cancer therapeutics. Cambridge Healthtech Institute’s Fourth Annual Personalized Cancer Vaccines conference will cover applications in several types of cancer and progress in the understanding of the immune system that has significantly advanced the potential of cancer vaccines.
TAKE a look at current AGENDA:
https://www.immuno-oncologysummit.com/Personalized-Cancer-Vaccines
8:30 PLENARY KEYNOTE SESSION
PANEL DISCUSSION: Partnering and Licensing in Immuno-Oncology
MODERATOR:
Melinda Griffith, JD
Vice President, Strategic Alliances; Chief Legal Counsel, Parker Institute for Cancer Immunotherapy
FAST PACED REAL WORLD activity vs large % of MB's
That's why:
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Life is what you make of it:
EACH and EVERY day:
My Mantra Do NOT put off till tomorrow what you can do TODAY:
I literally had a checklist notepad at 17 yrs old that was my GPS.
All because I came from a POOR highly dysfunctional non harmonious family where I had NO childhood due to getting into select NYC commuter schools since 12 yrs of age when I started working one job and then two jobs at 15 and putting myself thru college and my first job was at the venerable Bernstein & Co working under https://en.wikipedia.org/wiki/Lewis_Sanders right across the street from now Trump Towers which was 3 story Bonwit Tellers: a high end womens boutique on 56th St/FIFTH Ave the PRIMEST of NYC real estate two blocks from The Plaza Hotel near the amazing The Pierre Hotel.https://en.wikipedia.org/wiki/The_Pierre
PATIENCE and being resolutely grounded in one's complete due diligence and constantly ADDING to one's skillsets will win the day despite temporary setbacks.
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Sukus re
An important addendum re David Innes everyone has overlooked:
It was truly in David Innes interest to accept the Investors Relations job simply because David got ALL of OPCO clients into NWBO at almost 10 times what it is currently!
IF one does not or can not understand the above then you should have whatever of your shirt left to seek out a professional money manager where there is a
mutuality of interests!
Lots of big NWBO shareholders have confided that to me: (they should have used a professional money manager rather than doing it themself!....even one poster that has more than 7 figure shares owned.
To wit: IT SHOWS temperamentally in many ways for those pre 2016 owners (those with avg cost exceeding $3)
Taking a much needed long Sabbatical
Lykiri: Thank you for CONFIRMING my clear sense,
AND for ALL your Due Diligence CONTRIBUTIONS with backup CONFIRMATORIES
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TMB re:
Longfellow re
Thanks H2R for your candor and your contributions.
BTW I have interacted extensively with BSB both online; emails, and telephonically.
I think I understand where each of you are coming from.
I totally sympathize with your post: taken MANY needed sabbaticals from here:
INCREDIBLY difficult for investors here to deal with NWBO's plight but at least we are nearing journey's end.
One truly needs IMHO to fully understand the full panoply of key participants(BOTH their respective Strengths or Weaknesses) that make up the Supply/Demand MKT for NWBO. namely:
FOREMOST:
Makeup of CEO Linda Powers
Investing in a semi private company
Incessant funding needs of an Emerging Biotech
THEN:
LONGS:
Especially retail individuals here: my FIRST exposure in 2014
Neil Woodford's falling on his own sword.
SHORTS:
Professional Shorts namely Dedicated SHORT HEDGE FUNDS which I worked with the best of them in my past professional career.
understanding HOW THE CAPITAL MARKETS WORK!:
ie even Stock Lending
NONE of each of the above is easy to fully fathom.
FULL DISCLOSURE:
In ALL of my five years with NWBO, spoke to Les Godman ONCE in offering my advice that got CEO Linda Powers attention versus anything about where they are at in terms of their trials etc.
ALL of the above clearly explains IMHO why NWBO is at these absurd penny price levels.
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Technical Analysis is but A Tool that I use ONLY as a Confirmatory indicator backing up the varying conduits of Fundamental Security Analysis.
As it relates to NWBO, it was the last confirmatory sign that made me sell NWBO above $9.
I have used it during my Professional career as both a security analyst as well as a Portfolio Mgr.
I was fortunate enough to learn it from the one of the granddaddies of Technical Analysis my Merrill Lynch alumni's:
Robert J Farrell: https://www.nytimes.com/.../company-news-merrill-s-legendary-analyst-is-leaving-after-...
as well as from other members of Robert Farrell's staff:
Robert Prechter: Elliot Waves" https://en.wikipedia.org/wiki/Robert_Prechter
Randy Forsyth: https://www.barrons.com/authors/6036
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Tidbit: New NWBO Mktmkr MAXM: my take:
Yesterday I did a fairly comprehensive run down on them.
Some may recall easily a few years back MAXM's former Director of Research had mightily
praised now close to defunct IMUC .....over NWBO.
Well I looked at their research universe coverage/personnel and IMHO it would be a natural.
I said similarly:https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144995044
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Hopeful Dr Pazdur comments on RTOR intricacies:
CLEARLY RTOR is a PROCESS longer than we'd like: MONTHS with a LOT of PREREQUISITES that precede it!
With the FULL details and IF these are the SPECIFICS with FDA's OCE Pilot Test RTOR review perhaps
we can get down to the BOTTOM of complex FDA pronouncements:
ie FDA's merry go round with RIGHT TO TRY etc.(which CEO Linda Powers explained it was going to be ZERO compensation!
Here goes that more than likely will revert back to my viewpoint dealing with DC VAX L VERSUS the HUGE
DISTINCTIONS revealed BELOW versus with what The Follower posted (not his fault) NOR is it Sentiment's read:
Very interesting time tested compiled observations just merited my thumbs up as a follower.
Kund’s view coincided today with F1ash post!
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2 hr trading slowest SEEN
Surprisingly same volume for AVXL
Appears to be forming an interim bottom with good solid Bidders that aren’t being hit!
BUT might take another week or two?
Sojourner55?
My first post on precarious trading observation!
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FDA’s Office of Oncology Center of Excellence on RTOR needs a CAREFUL read:
REPosting this for the 4th time as RTOR would appear to be applicable but it’s really FDA’s RWE is applicable to NWBO’s DCVAX L
Superfluously obvious and hence redundant:
Everything posted IS pure speculation without a Press Release
or a corroborating link!
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NovoCure's Stock as viewed recently by a leading HC Portfolio Mgr
AVXL's Short Interest: Nasdaq.com
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
7/15/2019 5,236,358 682,283 7.674760
6/28/2019 4,057,301 892,490 4.546046
6/14/2019 4,132,319 286,591 14.418872
5/31/2019 4,182,308 520,125 8.040967
5/15/2019 4,647,019 372,532 12.474147
4/30/2019 4,925,533 328,341 15.001273
4/15/2019 4,912,843 330,565 14.861958
3/29/2019 4,821,344 561,555 8.585702
3/15/2019 4,906,260 464,449 10.563614
2/28/2019 5,040,864 167,839 30.033925
2/15/2019 5,092,904 248,149 20.523573
1/31/2019 5,270,975 110,885 47.535510
1/15/2019 5,294,791 246,484 21.481277
12/31/2018 5,132,444 513,470 9.995606
12/14/2018 5,542,513 186,519 29.715541
11/30/2018 5,542,897 150,113 36.924830
11/15/2018 5,744,717 160,815 35.722520
10/31/2018 5,783,150 426,886 13.547294
10/15/2018 5,553,619 220,507 25.185681
9/28/2018 5,765,630 363,517 15.860689
9/14/2018 5,689,444 180,832 31.462595
8/31/2018 5,740,454 183,845 31.224423
8/15/2018 5,814,264 287,331 20.235422
7/31/2018 5,619,190 323,299 17.380784
7/13/2018 5,512,714 1,629,466 3.383141
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http://shortsqueeze.com/shortinterest/stock/AVXL.htm
NEVER ever looked at above source.
Prompted by:https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150135984
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Immune therapy takes a 'BiTE' out of brain cancer